The purpose of this Amendment is to address questions and answers pertaining to RFQ VA119-14-Q-0103_4 Question 1: Currently, we do not have an indirect strategy for EP Catheters. As such, BWI is not involved in the MSPV program. We do not believe our competitors are either. At this point, we sells these catheters direct. Given this is the case, are we still able to bid on this solicitation? Answer 2: The requirement to be a part of authorized Medical/Surgical Prime Vendors (MSPV) has been deleted from the distribution section of the synopsis. Attachment-A Prime Vendor list has been deleted from the synopsis. Question 2: Will a full solicitation be issued with a 1449? Answer 2: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is VA-119-14-Q-0103 is issued as a request for quote (RFQ). The North American Industry Classification System (NAICS) code for this acquisition is 339112, with a small business size standard of 500 employees. Please identify your business size in your response based upon this standard. This requirement is put forth as unrestricted. The BPA will be for a 60 month ordering period after establishment of the BPA. The government will only establish BPA's with firms who comply with the criteria listed, offer a competitive price, and who the government determines represents a benefit to the government to establish the BPA. The Strategic Acquisition Center (SAC), U.S. Department of Veterans Affairs (DVA) is proposing to issue multiple Blanket Purchase Agreements (BPAs) with no more than twelve (12) companies that will provide Electrophysiology (EP) Catheters and products. The Government seeks to establish BPA's to include a manufacturer's complete product line for Electrophysiology Catheters and products. Electrophysiology is a medical branch related to the study of electrical activity within the heart. These catheters are slim, bendable or deflectable multi-electrode wires used in recording intra-cardiac electrical signals or in ablation of cardiac tissues responsible for heart rhythm disorders. In addition, sheaths are tubes that are used to direct the catheters to specific areas in the heart and connectors linking the catheters to monitoring or ablation systems. The EP Catheters and products are used for diagnostic testing and treatment for both invasive (intra-cardiac) and non-invasive procedures and are a critical part of cardiac patient care. These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures. This acquisition is under Federal Acquisition Regulation (FAR) Part 12, Acquisition of Commercial Items and FAR Part 13, Simplified Acquisition Procedures. This announcement constitutes the only solicitation. There will be no guarantee minimum any volume of purchases through this BPA. All vendors must be registered in the System for Award Management (SAM) database https://www.sam.gov/portal/public/SAM/#1. The Government intends to award up to up to twelve BPA's. The purpose of this request for quote is to establish Blanket Purchase Agreement(s) for up to Twelve (12) different manufacturer commercial product lines for Electrophysiology (EP) Catheters and products based on the minimum technical requirements listed below. The Contractor shall furnish all necessary equipment, supplies, and materials to provide EP Catheters and products to VA Medical Centers (VAMCs) in the continental United States and Puerto Rico. For standard delivery, the Contractor shall provide the requested items within 3 business days. The vendor must have the capability to receive payment upon delivery utilizing the Government Purchase Card (GPC). Offers are to be received at Strategic Acquisition Center (SAC), U.S. Department of Veterans Affairs 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408, ATTN: Antionette Collins-Somerville, no later than 3:00 P. M. Eastern Standard Time (EST) on August 6, 2014. Electronic copies of proposal may be submitted. [email protected] Contact Specialist; No Facsimile proposals will be accepted. Electronic offers are acceptable for this acquisition if received by date and time specified. The offeror is responsible for ensuring that the contract specialist has received the offer before the deadline for receipt of offers, and the government will not be responsible for delays or failures of either the contractor's email system or the Government's email system. BLANKET PURCHASE AGREEMENT (BPA) TERMS & CONDITIONS THE FOLLOWING TERMS AND CONDITIONS ARE MANDATORY: 1. DESCRIPTION OF AGREEMENT: The Department of Veteran Affairs (VA) is proposing to issue multiple Blanket Purchase Agreements (BPAs) for a period up to sixty (60) months for the acquisition of Electrophysiology (EP) Catheters. This requirement is unrestricted. Electrophysiology is a medical branch related to the study of electrical activity within the body. Catheters are slim, bendable tubes used in medical procedures or in ablation of cardiac tissues responsible for heart arrhythmia disorders. Physicians pass catheters through veins, arteries or organs to more effectively monitor activity in various areas of the body. EP catheter placement is done without surgery and the instruments are used to provide electrical pacing, recording, sensing, localization or mapping. Cardiac ablation is a popular procedure in which physicians guide EP catheters through blood vessels into the heart to destroy diseased tissue. The EP Catheters and products are used for diagnostic testing and treatment for both invasive (intra-cardiac) and non-invasive procedures and are a critical part of cardiac patient care. The Contractor shall ensure that any product provided under this BPA is approved in accordance with the pre-market notification process under the Food and Drug Administration (FDA) 510K Program and labeled accordingly. The BPA, including product, prices, and other terms and conditions, is public information and is releasable under the Freedom of Information Act (FOIA). Procurement related information, including negotiations, shall be treated as confidential and shall not be disclosed except as required by applicable laws and regulations. The BPA holder shall provide written notice to the Department of Veterans Affairs, Strategic Acquisition Center (SAC) BPA Administrator, of any changes, specifically to any items on this resultant BPA. Changes include, but are not limited to, price increases and decreases, product deletions, new technological refreshes to its product lines or of new product introductions, and/or change in vendor company information including contract administrator, company name, address and phone number. All orders placed against this BPA are subject to the terms and conditions and contained herein and all clauses and provisions in full text or incorporated by reference herein. 2. PERIOD OF AGREEMENT: This BPA shall be established for a period of up to sixty (60) months from the effective date of the BPA and will remain in effect for the 60 months or until it is terminated in accordance with the terms of this BPA, whichever is earlier. In accordance with FAR 13.303-6(b)(1), the Contracting Officer shall conduct an annual review of the established BPA. Upon completion of the annual review, a determination will be made whether or not it is in the best interest of the Government to continue with performance of the BPA. The maximum BPA ordering period is 60 months. 3. EXTENT OF OBLIGATION: The Government is obligated only to the extent of authorized purchases actually made under the resultant BPA. This BPA does not obligate any funds, nor is the Government obligated to make any purchases under this BPA. The Government does not guarantee any volume of purchases through a BPA. The terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the BPA Holder's invoice, the provisions of this BPA will take precedence. 3.1 Uninterrupted Source of Supply- By establishing an agreement, the offeror agrees to supply established item(s) to satisfy the Government's requirement when an order is placed under the BPA during the effective period of the established agreement. If, however, the offeror determines to terminate production of the selected item and contemplates replacement with alternative item, the Government reserves the right to evaluate the potential replacement item(s). There is no guarantee that the Government will evaluate any replacement item(s) favorably. If the Government determines the replacement item(s) as unacceptable, the individual item(s) or the entire BPA may be cancelled 3.2 Inspection and Acceptance- The acceptance paragraph in FAR 52.212-4 is based upon the assumption that the Government will rely on the contractor's assurances that the commercial item tendered for acceptance conforms to the agreement requirements. The Government inspection of commercial items will not prejudice its other rights under the acceptance paragraph. The provisions of FAR 52.212-4 are incorporated by reference. 4. PURCHASE LIMITATION: Ordering Officials may place orders against this agreement in excess of the SAT up to $6.5M as long as the Test Program for Certain Commercial Items under FAR Subpart 13.5 is in effect. Ordering Officials shall validate the SAT limitation and whether the Test Program under FAR Subpart 13.5 is in effect prior to placing any orders. In accordance with FAR Subpart 13.3(13.303-5(c)), the existence of a BPA does not justify purchasing from only one source or avoiding small business set-asides. FAR 13.303-5(d) requires that for a particular purchase greater than the micro-purchase threshold, and there is an insufficient number of BPAs to ensure maximum practicable competition, the contracting officer shall- (1) Solicit quotations from other sources (see 13.105) and make the purchase as appropriate; and (2) Establish additional BPAs to facilitate future purchases if- 5. BPA EFFECTIVE DATE: The BPA is effective 10 days after the date signed by the Government, or sooner upon mutual agreement. 6. AS214 PRODUCT MODIFICATION, REMOVAL OR RECALL (JAN 2008) If any product awarded under this solicitation requires modification, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor or manufacturer: a. Notify the Contracting Officer, VA Strategic Acquisition Center, 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408, in writing, in writing, within 48 hours or the next business day or after a weekend or holiday. The notification shall include, but not be limited to the following: (1) Complete item description and/or identification, order numbers from customers, and the contract number assigned as a result of an award on this solicitation. (2) Reasons for modifications, removal or recall. (3) Necessary instructions for return for credit, replacement or corrective action. b. A copy of the notification in a. above shall be provided to: Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 c. Provide the information in (a) above to all agencies and VA Facilities who purchased the product. Contract Specialist, Antionette Collins-Somerville ([email protected]) or whoever is listed at that time, shall be provided a copy of the notification in b above, and a list of all agencies and/or VA facilities notified. 7. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE BPA: Each US Department of Veterans Affairs, Medical Center (VAMC) who has direct ordering authority, on behalf of VA, to place BPA Orders, may use this BPA. 8. DISTRIBUTION: a. Direct Orders: The Contractor shall accept all items ordered under the resultant BPA for delivery within the continental United States and Puerto Rico within the time frame specified in this BPA. Contractors shall bill the individual ordering facilities directly. Ordering facilities are responsible for remitting payment in accordance with the Prompt Payment Clause. Government Participants - The Contractor shall provide delivery of United States Food and Drug Administration (FDA) approved EP Catheters as specified in the BPA. When an Order is placed against the BPA, the BPA holder shall ship directly to the applicable Veterans Affairs Medical Center (VAMC) set forth in the Order at the prices awarded herein and under the terms and conditions set forth in the BPA. Shipments to the VA facility shall commence upon receipt of a delivery order/purchase order signed by a person with purchasing authority on behalf of a VAMC; but in no event shall delivery exceed 3 business days after receipt of order. Individuals at VAMCs shall issue delivery orders to the contractor which shall indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures. 9. NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS The Contractor shall notify the Ordering Office point of contact within one (1) business day for non-emergency Orders and within four (4) hours of an emergency Order if any parts/materials cannot be delivered in accordance with the individual BPA Order delivery requirements. To ensure that the correct EP Catheter items are shipped, the Contractor shall not substitute items without prior approval by Ordering Official. Instances where the Contractor cannot meet the Government's requirement(s), the Contractor shall notify the Ordering Office of the shortest delivery period available. If the Contractor's shortest delivery period is not acceptable to the Government, the Government reserves the right to procure the item(s) from other sources. 10. PRODUCT REFRESH: The Contractor shall provide improved items within the awarded product line as appropriate new industry technologies emerge and obsolete items are replaced. By mutual agreement the Government Contracting Officer and the Contractor, the Contractor shall add the new or improved items to the BPA. The revised product listing shall be in writing and approved by both parties. Further, the Contractor shall ensure that all EP Catheters and products offered are state-of-the-art. "State-of-the-art" is defined as the most recently designed components approved by the FDA and are announced for marketing purposes. All improved or enhanced products shall be provided with the standard industry warranty. The Contractor shall ensure that all new products are approved in accordance with the pre-market notification under the Food and Drug Administration (FDA) 510K process and labeled appropriately for EP Catheter Studies. The Contractor shall provide the Contracting Officer the following information as items become obsolete: (1) A list of specific awarded items to be updated (Appendix 1 and Appendix 2 with changes proposed); (2) Product literature for the new items and a detailed description of the differences between the awarded items and the new items, and a specific analysis of the comparative advantages/disadvantages of the items involved; and (3) Proper identification of any new product requirements and/or procedures related to those new products. New products replacing awarded items and released to the market during the period of performance shall be offered to the Government at a discounted price. The Government reserves the right to not accept the new products. The Contractor shall continue to supply the Contracted item(s) as originally identified. 11. ORDERING METHOD: Orders will be placed against this BPA via Electronic Data Interchange (EDI), via facsimile, in writing, by phone, or through an individual authorized to purchase. Each new BPA Order placed under this BPA will be the result of a streamlined ordering process which includes a Request for Quotation (RFQ) 12. ORIGINAL EQUIPMENT MAUFACTURER GOODS: Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment such that OEM warranty and service are provided and maintained by the OEM. All warranties associated with the equipment shall be in accordance with the OEM terms and conditions. The Contractor shall provide only new equipment and new parts for the required products described herein. ABSOLUTELY NO "GRAY MARKET GOODS" shall be provided under any Delivery Order. Gray Market Goods are defined as genuine branded goods sold outside of an authorized sales-territory (or by non-authorized dealers in an authorized territory) at prices lower than being charged in authorized sales territories (or by authorized dealers). All Equipment must be covered by the manufacturer's warranty. 13. DELIVERY: All orders shall be delivered Free on Board, (FOB) destination to the ordering VAMC in the United States and Puerto Rico. The delivery time offered for all orders placed against the resultant BPA shall not exceed 3 business days After Receipt of Order (ARO). In some cases the product may be required on an emergency basis and must be delivered within 24 hours after receipt of the order(s). Delivery Requirements - All deliveries shall be made Free On Board, (FOB) destination. Upon delivery of equipment, VA shall thoroughly inspect the equipment. After the inspection has been performed, the ordering VA medical facility shall issue a written notice of acceptance or rejection. Emergency Turnaround-When identified on the individual order, the Contractor shall provide emergency shipping service for the requested item(s) within 24 hours after receiving the Emergency Order Request. Package Marking -The Contractor shall ensure the addressee information for any delivered item includes the Ordering Office point of contact(s) information on the outside packaging to ensure delivery to the correct location and correct person. 14. DELIVERY TICKETS: At a minimum, delivery tickets or sales slips must contain the following information and must accompany all deliveries under this BPA, unless otherwise agreed to: Name of the contractor Contract Number BPA Number Model Number or National Stock Number (NSN) Date of purchase Purchase Order Number Itemized list of supplies or services furnished Quantity, unit price, and extension of each item less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show the information) Date of delivery and shipment 15. PURCHASE CARD: (a) Definitions. "Government wide commercial purchase card" means a uniquely numbered credit card issued by a contractor under GSA's Government wide Contract for Fleet, Travel, and Purchase Card Services to named individual Government employees or entities to pay for official Government purchases. "Oral order" means an order placed orally either in person or by telephone, which is paid for by Government wide commercial purchase card. (b) The Contractor shall accept payments for oral or written delivery orders made using the Government wide commercial purchase card in the amount of $3,000.00 or less. (c) The Contractor shall not process a transaction for payment through the purchase card clearinghouse until the purchased supplies have been shipped or services performed. Unless the cardholder requests correction or replacement of a defective or faulty item in accordance with other contract requirements, the Contractor shall immediately credit a cardholder's account for items returned as defective or faulty. 16. INVOICES: An itemized invoice shall be submitted to the VA billing address listed on each delivery order. The requirements of a proper invoice for direct orders are as specified in the BPA. The itemized invoice shall identify the delivery ticket or packing list, ship-to-address of supplies, the BPA number, and the delivery/purchase order number assigned by the individual facility at the time of ordering. Additionally, copies of all invoices from the contractor shall be mailed to the BPA administrator at the address below on a quarterly basis: Attn: BPA Administrator Contracting Specialist Strategic Acquisition Center - Fredericksburg Department of Veterans Affairs 10300 Spotsylvania Ave. Suite 400 Fredericksburg, VA 17. REPORTS: The Contractor shall provide a quarterly report of sales by line item, no later than 60 calendar days after the end of each calendar quarter ending March, June, September, and December. Reports shall be sent electronically to the contract specialist referenced in the Contract Administration Data, Section B.1; until the contractor is notified, in writing, of a different point of contact. In order to track compliance, VA requires the contractor to submit the quarterly report of sales in the prescribed format. At time of establishment, VA will provide the Contractor with an electronic copy of the template that shall be used for all quarterly report of sales. Reports of government purchase card (GPC) usage by medical facilities shall be provided to the BPA administrator by the Contractor on a quarterly basis. The requirement for reports submission is contingent upon the government placing orders with the contractor. The contractor agrees by submitting an offer that they shall adhere to this requirement. 18. CONTRACT ADMINISTRATION: The SAC Contracting Officer will: (1) issue the multiple BPAs; and (2) provide overall management and oversight of the BPA and any resulting modifications to the BPA. Each BPA Order shall have a COR assigned who will coordinate with the Contracting Officer. Any individual who has ordering/contracting authority, on behalf of VA (as authorized below), to place delivery/purchase orders, may use this BPA in accordance with Section 10, Ordering Method of B.2 BPA Terms and Conditions. The Contracting Officer's Representative (COR) will be responsible for inspection and acceptance of all deliverables, as appropriate, to determine the contractor's adherence to prescribed performance and quality of products as outlined within the BPA. The COR will be designated/delegated at the ordering level by the Contracting Officer. Payments will be made upon delivery of the items ordered based upon verification that supplies were satisfactorily acceptable in accordance with the Inspection and Acceptance Clause incorporated under the BPA. In accordance with FAR 13.303-6(b)(1), the Contracting Officer shall conduct an annual review of the established BPA. 19. BPA MODIFICATION IMPLEMENTATION: The effective date for all product additions, deletions, and price changes is as follows: If the modification is signed by the Contracting Officer between the 9th and 23rd of the month, the effective date is the 1st day of the following month; If the modification is signed by the Contracting Officer between the 24th and 8th of the following month, the effective date is the 15th of the latter month. The Contracting Officer will determine the effective date for all other changes. 20. CANCELLATION: Either party may terminate this agreement at any time upon 90 days prior written notice to the other party. The cancellation will take effect 90 calendar days after the other party receives the notice of cancellation. This BPA ordering period expires sixty (60) months after award of BPA, including any extensions, whichever is earlier. The BPA Holder must immediately notify, in writing, the responsible VA SAC Contracting Officer if the BPA is no longer in force. 21. UNIVERSAL PRODUCT NUMBERS (UPNs): The Supplier that receives a BPA shall utilize Universal Product Numbers as product identifiers and UPN bar code compliant labels on all packaging sizes down to the unit of measure, as they become available from manufacturers of medical and surgical supplies. A UPN uniquely identifies healthcare products. It is derived from either the HIBCC-LIC or UCC/EAN bar code labeling data structures. The HIBCC-LIIC format is variable in length, alpha-numeric and consists of manufacturer LIC assigned by HIBCC, the labeler's products or catalog number, and the package level (or inventory unit) indicator. The UCC/EAN format is fixed length, all numeric and consists of the UCC/EAN assigned manufacturer number (company prefix), numeric item number, a package level (or inventory unit) indicator, and a calculated check character. When available, the contractor shall use UPNs as the key product unit identifier in its electronic product catalogs, order-processing systems, all product recalls, business documents, and reports called for under the terms of the contract. 22. ADDITIONAL OFFEROR'S INFORMATION: (Please Complete) Ordering Address: ________________________________________ Ordering Phone #: _________________ Fax: __________________ Tax I.D. Number: ________________________________________ DUNS Number: ________________________________________ Business Size: ____________________ Small Disadvantaged: Yes__________ No__________ Small Hubzone: Yes__________ No__________ Small Veteran Owned Yes__________ No__________ Small Disabled Veteran Owned: Yes__________ No__________ Small Woman Owned: Yes__________ No__________ Payment Terms: ____________________ (As stated in your BPA) Delivery: ____________________ (Shall not exceed 3 Business Days ARO in accordance with Section 10 of this document) Emergency Delivery Terms: _________________________________________ (Please reiterate, as stated in your BPA) Emergency Order Contact Person: _______________________________ Phone: _______________________________ Is your company EDI capable? Yes__________ No__________ (If yes, please provide registration number) ___________________________________ Company website: _______________________________________________________ Price/Cost Schedule All quantities listed are for informational and evaluation purposes only and do not obligate the Government to purchase such quantity nor does the Government guarantee any volume of purchases through this BPA. The estimated quantities are based upon FY2013 historical information. Provide all types and sizes available in commercial product line. ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 Contract Period: 60 Months POP Begin: Date of Award POP End: TBD The Contractor shall provide Electrophysiology (EP) Catheters as stated on the Product Description. Diagnostic electrophysiology catheters: Multipole, non- deflectable of multiple deflectable. Provide all types and sizes available in commercial product line. 2600.00 EACH __________________ __________________ 0002 Contract Period: 60 Months POP End: Date of Award POP End: TBD The Contractor shall provide Electrophysiology (EP) Catheters as stated on the Product Description. Ablation catheters: multi-pole non-irrigated radiofrequency, multiple irrigated radiofrequency, or cryoablation catheters. Provide all types and sizes available in commercial product line. 2600.00 EACH __________________ __________________ 0003 Contract Period: 60 POP End: Date of Award POP End: TBD The Contractor shall provide Electrophysiology (EP) Catheters as stated on the Product Description. Intracardiac ultrasound imaging catheters (equipment specific). Provide all types and sizes available in commercial product line. 2600.00 EACH __________________ __________________ 0004 Contract Period: 60 Months POP End: Date of Award POP End: TBD The Contractor shall provide Electrophysiology (EP) Catheters as stated on the Product Description. introducer sheaths: non-deflectable or deflectable. Provide all types and sizes available in commercial product line. 2600.00 EACH __________________ __________________ 0005 Contract Period: 60 Months POP End: Date of Award POP End: TBD The Contractor shall provide Electrophysiology (EP) Catheters as stated on the Product Description. Trans-septal catheterization needles. Provide all types and sizes available in commercial product line. 2600.00 EACH __________________ __________________ 0006 Contract Period: 60 Months POP End: Date of Award POP End: TBD The Contractor shall provide Electrophysiology (EP) Catheters as stated on the Product Description. 3D mapping electrodes and patches (equipment specific. Provide all types and sizes available in commercial product line. 2600.00 EACH __________________ __________________ 0007 Contract Period: 60 Months POP End: Date of Award POP End: TBD The Contractor shall provide Electrophysiology (EP) Catheters as stated on the Product Description. 3D mapping catheters (equipment specific). Provide all types and sizes available in commercial product line. 2600.00 EACH __________________ __________________ GRAND TOTAL __________________ PRODUCT DESCRIPTION Standardization of Electrophysiology (EP) Catheters ensures continuity of care from one Department of Veterans Affairs (VA) hospital to another across the United States and Puerto Rico. It also provides uniformity and quality products at lower-than-current market prices. This acquisition will provide EP Catheters to more than 40 VA Medical Centers (VAMC) for clinical use throughout the VA community. Intended Use: These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures: Product Description Diagnostic electrophysiology catheters: Multi-pole, non-deflectable or multiple deflectable Ablation catheters: multi-pole non-irrigated radiofrequency, multiple irrigated radiofrequency, or cryoablation catheters Intracardiac Ultrasound imaging catheters Electrophysiology introducer sheaths: non-deflectable or deflectable Trans-septal catheterization needles 3D mapping electrodes and patches 3D mapping catheters (equipment specific) Electrophysiology (EP) Catheters Minimum Requirements Intended Use: These items will be used in invasive cardiac electrophysiology laboratories and other procedural suites in the Veterans Health Administration for invasive electrophysiology and arrhythmia ablation procedures. MTR# Method of Evaluation 1. FDA Clearance 1.) The EP Catheters shall have appropriate FDA clearance. CFR - Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Subchapter H--Medical Devices, Part 814 - Premarket Approval of Medical Devices Literature Review 2. Cardiac Electrophysiology diagnostic catheters types: 1. Cardiac Electrophysiology diagnostic catheters 2. Ablation catheters: multi-pole non-irrigated radiofrequency, multiple irrigated radiofrequency, or cryoablation catheters. 3. Intracardiac Ultrasound imaging catheters 4. 3D mapping catheters Literature Review 3. EP Catheters Accessories 1. Electrophysiology introducer sheaths: nondeflectable or deflectable 2. Trans-septal catheterization needles 3. 3D mapping electrodes and patches Literature Review 4. Requirements 1.) The Offeror shall provide a Product Listing of all items relating to Electrophysiology Catheters provided by their company. 2.) The Offeror shall ensure that all pr...

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