Solicitation Number: 36C10G21Q0035 Notice Type: Combined Synopsis/Solicitation Synopsis: COMBINED SYNOPSIS/SOLICITATION This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation number 36C10G21Q0035 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2021-05, dated 10 March 2021. Requirement Description: VA has a requirement to purchase Cryotherapy Tissue Ablation Systems to deliver patient care at its VA Medical Centers around the country. Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated through the system. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues. Common applications of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney and prostate and for therapy intended to ablate particular tissues using catheterization procedures (e.g., cardiac). Specifically, Cardiac Cryoablation is a therapy that uses the removal of heat from tissue to treat cardiac arrhythmias. It restores normal electrical conduction by freezing the cardiac tissue or pathways that interfere with the normal distribution of the heart s electrical impulses. Cardiac Cryotherapy Tissue Ablation Systems are being procured to address this requirement and allow integration and compatibility with current Cryotherapy Tissue Ablation Systems in use. A single award Requirements contract will be awarded for the purchase of brand name or equal equipment in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the band name or equal equipment. The Government reserves the right to award without discussions. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as full and open competition. This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Medtronic® brand name or equal Cryotherapy Tissue Ablation Systems and related equipment and accessories as identified in ATTACHMENT A NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A NX EQ CRYOTHERAPY TISSUE ABLATION SYSTEMS PRICE COST SCHEDULE. The ordering period is for one year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities. The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including attached addenda to the provision. The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached. All interested Offerors must be registered in the System for Award Management (SAM) prior to submitting an offer or quotation. You may access SAM at https://sam.gov/SAM/. Questions regarding this combined synopsis/solicitation are due via email by 11:59PM EST on May 12, 2021 to Contract Specialist, Ninatile Bacote at [email protected] and Contracting Officer, Timothy Johnson at [email protected]. No calls will be accepted. Quotes are due via email by 11:59PM EST on May 28, 2021 to Contract Specialist, Ninatile Bacote at [email protected] and Contracting Officer, Timothy Johnson at [email protected]. Product Description Salient Characteristics Literature Review 1. SCOPE OF WORK: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cryotherapy Tissue Ablation Systems product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. Cryotherapy Tissue Ablation Systems are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation). Cryoablation is used in a variety of clinical applications using hollow needles (cryoprobes) through which cooled, thermally conductive, fluids are circulated through the system. Cryoprobes are inserted into or placed adjacent to tissue which is determined to be diseased in such a way that ablation will provide correction yielding benefit to the patient. When the probes are in place, the cryogenic freezing unit removes heat ("cools") from the tip of the probe and by extension from the surrounding tissues. Common applications of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney and prostate and for therapy intended to ablate particular tissues using catheterization procedures (e.g., cardiac). Specifically, Cardiac Cryoablation is a therapy that uses the removal of heat from tissue to treat cardiac arrhythmias. It restores normal electrical conduction by freezing the cardiac tissue or pathways that interfere with the normal distribution of the heart s electrical impulses. Cardiac Cryotherapy Tissue Ablation Systems are being procured to address this requirement and allow integration and compatibility with current Cryotherapy Tissue Ablation Systems in use. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Cryotherapy Tissue Ablation Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period with four 12-month option periods. 2. REQUIREMENT This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the quoter indicate that each product being offered as an equal product to the Medtronic CryoConsole Cardiac Cryoablation System. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. CONTRACT LINE ITEM# BRAND PART NUMBER DESCRIPTION 0001 Medtronic 106A3 CryoConsole 0002 Medtronic 104FS Foot Switch 0003 Medtronic 103N2 N2O Refrigerant Tank 0004 Medtronic 1038N Power Cord CE 0005 Medtronic 1035C Scavenging Hoses, 6.0 m - yellow 0006 Medtronic 1035CW Scavenging Hoses, 6.0 m - white 0007 Medtronic 1035D Scavenging Hoses, 7.5 m - yellow 0008 Medtronic 1035DW Scavenging Hoses, 7.5 m - white 0009 Medtronic 1035E Scavenging Hoses, 9.0 m - yellow 0010 Medtronic 1035EW Scavenging Hoses, 9.0 m - white 0011 Medtronic 1035F Scavenging Hoses, 12.0 m - yellow 0012 Medtronic 1035FW Scavenging Hoses, 12.0 m - white 0013 Medtronic 1035G Scavenging Hoses, 12.0 m WAGD (7.5mm) - purple 0014 Medtronic 1035H Scavenging Hoses, 12.0 m WAGD (5.5mm) - purple 0015 Medtronic 1036W Wrench 0016 Medtronic 2035W EGG Cable 0017 Medtronic 2037A Auto Connection Box 0018 Medtronic 65CS1 Cardioblate CryoFlex Control Panel 0019 Medtronic 671PCNA Cardioblate CryoFlex Control Panel Power Cord 0020 Medtronic 67RAXNA Cardioblate CryoFlex Regulator (with pressure sensor cable) 0021 Medtronic 67H08 Cardioblate CryoFlex Gas Hose 0022 Medtronic 67PS6 Cardioblate CryoFlex Pressure Sensor Cable (replacement only) 0023 Medtronic 65TC1 Cardioblate CryoFlex Tank Carrier 0024 Medtronic 60SF7 Cardioblate CryoFlex Single-Use Probe, 7 cm 0025 Medtronic 60SF2 Cardioblate CryoFlex Single-Use Probe, 10 cm 0026 Medtronic 60SF3 Cardioblate CryoFlex Single-Use Probe, 10 cm 0027 Medtronic 60CM1 Cardioblate CryoFlex Single-Use Clamp and Probe, 10 cm 0028 Medtronic N/A On-Site User Training 0029 Medtronic N/A On-Site Technical Training 0030 Medtronic N/A User Manual for CryoConsole System 0031 Medtronic N/A Service Manual for CryoConsole System 0032 Medtronic N/A Maintenance and Repair Program 0033 Medtronic 4FC12 Flexcath Steerable Sheath FLEXCATH ADVANCE 12F 0034 Medtronic 2ACH25 Achieve Advance Mapping Catheter Long MAPPING CATHETER ACHIEVE ST 25MM 0035 Medtronic 2ACHC Achieve Advance Cable 2ACHC ACHIEVE ST 10-PIN 0036 Medtronic 2ACH15 Achieve Advance Mapping Catheter MAPPING CATHETER ACHIEVE ST 15MM 0037 Medtronic 2ACH20 Achieve Advance Mapping Catheter MAPPING CATHETER ACHIEVE ST 20MM 0038 Medtronic 990066 Achieve Electrical Cable CABLE 990066 ACHIEVE ELECTRICAL 0039 Medtronic 990063-015 Achieve Mapping Catheter CATHETER 990063-015 ACHIEVE 15MM 0040 Medtronic 990063-020 Achieve Mapping Catheter CATHETER 990063-020 ACHIEVE 20MM 0041 Medtronic 2AF234 Arctic Front Advance Catheter CATH 2AF234 ARCTIC FRONT ADV US 23MM 0042 Medtronic 2AF284 Arctic Front Advance Catheter CATH 2AF284 ARCTIC FRONT ADV US 28MM 0043 Medtronic 203CX Coax Umb Cable (Individual) CABLE 203CX COAXIAL UMBILICAL 0044 Medtronic 203CXC Coax Umb Cables (Box) CABLE 203CXC COAXIAL UMBILICAL BOX 12 0045 Medtronic 2035U Electrical Umb Cable (Individual) CABLE 2035U ELECTRICAL UMBILICAL 0046 Medtronic 2035UC Electrical Umb Cable (Box) CABLE 2035UC ELECTRICAL UMBILICAL BOX 12 0047 Medtronic 307F1 Freezor Cath CATHETER 307F1 FREEZOR1 SHT RED 7F 0048 Medtronic 307F3 Freezor Cath CATHETER 307F3 FREEZOR3 MED BLUE 7F 0049 Medtronic 307F5 Freezor Cath CATHETER 307F5 FREEZOR5 LONG ORANGE 7F 0050 Medtronic 227F1 Freezor XTRA Cath CATH 227F1 FREEZOR XTRA1 SURGICAL SH 7F 0051 Medtronic 227F3 Freezor XTRA Cath CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F 0052 Medtronic 227F5 Freezor XTRA Cath CATH 227F5 FREEZOR XTRA5 SURGICAL LG 7F 0053 Medtronic 229F3 Freezor MAX Cath CATH 229F3 FREEZOR MAX3 SURGICAL MED 9F 0054 Medtronic 229F5 Freezor MAX Cath CATH 229F5 FREEZOR MAX5 SURGICAL LG 9F 0055 Medtronic 239F3 Freezor MAX Cath CATHETER 239F3 FREEZOR MAX3 MED BLUE 9F 0056 Medtronic 239F5 Freezor MAX Cath CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F 0057 Medtronic 20MRK Manual Retraction Kit KIT 20MRK ARCTIC FRONT MANUALRETRACTION 0058 Medtronic AFAPRO23 Arctic Front Advance Pro Catheter CATH AFAPRO23 AFA PRO 23 0059 Medtronic AFAPRO28 Arctic Front Advance Pro Catheter CATH AFAPRO28 AFA PRO 28 The Department of Veterans Affairs (VA) is seeking vendors who can provide Medtronic® Cryoconsole Cardiac Cryoablation System brand name or equal, Cryotherapy Tissue Ablation System as listed above or equal commodities which meet all of the following salient characteristics. Offeror may propose any product solution or configuration so long as they meet the salient characteristics. SC # CLINs SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE SC 1 0001 Must be FDA approved. Must demonstrate compliance with requirements of widely accepted product safety standards, as determined through independent testing by organizations such as the American National Standards Institute (ANSI), Underwriters Laboratories (UL), American Section of the International Association for Testing Materials, and International Electrotechnical Commission (IEC) Literature Review SC 2 0001 Must provide cardiac cryoablation treatment Literature Review SC 3 0001, 0024, 0025, 0026, 0033, 0034, 0036, 0037, 0039, 0040, 0041, 0042, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0058, 0059 Probes and catheters must be lightweight, quick and easy to attach/detach and must effectively manage heat, cold and defrost Literature Review SC 4 0001, 0018, 0028, 0030, 0031 Must have a user-friendly and intuitive user interface Literature Review SC 5 0001 Must have a sturdy console cart, easy to roll with adequate space for components and tanks. Cart must have locking casters Literature Review SC 6 0001, 0004, 0019 Must use a medical grade power cord with a hospital grade plug. Must use standard electrical wall outlet - 110V-120V circuit, 120V 60Hz AC input Literature Review SC 7 0001, 0018 Must have an integrated temperature indicator and a timer for monitoring and controlling therapy duration Literature Review SC 8 0001, 0018 Must be able to be cleaned using hospital grade cleaning solutions. Surfaces must be nonabsorbent. Surface material must be able to tolerate a very high frequency of intense cleaning. Vendor must provide manufacturer-cleaning guidelines Literature Review

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