The system shall measure pressure via a swallowed catheter to determine motility of the esophagus and test for acid and non-acid reflux disease and esophageal dysmotility. The system shall have the capability of measuring swallowing reflex or peristaltic action of the entire length of the esophagus by means of catheters with at least thirty sensor channels. The system shall be able to provide bolus transit dynamics and mapping. The system shall be able to complete testing of esophageal pressure and bolus transit dynamics in one swallow testing session. The system shall include components to measure pH and impedance by means of a catheter-based recording device. The system shall include components to measure pH by means of a capsule-based system. The system shall also include a capsule-based camera to image the esophagus. The system shall include one or more wireless recording devices to obtain data from the capsules. The system software shall allow for viewing and analyzing data collected during procedures. The data collected by the system shall be accessible by the end user for multiple purposes including: determining patient needs for anti-reflux surgery, diagnosis of esophageal motility disorders, and determining condition of the esophagus for medical management of functional diagnosis and post-operative issues. Training for staff on site shall be included. The electrical requirement for the system is 120VAC, 60Hz.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements

Based on the above information, the only technically acceptable system is provided by Given Imaging Inc.

This acquisition is being conducted under FAR Part 12 and 13. Provisions and clauses in effect through Federal Acquisition Circular 2005-72 are incorporated. This acquisition is being conducted under simplified acquisition procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 339112 with a Small Business Size Standard of 500 employees. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Capability statements (formats for submission: PDF, MS Word, or MS Excel) should be sent to Andrew Hampton at [email protected]. Closing date for capability statements is no later than 5:00 PM EST on 4 Apr 2014. No phone calls will be accepted.