Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice Page 8 of 8 *= Required Field Combined Synopsis/Solicitation Notice Page 1 of 11 Solicitation Number: 36C10G26Q0024 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; offers are being requested, and a written solicitation will not be issued. Solicitation number 36C10G26Q0024 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) 2025-06, dated August 27, 2025. This award will be made pursuant to 38 U.S.C. 8127, which authorizes the Department of Veterans Affairs to award sole-source contract to verified Service-Disabled Veteran-Owned or (Veteran-Owned) Small Businesses. Per Federal Acquisition Regulation Part 6.103-5(e), no justification and approval is required for contracts awarded under this statutory authority (except 8(a) sole source awards over $25 million, which is not applicable here. Requirement Description: VA has a requirement to purchase NX EQ CAPSULE ENDOSOPY to deliver patient care to its VA Medical Centers Nationwide and in outlying territories. Capsule Endoscopy systems are designed to examine various points along the intestinal tract using images captured with a tiny ingestible video camera. These systems typically consist of three components: a disposable ingestible camera pill/capsule that is swallowed by the patient and that transmits video images as it passes through the gastrointestinal tract, a recorder used by the patient (e.g., worn on a belt around the waist) that receives the signals transmitted by the camera, and a workstation appropriate for processing and displaying the images from the recorder. Ingestible camera endoscopic video systems are used to detect abnormalities (e.g., angioectasia, ulcers, tumors) especially in areas of the small intestine that are difficult or impossible to reach using endoscopes. A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Offers shall contain the terms for cost/price and technical capabilities of the brand 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 334510 Endoscopic equipment, electromedical (e.g., bronchoscopes, colonoscopes, cystoscopes), manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies. and the associated size standard is 750 employees. This procurement action is issued as a Sole Source award to verified Service-Disabled Veteran-Owned (or Veteran-Owned) Small Business. This acquisition is for a single award Requirements contract in accordance with FAR Part 16.03 for Medtronic brand name NX EQ CAPSULE ENDOSCOPY and related equipment and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ CAPSULE ENDOSOPY. All interested companies shall provide an offer for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE NX EQ CAPSULE ENDOSOPY and paragraph 2 below. The ordering period is for one 12-month base 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 Products and Commercial Services, applies to this acquisition including attached addenda (ATTACHMENT D) to the provision. The FAR provision at 52.212-2, Evaluation -- Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda (ATTACHMENT D) 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 Products and Commercial Services, with its offer. Clause at 52.212-4, Contract Terms and Conditions -- Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached (ATTACHMENT C). Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Products and Commercial Services, 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 (ATTACHMENT C). All interested offerors must be registered in the System for Award Management (SAM) prior to submitting an offer. You may access SAM at https://sam.gov/SAM/. Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM ET on December 22, 2025, to Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov. No calls will be accepted. Offers are due via email by 11:59 PM ET on December 29, 2025, to Contracting Officer, Hosea Berkley at Hosea.Berkley@va.gov. 1. SCOPE OF WORK: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Capsule Endoscopy product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. The Veterans Health Administration (VHA) Non-Expendable Equipment National Program is seeking offerors that can provide Capsule Endoscopy. The Capsule Endoscopy systems are designed to examine various points along the intestinal tract using images captured with a tiny ingestible video camera. These systems typically consist of three components: a disposable ingestible camera pill/capsule that is swallowed by the patient and that transmits video images as it passes through the gastrointestinal tract, a recorder used by the patient (e.g., worn on a belt around the waist) that receives the signals transmitted by the camera, and a workstation appropriate for processing and displaying the images from the recorder. Ingestible camera endoscopic video systems are used to detect abnormalities (e.g., angioectasia, ulcers, tumors) especially in areas of the small intestine that are difficult or impossible to reach using endoscopes. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Capsule Endoscopy to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods. 2. REQUIREMENT This requirement will be IAW FAR clause 6.103, Brand Name which requires the quoter indicate that the product being offered is a Capsule Endoscopy. Contract Line Items Manufacturer Part Number Description 0001 Medtronic FGS-0504 USBC 2PK 0002 Medtronic FGS-0688 PillCam® GENIUS SB 1 PK US 0003 Medtronic FGS-0802 SOFTWARE PillCam® 9.7 US 0004 Medtronic FGS-0806 Genius Sync Agent (GSA) OFFLINE PillCam® US 0005 Medtronic FGS-0808 BARCODE SCANNER 0006 Medtronic FGS-0668 PillCam® Patency Capsule 5-Pack 0007 Medtronic FGS-0347 PillCam® RECORDER DR3 X1 0008 Medtronic FGS-0355 PillCam® RECORDER CRADLE DR3X1 0009 Medtronic FGS-0362 PillCam® RECORD ACCESSORIESDR3 0010 Medtronic FGS-0498 PillCam® SB 3-EX CAPSULE 5-PACK 0011 Medtronic FGS-0499 PillCam® SB 3-EX CAPSULE 10-PK 0012 Medtronic FGS-0590 PillCam® SENSOR BELT MS SB 0013 Medtronic FGS-0591 PillCam® SENSOR ARRAY MS 0014 Medtronic FGS-0453 PillCam® SENSOR SLEEVES 10-PACK The Department of Veterans Affairs (VA) is seeking vendors who can provide the Capsule Endoscopy as listed above which meet all the following salient characteristics: Vendors must quote product solutions that meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor s pricing volume with a quantity of zero. ***** LOCATION IN TECHNICAL LITERATURE WHERE SC IS MET MUST BE COMPLETED IN THE FOLLOWING TABLE (NO EXCEPTIONS):****** SC # SALIENT CHARACTERISTICS Applicable CLIN METHOD OF EVALUATION SC Literature Map SC 1 Allow for direct visualization of small bowel via the paired recorder 0010, 0011 Literature Review Medtronic Page #39, 57 SC 2 Adaptive frame technology allows the capsule to capture images faster if the capsule is moving faster and slower if the capsule is moving slower and produces quality images 0002, 0010, 0011 Literature Review Medtronic Page #40 SC 3 Software for enhanced reading capabilities and reduced reading time 0003 Literature Review Medtronic Page #67 SC4 Optimized optics that deliver clear images and provide greater diagnostic ability 0002, 0010, 0011 Literature Review Medtronic Page #67 - 70 SC 5 Recorder which actively communicates with the capsule and indicates when paired with capsule 0002 Literature Review Medtronic Page #9 SC 6 Pillcam does not need to be retrieved to read data. 0002, 0010, 0011 Literature Review Medtronic Page #14, 40 SC 7 System must have FDA 510 K Approval All Literature Review Medtronic Page #56 - 66 SC 8 The Recorder system must have the ability to take video and still images. 0010, 0011 Literature Review Medtronic Page #57 SC 9 Patency capsule that can be used to verify an unobstructed small bowel prior to capsule endoscopy procedure 0002, 0010, 0011 Literature Review Medtronic Page #41 SC 10 Capable of remote ingestion 0002, 0010, 0011 Literature Review Medtronic Page #40 SC 11 System does not require capital equipment 0002 Literature Review Medtronic Page #40 The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this Combined Synopsis/Solicitation Notice.
