6515--NX EQ Capsule Endoscopy (VA-26-00006488)

1. DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Capsule Endoscopy System product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. The North American Industry Classification System (NAICS) code for Capsule Endoscopy System is 334510 Endoscopic equipment, electromedical (e.g., bronchoscopes, colonoscopes, cystoscopes), manufacturing: 6515 Medical and Surgical Instruments, Equipment, and Supplies. 2. SCOPE This requirement will be IAW FAR clause 6.303, Brand Name which requires the quoter indicate that the product being offered is a Capsule Endoscopy System from Medtronic. 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. 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 Medtronic Capsule Endoscopy System as listed below which meet all the following salient characteristics: 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 CLINs MANUFACTURERS PART NUMBERS DESCRIPTION BASE YEAR OPTION YEAR ONE OPTION YEAR TWO OPTION YEAR THREE OPTION YEAR FOUR 0001 - - 39 34 34 34 34 0002 - - 39 34 34 34 34 0003 - - 39 34 34 34 34 0004 - - 39 34 34 34 34 0005 - - 39 34 34 34 34 0006 - - 39 34 34 34 34 0007 - - 39 34 34 34 34 0008 - - 39 34 34 34 34 0009 - - 39 34 34 34 34 0010 - - 39 34 34 34 34 0011 - - 39 34 34 34 34 0012 - - 39 34 34 34 34 0013 - - 39 34 34 34 34 0014 - - 39 34 34 34 34 Responses to this Sources Sought Notice shall include the following: - - - - - 1) - Full name and address of company 2) - DUNS number/ CAGE Code/ SAM UIE 3) - Business Size 4) - Manufacturer or Distributor a. - If distributor provide full name, business size and address of manufacturer. 5) - Country of Origin designation for all products. 6) - Ability to provide uninterrupted supply of products on a national scale. 7) - Technical Literature that clearly shows product(s) meet the identified salient characteristics (if submitting an or-equal item). 8) - Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. 9) - All small business, VOSB, SDVOSB distributors shall provide a valid letter of authorization from the manufacturer of the product/brand that you intend to offer. The letter shall be printed on the manufacturers letter head and be no older than 6 months old. The letter shall also clearly state how long your agreement is place with the manufacturer, e.g., 6 month, 4 years, expires 4 years from XXX, end of 2025, etc. The letter shall also be signed by a legally, authorized representative of the manufacturer. Authorized Distributor Letter Certified by OEM with a current date.