6515--NX EQ Capsule Endoscopy (VA-26-00006488)
Closed Pre-Solicitation Posted
- Solicitation number
- 36C10G25Q0114
- Agency
-
Headquarters
Department of Veterans Affairs
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing
- Place of performance
- Nationwide
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Department of Veterans Affairs' Non-Expendable Equipment National Program is conducting market research for a nationwide single requirements contract to procure Medtronic Capsule Endoscopy Systems. These systems utilize ingestible video cameras to examine the intestinal tract and detect abnormalities in areas difficult to reach with traditional endoscopes, consisting of disposable camera capsules, patient-worn recorders, and image processing workstations. The procurement operates under FAR clause 6.303 Brand Name requirements, restricting offerings to Medtronic products only, with vendors required to demonstrate their products meet eleven specific salient characteristics including direct small bowel visualization, adaptive frame technology, FDA 510(k) approval, and enhanced software capabilities. Evaluation will be conducted through literature review against these salient characteristics, with vendors required to provide technical documentation proving compliance. Responses to this sources sought notice are due August 22, 2025, and must include company information, business size classification, manufacturer authorization letters for distributors, and proof of ability to provide uninterrupted national supply.
This opportunity does not utilize any set-aside designations and is open to all qualified vendors. The contract structure encompasses 14 contract line items (CLINs) covering various Medtronic components including PillCam capsules, recorders, software, sensors, and accessories, with a base year requiring 39 units per CLIN followed by four option years of 34 units each. The procurement falls under NAICS code 334510 for Electromedical and Electrotherapeutic Apparatus Manufacturing and PSC code 6515 for Medical and Surgical Instruments, Equipment, and Supplies. Small business distributors must provide valid manufacturer authorization letters no older than six months, clearly stating the duration of their agreement with Medtronic. Performance will be required nationwide, with the contracting office located in Fredericksburg, Virginia, indicating the scope and scale of this VA-wide medical equipment procurement initiative.
Notice text
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
Â
Â
Â
39
34
34
34
34
0002
Â
Â
Â
39
34
34
34
34
0003
Â
Â
Â
39
34
34
34
34
0004
Â
Â
Â
39
34
34
34
34
0005
Â
Â
Â
39
34
34
34
34
0006
Â
Â
Â
39
34
34
34
34
0007
Â
Â
Â
39
34
34
34
34
0008
Â
Â
Â
39
34
34
34
34
0009
Â
Â
Â
39
34
34
34
34
0010
Â
Â
Â
39
34
34
34
34
0011
Â
Â
Â
39
34
34
34
34
0012
Â
Â
Â
39
34
34
34
34
0013
Â
Â
Â
39
34
34
34
34
0014
Â
Â
Â
39
34
34
34
34
Responses to this Sources Sought Notice shall include the following:Â Â
        Â
1)Â Â Â Full name and address of company
2)Â Â Â DUNS number/ CAGE Code/ SAM UIE
3)Â Â Â Business Size
4)Â Â Â Manufacturer or Distributor
a.   If distributor provide full name, business size and address of manufacturer.
5)Â Â Â Country of Origin designation for all products.
6)Â Â Â Ability to provide uninterrupted supply of products on a national scale.
7)Â Â Â Technical Literature that clearly shows product(s) meet the identified salient characteristics (if submitting an or-equal item).
8)Â Â Â Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.
9)Â Â Â 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.
Files
| File | Type | Posted |
|---|---|---|
| 36C10G25Q0114.docx | DOCX document |
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