36C10G25Q0114.docx

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6515--NX EQ Capsule Endoscopy (VA-26-00006488)
Solicitation number
36C10G25Q0114
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This is a Sources Sought Notice issued by the Department of Veterans Affairs seeking vendors for a nationwide capsule endoscopy system contract. The VA's Non-Expendable Equipment National Program is conducting market research for a single requirements contract covering Medtronic capsule endoscopy systems, which use ingestible video cameras to examine the intestinal tract and detect abnormalities in areas difficult to reach with traditional endoscopes.

The procurement specifies 14 contract line items (CLINs) exclusively for Medtronic products under FAR clause 6.303 Brand Name requirements, including PillCam capsules, recorders, software, sensors, and accessories. The contract structure includes a base year with quantities of 39 units per CLIN, followed by four option years with 34 units each. Responses are due by August 22, 2025, at 15:30 Eastern Time. Vendors must demonstrate their products meet 11 salient characteristics including direct small bowel visualization, adaptive frame technology, enhanced software capabilities, FDA 510(k) approval, and the ability to provide uninterrupted national supply. Small business distributors must provide valid manufacturer authorization letters no older than six months. The contracting office is located in Fredericksburg, VA, with nationwide performance requirements under NAICS code 334510.

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Sources Sought Notice Sources Sought Notice

SUBJECT*
NX EQ Capsule Endoscopy (VA-26-00006488)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
22408-2697
SOLICITATION NUMBER*
36C10G25Q0114
RESPONSE DATE/TIME/ZONE
08-22-2025 15:30 EASTERN TIME, NEW YORK, USA
ARCHIVE
90 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N

SET-ASIDE

PRODUCT SERVICE CODE*
6515
NAICS CODE*
334510
CONTRACTING OFFICE ADDRESS
U.S. Department of Veterans Affairs

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contracting Specialist Hosea Berkley hosea.berkley@va.gov 202-276-2992

PLACE OF PERFORMANCE

ADDRESS
Nationwide

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL
https://www.va.gov/opal/sac/index.asp
URL DESCRIPTION
VA | OALC | OPAL | SAC
AGENCY CONTACT’S EMAIL ADDRESS
hosea.berkley@va.gov
EMAIL DESCRIPTION
hosea.berkley@va.gov

DESCRIPTION

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
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
39
34
34
34
34
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.

*= Required Field
Sources Sought Notice

Sources Sought Notice

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