6515--NX EQ Cryotherapy System: Tissue Ablation - Endoscopic

Solicitation Number: 36C10G25Q0093

Notice Type: Combined Synopsis/Solicitation

Synopsis: COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for 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; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C10G25Q0093 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 2025-03, dated January 17, 2025.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cryotherapy Systems: Tissue Ablation Endoscopic product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

This requirement will be IAW FAR 16.503(a)(1) and (2), Requirements Contracts for Cryotherapy Systems: Tissue Ablation - Endoscopic. IAW FAR 52.211-6 Brand Name or Equal, for each equal product, the offeror must include a description reflecting the Salient Characteristic (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

A single award Firm Fixed Price Requirements contract will be awarded IAW FAR IAW FAR 16.503(a)(1) and (2) by all terms, conditions, provisions, specifications, and schedule of this solicitation herein.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies, and the associated size standard is 1,250 employees. This procurement action is issued as small business set-aside open-market solicitation.

All interested companies shall provide a quote for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE - NX EQ CRYOTHERAPY SYSTEM.

The proposed acquisition is for a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract.

The type of Cryotherapy Systems: Tissue Ablation Endoscopic required for this program has been identified as most advantageous to the Government to be incorporated into a national Requirements Contract. The Salient Characteristics (SC) for these commercial items are identified in the NX EQ Cryotherapy Systems: Tissue Ablation Endoscopic Product Description.

The period of performance is for a base of 12 months with four 12-month option periods. Delivery is FOB destination. Firm-fixed price Orders will be placed against this Requirements 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, applies to this acquisition including the attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also apply to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. The addendum is attached.

Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause apply to the acquisition. The addendum is attached.

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/. Quotes shall contain the terms for cost/price and technical capabilities of the equipment. The Government reserves the right to award without discussions. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 12:00 PM EST on September 10, 2025, to Contract Specialist, Levi Russin at Levi.Russin@va.gov and Contracting Officer, Jessica Edwards at Jessica.Edwards6@va.gov. No calls will be accepted.

Quotes are due via email by 12:00 PM EST on September 19, 2025, to Contract Specialist, Levi Russin at Levi.Russin@va.gov and Contracting Officer, Jessica Edwards at Jessica.Edwards6@va.gov.

1. SCOPE OF WORK

Cryotherapy Systems: Tissue Ablation - Endoscopic are used for Cryoablation, a process that uses extreme cold (cryo) to destroy or damage tissue (ablation) whereby producing tissue necrosis at temperatures well below the freezing point of water (typically less than -20 degrees Celsius/-4 degrees Fahrenheit) using minimally invasive procedures. These systems typically consist of a central unit that provides the cryogen and includes electronic and mechanical components to perform and control the ablation; tubing to deliver the cryogen; and a probe (e.g., an applicator, needle, cannula, or catheter) to apply the cryogen directly or indirectly to the tissue. Ablation occurs when the cryogenic substance or cryogenic probe contacts the tissue. As the cells freeze, ice crystals form inside the cell and the subsequent cycle of freezing and thawing that follows actually destroys the tissue cells. Specifically, Cryotherapy Systems: Tissue Ablation - Endoscopic equipment are intended for use in open, minimally invasive or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery, and thoracic surgery for prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Cryotherapy Systems: Tissue Ablation - Endoscopic 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

The objective of this procurement is to establish a single Requirements contract for Cryotherapy Systems: Tissue Ablation - Endoscopic for inclusion in the NEC and nationwide usage. VHA aims to ensure availability and consistency of NX equipment and to obtain volume-based, standardized pricing. VHA desires to continue the practice of achieving cost avoidance while simultaneously balancing clinician considerations for obtaining quality equipment. For each product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the physical, functional, or performance characteristics of the product(s) specified in the solicitation. The offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements. The following line items comprise the Cryotherapy Systems: Tissue Ablation - Endoscopic product line:

Contract Line Items

Description

0001

ICEfx Cryoablation System (Includes: ICEfx Cryoablation Console, 10.1-inch Touchscreen Monitor, Power Cord, Console Cover, USB Flash Drive (4 GB), Wrench, Accessory Bag, Argon Gas Supply Line, Dual Cylinder Adapter, User Manual, Quick Reference Guide, and 1 year warranty)

0002

ICEfx Cart, With Wheels and Wheel Locks

0003

IceRod 1.5 CX, Straight, 17.5 cm, 17 ga, Red

0004

IceRod 1.5 CX, Angled 90º, 17.5 cm, 17 ga, Red

0005

IceSeed 1.5 CX, Straight, 10 cm, 17 ga, Black

0006

IceSeed 1.5 CX, Angled 90º, 17.5 cm, 17 ga, Black

0007

IceSeed 1.5 CX S, Angled 90º, 10 cm, 17 ga, Black

0008

IceSphere 1.5 CX, Straight, 17.5 cm, 17 ga, Yellow

0009

IceSphere 1.5 CX, Angled 90º, 17.5 cm, 17 ga, Yellow

0010

IceSphere 1.5 S, Angled 90º, 17.5 cm, 17 ga, Yellow

0011

IceForce 2.1 CX, Straight, 17.5 cm, 14 ga, Gray

0012

IceForce 2.1 CX, Angled 90º, 17.5 cm, 14 ga, Gray

0013

IceForce 2.1 CX L, Angled 90º, 23 cm, 14 ga, Gray

0014

IcePearl 2.1 CX, Straight, 17.5 cm, 14 ga, White

0015

IcePearl 2.1 CX, Angled 90º, 17.5 cm, 14 ga, White

0016

IcePearl 2.1 CX L, Angled 90º, 23 cm, 14 ga, White

0017

Dual Tank Cylinder Gas Adapter, 5M PSI

0018

Preventative Maintenance Services, Required Bi-Annual (2 Year Interval), Single Unit

0019

EssentialCare Service Agreement, Single Unit, 1 Year- Point of Sale

0020

EssentialCare Service Agreement, Single Unit, 2 Year- Point of Sale

0021

EssentialCare Service Agreement, Single Unit, 3 Year- Point of Sale

0022

EssentialCare Service Agreement, Single Unit, 4 Year- Point of Sale

0023

EssentialCare Service Agreement, Single Unit, 1 Year- POST Warranty

0024

EssentialCare Service Agreement, Single Unit, 2 Year- POST Warranty

0025

EssentialCare Service Agreement, Single Unit, 3 Year- POST Warranty

0026

EssentialCare Service Agreement, Single Unit, 4 Year- POST Warranty

The Department of Veterans Affairs (VA) is seeking vendors who can provide Cryotherapy Systems: Tissue Ablation Endoscopic identified above which meet all the salient characteristics (SC) listed below. The Government's intent is for offerors to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

System must be FDA approved to provide cryoablation treatment to effectively ablate liver, prostate, kidney, and other soft tissue tumors

Literature Review

SC 2

System must have a touchscreen user interface with integrated temperature, power, and timer to monitor, display, and control treatment duration

Literature Review

SC 3

System must provide audible and visual alarms, alerts, and/or warnings

Literature Review

SC 4

System must include a dedicatedconsole cart equipped with locking wheel casters

Literature Review

SC 5

Probes/Applicators/Needles must be offered in various lengths including equal to or longer than 23 cm

Literature Review

SC 6

Must provide a minimum one-year Manufacturer warranty

Literature Review

Vendors may quote any product solution or configuration so long as they meet the SC s. 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 quoted solution; these items must be captured in the Vendor s pricing volume with a quantity of zero.

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this Combined Synopsis/Solicitation Notice.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ CRYOTHERAPY SYSTEMS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ CRYOTHERAPY SYSTEMS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ CRYOTHERAPY SYSTEMS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ CRYOTHERAPY SYSTEMS.

See attached document: ATTACHMENT E REPORTING TOOL - NX EQ CRYOTHERAPY SYSTEMS.

See attached document: ATTACHMENT F - PAST PERFORMANCE REFERENCE - NX EQ CRYOTHERAPY SYSTEMS.

See attached document: ATTACHMENT G - PAST PERFORMANCE QUESTIONAIRE _ NX EQ CRYOTHERAPY SYSTEMS.

See attached document: ATTACHMENT H RFQ QUESTIONS - NX EQ CRYOTHERAPY SYSTEMS.