6515--NX EQ Radiofrequency Therapy System: Tissue Ablation

Combined Synopsis/Solicitation Notice

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Page 1 of

Combined Synopsis/Solicitation Notice

Solicitation Number:

36C10G22Q0101

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; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C10G22Q0101 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) 2022-06, dated 26 May 2022.

Requirement Description:

VA has a requirement to purchase Radiofrequency Therapy System: Tissue Ablation to deliver patient care at its VA Medical Centers around the country. Radiofrequency Therapy System: Tissue Ablation deliver medium frequency electric current (in the range of 300 kHz to 3 MHz) for the destruction of tissue, lesioning of nerves, or for pain management. Radiofrequency generators should not be confused with high frequency (greater than 3 MHz) tumor ablation devices, or with general-purpose electrosurgical units used to cut and coagulate tissue. Radiofrequency generators produce a protein-denaturing alternating current that is used to selectively obliterate certain tissues without collateral damage to surrounding tissue. Nerve lesioning applications include treatment for trigeminal neuralgia (a form of chronic facial pain) and severe lower back and leg pain by obliterating pain-carrying nerve fibers.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes 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 Electro Medical and Electrotherapeutic Apparatus Manufacturing: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,250 employees. This procurement action is issued as full and open competition.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Stryker brand name or equal Radiofrequency Therapy System: Tissue Ablation and related equipment and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ RADIOFREQUENCY THERAPY SYSTEM: TISSUE ABLATION. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE - NX EQ RADIOFREQUENCY THERAPY SYSTEM: TISSUE ABLATION.

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, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda 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 Items, with its offer.

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

Clause at 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 are applicable to the acquisition. Addendum is attached.

All interested quoters must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59PM EST on July 12, 2022, to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov. No calls will be accepted.

Quotes are due via email by 11:59PM EST on July 28, 2022, to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov.

1. BACKGROUND:

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

Radiofrequency Therapy System: Tissue Ablation deliver medium frequency electric current (in the range of 300 kHz to 3 MHz) for the destruction of tissue, lesioning of nerves, or for pain management. Radiofrequency generators should not be confused with high frequency (greater than 3 MHz) tumor ablation devices, or with general-purpose electrosurgical units used to cut and coagulate tissue. Radiofrequency generators produce a protein-denaturing alternating current that is used to selectively obliterate certain tissues without collateral damage to surrounding tissue. Nerve lesioning applications include treatment for trigeminal neuralgia (a form of chronic facial pain) and severe lower back and leg pain by obliterating pain-carrying nerve fibers.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Radiofrequency Therapy System: Tissue Ablation 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 52.211-6, Brand Name or Equal which requires the offeror indicate that each product being offered as an equal product to the Stryker MultiGen 2® Radiofrequency Therapy System: Tissue Ablation. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal 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.

CONTRACT LINE ITEMS

BRAND

PART NUMBER

DESCRIPTION

0001

Stryker

8400-000-000

Multigen2 RF Generator

0002

Stryker

8400-800-000

Multigen2 Splitter Cable

0003

Stryker

0406-850-200

Monopolar Return Electrode Cable

0004

Stryker

8400-825-010

VENOM100M Multigen2 Electrode

0005

Stryker

8400-825-015

VENOM15000M Multigen2 Electrode

The Department of Veterans Affairs (VA) is seeking vendors who can provide Stryker MultiGen 2® Radiofrequency Therapy System: Tissue Ablation or equal as listed above which meet all of the following salient characteristics. Vendors may quote any product solution or configuration so long as they 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.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

APPLICABLE CLINS

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

FDA Cleared

Literature Review

0001 - 0005

SC 2

Therapeutic Energy Delivered by Generator Output Power Over 50 - 100 Watt

Literature Review

0001 - 0005

SC 3

Start Safety Features

Literature Review

0001 - 0005

SC 4

Stimulator Radiofrequency Output Range 3 -10 Volts

Literature Review

0001 - 0005

SC 5

Temperature Check Safety Features

Literature Review

0001 - 0005

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.