6515--NX EQ Electrosurgical Units, Argon-Enhanced Coagulation (VA-26-00034663) (VA-26-00034663)

DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified Electrosurgical Units (ESUs); Argon-Enhanced Coagulation product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

The Department of Veterans Affairs (DVA) Office of Procurement, Acquisition and Logistics (OPAL) Strategic Acquisition Center (SAC) on behalf of VHA is issuing this Request for Information (RFI) in accordance with the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources. The period of performance will consist of a base of 12-months with four 12-month option periods from the date of award.

The SAC in conjunction with VHA is seeking a qualified source to manufacture Electrosurgical Units (ESUs); Argon-Enhanced Coagulation on an agency wide basis. VA intends to award a Brand Name or Equal (BNOE) single award Requirements contract for this requirement IAW with FAR 16.503. Vendors will be required to deliver Electrosurgical Units (ESUs); Argon-Enhanced Coagulation to VA medical centers and facilities throughout the United States.

The anticipated period of performance is for one (1) 12-month base period with four (4) 12-month option periods from the date of award. However, the Government's decision as to whether or not to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical and Medical Instrument Manufacturing and the associated size standard is 1,000 employees. The FAR Provision found at 52.204-7 requires that All interested Offerors must be registered in SAM prior to submitting an offer or proposal. You may access the SAM website at Home | SAM.gov. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the Small Business Administration (SBA) database at Veteran Small Business Certification (VetCert) database at: Veteran Small Business Certification (sba.gov) at the time of proposal submission.

This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes.

2.0 SCOPE

Electrosurgical Units (ESUs); Argon-Enhanced Coagulation (AEC) are advanced, energy based surgical systems used to perform precise tissue coagulation and devitalization across Veterans Affairs Medical Centers (VAMCs), particularly in operating rooms (OR), procedural suites, and endoscopy units. They deliver radiofrequency (RF) energy through specialized electrodes while directing a controlled flow of inert argon gas to create a conductive plasma at the tissue surface. This results in uniform, noncontact coagulation with minimal tissue penetration, improved visualization, and reduced bleeding. ESUs with AEC are designed to enhance surgical efficiency, improve hemostasis, and support consistent, replicable outcomes across a range of open, laparoscopic, and endoscopic procedures.

These systems provide real-time, automated control of power delivery, argon flow, and activation mode, with integrated safety monitoring and configurable presets for procedure-specific use. They are optimized to increase clinical efficiency and reduce complications through precision energy delivery, reliable tissue effect profiles, and comprehensive safety interlocks.

The following Contract Line Items are being considered:

Contract Line Item#

Brand

Part Number

Description

0001

ERBE USA INC.

VIO® 3

0001A

ERBE USA INC.

10160-000

VIO® Electrosurgical unit

0001B

ERBE USA INC.

20189-353

Two-pedal foot switch, VIO® 3 ReMode®, bracket, middle piece

0001C

ERBE USA INC.

20188-350

One-pedal foot switch, VIO® 3 ReMode®

0001D

ERBE USA INC.

20180-000

VIO® CART System carrier for VIO®

0001E

ERBE USA INC.

20180-010

Wire basket, 339 x 205 x 155 / 100 mm

0002

ERBE USA INC.

Attachment Sets

0002A

ERBE USA INC.

20180-140

Fastening set for VIO® 3 on VIO® Cart

0002B

ERBE USA INC.

20180-143

Fastening set VIO® 3 for APC® 3 on boom mount

0002C

ERBE USA INC.

20180-144

Fastening set VIO® 3 for APC® 3 on ERBEJET® 2

0003

ERBE USA INC.

Instrument cables from Erbe

0003A

ERBE USA INC.

20192-133

Monopolar cable MO 3Pin; MIS OD 4mm; L 4.5m

0003B

ERBE USA INC.

20192-134

Monopolar cable MO 3Pin; OD 4.5mm pin; L 4.5m

0003C

ERBE USA INC.

20192-135

Monopolar cable MO 3Pin; OD 3mm socket; L 4.5m

0003D

ERBE USA INC.

20196-064

Bipolar cable BI 2Pin28; ang.; forceps; L 4.5m

0003E

ERBE USA INC.

20196-067

Bipolar cable BI 2Pin28; grasp. forceps; L 4.5m

0003F

ERBE USA INC.

20196-127

Bipolar cable BI 2Pin28; forceps 2Pin; L 4m

0003G

ERBE USA INC.

21196-115

Bipolar Conecting Cable; MF-U Olympus Resectoscope; L 4.5m

0003H

ERBE USA INC.

21196-118

Bipolar Connecting Cable; MF-U Storz Resectoscope; L 4.5m

0003I

ERBE USA INC.

21196-119

Bipolar Connecting Cable; MF-U Wolf Resectoscope; L 4.5m

0004

ERBE USA INC.

VIO® 300 D

0004A

ERBE USA INC.

10140-100

VIO® 300 D Electrosurgical Unit 120V/60HZ UL , Software Version 2.X Constant Voltage

0004B

ERBE USA INC.

20189-305

VIO® two pedal footswitch w/ReMode® w/Bracket (Remode Feature Allows Changing between Preset Programs)

0004C

ERBE USA INC.

20180 131

Connection Adapter, Cryo Probe to Erbokryo CA

0004D

ERBE USA INC.

20183-053

Adapter for BICAP or Gold Probe

0004E

ERBE USA INC.

20193-084

NESSY® Omega monitoring pad with cable (50 per case)

0004F

ERBE USA INC.

20180-000

VIO® Cart with footswitch holder, cable wrap and 1 tank fixation kit

0004G

ERBE USA INC.

20180-010

VIO® Cart wire basket

0004H

ERBE USA INC.

20180-131

VIO®/APC® 2 to VIO® Cart fastening set (with grounding cable)

The Department of Veterans Affairs (VA) is seeking vendors who can provide Erbe® VIO 3 Electrosurgical Units (ESUs); Argon-Enhanced Coagulation system or equal as listed above which meet all 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.

Apply the following SCs to CLIN s 0001-0004

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC1

Must be cleared by the U.S. Food and Drug Administration (FDA) as an electrosurgical generator with compatible argon-enhanced coagulation capability for cutting and coagulation of tissue in general, laparoscopic, and endoscopic surgery, including hemostasis and devitalization of soft tissues.

Literature Review

SC2

Must provide a centralized color touchscreen user interface that allows the operator to select, monitor, and adjust at minimum: Electrosurgical mode (e.g., monopolar cut, monopolar coag, bipolar, argon coagulation); Output power settings (watts); Application-relevant parameters (e.g., argon gas flow and effect settings for argon-enhanced coagulation); and Treatment or activation time (timer or activation counters).

Literature Review

SC3

Must be compatible with a range of monopolar and bipolar instruments, as well as compatible argon probes/catheters and applicators, in various working lengths suitable for open and endoscopic procedures.

Literature Review

SC4

Must consist of modular argon plasma capability with adjustable gas flow rates (0.1 to 6 L/min) and multiple APC waveforms (precise, pulsed, forced) for non-contact surface coagulation, enabling effective hemostasis and tissue ablation in gastrointestinal, respiratory, and other anatomical applications.

Literature Review

SC5

Must have advanced neutral electrode monitoring (such as NESSY technology) that dynamically tracks patient impedance levels and return electrode contact/orientation, along with proprietary spark recognition and control algorithms to minimize carbonization, tissue adhesion, and unintended thermal injury.

Literature Review

SC6

Must consist of compact design with multiple socket configurations (monopolar, bipolar, universal connections) accommodating international and manufacturer-specific instrument standards, wireless and wired footswitch options, and compatibility with smoke evacuation and insufflation systems for streamlined OR workflow.

Literature Review

SC7

Must include a minimum one year manufacturer warranty covering parts and labor, with availability of installation, user training, and ongoing service support programs.

Literature Review

Evaluation Sub-factors

1. Design: Design features and function will be evaluated based on, but not limited to, the following:

Centralized touchscreen user interface: Large, color touchscreen with logical application-oriented men for quick selection and confirmation of modes to include APC settings.

Multi-instrument connectivity and APC integration to include argon probes and APC hand pieces.

Procedure and instrument-based presents: Recognizes instrument and procedure-specific programs that automatically load parameters and standardizes set-up.

2. Performance: Performance capabilities, features and functions of the device offered will be evaluated for technical performance, reliability, and clinical effectiveness. These elements include, but are not limited to:

High dynamic power delivery: Power supply is able to maintain stable output under variable loads and APC modes.

Rapid response measurement rate: High measurement of frequency of target tissue effects across different tissue types and cutting speeds supporting argon-assisted coagulation lines.

Multi-modality support: Concurrent support for monopolar, bipolar, and hybrid/argon-assisted applications across platforms without swapping generators during an on-going procedure.

3. Safety: All features and functions of the equipment shall be evaluated for the ability to be safely installed, secured, and protected against harm; physical or any form. These elements include, but are not limited to:

Regulatory compliance and clearances: FDA 510(K) clearance status.

Systems and operational features safety related to electrical and argon-gas.

Warning and alarms capability

4. Quality/Construction/Training: Elements will include, but are not limited to:

Robust construction and medical-grade standards.

Power consumption, backup power, and energy efficiency.

Terms and conditions of installation, training, and service agreement programs.

Expected life cycle to include sanitation, infection control, and maintenance.

For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the SCs specified above.

The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer (OEM) and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the SCs. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number.

Responses to this Sources Sought Notice shall include the following:

Does vendor offer an annual service plan, Yes or No?

If Yes:

What does the plan cover?

Does plan cover software updates only?

Does the plan cover parts repair or replacement only?

Does the plan cover both software and parts?

If applicable, vendors are requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

Full name and address of company

SAM Unique Entity Identifier (UEI) / CAGE Code

Business Size

Manufacturer or Distributor

If the distributor, provide manufacturer s full name, business size and address.

Country of Origin designation for all products.

Ability to provide uninterrupted supply of products on a national scale.

Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met.

Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified.

Authorized Distributor Letter Certified by OEM with a current date.

Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.

Contractors submitting capability statements in response to this RFI must specifically address the questions outlined above. Generic capability statements that do not directly pertain to this RFI will not be considered. Additionally, links requesting capability statements or further information will not be accessed. All responses must be submitted as an actual file attachment.