6515--NX EQ Image Guided Surgical Navigation System

1.0 DESCRIPTION

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The Department of Veterans Affairs (VA) Enterprise Procurement Office (EPO), formerly the Strategic Acquisition Center (SAC), is issuing this Sources Sought Notice as a means of conducting market research to identify qualified sources with the capability and the resources to meet the Veterans Health Administration s (VHA) Non-Expendable Equipment National Program requirement for Image-Guided Surgical Navigation Systems.

The EPO in conjunction with VHA is seeking a qualified source to supply brand name or equal Medtronic Stealthstation Image-Guided Surgical Navigation System on an agency-wide basis. VA intends to award a single Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contracts, to a supplier of this equipment. Vendors will be required to deliver complete image-guided stereotactic systems to VA medical centers and facilities throughout the United States.

The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Electrotherapeutic Apparatus and the associated size standard is 1,250 employees.

The FAR Provision found at 52.204-7 requires that The Offeror shall have an active Federal Government contracts registration in the System for Award Management (SAM) when submitting an offer or quotation. You may access the SAM website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://www.sba.gov/veterans/#vetcert at the time of submission.

Submissions for this sources sought shall be submitted by email no later than August 26, 2026, 12:00pm Eastern to all the following:

Alanna.Wilson@va.gov

Sara.Vickroy@va.gov

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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time.

2.0 SCOPE OF WORK

The Image-Guided Surgical Navigation System is a stereotactic computer-aided surgical system designed to aid in the performance of minimally invasive procedures by combining medical imaging, dedicated computer software, and instrument tracking systems for guidance. The systems provide real-time, three-dimensional (3D) positioning and orientation of instruments relative to the patient s anatomy on a video display during surgery without requiring the use of an endoscope. Image-guided surgical navigation systems work in a similar way to global positions systems (GPS) applied to the human body. They provide medical images that show the location of the instruments in real time during the procedure, and one or more imaging modalities, such as computed tomography (CT) and/or magnetic resonance imaging (MRI), may be used in the procedure. Dedicated image-guided stereotactic systems intended for particular procedures such as neurosurgery, cardiac mapping and ablation, mammographic biopsy, and cranial, spinal, orthopedic, and laryngological surgery procedures are available. Image-guided systems intended to facilitate radio surgical procedures from the exterior of the body are also available.

The following Contract Line Items (CLINs) are being considered:

Contract Line Item#

Brand

Part Number

Description

0001

Medtronic

9735665

STEALTHSTATION S8 MAIN CART W/MONITOR

0002

Medtronic

9735670

STEALTHSTATION S8 CAMERA CART

0003

Medtronic

9735943

POWER PACK 9735943 STEALTH S8 ENG ONLY

0004

Medtronic

M072707M014

STEALTHSTATION S7 to S8 System Trade In

0005

Medtronic

M072707M015

STEALTHSTATION S8 System Do the SCs apply to this CLIN?

- New

0006

Medtronic

9735740

STEALTHSTATION SPINE SOFTWARE

0007

Medtronic

9736428

REF SET 9736428 SPINE REFERENCING

0008

Medtronic

9735502

UPGRADE SET 9735502 PERC PIN

0009

Medtronic

9735501

Revision Referencing Tray

0010

Medtronic

9735522

Revision Referencing Tray Upgrade

0011

Medtronic

NAV2024K

DRIVER NAV2024 SOLERA 4.75 STANDARD MAS

0012

Medtronic

NAV2025K

DRIVER NAV2025 SOLERA 4.75 REDUCT MAS

0013

Medtronic

9735465

CD HORIZON® SOLERA® Awl-Tip Taps

0014

Medtronic

9735469

CD HORIZON SOLERA Taps

0015

Medtronic

9734492

SOLERA DEFORMITY TAPS UPGRADE

0016

Medtronic

9735283

SOLERA 5.5/6.0 DRIVERS

0017

Medtronic

9735285

SOLERA ILIAC TAPS

0018

Medtronic

9734838

TAP KIT 9734838 SOLERA 8.5 CANNULATED

0019

Medtronic

9734494

INST SET 9734494 TACTILE PROBES

0020

Medtronic

9735173

INST KIT 9735173 2.25MM PED PROBE

0021

Medtronic

9734836

INSERTER, CAPSTONE & CLYDESDALE SET

0022

Medtronic

9734833

NAVLOCK NAVIGATION INSTRUMENT SET

0023

Medtronic

9734834

CAPSTONE TRIALS SET (TLIF/PLIF)

0024

Medtronic

9734507

STEALTHSTATION® UNIVERSAL DRILL GUIDE

0025

Medtronic

9734835

CLYDESDALE TRIALS SET (DLIF)

0026

Medtronic

9734435

TACTILE AWL

0027

Medtronic

9735032

POWEREASE ADAPTER

0028

Medtronic

9735737

STEALTHSTATION CRANIAL SOFTWARE

0029

Medtronic

9735743

STEALTHSTATION 3D SOFTWARE

0030

Medtronic

9735745

STEALTHSTATION MERGE SOFTWARE

0031

Medtronic

9735739

STEALTHSTATION STEREOTAXY SOFTWARE

0032

Medtronic

9735738

STEALTHSTATION DBS SOFTWARE

0033

Medtronic

9735921

STEALTHSTATION DBS + STEREOTAXY SOFTWARE

0034

Medtronic

9735747

SCHALTENBRAND WHAREN ATLAS

0035

Medtronic

9736423

SW KIT 9736423 S8 2.0 TRACTOG

0036

Medtronic

9733935

CRANIAL INSTRUMENT SET - PASSIVE

0037

Medtronic

9730092

INST HNDL 9730092 PASS CATHETER INTROD

0038

Medtronic

9731965

TOUCH-N-GO KIT 9731965

0039

Medtronic

9733157

PROBE, 9733157, NAVIGUS

0040

Medtronic

9730269

MICROSCOPE PROBE

0041

Medtronic

9733936

VERTEK PASSIVE BIOPSY KIT

0042

Medtronic

961-337

INST REF FRAME 961-337 SM PASSIVE CR

0043

Medtronic

960-556

PASSIVE PLANAR BLUNT PROBE

0044

Medtronic

961-574

INSTRUMENT SET - SURETRAK II PASSIVE

0045

Medtronic

9734252

ARM 9734252 VERTEK II

0046

Medtronic

9735955

STEALTHSTATION EM KIT S8 CRANIAL ACCESSORIES

0047

Medtronic

9736149

ZEISS KINEVO INTERFACE KIT

0048

Medtronic

9736150

S8 DIGITAL HUD UPGRADE KIT

0049

Medtronic

KINEVOS8 UPGRADE

KINEVO KIT W/ S8 UPGRADE HARDWARE

0050

Medtronic

9736023

INTF KIT 9736023 ZEISS PENTERO HUD S8

0051

Medtronic

9736042

SCOPE KIT 9736042 S8 ZEISS UPG

0052

Medtronic

9736027

INTF KIT 9736027 LEICA HUD S8

0053

Medtronic

9736028

INTF KIT 9736028 LEICA PTR ONLY S8

0054

Medtronic

9735959

STEALTHSTATION EM KIT S8 FLAT EMITTER

0055

Medtronic

9735736

STEALTHSTATION ENT SOFTWARE

0056

Medtronic

9735742

SFW 9735742 STEALTH 3D ENT

0057

Medtronic

9733452XOM

ENT NAVIGATION INSTRUMENT SET

0058

Medtronic

9736325

Monitor Cover 9736325 Stealth S8 SVC

0059

Medtronic

9736326

Camera Cover 9736326 Stealth S8 SVC

0060

Medtronic

AUTOGUIDE_SYSTEM

Stealth Autoguide System

0061

Medtronic

9736464

Stealth Autoguide Instrument Set

0062

Medtronic

AUTOGUIDE_REG_KIT

Stealth Autoguide Non-sterile Registration Kit

0063

Medtronic

9736189

Stealth Autoguide Visualase Instrument Set

0064

Medtronic

9736377

Stealth Autoguide STERILIZATION TRAY 9736377 AUTOGUIDE II

0065

Medtronic

9736382

Stealth Autoguide STERILE TRAY 9736382 AUTOGUIDE AND MR8

0066

Medtronic

BI70002000

O-ARM O2 BASE

0067

Medtronic

BI75000027

CONFIG BI75000027 O2 SYSTEM NAVIGATION INTERFACE

0068

Medtronic

BI75000034

CONFIG BI75000034 O2 MULTIPLE FIELD OF VIEW

0069

Medtronic

BI75000030

CONFIG BI75000030 O2 ADVANCED VIEWING

0070

Medtronic

BI75000031

CONFIG BI75000031 O2 ISO-WAG ROTATION

0071

Medtronic

BI75000032

CONFIG BI75000032 O2 COLLIMATED AXIAL 3D

0072

Medtronic

BI75000029

CONFIG BI75000029 O2 HIGH DEFINITION 3D HD3D

0073

Medtronic

BI75000045

O-ARM O2 2D LONG FILM - NEW SYSTEM

0074

Medtronic

BI71000875

O-ARM O2 2D LONG FILM UPGRADE - EXISTING SYSTEM

0075

Medtronic

BI75000046

O-arm O2 Medtronic Implant Resolution (MIR)

0076

Medtronic

BI75000047

O-arm O2 Spine Smart Dose (SSD)

0077

Medtronic

BI75000048

O-arm O2 3D Long Scan (3DLS)

0078

Medtronic

BI75000050

O-arm O2 4.3.0, MIR, SSD and 3DLS - Active Service Agreement Customer

0079

Medtronic

BI75000049

O-arm O2 4.3.0, MIR, SSD and 3DLS, and Computer for Non -Service Agreement Customer

0080

Medtronic

BI75000051

O-arm O2 4.3.0, MIR, SSD and 3DLS, without computer for Non -Service Agreement Customer

Offerors must propose a complete solution including associated accessories, as required for the system s full functionality.

The following Salient Characteristics (SCs) are being considered:

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

SC 1

Must have a minimum of 27 high resolution touchscreen monitor

Literature Review

SC 2

Must have Real-time navigation of images with the ability to fuse 3D preoperative images for advanced planning

Literature Review

SC 3

Must be capable of interfacing with all of the following intraoperative imaging systems: MRI, CT, and 3D Ultrasound.

Literature Review

SC 4

Must have the ability to integrate with external devices for streamlined visualization workflows.

Literature Review

SC 5

Must be able to perform navigation for cranial neurosurgery and spine applications.

Literature Review

SC 6

Must have optical and EM tracking capabilities

Literature Review

SC 8

Must be FDA 510(k) Approved

Literature Review

SC 9

Must provide a minimum one-year Manufacturer Warranty

Literature Review

SC 10

Must be interoperable with the VA Electronic Health Record System

Literature Review

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

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

In addition to the above CLINs and salient characteristics, the Government contemplates utilizing the below evaluation subfactors:

Evaluation Subfactors

1. Safety

Safety features and functions of the offered equipment will be evaluated. Areas may include but are not limited to the following:

System security

Maintenance reminders

Emergency alarms

2. Design

Design features and functions of the equipment offered will be evaluated. Areas may include but are not limited to the following:

Touchscreen user interface and ease of use

Image display quality and resolution

Data storage and RAM memory

Patient data management

External device and instrument compatibility

System footprint and weight

Power and environmental requirements

Optical and EM tracking capabilities

Optical tracking volume

Different types of Intraoperative imaging systems capable of interfacing with Ergonomics

3. Diagnostic Tools and Imaging Techniques

Diagnostic tools and imaging techniques of the offered equipment will be evaluated. Areas may include but are not limited to the following:

Patient registration

Surgical navigation

Tool tracking

Image merging

Procedure specific software applications

Pre and intraoperative planning

4. Quality/Construction

Aspects of the construction and quality of material of the equipment will be evaluated and may include but not limited to the following:

Life span

Warranty terms and conditions

Maintenance requirements

Service plans terms and conditions

Training options

Responses to this Sources Sought Notice shall include the following:

Full name and address of company.

SAM Unique Entity Identifier (UEI).

Business Size.

Manufacturer or Distributor:

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

If distributor, provide evidence that your firm is currently an authorized distributor for the manufacturer of the products proposed, e.g. an authorized distributor letter with current date certified by the OEM.

Country of Origin designation for all products proposed.

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

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

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?

Vendor is requested to provide documentation that shows information on their service plan.

Is the service provided by the OEM or a subcontractor?

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

Item pricing information of products, inclusive of flat rate shipping. Include any quantity discounts, noting at what level of quantity ordered should the Government expect tiered price reductions, if any.

NOTE: In order for the Contracting Officer to determine whether a set-aside can be pursued, it is essential to provide pricing information. Without this information, the Contracting Officer will be unable to assess whether there is a reasonable expectation of receiving fair and reasonable pricing from socio-economic concerns.

Does your firm have any subcontracting opportunities for this equipment?

Identify any federal contracts vehicles held by your firm that provides this equipment.

Are there any further standards or criteria, to include salient characteristics and subfactors, VA should consider in a procurement action for this equipment?

Are the Government s specifications unduly restrictive?

Any additional information the Government should know prior to issuing a solicitation.