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.

• NAICS334510
• PSC6515

• attachment

  Not yet available
• 36C10X26Q0242.docx

  .docx43 KB
  Download

• Alanna Wilson
  Contract Specialist
  alanna.wilson@va.gov202-316-4366