6515--Medtronic brand name or equal- ENT Surgical Navigation System
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract awards the purchase and installation of a Medtronic brand name or equal ENT Surgical Navigation System to VETERANS HEALTHCARE SUPPLY SOLUTIONS, INC., a certified Service-Disabled Veteran-Owned Small Business (SDVOSB), under a Firm-Fixed-Price contract with a total value of $72,703.60. The procurement is structured as a set-aside exclusively for SDVOSBs and is governed by stringent socioeconomic requirements under 38 U.S.C. § 8127 and 13 CFR Part 128, including mandatory performance of at least 50% of the contract value by the prime contractor, excluding materials, with all subcontractors also required to be certified SDVOSBs. The system supports Functional Endoscopic Sinus Surgery and anterior skull-base procedures, and must be FDA-cleared as a Class II medical device with technical specifications including tracking accuracy of no more than 2mm, EM/optical tracking capability, and DICOM compatibility. Delivery is required within 30 days after receipt of order to the Central Arkansas Veterans Healthcare System in Little Rock, Arkansas, under FOB DESTINATION terms, with acceptance occurring upon successful delivery, installation, and training. The contract mandates full compliance with the Buy American Act, as amended, and incorporates a deviation for the Buy American clause, requiring domestic sourcing of supplies. All deliverables, including software and generated records, are owned by the U.S. Government with unlimited rights. Vendor certification of OEM capability, current Buy American and SDVOSB subcontracting compliance statements, and proof of small business status are mandatory for eligibility. The award follows a Lowest Price Technically Acceptable evaluation method, where technical acceptability is a non-negotiable threshold and price determines selection among qualified offers. The contractor must adhere to VA-specific data security rules, including prohibition of unauthorized removal or retention of sensitive VA information, and ensure all personnel receive VA-record management training. Failure to comply with SDVOSB certification or subcontracting limits may result in debarment for up to five years. The contract includes clauses on whistleblower rights, affirmative action for workers with disabilities, combating trafficking in persons, and employment of minors in violation of law, all incorporated by reference under standard FAR and VAAR provisions.
General Info
Contract Value
$72,703.6Place of Performance
MS, USASet-Aside
Award Issued Date
Timeline
Organization & Contact Information
Full Description
Medtronic brand name or equal equipment. Medtronic part numbers are reference only and that equivalency is determined solely by salients.
- Scope: Contractor shall provide all shipping, labor, tools, training, equipment, installation, delivery, software, personnel, integration, validation, and training for a new brand name or equal Medtronic ENT Surgical Navigation System (cart or tower‑integrated) to support Functional Endoscopic Sinus Surgery (FESS), rhinology procedures, and anterior skull‑base surgical interventions.
- System Requirements: Brand name or equal ENT Navigation System shall meet the following minimum requirements:
- Navigation Technology
- Electromagnetic (EM) and/or optical tracking capability.
- Ability to track multiple surgical instruments simultaneously.
- Accuracy suitable for ENT/skull‑base procedures (≤ 2 mm typical).
- Imaging Compatibility
- Full Digital Imaging and Communications in Medicine compatibility for Computed Tomography and Magnetic Resonance Imaging datasets.
- Ability to import, display, and register patient imaging.
- Support for automatic, manual, and landmark-based registration.
- Operating Room Integration
- Integration with existing endoscopic video towers.
- Ability to display navigation overlays on primary OR monitors.
- Support for sterile field interaction (e.g., pointer-driven controls, workflow steps).
- Software Features
- Preoperative planning tools.
- Anatomical mapping and sinus cavity segmentation.
- Accuracy check function with real-time updates.
- User profiles, case saving, and documentation tools.
- Hardware Requirements
- Mobile cart or tower system with medical‑grade displays.
- Tracking emitter/sensor mounts suitable for ENT surgical positioning.
- Food and Drug Administration-cleared Class II medical device.
- Specifications: Brand name or equal system shall include but not limited to the minimum:
- One (1) Navigation System Main Console
- One (1) Tracking System (Electromagnetic Tracking System or optical)
- One (1) Navigation‑ready medical‑grade display (24–32 inches)
- Instrument tracking coils or reflectors as applicable
- Navigation-enabled ENT surgical instruments or adapters
- Sterile drapes for navigation sensors and instruments
- All required cabling, power cords, and integration accessories
- Pre-validated software version with all ENT modules licensed
- Compliance with Food and Drug Administration 21 Code of Federal Regulations 820 Quality System Regulation
- Compliance with Veterans Administration cybersecurity and interconnection requirements (Memorandum of Understanding – Interconnection Security Agreement) If applicable
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