Single Source Justification Medtronic PTeye_Redacted.pdf

Revision: 01 Effective Date: 11/15/2024 Acquisition ID# 36C248-25-AP-3707

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:

1. Contracting Activity: Department of Veterans Affairs, VISN 08, James A. Haley

Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL, 33596. 2237:

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Medtronic PTeye Parathyroid detection system is an intraoperative probe-based near-infrared autofluorescence (NIRAF) detection system. James A. Haley Veterans’ Hospital Surgeons currently perform thyroidectomy and parathyroidectomy using a combination of preoperative imaging, intraoperative ultrasounds, frozen sections, and intraoperative Parathyroid Hormone (PTH) monitoring. Primarily used in the operating room, the Medtronic PTeye Parathyroid detection system works by emitting light at wavelengths suitable for stimulating native fluorescence in biological tissues from a small probe to allow for in vivo and ex vivo real-time detection and confirmation of parathyroid tissue.

Parathyroid glands, due to their biochemical composition, emit a distinct autofluorescence when illuminated by this light emitting probe. The system then captures and analyzes the emitted fluorescence in real-time. This system will enable physicians to detect parathyroid tissue quickly and accurately during surgical procedures.

The estimated amount is between .

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Medtronic PTeye Parathyroid detection system is unique and highly specialized equipment that helps physicians differentiate between parathyroid glands and other tissues. The technology identifies normal and pathologic parathyroid tissue making it useful for parathyroidectomy and thyroidectomy. This PTeye parathyroid detection system will contribute to reducing surgical errors by confirming the tissues targeted for removal and protecting healthy parathyroid tissues. This aids in preventing the complication of permanent hypoparathyroidism, which leads to hypocalcemia. Hypocalcemia or low calcium levels can cause numbness in fingers and toes, muscle cramps in legs and feet, irritability, and seizures. This problem causes long-term complications related to bone and kidney health and is hard to manage on a day-to-day basis. For this reason, it can lead to life-threatening heart arrhythmias due to fluctuations in calcium levels in the blood. In a sensitive patient population, such as Veterans, preserving parathyroid tissues and their functions is essential to patient health and well-being. The PT Eye machine may help reduce the risk of postoperative

Revision: 01 Effective Date: 11/15/2024 Acquisition ID# 36C248-25-AP-3707 hypoparathyroidism. The facility’s primary goals are to maintain high quality care, standardize and improve safety, more effective and efficient use of staff and overall improvement in patient care. By procuring the Medtronic PTeye Parathyroid detection system, a device that is proven to decrease surgical error and increase accuracy, medical care can be improved.

This is a brand name only requirement as this technology and its capabilities are limited to Medtronic, as it is the first and only dye-free parathyroid detection system on the market.

This physical equipment and supplies necessary to enable the required functional characteristics of a near infared autofloursecence parathyroid laser probe detection system for real time identification of parathyroid tissue without the use of dyes consists of:

MPN Description Quantity PT102 Basic PTeye bundle 1 PTEYE Console 1 PTEYE-2 Footpedal 1 PTEYE-3 Power supply (120v – 240v) 1 PTEYE-4 Power cord 1 PTEYE-1 Fiber optic probe 1

4. Description of market research conducted and results or statement why it was not conducted: Searching contractdirectory.gov produced no results. Searching FPDS produced only two similar results, one purchase sole source to the OEM and one purchase as a small business set-aside. Searching the VA Supply Chain Master Catalog found one Service Disabled Veteran Owned Business (SDVOSB).

An email was sent to the OEM Medtronic asking if there are any authorized distributors for the PTEye Bundle and fiber optic probe. Medtronic confirmed four authorized Service Disabled Veteran Owned Businesses. The NAICS code selected for this procurement is 334510 due to its characteristics of having a laser incorporated. The non-manufacturing rule is waived by the SBA for NAICS code 334510. Since at least two SDVOSBs can distribute the items requested this requirement will be posted as SDVOSB Set-aside brand name only requirement on sam.gov.

5. Contracting Officer's Certification: Purchase is approved in accordance with

FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Officer Date