P03 FAR 13.5 Justification SAT Redacted.pdf

Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24

REVISION: 01

Acquisition ID#: 36C249-25-AP-2883

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR

CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C249-25-AP-2883

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Integrated Services

Network (VISN 09), Network Contracting Office (NCO) 9, Robley Rex VAMC, 800 Zorn

Ave Louisville, KY 40206.

PR/2237: 603-25-4-175-0074

2. Nature and/or Description of the Action Being Processed:

This procurement is for brand name products set forth in section 3 below to be awarded under a firm-fixed price contract in accordance with (IAW) FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation

Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. The requested equipment below is a lease of spinal surgical system for Robley

Rex VAMC Surgical Services neurosurgery program.

3. Description of Supplies/Services Required to Meet the Agency�s Needs:

Requested equipment are items peculiar to the following manufacturer Medtronic USA Inc

(Large Business). These items are to be leased and used at the Robley Rex VAMC Surgical for 3 years until the completion of the new hospital, at which time it will be readdressed for a new requirement.

Equipment Included in Rental Agreement

Item Number Item Description QTY

MAZORXRGSUS Mazor X Robotic Guidance System 1

MAZORSTEALTH Mazor X Stealth Navigation Camera Cart 1

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Acquisition ID#: 36C249-25-AP-2883

CART and Software

KIT0762 KIT0762 MAZOR X BONE MOUNT SET 1

MAZORXGENINS

T

Mazor X Stealth Edition General Spine Instruments

REFFRAMEKIT Mazor X Stealth Ed Reference Frame Kit 2

NAVTRACKERKI

T

Stealth Navigation Tracker Kit 2

MAZORX5.5/6.0D

RIVE

Mazor X Stealth Edition 5.5/6.0 Screwdriver

MAZORX4.75DRI

VER

Mazor X Stealth Edition 4.75 Screwdriver 2

MAZORXBALLA

STDRIVE

Mazor X Stealth Edition Ballast 2

MAZORX5.5/6.0E

XT

Mazor X Stealth Edition 5.5/6.0 Specialty Screwdrivers

MAZORX4.75EXT Mazor X Stealth Edition 4.75 Specialty 2

MAZORMIDASM

R8INS

Mazor X Navigated Midas MR8 Full Set (Attachment only)

BI70002000 O-ARM SYS BI70002000 O2 1

BI75000027 CONFIG BI75000027 O2 SYS NAV

INTERFACE

BI75000024 KIT BI75000024 MVS PRINTER FIELD

INSTALL

BI75000034 CONFIG BI75000034 O2 MULTI FIELD

OF VIEW

BI75000030 CONFIG BI75000030 O2 ADVANCED

VIEWING

BI75000031 CONFIG BI75000031 O2 ISOWAG

ROTATION

BI75000032 CONFIG BI75000032 O2 COLLIMATED

AXIAL 3D

BI75000033 CONFIG BI75000033 O2 ENHAN CRAN

3D EC3D

BI75000029 CONFIG BI75000029 O2 HI DEF 3D

HD3D

BI75000035 CONFIG BI75000035 O2 STEREOTAXY 1

BI75000045 CONFIG BI75000045 O2 2D LONG

FILM

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Acquisition ID#: 36C249-25-AP-2883

M072707M015 S8 New 1

9735740 SW KIT 9735740 S8 2.1 SPINE EU-SC 1

9736428 REF SET 9736428 SPINE

REFERENCING

9735502 UPGRADE SET 9735502 PERC PIN 2

9735465 TAPS KIT 9735465 SOLERA AWL TIP

TAPS

9735283 INST SET 9735283 SOLERA 5.5/6.0

DRVR

9734833 INST SET 9734833 UNIVERSAL

NAVLOCK

9735737 SW KT 9735737 STEALTH S8 1.3.2

CRANIAL

9735743 SFW 9735743 STEALTH 3D CRANIAL 1

9735921 SW KIT 9735921 S8 2.1 DBS STRT EU-E 1

9736423 SW KIT 9736423 S8 2.1 TRACTOG EU-E 1

9733935 INST SET 9733935 CRANIAL PASSIVE 2

9731965 PROBE 9731965 BALL TIP ASSY -

4.3MM

9733157 PROBE 9733157 NAVIGUS 2

9730269 PROBE 9730269 MICROSCOPE 2

9735955 EM KIT 9735955 S8 CRANIAL ACC 1

9735745 SFW 9735745 S8 STEALTHMERGE 1

M072707M017 S8 Planning Station 1

9735916 SW KIT 9735916 S8 2.1 CRAN PS EU-

SC

9736426 SW KIT 9736426 S8 2.1 TRACTOG 2ND

EU-E

EK001 KIT INTEGRATED POWER CONSOLE

NT

EK800 KIT MIDAS REX MR8 ELECTRIC

MOTOR

EK800N KIT MIDAS MR8 ELEC MOTOR

STEALTH-MIDAS

MR8-AD03 ATT MR8-AD03 MR8 PERFORATR

DRVER 1000RPM

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Acquisition ID#: 36C249-25-AP-2883

MR8-ASMC09 ATT MR8-ASMC09 MR8 9CM METAL

CUT 3.2MM

MR8-AF01 ATT MR8-AF01 MR8 FOOTED F1 B5

2.4MM

MR8-AF02 ATT MR8-AF02 MR8 FOOTED F2 B1

2.4MM

MR8-AF03 ATT MR8-AF03 MR8 FOOTED F3 S1

3.2MM

MR8-AS07 ATT MR8-AS07 MR8 7CM STRAIGHT

2.4MM

MR8-AVA14 ATT MR8-AVA14 MR8 14CM VAR ANG

3.2MM

MR8-AVS15 ATT MR8-AVS15 MR8 15CM VAR STR

2.4MM

MR8-AVS14 ATT MR8-AVS14 MR8 14CM VAR STR

3.2MM

EK810 KIT MIDAS REX MR8 ELECTRIC

TOUCH MOTOR

EA815 ACCY EA815 MR8 ELECTRIC

CONTROL SWITCH

The estimated delivery for these items is 30 days after receipt of order (ARO).

NOTE: None of the items in this lease agreement are disposable/consumables and those items must be procured through other contracting methods or via Government Purchase Card if under the Micro purchase Threshold.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

5. Demonstration that the Contractor�s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The Robley Rex VAMC Surgical Services is requesting brand name, Mazor X Robotic Guidance System as a leased item for a base plus two-year option agreement by Medtronic due to many specific qualities which best meet the service�s needs. Currently, the surgical clinic is outsourcing approximately 6-7 cases per week over the last four years, which costs

REVISION: 01

Acquisition ID#: 36C249-25-AP-2883 approximately $60,000 per case. This results in a cost of $21,840,000.00 per year if we continue to outsource.

The Mazor robotic guidance system combines surgical navigation with operative planning so you can perform spinal surgery more efficiently. The system makes it efficient and intuitive to plan and simulate your cages and screws for a more efficient procedure. The automatic recognition feature allows visualize spinal elements in relation to one another, and an enhanced interface delivers fast and seamless access. It also features a locking mechanism that rotates to tighten the connection between the attachment and the motor to ensure navigation stays accurate throughout the case. The robotic system works with the O-arm surgical imaging system and Stealth Station navigation system. Together it uses 3D planning and robotic guidance to assist surgeons in placing implants and instruments during procedures, potentially leading to less invasive surgeries, faster recovery, and improved clinical outcomes.

The equipment is needed to complete spinal surgeries. This equipment is intended to provide real time, intra-operative imaging for the surgeon to visualize the patient�s anatomy when installing hardware (screws and rods). The unique robotic system is used to enhance the precision of the procedures. The O-arm surgical imaging system is an interoperative 2-D/3-D imaging device that can help confirm alignment and accuracy during spinal procedures. The Stealth Station navigation system provides robust image-guided navigation, enabling precise localization and minimizing the margins of error in both brain and spine surgeries.

While there are similar systems available, they do not perform the same functions as this equipment. For instance, companies like Intuitive Surgical, primarily known for their da Vinci Surgical System, specialize in robotic assisted minimally invasive surgeries but do not offer the same advanced intraoperative imaging and navigation solutions combined with the precision robotics for spinal surgery that Medtronic does.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Market research was conducted and the effort did not yield any additional sources that could meet the government�s requirement. This is a sole source action and there is no competition anticipated for this requirement.

A Sources Sought Notice (SSN) 36C24925Q0431 was posted on sam.gov Contract Opportunities from 08/13/2025 to 08/18/2025, with no responses from any interested parties identifying any other domestic brand and model that are capable of meeting or being able to modify their product to meet this requirement. The contracting officer determined that a shorter response time was necessary IAW FAR 5.203(b). The response time was due to the end of fiscal year 25 in which the funds are committed.

1) Veterans� Healthcare Supply Solutions (SDVOSB)- Mazor X Robotic Guidance System � Purchased through ECAT contract SPE2DE-24-D-A006. This is not leased.

2) Begini Howard Private Equity (BHPE) LLC (SDVOSB)- Responded as an interested vendor. There was no indication of the item purposed.

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Acquisition ID#: 36C249-25-AP-2883

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Fair and reasonable will be determined via one of the basis for award found under FAR 13.106-3 prior to contract award.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition. Market research consisted of the following:

reviewed the results of recent market research undertaken to meet similar or identical requirements; queried commercial and the Government-wide database of contracts and other procurement instruments intended for use by multiple agencies; participated in interactive, on-line communication among industry, acquisition personnel, and customers; reviewing catalogs and other generally available product literature published by manufacturers, distributors, and dealers or available on-line.

Market research was not able to identify domestic commercial products that can meet this requirement. Market research found the Medtronic Mazor X Robotic Guidance System is the only system capable of meeting the VA�s requirement. The Buy American Act (BAA) does apply. Research revealed the Stealth Station navigation system is manufactured in the United States. The Mazor robot is manufactured in Israel and the O-arm is manufactured in Mexico. The government is seeking a BAA nonavailability waiver for the Mazor and the O-arm to include hardware and software for these systems.

The NMR does not apply to Medtronic (Large Business) because they are the manufacturer of the Mazor robotic guidance system.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Medtronic will be solely responsible for installing and maintaining the Equipment and shall keep the Equipment in good mechanical condition and running order, normal wear and tear excepted. Medtronic shall, during the leasing term, provide any necessary repairs to Equipment at no charge to the Customer. All parts, attachments, accessories, repairs, substitutions and replacements made to or placed upon the Equipment shall become part of the Equipment and shall be and remain the property of Medtronic.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Medtronic USA Inc. (Large Business) has expressed interest in providing the exact equipment requested to meet this requirement.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any