DRAFT W81K0224Q0030 SOW.pdf

W81K0224Q0030 Statement of Work For

Excelsius GPS

I. INTRODUCTION

This action is for the procurement of two minimally invasive surgical robot systems for performing delicate spinal surgery within Defense Health Agency (DHA) medical Treatment Facilities (MTF). The contractor shall supply two

(2) spinal robotic systems to support DHA mission requirements. One system to be delivered to Madigan Army Medical Center in Fort Lewis, Washington and one system to be delivered to Mike O’Callaghan Military Medical Center at Nellis Air Force Base, Nevada.

The Excelsius GPS Robotic Navigation System will be utilized in the Sterile Processing Department at the Mike O’Callaghan Federal Hospital (MOFH) at Nellis Air Force Base, NV, and Madigan Army Medical Center (MAMC) at Joint Base Lewis-McChord, WA.

II. BACKGROUND

MOFH and MAMC provides preventative, emergency, and acute care services for approximately 78,000 beneficiaries to include active duty, Guard, Reserve, NATO, retirees, VA, and all eligible dependents. This equipment is needed in the Ortho Spine Program to improve patient care capabilities.

The Excelsius GPS System is a robotic guided spine system with Excelsius surgical instruments that is used to treat multiple spine pathologies. It is used pre-operatively and intra-operatively to plan spinal procedures of both acute and chronic spinal morphology. It is used for both diagnostic and intervention applications, including identification vertebral anatomy and deformities. It can read CT imagery and allows the surgeon to accurately measure disc space to execute surgery in a precise manner avoiding future revisions. This system will be used to assist in the safe and accurate placement of pedicle screws during spine fusion surgeries. It will assist in the placement of minimally invasive (MIS) percutaneous pedicle screws without the use of excessive radiation or the extra cost and steps of using K-Wires, Jamshidis, or cannulated pedicle screws. This system will allow for 100% accuracy of implant placement of spinal cases. This system will facilitate the wider adoption of Minimally Invasive Spine Surgery (MIS) which we believe to be safest and best form of care for our patients.

III. SCOPE

The overall purpose of this requirement is to provide the government delivery of two Excelsius GPS Spine Robot Systems to MAMC and MOFH. The Excelsius GPS Spine Robot will be in the operating room at each facility. The software for this device is included with the procurement of spine robot system.

IV. WORK REQUIREMENTS

The contractor shall deliver, install, and provide training for the Excelsius GPS system to ensure the systems function as designed.

a. The contractor shall provide all equipment, software, and complete the install. Installation will not be marked complete until the contractor submits letter of readiness to inspect, and the COR ensures the system functions as designed.

b. The contractor shall provide Excelsius GPS 101 Surgeon Training, a one-day Excelsius certification training, which includes didactic and cadaveric training. The training shall provide an in-depth cadaver lab experience for the Surgeon to gain experience and knowledge on the system, instruments, and workflows. The training should teach the start-to-finish operations of the Excelsius GPS to include system setup, software troubleshooting, and procedural workflows.

c. The contract shall provide Excelsius GPS Staff Training Overview, an in-service training class onsite that provides a comprehensive review of system components, system setup, image acquisition, and the spine surgical workflow. This training shall focus on incorporating Excelsius GPS into the current spine procedure workflow and include cervical, thoracic, lumbar, sacroiliac, and lateral approaches.

d. The contractor should provide all documentation related to certification after completion of training.

e. The Contractor shall deliver the following Excelsius GPC Spine Robot system, including the following part numbers to MAMC:

Item Description

Quantity

6143.1001 Excelsius GPS 1

6258.2100 Laptop Kit, Drive 1

6143.2103 Fluoroscopy Registration Fixture 12 inch 1

6143.2501 End Effector, 15mm 3

999.893 Spine Software Module 1

999.894 Fluoroscopy Registration Fixture 12 inch 1

9143.9002 Navigation GPS Set 3

9143.2514 End Eflector & PTA 15mm 3

6143.2545 Intra-Op CT Registration Fixture 3

6143.2546 Intra-Op CT Registration Fixture Pivot Arm 3

9143.9004 CREO Amp GPS 2

9143.9005 CREO MIS GPS 2

9143.9008 SI-LOK, GPS 1

9143.9009 Ellipse & Quartex GPS 1

9143.9013 Globus Power, GPS Instrument Set 2

9143.9002 Navigation GPS Set 2

6143.2001S Arm Drape 10 CT 2 6143.2003S Monitor Drape, 20 CT 1 6143.2582S High Speed Drill Bit 3.5mm, GPS 4 6143.2584S High Speed Drill Bit 4.5mm, GPS 6

6143.2659 CREO AMP Cannulated Modular Screwdriver 2

6143.2602 Pedicle Probe Straight GPS 2

6143.2655 CREO 5.5 Rigid Screwdriver Thread GPS 2

6143.2651 CREO 5.5 Rigid Screwdriver GPS 2

f. The Contractor shall deliver the following Excelsius GPC Spine Robot system, including the following part numbers to MOFH:

Item Description

Quantity

6143.1001 Excelsius GPS 1

6258.2100 Laptop Kit, Drive 1

6143.2103 Fluoroscopy Registration Fixture 12 inch 1

6143.2501 End Effector, 15mm 3

999.893 Spine Software Module 1

999.894 Fluoroscopy Registration Fixture 12 inch 1

9143.9002 Navigation GPS Set 3

9143.2514 End Eflector & PTA 15mm 3

6143.2545 Intra-Op CT Registration Fixture 3

6143.2546 Intra-Op CT Registration Fixture Pivot Arm 3

9143.9004 CREO Amp GPS 2

9143.9005 CREO MIS GPS 2

9143.9008 SI-LOK, GPS 1

9143.9009 Ellipse & Quartex GPS 1

9143.9013 Globus Power, GPS Instrument Set 2

9143.9002 Navigation GPS Set 2

6143.2001S Arm Drape 10 CT 2 6143.2003S Monitor Drape, 20 CT 1 6143.2582S High Speed Drill Bit 3.5mm, GPS 4 6143.2584S High Speed Drill Bit 4.5mm, GPS 6

6143.2659 CREO AMP Cannulated Modular Screwdriver 2

6143.2602 Pedicle Probe Straight GPS 2

6143.2655 CREO 5.5 Rigid Screwdriver Thread GPS 2

6143.2651 CREO 5.5 Rigid Screwdriver GPS 2

g. Warranty Period: IAW the Contractor’s standard commercial warranty terms, the contractor guarantees the Excelsius GPC Spine Robot systems delivered under this contract for a period of 12 months from the date of completed installation acceptance IAW Section IV Paragraph a.

V. TECHNICAL

The contractor shall be certified to repair Excelsius GPS Spine Robot during the warranty period. The contractor will respond to warranty repairs via telephone within 4 hours and have a field service Engineer onsite within 24 hours of initial notification by the government. Out of warranty maintenance specifications will be addressed in a separate service maintenance agreement between the Government and the Contractor.

VI. SECURITY REQUIREMENTS

The contractor must comply with all Nellis AFB and Fort Lewis security requirements.