Attachment No. 5 SOW.pdf

Draft - Statement of Work (SOW)

Background This procurement is to support regulatory science tool development for novel sacroiliac joint fusion devices in the Orthopedics program area. The Office of Health Technologies

– 6 (Orthopedic Devices) has noticed a substantial increase in submissions of in-line sacroiliac joint devices, which provide a minimally invasive posterior approach for implantation. However, this is an emerging technology with only five such devices cleared till date. The unique design approach of each of these devices has required applying non-standardized special controls during regulatory review (biomechanical evaluation via cadaver testing). However, lack of standardization of such techniques has resulted in lengthy regulatory reviews. Further, it remains unclear whether female SIJ biomechanics are considered during device design. The novel study design and methodologies employed in this study will provide an invaluable set of data which will substantially reduce the burden on innovators, manufacturers, and regulatory reviewers.

To satisfactorily solve these unknown regulatory review challenges, the Division of Applied Mechanics Orthopedics program area has proposed a study that will address these knowledge gaps investigating the biomechanical response of the female and male sacroiliac joints under a variety of physiologically relevant loading and boundary conditions to develop a female-specific cadaver testing protocol.

To develop a reliable cadaver testing protocol, we need to procure 9 female pelvic cadaver specimens. This will allow us to publish a validated cadaver testing protocol for novel sacroiliac joint devices. The regulatory science tools stemming from this work with directly support the Center of Devices and Radiological Health mission of protecting and promoting public health by using applied mechanics to investigate interactions between medical devices and the human body.

Objectives The overall objective of the requirement is to develop optimized female-specific cadaver testing protocols that can be used by medical device manufacturers to assess bone-implant interface integrity of sacroiliac joint fusion devices.

The expected goal is to identify the ideal mechanical protocol to thoroughly investigate any sacroiliac joint fusion device requesting marketing approval.

If the contract is successful, we will receive 9 female pelvic cadavers per the requirements.

SOW

Tasks The 9 female pelvic cadaver specimens must meet both general and specific requirements:

GENERAL REQUIREMENTS

• All cadaveric donors, from which the specimens are extracted, must be tested at a minimum for Hepatitis B, Hepatitis C, Human Immunodeficiency Virus 1, Human Immunodeficiency Virus 2, Tuberculosis, and Covid-19. All donors must have negative results, and a written certificate of testing results must accompany each specimen.

• Shipping method must ensure that specimens arrive undamaged, in intact condition, and frozen with uncompromised tissue integrity.

• All specimens will be subject to inspection upon receipt. If they fail to meet requirements, they will not be counted towards the total number of required specimens.

• Any data provided about the cadaveric donors cannot include personally identifiable information.

• Support: Available during normal business hours

• Quotes must Include all Shipping and Handling costs.

SPECIFIC REQUIREMENTS

Pelvic Cadaver Specimens from Female Donors

• Number of pelvic specimens required: 9

• Full pelvic cadaver specimens with both proximal femurs intact and lumbar spinal levels L3, L4, and L5 intact. The proximal femurs are cut 6 inches distal to the inner groin.

• The pelvis specimens must come from a cadaveric donor born as female.

• All organs eviscerated.

• All supporting ligaments and joints left intact including hip joint. Muscle can be removed but ligaments cannot be damaged.

• No diagnosis/history of bone disease or any treatment history that would affect bone quality.

• Age range of cadaveric donor: 21-75 years

• Specimen condition: Fresh frozen

Delivery The Contractor shall deliver 9 female pelvis cadaver per requirements within 120 days of award. The contractor will ship three samples at a time resulting in a total of 3 shipments (total of 9 samples delivered). All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in acceptable condition.

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) N/A

Security

Travel

Special Material Requirements

Other Unique Requirements

Place of Performance

SHIP TO:

US FDA CDRH

Division of Applied Mechanics Attention: Snehal Shetye 10903 New Hampshire Avenue

WO62 RM 2118

Silver Spring, Maryland 20993

PH: 240-402-0514

Email: Snehal.Shetye@fda.hhs.gov

Period of Performance It is requested that the specimens be delivered 3 at a time over a period of 4 months after award of contract. This will result in a total of 3 shipments and 9 specimens (9 female).

The work is expected to be completed in the 1st year after receiving of last shipment.

Point of Contact

Contracting Officer’s Representative (COR) Todd Johnston Email: Todd.Johnston@fda.hhs.gov mailto:Todd.Johnston@fda.hhs.gov

Technical Point of Contact (TPOC) Snehal Shetye Email: Snehal.Shetye@fda.hhs.gov Phone # 240-402-0514 mailto:Snehal.Shetye@fda.hhs.gov