MTF FASCIA

K120479 · Musculoskeletal Transplant Foundation · OWY · Nov 8, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120479
• Device Name: MTF FASCIA
• Applicant: Musculoskeletal Transplant Foundation
• Product Code: OWY · General, Plastic Surgery
• Decision Date: Nov 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MTF Fascia is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. It is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. MTF Fascia is for single patient use only.

Device Story

MTF Fascia is a dehydrated, decellularized human allograft fascia reinforced with a resorbable Poly-L-Lactic Acid (PLLA) fiber. The device is used by surgeons during tendon repair procedures to reinforce soft tissues repaired by sutures or anchors. It requires rehydration prior to use. The device does not provide primary mechanical strength; this is provided by the sutures and bone anchors. The allograft component preserves the extracellular matrix, while the PLLA fiber enhances suture retention. The device is intended for single-patient use.

Clinical Evidence

No clinical human trials. Evidence includes bench testing (ISO 10993 biocompatibility, cytotoxicity, PLLA fiber testing), animal studies for subchronic toxicity, and literature-based comparisons to predicate devices.

Technological Characteristics

Dehydrated, decellularized human allograft fascia reinforced with resorbable Poly-L-Lactic Acid (PLLA) fiber. Aseptically processed (no terminal sterilization). Complies with USP sterility and LAL endotoxin limits. Requires rehydration before use.

Indications for Use

Indicated for reinforcement of soft tissues during tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons). Not for replacing normal body structure or providing primary mechanical strength for tendon repair.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• OrthADAPT® PR (K090288)
• Synthasome X-Repair (K083307)

Submission Summary (Full Text)

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NOV

8 2012

#### K120479 510(k) SUMMARY (Per 21 CFR 807.92)

#### General Company Information

Name: Contact:

Musculoskeletal Transplant Foundation Nancy Joy Senior Regulatory Affairs Submission Specialist

Address:

125 May Street Edison, NJ 08837 USA

Telephone: Fax:

[phone] [phone]

## Date Prepared

November 5, 2012

### General Device Information

Product Name:

MTF Fascia

Classification:

Surgical Mesh 21 CFR §878.3300 - Product codes: OWY, OWW Class II

### Predicate Devices

OrthADAPT® PR Pegasus Biologics, Inc 510(k) K090288

Synthasome X-Repair Synthasome, Inc. 510(k) K083307

#### Description

MTF Fascia is dehydrated, decellularized human allograft fascia minimally processed to preserve the extracellular matrix of the fascia. The fascia is reinforced with a resorbable Poly-L-Lactic Acid (PLLA) fiber woven into the fascia to enhance suture retention of the fascia. MTF Fascia is aseptically processed-no terminal sterilization is conducted. The device passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for medical devices. The device must be rehydrated prior to use following the procedures described in the Instructions for Use.

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#### Intended Use (Indications)

MTF Fascia is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. It is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. MTF Fascia is for single patient use only.

### Substantial Equivalence

This submission supports the position that the MTF Fascia is substantially equivalent to two previously cleared devices:

OrthADAPT® PR - Pegasus Biologics, Inc. [K090288] Synthasome X-Repair - Synthasome. Inc. [K083307]

MTF Fascia is substantially equivalent to Synthasome X-Repair in material and biomechanical and histologic outcomes obtained from both clinical (cadaver) and preclinical in vivo models. MTF Fascia is substantially equivalent to OrthADAPT PR in indication for use, and both devices are composed of a collagen matrix reinforced with a polymer component.

The clinical (cadaver) and preclinical tests demonstrated the biocompatibility and substantial equivalence of MTF Fascia in comparison to its predicate devices:

- ISO 10993 testing of the PLLA fiber .
- Cytotoxicity Study Using the ISO Elution Method .
- Risk Analysis for MTF Fascia .
- . Established history of using the material components of the device
- . Published literature
- Animal studies were included in this 510(k) submission to serve as . subchronic toxicity tests for MTF Fascia. In addition, a cytotoxicity study has demonstrated that MTF Fascia is not cytotoxic.
- Data presented in peer-reviewed journals and submitted within this 510(k) . supported a finding of substantial equivalencies between MTF Fascia and Synthasome X-Repair.

The MTF Fascia has been demonstrated to be substantially equivalent to its predicate devices.

#### Safety Information

MTF Fascia is single-donor processed. This device was not subjected to terminal sterilization. MTF Fascia is aseptically processed and passes USP <71> Sterility Tests. The donor suitability criteria used to screen this donor are in compliance with the FDA regulations published in 21 CFR Part 1271 Human Cells, Tissues, And Cellular and Tissue Based Products, as applicable.

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## Conclusion

Musculoskeletal Transplant Foundation believes that the information provided in this 510(k) submission establishes that similar legally marketed devices have been used for the same clinical applications as MTF Fascia. The materials from which MTF Fascia is fabricated have an established history of use, and the device has been tested in accordance with applicable FDA guidelines.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Musculoskeletal Transplant Foundation % Hogan and Hartson, LLP Ms. Nancy Joy Senior Regulatory Affairs Submission Specialist 555 Thirteenth Street, Northwest Washington, District of Columbia 20004-5794

Re: K120479

Trade/Device Name: MTF Fascia Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OWY, OWY, OWW Dated: September 27, 2012 Received: September 28, 2012

November 8. 2012

Dear Ms. Joy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Nancy Joy

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

#### Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# V. INDICATIONS FOR USE

510(k) Number (if known): not known

Device Name: MTF Fascia

Indications for Use:

MTF Fascia is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

MTF Fascia is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

MTF Fascia is for single patient use only.

Prescription Use X OR (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krave for WM
(Division Sign-Off)

Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K120479

Confidential