PROPATCH SOFT TISSUE REPAIR MATRIX

K101587 · Cryolife, Inc. · FTM · Sep 16, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101587
• Device Name: PROPATCH SOFT TISSUE REPAIR MATRIX
• Applicant: Cryolife, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Sep 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures. ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

Device Story

ProPatch is a surgical mesh derived from decellularized bovine pericardium. The tissue undergoes chemical microbial and viral inactivation, inspection, and terminal sterilization via gamma radiation. The device is a single-layer, 0.6 mm thick matrix provided in a fully hydrated, sterile, non-pyrogenic state, ready for immediate implantation without rinsing. It is used by surgeons in clinical settings to reinforce soft tissues during reconstructive procedures, hernia repairs, or tendon repair surgeries. By providing a structural scaffold, it supports tissue integrity when used in conjunction with sutures or suture anchors, potentially improving surgical outcomes in soft tissue repair.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics and intended use to the predicate device.

Technological Characteristics

Material: Decellularized bovine pericardium. Form: Single-layer surgical mesh, 0.6 mm nominal thickness. Sterilization: Gamma radiation. State: Fully hydrated, sterile, non-pyrogenic. No electronic components or software.

Indications for Use

Indicated for patients requiring soft tissue reinforcement due to weakness (e.g., abdominal/thoracic wall defects, hernias, prolapse) or during tendon repair surgery (e.g., rotator cuff, patellar, Achilles, biceps, quadriceps) using sutures or suture anchors.

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

• ProPatch® Soft Tissue Repair Matrix (K061892)

Submission Summary (Full Text)

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# ProPatch® Soft Tissue Repair Matrix Special 510(k) Submission CryoLife, Inc.

## 510(k) Summary

SEP 1 6 2010

| Submitter: | CryoLife, Inc. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bryan Brosseau<br>Regulatory Affairs Specialist |
| Address: | 1655 Roberts Blvd. NW<br>Kennesaw, GA 30144 |
| Phone: | 770-419-3355 |
| Fax: | 770-590-3783 |
| Date: | June 4, 2010 |
| Trade Name: | ProPatch® Soft Tissue Repair Matrix |
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical (21 CFR 878.3300, Product Code FTM) |
| Predicate Device: | ProPatch® Soft Tissue Repair Matrix<br>K061892 - 11/22/2006<br>CryoLife, Inc.<br>1655 Roberts Blvd. NW<br>Kennesaw, GA 30144 |

#### Intended Use:

ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.

ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

#### Device Description:

ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial

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and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.

ProPatch is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.

## Equivalence to Predicate Device:

:

This submission is related to changes to the ProPatch Instructions for Use and a minor manufacturing change. The indicated uses and technological characteristics are identical to the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

CryoLife, Incorporated % Mr. Bryan Brosseau Regulatory Affairs Specialist 1655 Roberts Boulevard Northwest Kennesaw, Georgia 30144

JUN 22 2012

Re: K101587

Trade/Device Name: ProPatch® Soft Tissue Repair Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM, OXK, OXB, OXH, OXE, OWY Dated: August 25, 2010 Received: August 27, 2010

Dear Mr. Brosseau:

This letter corrects our substantially equivalent letter of September 16, 2010.

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 (PMA). You may, therefore, market the device, subject to the general controls 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.

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 - Mr. Bryan Brosseau

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jo / Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K101587

Device Name: ProPatch Soft Tissue Repair Matrix

Indications for Use:

### Non-Joint Related Repair

ProPatch is indicated for implantation to reinforce soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement, and reconstructive procedures.

### Joint Related Repair

ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Qffice of I

Daniel Kane for WPD
(Division Sign-Off)

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510(k) Number_K101587

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