PERMACOL

K992556 · Tissue Science Laboratories, Plc · FTL · Feb 17, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K992556
• Device Name: PERMACOL
• Applicant: Tissue Science Laboratories, Plc
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Feb 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical and incisional hernias; colon, rectal, urethral and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.

Device Story

Permacol™ is a sterile, acellular, crosslinked porcine dermal collagen and elastin flat sheet. Used as a surgical patch to reinforce or repair soft tissue membranes; applied by surgeons in clinical settings. Device provides mechanical support for hernia repairs, prolapse, and pelvic floor reconstruction. Biocompatible material integrates into host tissue. Clinical benefit includes ease of handling and successful repair of damaged soft tissue.

Clinical Evidence

Clinical experience in several hundred European patients; case histories for 60 patients undergoing various soft tissue repairs. Results demonstrated ease of handling, successful clinical outcomes in nearly all cases, and no product-related adverse effects. Supporting data includes 6-month rat implantation histological evaluation and standard biocompatibility testing (hemolysis, cytotoxicity, systemic toxicity, genotoxicity, sensitization, pyrogenicity).

Technological Characteristics

Acellular crosslinked porcine dermal collagen and elastin flat sheet. Sterile, moist, flexible, fibrous material. Biocompatibility testing performed per FDA memorandum #G95-1. Non-synthetic, biological mesh.

Indications for Use

Indicated for patients requiring soft tissue reinforcement or repair of damaged/ruptured membranes, including hernia repair (abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional), prolapse repair (colon, rectal, urethral, vaginal), muscle flap reinforcement, pelvic floor reconstruction, sacrocolposuspension, and urethral sling procedures.

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

• GraftPatch®
• Rapi-Seal™ Patch
• Biosynthetic Surgical Mesh
• Peri-Guard® family of products
• Glycar Tissue Repair Patch

Submission Summary (Full Text)

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Permacol™ Porcine Collagen Surgical Mesh 510(k) Premarket Notification Submission

FEB 1 7 2000

## 510(k) Summary

Sponsor: Tissue Science Laboratories, PLC Grevholme House Victoria Road Aldershot Hants GU11 1SJ United Kingdom

### Contact Person:

Dr. Allison F. Wren The Wren Group 7124 La Jolla Blvd La Jolla CA 92037 Tel: [phone] Fax: [phone] E-mail: [e-mail]

or

Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, DC 20004 Tel: [phone] Fax: [phone] E-mail: [e-mail]

- Submission July 31, 1999 Date:
- Device Name: Permacol™
- Classification: Polymeric Surgical Mesh

Predicate Devices:

GraftPatch® Rapi-Seal™ Patch Biosynthetic Surgical Mesh Peri-Guard® family of products Glycar Tissue Repair Patch

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### Permacol™ Porcine Collagen Surgical Mesh 510(k) Premarket Notification Submission

Device Description: Permacol™ is a sterile, tough. off-white. moist. flexible, fibrous flat sheet solely comprised of acellular crosslinked porcine dermal collagen and elastin Intended Use: Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for use in the following types of soft tissue repair procedures: abdominal, inquinal, diaphragmatic, femoral, scrotal, . umbilical, and incisional hernias; . colon, rectal, urethral, and vaginal prolapse: muscle flap reinforcement; . . reconstruction of the pelvic floor; sacrocolposuspension; and . . urethral sling. Substantial Equivalence: Permacol™ is substantially equivalent to the predicate devices in terms of its intended use, specific indications, and performance. There are minor differences in the technological characteristics, but laboratory and animal testing as well as clinical experience have shown that these do not raise any new concerns of either safety or effectiveness. Safetv Evaluation: Standard biocompatibility testing was performed according to the FDA-modified matrix recommended in FDA memorandum #G95-1. The product passed all of the following tests: Hemolysis Cytotoxicity - elution method Acute Systemic Toxicity Implantation/Subchronic Toxicity Genotoxicity - Ames Mutagenesis Genotoxicity - Bone Marrow Micronucleus Genotoxicity - Mouse Lymphoma Mutagenesis Sensitization-Magnusson and Kligman Pyrogenicity

2

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| | Permacol™ Porcine Collagen Surgical Mesh<br>510(k) Premarket Notification Submission |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In addition to standard biocompatibility testing, a histological<br>evaluation of the material after implantation in rats for 6<br>months demonstrated that Permacol™ is safe and well<br>tolerated. |
| Clinical<br>Evaluation: | Clinical experience in several hundred patients in Europe<br>also has demonstrated that Permacol™ is safe and well<br>tolerated. Case histories for 60 patients undergoing a<br>variety of soft tissue repair procedures demonstrate that<br>Permacol™ is easy to handle, and successful clinical<br>outcomes were achieved in nearly all cases. No<br>product-related adverse effects were noted in any of the<br>procedures. |
| Conclusions<br>Drawn: | Permacol™ is biocompatible, safe and effective for its |

intended use.

\\\DC - 59177/1 - 0790126.01

The Wren Group on Behalf of Tissue Science Laboratories, PLC Aldershot, UK

:

.

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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three overlapping lines that form a shape similar to a bird in flight or a stylized human figure.

#### Public Health Service

# FEB 1 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tissue Science Laboratories, PLC c/o Mr. Howard M. Holstein, Esq. Hogan & Hartson, LLP 555 Thirteenth Street, N.W. Washington, D.C. 20004

K992556 Re: Trade Name: Permacol™ Regulatory Class: II Product Code: FTL Dated: December 22, 1999 Received: December 22, 1999

### Dear Mr. Holstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Howard M. Holstein, Esq.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil K.R. Ogden

ದ್ದಾಗಿ Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K992556 |
|---------------------------|-----------|
| Device Name: | Permacol™ |

Indications for Use:

Permacol™ is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical and incisional hernias; colon, rectal, urethral and vaginal prolapse; muscle flap reinforcement; reconstruction of the pelvic floor and procedures such as sacrocolposuspension and urethral sling.

| | <i>NRO for JZD</i> |
|-----------------------------|--------------------|
| (Division Sign-Off | |
| Division of General Devices | |
| 510(k) Number | K992556 |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

| Prescription Use | |
|----------------------|--|
| Use | |
| (Per 21 CFR 801.109) | |

Over-The-Counter

(Optional Format 1 - 2.96) (Form prepared by The Wren Group)