PERMACOL SURGICAL IMPLANT

K043366 · Tissue Science Laboratories, Plc · FTL · Dec 17, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K043366
• Device Name: PERMACOL SURGICAL IMPLANT
• Applicant: Tissue Science Laboratories, Plc
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permacol® Surgical Implant is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

Device Story

Permacol® Surgical Implant is a crosslinked porcine dermal collagen mesh used as a soft tissue patch. It is implanted by surgeons during surgical procedures to reinforce or repair abdominal wall defects and hernias. The device provides a scaffold for tissue repair. It is used in clinical settings (OR) by physicians. The device benefits patients by providing structural support to weakened or ruptured soft tissue membranes, facilitating healing and hernia repair.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed that materials are non-toxic and non-sensitizing to biological tissues. Laboratory testing verified that the device meets performance requirements for its intended use in surgical repair.

Technological Characteristics

Crosslinked porcine dermal collagen mesh. Device is a soft tissue patch used for reinforcement. Characteristics include specific dimensions and thickness consistent with predicate surgical meshes. Sterilization and specific material standards are not detailed beyond the collagen source.

Indications for Use

Indicated for the surgical repair of abdominal wall defects and hernias, including parastomal hernias, in patients requiring soft tissue reinforcement or repair of ruptured soft tissue membranes.

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

• Permacol® Crosslinked Porcine Dermal Collagen Surgical Mesh (K992556)
• BioSurgery Sponges (K980431)
• Cook Biotech Inc. SurgiSIS™ (K980431)
• Bard's® CK Parastomal Hernia Patch (K042026)

Submission Summary (Full Text)

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K043366\$_{Pi/2}\$

### 510(k) SUMMARY

DEC 17 2004

## Tissue Science Laboratories, plc's Permacol® Surgical Implant Crosslinked Porcine Dermal Collagen Mesh

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Victoria Taylor Tissue Science Laboratories, plc 1141 Clark Street, Suite D Covington, GA 30014 Phone: [phone] [phone] Fax: Email: [e-mail]

Contact Person: Victoria Taylor

December 06, 2004 Date Prepared:

# Name of Device and Name/Address of Sponsor

Tissue Science Laboratories, plc 7th Floor, Victoria House Victoria Road Aldershot Hampshire GU111 1EJ United Kingdom

# Common or Usual Name

Surgical Mesh

## Classification Name

Surgical Mesh

#### Predicate Devices

Permacol® Crosslinked Porcine Dermal Coilagen Surgical Mesh (K992556), BioSugar Sungers (19), Cross 110), Box 1002162), Cook Biotech 1 V ascular Inc S Supple Felf-Guard® (11705163).
SurgiSIS™ (K980431) and Bard's® CK Parastomal Hernia Patch (K042026).

## Intended Use

Permacol® Surgical Implant is intended for use as a soft tissue patch to reinforce Permiacol® Surgical implant is intensed or ruptured soft tissue

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K043366

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membranes. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

# Technological Characteristics and Substantial Equivalence

Permacol® is substantially equivalent to its predicates because it has the same intended use and very similary equivalent with to tax to the soft tiseve intended use and very simmal teenge of surgical procedures for soft tissues and are intended for use in a broad fange of saige of saige of Sarge of Service, includes include repairremforcement. Permacol® and Burd 50 Corrent wall defects and hernias, including parastomal hernias.

The technological characteristics of Permacol® are very similar to its predicate The technological characteristics of I climits on I cimensions, technological characteristics, and thickness.

## Performance Data

Biocompatibility and bench testing have been completed and support the safety and effectiveness of the Permacol® Surgical Implant for its intended use.

The biocompatibility test results show that the materials used in the design and manufacture of the device are non-toxic and non-sensitizing to biological tissues manufacture of the device are non toxic and new teen tresults demonstrate that the materials materials consistent with then michded use. Laboratory termacol® Surgical Implant will meet chosen and the design unfized in manufacturing i critation of tormance during their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines above a wavy line.

Public Health Service

DEC 17 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Victoria Taylor Associate Director of Regulatory Affairs Tissue Science Laboratories plc North American Division 1141 Clark Street, Suite D Covington, Georgia 30014

Re: K043366

Trade/Device Name: Permacol® Surgical Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Polymeric surgical mesh Regulatory Class: II Product Code: FTL Dated: December 6, 2004 Received: December 8, 2004

Dear Ms. Taylor:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave rowled 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 for use stated in the encrease, 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). and cosmetie fore, 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 (PMA), 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 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); good manufacturing practice requirements as set 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.

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Page 2 - Ms. Victoria Taylor

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with and my of substantial equivalence of your device 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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# K043366

# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Permacol® Surgical Implant Device Name:

Indications for Use:

Permacol® is intended of use as a soft tissue patch to reinforce soft tissue where weakness exists Pennacol® is intended of ass a box or ruptured soft tissue membranes. It is specifically alld for the surgical repair of damages wall defects and hernias, including but not limited to parastomal hernias.

Prescription Use _ V (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, Office of Device Evaluation (ODE)

iriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K643366
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