PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150

K050355 · Tissue Science Laboratories, Plc · PAI · Mar 9, 2005 · Obstetrics/Gynecology

Device Facts

• Record ID: K050355
• Device Name: PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150
• Applicant: Tissue Science Laboratories, Plc
• Product Code: PAI · Obstetrics/Gynecology
• Decision Date: Mar 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5980
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocclc-picces are shaped for use in rectocele repair.

Device Story

Permacol® Surgical Implants are crosslinked porcine dermal collagen surgical meshes. Devices are pre-shaped into T-piece or Rectocele-piece configurations to facilitate specific surgical repairs. Used by surgeons in clinical settings to support or reinforce soft tissue during rectal intussusception or rectocele repair procedures. The implant provides a structural scaffold for tissue reinforcement. Benefit to patient includes surgical repair of pelvic floor or rectal conditions through tissue support.

Clinical Evidence

Bench testing only. Biocompatibility studies confirm materials are non-toxic and non-sensitizing. Laboratory testing demonstrates that design and materials meet established specifications for performance.

Technological Characteristics

Crosslinked porcine dermal collagen surgical mesh. Pre-shaped T-piece and Rectocele-piece configurations. Biocompatible, non-toxic, non-sensitizing material.

Indications for Use

Indicated for patients requiring soft tissue support or reinforcement during surgical procedures, specifically rectal intussusception repair (T-piece) or rectocele repair (Rectocele-piece).

Regulatory Classification

Identification

Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).

Predicate Devices

• Permacol® Crosslinked Porcine Dermal Collagen Surgical Mesh (K992556)
• Permacola Surgical Implant (K043366)

Submission Summary (Full Text)

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MAR 9 - 105

K050355
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### 510(k) SUMMARY

# Tissue Science Laboratories PLC, Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece

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

Victoria Taylor Tissue Science Laboratories PLC 1141 Clark Street Suite D Covington, Georgia 30014 USA Tel. (678) 342 - 7808 Fax: (678) 342 - 7844 Email: [e-mail]

Contact Person: Victoria Taylor

Date Prepared: 11th February 2005

Name of Device and Name/Address of Sponsor

Tissue Science Laboratories PLC 7th Floor, Victoria House Victoria Road Aldreshot Hampshire GU11 1 EJ United Kingdom

# Trade Name

Permacol® Surgical Implant T-piece Permacol® Surgical Implant Rectocele-piece

# Common or Usual Name

Surgical Mesh

#### Classification Name

Surgical Mesh

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# Predicate Devices

Permacol® Crosslinked Porcine Dermal Collagen Surgical Mesh (K992556) and Permacola Surgical Implant (K043366)

# Intended Use

Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical procedures. Permacol® Surgical Implant T-pieces are shaped for use in rectal intussusception repair and Permacol® Surgical Implant Rectocclc-picces are shaped for use in rectocele repair.

# Technological Characteristics and Substantial Equivalence

Permacol® T-piece and Permacol® Rectocele-piece are substantially equivalent to the predicate devices because they have the same intended uses and very similar technological characteristics.

### Performance Data

Biocompatibility and bench studies have been completed and support the safety and effectiveness of Permacol® Surgical Implant for its intended use, therefore data supporting the biocompatibility of Permacol® Surgical Implant T-piece and Permacol® Surgical Implant Rectocele-piece is 111corporated by reference.

The biocompatibility test results show that the material used in the design and manufacture of the devices are non-toxic and non-sensitizing to biological tissues consistent with their intended use. Laboratory test results demonstrate that the materials chosen and the design utilized in manufacturing Permacole Surgical Implant T-piece and Permacolo Surgical Implant Rectocele-piece will meet the established specification necessary for consistent performance during their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

Ms. Victoria Taylor Associate Director of Regulatory Affairs Tissue Science Laboratories, PLC 1141 Clark Street, Suite D COVINGTON GA 30014

SEP 2 8 2012

Re: K050355 Trade/Device Name: Permacol® Surgical Implant T-piece Permacol® Surgical Implant Rectocele-piece Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAI Dated: February 11, 2005 Received: February 14, 2005

Dear Ms. Taylor:

This letter corrects our substantially equivalent letter of March 9, 2005.

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 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 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

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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 of medical device-related adverse events) (21 CFR 803); 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.

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" (21 CFR 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,

Sincerely yours,

Benjamin R. Perkins

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KOTOBIT

# Indications for Use

510(k) Number (if known): K050355

Permacol® Surgical Implant T-piece Device Name: Permacol® Surgical Implant Rectocele-piece

Indications for Use:

Permacol® Surgical Implants are intended for use to support/reinforce soft tissue in surgical remator - Bargious miles and Implant T-pieces are shaped for use in rectal intussusception procedures - I waical of Surgical Implant Rectocele-pieces are shaped for use in rectocele repair.

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 LINF-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Divisic Sign-Off) Division of General, Restorative, and Newslogical Dollees

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510(k) Number. Ko 50355