TBD ETHICON MESH

K082216 · ETHICON, Inc. · FTL · Sep 5, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082216
• Device Name: TBD ETHICON MESH
• Applicant: ETHICON, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Sep 5, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Device Story

ETHICON Mesh is a sterile, partially absorbable surgical implant used for pelvic floor repair. It consists of knitted filaments of poliglecaprone-25 (absorbable) and polypropylene (nonabsorbable) monofilament fibers. The device is implanted by a surgeon during procedures to treat vaginal wall prolapse, serving as mechanical support or bridging material for fascial defects. It provides long-lasting stabilization of pelvic floor structures. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided. Biological reactivity assessed per ISO 10993-1. Functional performance testing indicates the device meets or exceeds requirements.

Technological Characteristics

Sterile, partially absorbable knitted mesh. Materials: poliglecaprone-25 monofilament fiber and polypropylene monofilament fiber. Biocompatibility testing per ISO 10993-1.

Indications for Use

Indicated for tissue reinforcement and stabilization of pelvic floor fascial structures in patients with vaginal wall prolapse requiring surgical intervention.

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

• GYNECARE GYNEMESH® PS PROLENE® Soft Mesh (K013718)
• GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems (K071512)

Submission Summary (Full Text)

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K082216

# SEP - 5 2008

### SUMMARY OF SAFETY AND EFFECTIVENESS

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, in respect to safety and effectiveness is summarized below.

#### Submitted by:

Bryan A. Lisa Manager, Regulatory Affairs ETHICON, Inc., A Johnson & Johnson Company Route 22 West, PO Box 151 Somerville, NJ 08876 Phone: [phone] / Fax: [phone]

#### Name/Classification of Device:

Class II in 21 CFR § 878.3300, Surgical Mesh (FTL)

#### Trade Name:

ETHICON Mesh (TBD)

#### Predicate Devices:

- GYNECARE GYNEMESH® PS PROLENE® Soft Mesh (ETHICON, Inc.)-K013718 .
- GYNECARE PROLIFT+M™ Pelvic Floor Repair Systems (ETHICON, Inc.) K071512 .

#### Statement of Intended Use:

ETHICON Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

#### Device Description:

The proposed ETHICON Mesh is a sterile partially absorbable mesh implant, designed for repair of fascial structure of the pelvic floor in vaginal wall prolapse. The mesh implant is constructed of knitted filaments of equal parts of absorbable poliglecaprone-25 monofilament fiber and nonabsorbable polypropylene monofilament fiber.

# Summary of Technological Characteristics of New Device to Predicate Devices:

The modified device has similar technological characteristics as the predicate devices. Like currently marketed devices, the implantable component is a sterile, mesh implant intended for the repair of vaginal wall prolapse. The mesh implant component of the proposed device is made of nonabsorbable and absorbable polymers.

#### Performance Data:

Biological reactivity of the materials has been assessed using methods specified in ISO 10993-1, and the material was found to be acceptable for its intended use. Results of functional performance testing indicate that the proposed device meets or exceeds all functional requirements.

#### Conclusions:

Based on the similarities to the predicate devices identified in this submission, we conclude that the modified device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The image is in black and white.

SEP - 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ETHICON, Inc. % Mr. Bryan A. Lisa Manager, Regulatory Affairs Route 22 West, P.O. Box 151 Somerville. New Jersey 08876

Re: K082216

Trade/Device Name: ETHICON Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 4, 2008 Received: August 6, 2008

Dear Mr. Lisa:

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.

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 - Mr. Bryan A. Lisa

This letter will allow you to begin marketing your device as described in your Section 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, permitte 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket Surveillance at [phone]. For questions regarding the reporting of device adverse eventual (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely vours.

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082216

# INDICATIONS FOR USE

510(k) Number (if known):

Device Name: ETHICON Mesh

Indications for Use: ETHICON MESH is indicated for tissue reinforcement and long lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Mark A. Mellersen

K082216

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

510(k) Number_

Prescription Use *X* AND/OR Over-The-Counter Use **__**
(Part 21 CFR 801 Subpart D) (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)