IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX

K071470 · Implantech Associates, Inc. · FTL · Aug 31, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071470
• Device Name: IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
• Applicant: Implantech Associates, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ePTFE Sheeting is intended for use in the augmentation or repair of the soft tissue of the facial area.

Device Story

ePTFE Sheeting is a surgical implant material used for facial soft tissue augmentation or repair. The device is intended for use by surgeons in a clinical or surgical setting. It functions as a permanent implant to provide structural support or volume to facial tissues. The device is provided as a sheet, which the surgeon may trim or shape to fit the specific anatomical requirements of the patient's facial defect or augmentation site. By providing a stable, biocompatible scaffold, the device assists in the reconstruction or enhancement of facial contours.

Clinical Evidence

bench testing only

Technological Characteristics

Material: expanded Polytetrafluoroethylene (ePTFE). Form factor: sheeting. Intended for permanent implantation in facial soft tissue.

Indications for Use

Indicated for patients requiring soft tissue augmentation or repair in the facial area.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Implantech Associates, Inc. % Mr. Stephen Meade RA/QA Manager 6025 Nicoole Street. Suite B Ventura, CA 93003

AUG 3 1 2007

Re: K071470 Trade/Device Name: ePTFE Sheeting Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: July 27, 2007 Received: July 30, 2007

Dear Mr. Meade:

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. Stephen Meade

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, 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 gencral 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 yours,
Mark N. Mellekers

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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## Indications for Use

510(k) Number (if known):

Device Name:

ePTFE Sheeting

Indications For Use:

The ePTFE Sheeting is intended for use in the augmentation or repair of the soft tissue of the facial area.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkus Page 1 of 1

(Division Sign-Of (Division Sign of General, Restorative, and Net

**510(k) Number**_