ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT

K992991 · Atrium Medical Corp. · FTL · Jan 27, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K992991
• Device Name: ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT
• Applicant: Atrium Medical Corp.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Jan 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atrium Advanta™ PTFE Facial Implant is intended for use in Facial Plastic and Reconstructive Surgery.

Device Story

Atrium Advanta™ PTFE Facial Implant is a synthetic implant used in facial plastic and reconstructive surgery. Device serves as a scaffold for soft tissue augmentation or reconstruction. Implant is placed by a surgeon during a clinical procedure. Device provides structural support to facial tissues; benefits include restoration of contour or volume in reconstructive applications. No electronic components, software, or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polytetrafluoroethylene (PTFE) facial implant. Solid, biocompatible synthetic material. Non-resorbable. No energy source, connectivity, or software components.

Indications for Use

Indicated for use in facial plastic and reconstructive surgery for patients requiring soft tissue augmentation or reconstruction.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.

Public Health Service

JAN 27 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Hall RA/QA Manager Atrium Medical Corporation 5 Wentworth Drive Hudson, New Hampshire 03051

K992991 Re:

> Trade Name: Atrium Medical Corporation Advanta™ PTFE Facial Implant Regulatory Class: II Product Code: FTL Dated: December 3, 1999 Received: December 6, 1999

Dear Ms Hall:

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 (OS) 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.

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.

{1}------------------------------------------------

Page 2 - Ms. Karen Hall

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,

Mail R.P. Ogden

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known) | k992991 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Atrium Advanta ^TM PTFE Facial Implant |
| Indications for Use: | The Atrium Advanta ^TM PTFE Facial Implant is intended for use in Facial Plastic and Reconstructive Surgery. |

## PLEASE DO NOTY WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Prescription Use

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

NRO for JZD

(Division Sign-Off)
Division of General Restorative Devices K99299
510(k) Number

Atrium Medical Corporation

...