SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)

K021889 · Surgical Technology Laboratories, Inc. · KKY · Oct 16, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021889
• Device Name: SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
• Applicant: Surgical Technology Laboratories, Inc.
• Product Code: KKY · General, Plastic Surgery
• Decision Date: Oct 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surgiform Technology Ltd.'s S.F.A.M. implant is intended for augmentation or repair of the soft tissues of the facial area.

Device Story

Surgiform Augmentation Material (S.F.A.M.) is a synthetic implant used for facial soft tissue augmentation or repair. Available in sheet or strand form factors. Implanted by surgeons during plastic and reconstructive procedures. Provides structural support or volume restoration to facial tissues. Contraindicated for use in cardiovascular, TMJ, or dermal applications.

Technological Characteristics

Polytetrafluoroethylene (PTFE) with carbon fibers composite implant material. Available as sheets (5-100mm length/width, 0.2-0.4mm thickness) or strands (5-15cm length, 1.0-4.0mm OD).

Indications for Use

Indicated for plastic and reconstructive surgery for soft tissue augmentation or repair in the facial area. Contraindicated for cardiovascular defects, temporomandibular joint (TMJ) reconstructions, and dermal placement.

Regulatory Classification

Identification

A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

Submission Summary (Full Text)

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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 stylized depiction of a human figure in profile, with three faces overlapping each other. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 6 2002

Mr. Cameron J. Fordyce President Surgical Technology Laboratories, Inc. 11476 Hawke Road, #C Columbia Station, OH 44028

Re: K021889

Trade/Device Name: Surgiform Augmentation Material Regulation Number: 878.3500 Regulation Name: Polytetrafluoroethylene with carbon fibers composite implant material Regulatory Class: II Product Code: KKY Dated: August 26, 2002 Received: September 20, 2002

Dear Mr. Fordyce:

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. Cameron J. Fordyce

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Styph Shrode
Z. 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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KO21B3:9/A'

| 510(k) Number (if known): | K021889 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

| Device Name: | Surgiform Augmentation Material |
|----------------------|---------------------------------|
| Indications For Use: | |

| Indications: | For Plastic and Reconstructive Surgery |
|--------------|----------------------------------------|
|--------------|----------------------------------------|

Product Description:

The Surgiform Technology Ltd.'s S.F.A.M. implant

is intended for augmentation or repair of the soft tissues of the facial area. The product is available in sheets or strands of the following sizes:

| Sheets | Length | Width | Thickness |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| and and any and the program and the program and the provinces of the program and | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | www.alla.com/articles/arguint/deal/grams/production/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/articles/artic |
| | 5-100mm | 5-100mm | 0.2-0.4mm |

Strands

5-15cm

OD-1.0-4.0mm

## Contraindictions:

- Cardiovascular defects

- Temporomandibular joint (TMJ) reconstructions
-Dermal Placement

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styt Ruveli
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Prescription Use_V (Per 21 CFR 801.109)

(Optional Formal 1-2-؛

SK 445