SOFTFORM FACIAL IMPLANT

K973462 · Tissue Technologies, Inc. · FTL · Nov 24, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973462
• Device Name: SOFTFORM FACIAL IMPLANT
• Applicant: Tissue Technologies, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Plastic and Reconstructive Surgery

Device Story

SoftForm™ Implant is a surgical implant used in plastic and reconstructive surgery. The device is intended for implantation by a physician to assist in reconstructive procedures. It functions as a structural or space-filling material to support tissue repair or augmentation. The device is provided for professional use in clinical or surgical settings. By providing a stable implantable structure, it aids in the restoration of form or function in patients requiring reconstructive intervention.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Implantable device for plastic and reconstructive surgery. Specific materials, dimensions, and sterilization methods are not detailed in the provided text.

Indications for Use

Indicated for use in plastic and reconstructive surgery. Available by prescription only.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jesse Kramer, Ph.D. Tissue Technologies, Inc. 1370 Green Street San Francisco, California 94109

NOV 2 4 1997

K973462 Re: Trade Name: SoftForm™ Implant Regulatory Class: II Product Code: FTL ......... . Dated: September 11, 1997 Received: September 12, 1997

Dear Dr. Kramer:

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 requirements , as set forth in the Quality System Regulation (QS) 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.

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Page 2 - Jesse Kramer, Ph.D.

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.

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,

J. Collett

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1370 Grupp 218881. SAN FRANCISCO, CA 94109 TISSUE TECHNOLOGIES, INC.

PHONE [phone] Fax [phone]

## INDICATIONS FOR USE PAGE

November 20, 1997

Softform™ Implant PRODUCT:

510(k)#: K973462 REFERENCE:

For Plastic and Reconstructive Surgery* INDICATIONS:

Prescription Use
(Per 21 CFR 801.109)

* This product is available by prescription only.