SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL

K982475 · Tissue Technologies, Inc. · FTL · Sep 22, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982475
• Device Name: SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL
• Applicant: Tissue Technologies, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For Plastic and Reconstructive Surgery* * This product is available by prescription only.

Device Story

Softform® Implant is a soft tissue augmentation tube used in plastic and reconstructive surgery. Device is implanted by a surgeon to provide structural support or volume to soft tissue. It is supplied with an insertion tool to facilitate placement. The device functions as a physical implant to augment tissue contours. Clinical benefit includes correction of soft tissue deficits or aesthetic enhancement. Used in clinical settings by qualified plastic and reconstructive surgeons.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Soft tissue augmentation tube; supplied with insertion tool. Class II device. Mechanical implant for surgical use.

Indications for Use

Indicated for patients undergoing plastic and reconstructive surgery requiring soft tissue augmentation. 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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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 with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

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

Re: K982475 Trade Name: Softform® Implant Regulatory Class: II Product Code: FTL Dated: July 14, 1998 Received: July 16, 1998

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 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). 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 yilry 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/dsma/dsmamain.html".

Sincerely yours,

f. Joseph

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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## TISSUE TECHNOLOGIES, INC.

1370 Green Street SAN FRANCISCO, CA 94109

PHONE [phone] FAX [phone]

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September 15, 1998

- PRODUCT: Softform® Implant
REFERENCE: 510(k)#: K982475 Soft Tissuc Augmentation Tube with Insertion Tool - Size Modifications

INDICATIONS: For Plastic and Reconstructive Surgery*

* This product is available by prescription only.

Prescription Use
(Per 21 CFR 801.109)

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