SILIMED TISSUE EXPANDER

K981852 · Silimed, LLC · LCJ · Aug 5, 1998 · SU

Device Facts

• Record ID: K981852
• Device Name: SILIMED TISSUE EXPANDER
• Applicant: Silimed, LLC
• Product Code: LCJ · SU
• Decision Date: Aug 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Silimed Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities. Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Device Story

Silimed Tissue Expander is a medical device for temporary subcutaneous implantation. It functions by expanding tissue to create surgical flaps or additional coverage. Used by surgeons in clinical settings for reconstructive procedures, including post-mastectomy breast reconstruction, treatment of underdeveloped breasts, and correction of soft tissue deformities. The device is implanted by a physician; it is not a permanent implant. It provides a mechanical means to generate new tissue growth through controlled expansion, facilitating subsequent reconstructive surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary subcutaneous tissue expander. Materials and specific technical standards are not detailed in the provided documentation.

Indications for Use

Indicated for patients requiring temporary subcutaneous implantation for surgical flap development and tissue expansion; applications include post-mastectomy reconstruction, treatment of underdeveloped breasts, and correction of soft tissue deformities.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 1998

Silimed, LLC c/o Smith Associates Mr. E.J. Smith P.O. Box 4341 Crofton, Maryland 21114

Re: K981852 Trade Name: Silimed Tissue Expander Regulatory Class: Unclassified Product Code: LCJ Dated: May 25, 1998 Received: May 26, 1998

Dear Mr. Smith:

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 (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 - Mr. E.J. Smith

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,

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K981852

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510(k) Number (if known): K981852

Device Name: Silimed Tissue Expander

Classification Panel: 79LCJ

Indications for Use:

Silimed Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Or

Over-the Counter Use

Adee