SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING

K991312 · Library Medical, Inc. · MDA · Aug 20, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991312
• Device Name: SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
• Applicant: Library Medical, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Aug 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

To be used in the management of Hypertrophic and Keloid scars that are the result of surgery, trauma, and burns. Also, LMI Scar Management Silicone Sheeting may prevent Hypertrophic and Keloid scars from forming.

Device Story

LMI Scar Management consists of silicone sheeting applied topically to skin. Device functions as physical barrier to manage existing hypertrophic and keloid scars or prevent their formation following surgery, trauma, or burns. Used in home or clinical settings; patient-applied. Output is physical coverage of scar tissue; intended to improve scar appearance and texture through hydration and occlusion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Silicone sheeting; passive occlusive dressing; non-sterile or sterile (implied by general medical device standards); standalone physical barrier.

Indications for Use

Indicated for management of hypertrophic and keloid scars resulting from surgery, trauma, or burns; also indicated for prevention of hypertrophic and keloid scar formation.

Regulatory Classification

Identification

Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1999

Mr. Richard A. Hartman President Library Medical, Inc. 60 Terence Drive Pittsburgh, Pennsylvania 15236

Re: K991312 Trade Name: LMI Scar Management Regulatory Class: Unclassified Product Code: MDA Dated: July 23, 1999 Received: July 26, 1999

Dear Mr. Hartman:

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. Richard A. Hartman

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,

Russell T. Ryan

- Sur 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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K991312

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K991312

Device Name: _________________________________________________________________________________________________________________________________________________________________ LMI Scar Management

Indications For Use:

To be used in the management of Hypertrophic and Keloid scars that are the result of surgery, trauma, and burns. Also, LMI Scar Management Silicone Sheeting may prevent Hypertrophic and Keloid scars from forming.

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

> > Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

he-Counter Use X

Amett. H. Hagen. Ser J.P.

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

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