PMT NEW BEGINNINGS GELSHAPES & AMEND

K972597 · Pmt Corp. · MDA · Oct 1, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972597
• Device Name: PMT NEW BEGINNINGS GELSHAPES & AMEND
• Applicant: Pmt Corp.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Management of hypertrophic and keloid scars.

Device Story

PMT New Beginnings™ GelShapes™ & Amend™ are medical-grade silicone gel sheets designed for external application to hypertrophic or keloid scars. The device consists of a solid low-durometer silicone layer with a thin, high-durometer silicone backing; some versions include reinforcement material for added strength. Used by physicians or patients (via pharmacy/direct order) to soften or lighten scar color. Applied topically to intact skin. The device functions as a passive physical barrier/occlusive dressing. Provided sterile or non-sterile in Tyvek/Mylar pouches.

Clinical Evidence

No clinical data provided. The submission relies on the established history of gel sheeting for scar management and literature references provided to the reviewer.

Technological Characteristics

Materials: Medical grade silicone (low durometer gel, high durometer backing), optional reinforcement material. Form factor: Solid gel sheeting. Sterilization: 100% Ethylene Oxide (overkill method, SAL 10^-6). Packaging: Tyvek and Mylar pouch with chevron opening.

Indications for Use

Indicated for the management of hypertrophic and keloid scars on intact skin.

Regulatory Classification

Identification

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

Predicate Devices

• ReJuveness
• McGhan Medical Corporation gel sheeting
• Geligne Medical gel sheeting
• Medical Z gel sheeting
• CUI Corporation gel sheeting
• Biodermis gel sheeting

Submission Summary (Full Text)

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97257

061 - 1 991 510(k) Notification New Beginnings™ GelShapes™ & Amend™ July 8, 1997

PMT® Corporation

| Premarket Notification [510(k)] | | Summary |
|---------------------------------|-----------------------------------------------------------|---------|
| Submitters name: | PMT CORPORATION | |
| Submitters Address: | PMT Corporation<br>1500 Park Road<br>Chanhassen, MN 55317 | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Contact name: | Steve Trinter | |
| Date: | July 8, 1997 | |
| Trade name: | PMT® New Beginnings™ GelShapes™ & Amend™ | |
| Common name: | Gel Sheeting | |

lassification name:

Equivalent device(s):

ReJuveness, McGhan Medical Corporation, Geligne Medical, Medical Z, CUI Corporation, Biodermis produce equivalent devices to those offered by PMT Corp.

## Device Description:

PMT®'s Model 5100 New Beginnings™ GelShapes™ & Amend™ consist of a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing. Certain GelShapes™ & Amend™ also have reinforcement material for added strength. The silicone gel sheeting is used on hypertrophic or keloid scars in order to soften or lighten the color of these scars. The model 5100 New BeginningsTM GelShapes™ & Amend™ are used only externally and on intact skin.

This is a product which is commonly used by physicians treating hypertrophic or keloid scars, but is also now available at pharmacies and through direct phone orders.

While May of keloid and hypertrophic scars by gel sheeting is a common procedure that has been around for many years, we have included a number of different articles within this submission for the reviewer.

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The PMT New Beginnings™ GelShapes™ & Amend™ are packaged in a pouch constructed of Tyvek and Mylar. The package will employ a chevron opening feature.

The PMT New Beginnings™ GelShapes™ & Amend™ are provided sterile or nonsterile. The type of sterilization is 100% Ethylene Oxide. The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a nonsterile unit of 10-6.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird figure. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 1 1997

Mr. Steve Trinter .General Manager, Plastic Surgery Products Divison PMT® Corporation 1500 Park Road Chanhassen, Minnesota 55317

Re: K972597

> Trade Name: PMT® New Beginnings™ GelShapes™ & Amend™ Regulatory Class: Unclassified Product Code: MDA Dated: July 8, 1997 Received: July 11, 1997

Dear Mr. Trinter:

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 (OS) 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. Steve Trinter

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

Enclosure

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K972597 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name PMT New Beginnings™ GelShapes TM and AmendTM

Indications For Use:

13 : . . . . . . . . .

Management of hypertrophic and keloid scars.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)

bcoll
(Division Sign-Off)
Division of General Restorative Devices K972597
510(k) Number

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Format 1-2-96)