SKIN 2 FORTE SILICONE SHEETING

K990651 · United Hospital Technologies, Inc. · MDA · Aug 13, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990651
• Device Name: SKIN 2 FORTE SILICONE SHEETING
• Applicant: United Hospital Technologies, Inc.
• Product Code: MDA · General, Plastic Surgery
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4025
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

SKIN 2 forté Silicone Sheeting is indicated for the management of hypertrophic and keloid scars. Consistent use of SKIN 2 forte can reduce hypertrophic and keloid scars. SKIN 2 forté may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic and keloid scars. SKIN 2 forté may be used as soon as the wound is closed, dry and the sutures or staples have been removed.

Device Story

SKIN 2 forté is a silicone elastomer sheeting designed for scar management. Applied topically to closed, dry wounds; functions by softening, smoothing, and flattening scar tissue while restoring skin color and texture. Used for both existing hypertrophic/keloid scars and as prophylaxis following surgical or traumatic injury. Intended for over-the-counter use by patients. Device provides physical barrier/occlusion to the scar site to aid in tissue remodeling.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 and Tripartite guidance. Testing included cell culture (Neutral Red Uptake), Ames bacterial mutagenicity, hemolysis, USP pyrogenicity, USP Class V extractables, intracutaneous reactivity, skin sensitization, and 90-day implant study. All results demonstrated non-cytotoxic, non-hemolytic, non-pyrogenic, and non-sensitizing properties.

Technological Characteristics

Biomedical grade silicone elastomer. Biocompatibility testing performed per ISO 10993-1 and Tripartite guidance. Form factor is a flexible sheet for topical application. No energy source or software components.

Indications for Use

Indicated for management of hypertrophic and keloid scars in patients with surgical or traumatic dermal injuries. Prophylactic use permitted once wounds are closed, dry, and sutures/staples removed.

Regulatory Classification

Identification

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

Predicate Devices

• The ReJuveness product (K974380)

Submission Summary (Full Text)

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AUG 13 879

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SKIN 2 forte 510(k) Notification United Hospital Technologies, Inc.

K990651

#### 1. 510(k) Summary

Trade Name - SKIN 2 forté™ Silicone Sheeting Common Name - silicone sheeting Classification Name - Silicone elastomer for scar management

# Substantial Equivalence

new product is substantially equivalent to the currently marketed The ReJuveness product manufactured and marketed by RichMark International Corp. (K974380). The ReJuveness product is offered for sale as an "over the counter" product.

## Description

Skin 2 forté Silicone Sheeting is a non-surgical, medically proven product that can help reduce your old scars and prevent new scars from developing. Skin 2 forté softens, smoothes and flattens scar tissue and restores a more normal skin color and texture. Consistent use of the SKIN 2 forté system can reduce hypertrophic and keloid scars.

### Indications for Use

SKIN 2 forté Silicone Sheeting is indicated for the management of hypertrophic and keloid scars. Consistent use of SKIN 2 forté can reduce hypertrophic and keloid scars.

SKIN 2 forté may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic and keloid scars. SKIN 2 forté may be used as soon as the wound is closed, dry and the sutures or staples have been removed.

### Biocompatibility Studies

SKIN 2 forté Silicone Sheeting is composed of a biomedical silicone elastomer that has been extensively evaluated for biocompatibility during limited and prolonged patient exposure, based on currently recognized regulatory requirements (ISO 10993-1, "Biological Testing of Medical and Dental Materials Guidance on Selection of Tests" and "Tripartite and Devices, Part 1: Biocompatibility Guidance for Medical Devices.") Results from this testing are summarized in the table below.

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| Biocompatibility of Biomedical Grade Silicone Elastomer | | |
|---------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------|
| TEST | SAMPLES TESTED | OUTCOME |
| Cell culture with<br>Neutral Red Uptake | Elastomer | No Cytopathic effects<br>(morphology Change) |
| | Cell culture medium<br>extract of elastomer | No Cytopathic effects<br>(morphology Change) |
| | Acetone extract of<br>elastomer | No evidence of genetic<br>activity or cytotoxicity |
| Ames Bacterial<br>Reverse Mutagenicity | Saline extract of<br>elastomer | No evidence of genetic<br>activity of cytotoxicity |
| Hemolysis | Elastomer | Nonhemolytic |
| | Saline extract of<br>elastomer | Nonhemolytic |
| USP Pyrogen | Saline extract of<br>elastomer | Nonpyrogenic |
| USP Class V<br>Extractables<br>System Toxicity | Extracts of elastomer in:<br>Saline | Nonirritating and nontoxic<br>relative to controls |
| | 5% ethanol in saline | Nonirritating and nontoxic<br>relative to controls |
| Intracutaneous<br>Reactivity | Polyethylene 400 | Nonirritating and nontoxic<br>relative to controls |
| | Cottonseed oil | Nonirritating and nontoxic<br>relative to controls |
| Skin Sensitization | Elastomer | No sensitization |
| | Saline Extract | No Sensitization |
| | Ethanol or acetone<br>extract | No sensitization |
| 90-day Implant | Elastomer | Reaction equivalent to or<br>lesser than negative<br>control |

な

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651

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 13 1999

United Hospital Technologies, Inc. c/o Mr. Samuel Swetland Vice President, Regulatory Affairs and Compliance Guidelines, Inc. 10320 USA Today Way Miramar, Florida 33025

Re: K990651

Trade Name: Skin 2 Forte Silicone Sheeting Regulatory Class: Unclassified Product Code: MDA Dated: June 24, 1999 Received: June 25, 1999

Dear Mr. Swetland:

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 - Mr. Samuel Swetland

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" (21CFR 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,

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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510(k) Number (if known): K990651

Device Name: SKIN 2 forté Silicone Sheeting

Indications For Use:

SKIN 2 forté Silicone Sheeting is indicated for the management of hypertrophic and keloid scars. Consistent use of SKIN 2 forte can reduce hypertrophic and keloid scars.

SKIN 2 forté may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic and keloid scars. SKIN 2 forté may be used as soon as the wound is closed, dry and the sutures or staples have been removed. ・・

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K990651
510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use X

(Optional Format 1-2-96)