(165 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of silicone sheeting for scar management, with no mention of AI or ML technologies.
Yes
Explanation: The device is indicated for the management, reduction, and prevention of hypertrophic and keloid scars, which are therapeutic actions. It also states that it "softens, smoothes and flattens scar tissue and restores a more normal skin color and texture," further indicating a therapeutic effect.
No
Explanation: The device is indicated for the management and prevention of hypertrophic and keloid scars by softening, smoothing, and flattening scar tissue. It does not diagnose any condition but rather treats or prevents a physical manifestation on the skin.
No
The device description clearly indicates it is a physical product ("Silicone Sheeting") used for scar management, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and prevention of hypertrophic and keloid scars on the skin. This is a therapeutic and preventative application directly on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a silicone sheeting applied to the skin. This is a physical barrier/treatment, not a reagent or instrument used to analyze biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The focus is on treating and preventing scar formation.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
MDA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4025 Silicone sheeting.
(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
AUG 13 879
Image /page/0/Picture/1 description: The image shows a logo and some text. The logo is a circle with a stylized "G" inside of it. To the right of the logo is the text "GUIDE" on the top line and "INCORP" on the bottom line. Above the logo and text is the text "AUG 13".
SKIN 2 forte 510(k) Notification United Hospital Technologies, Inc.
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.
1
·
| Biocompatibility of Biomedical Grade Silicone Elastomer | ||
|---|---|---|
| TEST | SAMPLES TESTED | OUTCOME |
| Cell culture with | ||
| Neutral Red Uptake | Elastomer | No Cytopathic effects |
| (morphology Change) | ||
| Cell culture medium | ||
| extract of elastomer | No Cytopathic effects | |
| (morphology Change) | ||
| Acetone extract of | ||
| elastomer | No evidence of genetic | |
| activity or cytotoxicity | ||
| Ames Bacterial | ||
| Reverse Mutagenicity | Saline extract of | |
| elastomer | No evidence of genetic | |
| activity of cytotoxicity | ||
| Hemolysis | Elastomer | Nonhemolytic |
| Saline extract of | ||
| elastomer | Nonhemolytic | |
| USP Pyrogen | Saline extract of | |
| elastomer | Nonpyrogenic | |
| USP Class V | ||
| Extractables | ||
| System Toxicity | Extracts of elastomer in: | |
| Saline | Nonirritating and nontoxic | |
| relative to controls | ||
| 5% ethanol in saline | Nonirritating and nontoxic | |
| relative to controls | ||
| Intracutaneous | ||
| Reactivity | Polyethylene 400 | Nonirritating and nontoxic |
| relative to controls | ||
| Cottonseed oil | Nonirritating and nontoxic | |
| relative to controls | ||
| Skin Sensitization | Elastomer | No sensitization |
| Saline Extract | No Sensitization | |
| Ethanol or acetone | ||
| extract | No sensitization | |
| 90-day Implant | Elastomer | Reaction equivalent to or |
| lesser than negative | ||
| control |
な
.
651
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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.
3
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
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. ・・
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)