(82 days)
Not Found
Not Found
No
The device description is for a silicone gel sheeting product, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text.
Yes
The device is described as "used on hypertrophic or keloid scars in order to soften or lighten the color of these scars," indicating an action to treat or manage a medical condition.
No
The device description indicates it is used for softening or lightening the color of scars, which is a treatment, not a diagnostic function.
No
The device description explicitly states it consists of "a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Management of hypertrophic and keloid scars." This is a therapeutic or management purpose, not a diagnostic one.
- Device Description: The device is a silicone gel sheeting applied externally to intact skin. This is a physical barrier or treatment, not something that analyzes samples from the body (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information for diagnosis.
IVD devices are specifically designed 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
Management of hypertrophic and keloid scars.
Product codes
MDA
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.
The PMT New Beginnings™ GelShapes™ & Amend™ are packaged in a pouch constructed of Tyvek and Mylar. The package will employ a chevron opening feature.
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
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
ReJuveness, McGhan Medical Corporation, Geligne Medical, Medical Z, CUI Corporation, Biodermis
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
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 | |
| 1500 Park Road | ||
| Chanhassen, MN 55317 | ||
| Phone: | (612) 470-0866 | |
| Fax: | (612) 470-0865 | |
| 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.
1
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.
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 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.
3
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 (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" (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 (800) 638-2041 or (301) 443-6597 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
4
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
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)