(31 days)
No
The device description and intended use focus on the physical properties and function of a silicone gel sheet for scar management, with no mention of AI or ML capabilities.
Yes
The device is intended for the management of scars resulting from various wounds, which suggests a therapeutic purpose by aiding in the healing or improvement of these conditions.
No
This device is a scar management product designed to aid in the healing and appearance of scars, not to diagnose a medical condition. Its intended use is for "management of old and new hypertrophic and keloid scarring," which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a physical sheet made from medical grade silicone, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Advanced Medical Solutions Silicone Scar Management Sheet is a topical device applied directly to the skin to manage scars. It does not involve testing samples taken from the body. Its function is physical management of scar tissue.
Therefore, this device falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Advanced Medical Solutions Silicone Scar Management Sheet Intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Advanced Modical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of:
Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Product codes
MDA
Device Description
Advanced Medical Solutions Silicone Scar Management Gel sheet is a soft, self-adhesive, semi-occlusive sheet made from medical grade silicone with a polyurethane film backing paper and a non siliconised polyester release paper.
The primary function of the dressing is to aid in the management of both existing and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
The Advanced Medical Solutions Silicone Scar Management Sheet comes in two sizes 3in. x 4in. and 1in. x 4in. the sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar, also two or more sheets may be placed together to cover a scar area that is greater than the area of a single sheet.
The Advanced Medical Solutions Silicone Scar Management Sheet is self adhesive but can also be secured by a lightly conforming bandage or tape if so desired.
The gel sheets are supplied either sterile or non-sterile in foil laminated sterilizable pouches.
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
9-Jun-99 14:47;
. ··
JUN 11 1999
Attachment 3
Summary of Safety and Efficacy Summary of Advanced Medical Solutions Silicone Scar Management Sheet
| Manufacturer: | Advanced Medical Solutions, Group plc
Road Three, Winsford Industrial Estate
Cheshire CW7 3FD, United Kingdom |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Christopher Oakos, Manager |
| Telephone: | 44 1606 863 500 |
| Date Summary Prepared: | May 25th, 1999 |
| Device Trade Name: | Silicone Gel Scar Management Sheet |
| Common or Usual Name: | Silicone Gel Sheeting |
| Classification: | Currently unclassified by FDA. |
| Description: | Advanced Medical Solutions Silicone Scar
Management Gel sheet is a soft, self-adhesive,
semi-occlusive sheet made from medical grade
silicone with a polyurethane film backing paper and
a non siliconised polyester release paper. |
| | The primary function of the dressing is to aid in the
management of both existing and new hypertrophic
and keloid scarring on scars resulting from burns,
general surgical procedures and trauma wounds. |
| | The Advanced Medical Solutions Silicone Scar
Management Sheet comes in two sizes 3in. x 4in.
and 1in. x 4in. the sheet maybe cut or trimmed to
the desired shape or size prior to placement on the
scar, also two or more sheets may be placed
together to cover a scar area that is greater than the
area of a single sheet. |
| | The Advanced Medical Solutions Silicone Scar
Management Sheet is self adhesive but can also be
secured by a lightly conforming bandage or tape if
so desired. |
| | The gel sheets are supplied either sterile or non-
sterile in foil laminated sterilizable pouches. |
| Intended Use: | The Advanced Medical Solutions Silicone Scar
Management Sheet intended for the management of
old and new hypertrophic and keloid scarring on
scars resulting from burns, general surgical
procedures and trauma wounds. |
1
K991630
Residual Limits (Federal Register June 1978)
| ETO: | 100ppm |
|---|---|
| ECH: | 100ppm |
| EG: | 2000ppm |
INTENDED USE AND DIRECTIONS FOR USE
The Advanced Medical Solutions Silicone Scar Management Sheet Intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional.
Not for use on third degree burns.
Not to be used on open wounds.
Not for patients with dermatological conditions which disrupt the integrity of the skin in areas of coverage.
LABELS AND PRODUCT LABELING
Package labeling Is presented in Attachment 1. Currently no promotional literature is available for the device.
- r. A STATEMENT INDICATING THE DEVICE IS SIMILAR TO ANDIOR DIFFERENT FROM OTHER PRODUCTS OF COMPARABLE TYPE IN COMMERCIAL DISTRIBUTION. ACCOMPANIED BY DATA TO SUPPORT THE STATEMENT. THIS INFORMATION MAY INCLUDE AN IDENTIFICATION OF SIMILAR PRODUCTS, MATERIALS, DESIGN CONSIDERATIONS. ENERGY EXPECTED TO BE USED OR DELIVERED BY THE DEVICE, AND A DESCRIPTION OF THE OPERATIONAL PRINCIPLES OF THE DEVICE.
The Advanced Medical Solutions Sillcone Scar Management Sheet Is essentially similar to other devices approved by the FDA under the device classification. Elastomer. Silicone for scar management. Predictive devices include Spenco Silicone Gel Sheet 510(k) K981902, Spenco Medical Corp.
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 a stylized image of an eagle or bird with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1999
Mr. Christopher James Oakes Regulatory Affairs Manager Advanced Medical Solutions Group plc. Road Three, Winsford Industrial Estate Cheshire CW7 3PD United Kingdom
Re: K991630
Trade Name: Silicone Gel Scar Management Sheet Regulatory Class: Unclassified Product Code: MDA Dated: May 5, 1999 Received: May 11, 1999
Dear Mr. Oakes:
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.
3
Page 2 - Mr. Christopher James Oakes
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,
2 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
510(k) Number (if known): K991630
Device name: Advanced Medical Solutions Silicone Gel Scar Management Sheet
Indications For Usc:
Advanced Modical Solutions Silicone Gel Scar Management Sheet is intended for OTC use for the management of:
Old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription The (Per 21 CFR 801.109) OR Over The Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices K991630
510(k) Number