(69 days)
Not Found
No
The device description and intended use clearly describe a topical silicone gel for scar management, with no mention of any computational or analytical capabilities that would involve AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is intended for the management of scars by softening, smoothing, and flattening them, which is a therapeutic purpose.
No
Explanation: The device is a silicone gel intended for the management of scars by softening, smoothing, and flattening them. Its function is therapeutic/management, not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly states it is a "topical gel made from medical grade silicone" and comes in a "15g pump applicator," 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 clearly states that the product is for the "management of old and new hypertropic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds." This is a topical application for treating a physical condition on the skin.
- Device Description: The description confirms it's a "self drying, topical gel made from medical grade silicone." It's applied directly to the scar.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition by examining specimens from the human body. IVDs are used to perform tests on samples like blood, urine, tissue, etc.
This device falls under the category of a medical device used for treatment and management of scars, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
MedTrade Products Scar Gel is intended for the management of old and new hypertropic 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.
MedTrade Product's Silicone Scar Gel is intended for the management of:
- Old and new hypertropic and keloid scarring on scars resulting from burns, . general surgical procedures and trauma wounds
- Help Soften, Smooth and Flatten Scars .
It is not indicated for use on:
- Open or infected wounds, scabs or stitches .
- New wounds which have breached the dermis .
- Materials present in the product do not contra-indicate topical (skin/scar) . applications.
- The components do not contain animal ingredients. .
Product codes (comma separated list FDA assigned to the subject device)
MDA
Device Description
MedTrade Product's Silicone Scar Gel is a self drying, topical gel made from medical grade silicone.
The primary function of the dressing is to aid in the management of both existing and new hypertropic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
MedTrade Product's Silicone Scar Gel comes in a 15g pump applicator, making it easy to apply to difficult areas. It is safe, hygienic and easy to use. It can be worn during the day or overnight.
The gel is supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scars on skin
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Tel: +44 1270 500019 Fax: +44 1270 500045 Electra House, Crewe Business Park, Crewe, Cheshire, CW1 6GL, UK.
FEB 1 4 2002
Summary of Safety and Efficacy Summary of MedTrade Products Silicone Scar Gel
MedTrade Products Ltd
Hុ. Safety & Effectiveness:
| Manufacturer: | MedTrade Product's Ltd, Electra House, Crewe Business Park
Crewe, Cheshire. CW1 6GL. UK |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jonathan Ranfield, Director, Quality Assurance & Regulatory Affairs |
| Telephone: | 011 44 1270 500019 |
| Prepared: | November 28, 2001 |
| Device Trade Name: | MedTrade Products Silicone Scar Gel |
| Common or usual name: | Silicone Scar Gel |
| Classification Name: | MDA Elastomer, Silicone, for Scar Management |
| Description: | MedTrade Product's Silicone Scar Gel is a self
drying, topical gel made from medical grade silicone.
The primary function of the dressing is to aid in the management of
both existing and new hypertropic and keloid scarring on scars
resulting from burns, general surgical procedures and trauma wounds.
MedTrade Product's Silicone Scar Gel comes in a 15g pump
applicator, making it easy to apply to difficult areas. It is safe, hygienic
and easy to use. It can be worn during the day or overnight.
The gel is supplied non-sterile. |
| Intended Use: | MedTrade Products Scar Gel is intended for the management of old
and new hypertropic 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.
Biocompatability testing has been successfully completed per
ISO/Tripartite guidelines.
MedTrade Product's Silicone Scar Gel is substantially equivalent in
design, composition and function Kilo-cote Manufactured by Advanced
Bio-Technologies 510(k) # K002488. |
Bio-Technologies 5 fb(k) # Rooz400.
A table of comparative features may be found an pages 16 to 19 A table of Comparative reatures may be found on pages 16 to 19.
| Characteristics | MedTrade Product's
Silicone Scar Gel | Advanced Bio-Technologies, Inc
Kelo-cote Topical Gel |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Self drying, topical gel made from medical
grade silicone | Self drying, topical gel made from medical
grade silicone |
| Appearance | Clear translucent gel | Clear translucent gel |
| Indications For Use | For Management of old and new
hypertrphic and keloid scarring on scars
resulting from burns, general surgical
procedures and trauma wounds. | For Management of old and new
hypertrphic and keloid scarring on scars
resulting from burns, general surgical
procedures and trauma wounds. |
| | Help Soften, Smooth and Flatten Scars | Help Soften, Smooth and Flatten Scars |
| Sterilisation Method | Non Sterile | Non Sterile |
COMPARATIVE FEATURES
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2002
Mr. Jonathan Ranfield Director, Quality Assurance and Regulatory Affairs Medtrade Products Limited Electra House, Crewe Business Park Crewe Cheshire CW1 6GL UK
Re: K014036
Trade/Device Name: MedTrade Product's Silicone Scar Gel Regulatory Class: Unclassified Product Code: MDA Dated: November 28, 2001 Received: December 7, 2001
Dear Mr. Ranfield:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars at ment date of the Medical Device Amendments, or to comments phor to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have occh roomsomed in assee approval of a premarket approval application (PMA). and Costinetter rior (110.) that to nevice, subject to the general controls provisions of the Act. The I ou may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olabilition (600 %) of of als. Existing major regulations affecting your device can inay oc subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of deviloed that I Drivination that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Jonathan Ranfield
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
uriam c. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
Page 1 of 1
510(k) Number (if known) K01 4036
Device Name: MedTrade Product's Silicone Scar Gel
Indications for Use:
12/11/1
MedTrade Product's Silicone Scar Gel is intended for the management of:
- Old and new hypertropic and keloid scarring on scars resulting from burns, . general surgical procedures and trauma wounds
- Help Soften, Smooth and Flatten Scars .
It is not indicated for use on:
- Open or infected wounds, scabs or stitches .
- New wounds which have breached the dermis .
- Materials present in the product do not contra-indicate topical (skin/scar) . applications.
- The components do not contain animal ingredients. .
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.190) | X | Or Over The Counter Use
(Optional Format 1-2-96) | X |
| ------------------------------------------ | ---------- | ----------------------------------------------------- | ---------- |
|---|
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K014036 |
|---|---|
| --------------- | --------- |