(69 days)
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.
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.
This document describes a 510(k) premarket notification for MedTrade Product's Silicone Scar Gel, which is intended for the management of hypertrophic and keloid scarring. The filing establishes substantial equivalence to a predicate device, Kelo-cote Topical Gel (K002488), manufactured by Advanced Bio-Technologies, Inc. Since this is a submission for a silicone scar gel, the acceptance criteria and related studies are focused on demonstrating biocompatibility and substantial equivalence in composition, appearance, indications for use, and sterilization method, rather than performance metrics typically associated with AI/ML medical devices.
Here's an analysis of the provided information based on the requested categories:
1. A table of acceptance criteria and the reported device performance
For this type of medical device (silicone scar gel), the "acceptance criteria" are not performance metrics like accuracy or sensitivity, but rather demonstration of substantial equivalence to a legally marketed predicate device. The "reported device performance" directly addresses this by showing identical characteristics to the predicate.
| Acceptance Criteria Category | MedTrade Product's Silicone Scar Gel Report | Predicate Device (Kelo-cote) Report |
|---|---|---|
| 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 hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds. Help soften, smooth, and flatten scars. | For management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds. Help soften, smooth, and flatten scars. |
| Sterilization Method | Non Sterile | Non Sterile |
| Biocompatibility | Successfully completed per ISO/Tripartite guidelines. | Not explicitly stated in the comparative table, but assumed acceptable for a legally marketed device. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This submission relies on demonstrating substantial equivalence in design, composition, and function, rather than clinical efficacy studies with a "test set" of patients or data in the context of an AI/ML device. The "test" here is the comparison of characteristics against the predicate device.
- Data Provenance: The submission is from MedTrade Products Ltd, UK. The data proving substantial equivalence is the comparison of device characteristics against a legally marketed predicate device by Advanced Bio-Technologies, Inc. Further details on the origin of data related to biocompatibility testing are not provided beyond "per ISO/Tripartite guidelines."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not applicable. Ground truth in the context of AI/ML evaluation (e.g., disease presence) is not relevant for this device. The "ground truth" for substantial equivalence is the established characteristics and regulatory approval of the predicate device.
- Qualifications of Experts: N/A.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This type of submission does not involve adjudication of clinical data or image interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is not an AI/ML medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" in this context is the regulatory status and established product characteristics of the predicate device (Kelo-cote Topical Gel, K002488). By demonstrating identical or very similar characteristics, the new device is deemed substantially equivalent. Biocompatibility testing results (though not detailed here) also form a type of "ground truth" for material safety.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML medical device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. This is not an AI/ML medical device.
In summary:
This 510(k) submission for MedTrade Product's Silicone Scar Gel is a substantial equivalence (SE) determination based on a comparison to a predicate device. The "acceptance criteria" are met by demonstrating that the device is substantially equivalent in design, composition, function, indications for use, and sterilization method to a legally marketed device (Kelo-cote Topical Gel, K002488). The study supporting this is a comparative feature analysis and biocompatibility testing, not a clinical performance study with a test set, ground truth experts, or AI/ML specific evaluations.
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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 ParkCrewe, 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 selfdrying, topical gel made from medical grade silicone.The primary function of the dressing is to aid in the management ofboth existing and new hypertropic and keloid scarring on scarsresulting from burns, general surgical procedures and trauma wounds.MedTrade Product's Silicone Scar Gel comes in a 15g pumpapplicator, making it easy to apply to difficult areas. It is safe, hygienicand 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 oldand 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 seekguidance 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 theintegrity of the skin in areas of coverage.Biocompatability testing has been successfully completed perISO/Tripartite guidelines.MedTrade Product's Silicone Scar Gel is substantially equivalent indesign, composition and function Kilo-cote Manufactured by AdvancedBio-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'sSilicone Scar Gel | Advanced Bio-Technologies, IncKelo-cote Topical Gel |
|---|---|---|
| Composition | Self drying, topical gel made from medicalgrade silicone | Self drying, topical gel made from medicalgrade silicone |
| Appearance | Clear translucent gel | Clear translucent gel |
| Indications For Use | For Management of old and newhypertrphic and keloid scarring on scarsresulting from burns, general surgicalprocedures and trauma wounds. | For Management of old and newhypertrphic and keloid scarring on scarsresulting from burns, general surgicalprocedures and trauma wounds. |
| Help Soften, Smooth and Flatten Scars | Help Soften, Smooth and Flatten Scars | |
| Sterilisation Method | Non Sterile | Non Sterile |
COMPARATIVE FEATURES
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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.
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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
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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 |
|---|---|
| --------------- | --------- |
§ 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.