(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.
§ 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.