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510(k) Data Aggregation
(42 days)
BEAU RX SCAR CARE GEL
The Beau RX™ Scar Care Gel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting for burns, general surgical procedures and trauma wounds
Beau RxTM Scar Care Gel is a non sterile viscous emulsion/gel formulation, which is presented for over-the-counter use It is applied topically to aid in the management of both old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds
The manufacturer, Beau Rx Solutions, LLC, did not conduct a study to prove that the device meets specific acceptance criteria based on performance metrics. Instead, they performed biocompatibility testing and sought to demonstrate substantial equivalence to legally marketed predicate devices (Kelo-cote® Scar Gel and Silicone Scar Gel) under a 510(k) premarket notification.
The "acceptance criteria" in this context are not quantitative performance metrics for the device's efficacy in scar management, but rather the criteria for demonstrating substantial equivalence to a predicate device, primarily focusing on design, composition, function, intended use, and safety (biocompatibility).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence rather than a de novo marketing application requiring novel efficacy data, the "acceptance criteria" are tied to alignment with the predicate devices.
| Acceptance Criteria (based on predicate device characteristics) | Reported Device Performance (Beau Rx™ Scar Care Gel) |
|---|---|
| Intended Use: Management of old and new hypertrophic and keloid scarring on scars from burns, general surgical procedures, and trauma wounds. | Meets: Beau Rx™ Scar Care Gel is intended for "management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds." |
| Composition: Self-drying topical emulsion/gel made from medical-grade silicones. | Meets: Beau Rx™ Scar Care Gel is a "non-sterile viscous emulsion/gel formulation" and its composition involves ST-Dimethiconol, Dimethicone, and Silky Wax 10 (Stearoxytrimethylsilane and Stearyl alcohol), which are silicone-based components forming a film. The document explicitly states "Self-drying topical emulsion made from medical grade silicones." |
| Sterilization Method: Non-sterile. | Meets: The emulsion is supplied non-sterile. |
| Appearance: (Predicate Kelo-Cote®: Clear translucent gel; Predicate Silicone Scar Gel: Not explicitly stated, but often clear/translucent) | Differs: Beau Rx™ Scar Care Gel is a "White gel." The submission addresses this difference, stating it does not raise new safety or effectiveness concerns. |
| Gelling/Adhesion Agents: Predicate devices use Fumed Silicone Dioxide. | Differs: Beau Rx™ Scar Care Gel uses ST-Dimethiconol, Dimethicone, and Silky Wax 10 to form a film and provide adhesion. The submission addresses this difference, stating it does not raise new safety or effectiveness concerns. |
| Biocompatibility: Must be satisfactory. | Meets: "All required testing to assess the safety and efficacy of Beau Rx™ Scar Care Gel have been conducted and all results were satisfactory." Biocompatibility testing results are documented in Sections 21-25. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No specific clinical test set for performance efficacy in scar reduction is described. The "testing" mentioned refers to biocompatibility screenings of individual materials used in the gel, not a clinical study on patient scars. The data provenance is from the specific materials used in the device. The document does not specify country of origin or whether chemical testing data was retrospective or prospective, but it implies standard lab testing results.
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)
Not applicable. The ground truth for biocompatibility is established by standardized material testing according to recognized protocols (e.g., ISO standards, though not explicitly cited, it's implied for medical device materials). There's no mention of experts establishing ground truth for clinical outcomes as no clinical efficacy study was performed for this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was performed.
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
Not applicable. This device is a topical scar gel, not an AI-powered diagnostic or treatment assistance tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the submission is primarily based on the established safety and performance characteristics of the predicate devices and the results of biocompatibility testing for the component materials of Beau Rx™ Scar Care Gel. This is a regulatory "ground truth" (i.e., substantial equivalence has been met), not a clinical efficacy ground truth from patient outcome data.
8. The sample size for the training set
Not applicable. No algorithm or AI system was developed that would require a training set. The "training set" in a broader sense would be the cumulative knowledge and regulatory history surrounding silicone scar gels that underpin the substantial equivalence argument, but this isn't a quantifiable "sample size."
9. How the ground truth for the training set was established
Not applicable. As above, no training set in the AI sense was used. The "ground truth" for the regulatory submission (substantial equivalence) was established through comparison to predicate devices, supported by material biocompatibility testing.
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