(144 days)
KMC Ultra-Sil Scar Management System is a thin, soft silicone KMC ofera-SIF Scar handyement application for keloid and hypertrophic scar management.
KMC Ultra-Sil Scar Management System is intended to be used only on healed scars.
KMC Ultra-Sil Scar Management System is a thin, soft silicone sheet designed to be applied externally, in a non-invasive manner to healed keloid and hypertrophic scars. Scar area is to be washed and towel dried before application. KMC Ultra-Sil Scar Management System is applied to scar area with 1/2 inch overlap. Initial application to last 2-3 hours. Successive applications will increase contact by 1 hour each until 8 hour contact is reached. Application time of 20 hours is recommended.
The provided text does not contain information about acceptance criteria, device performance, or any studies with sample sizes, expert involvement, or statistical analysis. The document is a 510(k) summary for the "KMC Ultra-Sil Scar Management System," which primarily focuses on establishing substantial equivalence to a predicate device (Degania Silicone Sil-K, 510(k) No. K971482).
The 510(k) summary outlines:
- Device Description and Use: A thin, soft silicone sheet for external, non-invasive application to healed keloid and hypertrophic scars. It details application instructions (e.g., wash scar area, initial application of 2-3 hours, increasing to 8 hours, with 20 hours recommended).
- Manufacturing: States it uses essentially the same silicone materials and manufacturing practices as the predicate device.
- Substantial Equivalence: The core claim, stating it's substantially equivalent to the Degania Silicone Sil-K.
Therefore, I cannot populate the requested table or provide details about a study that proves the device meets acceptance criteria. The document does not describe such a study or associated data points. The FDA's letter (Document {1}) confirms the substantial equivalence determination, allowing the device to be marketed, but does not refer to specific performance criteria or a study done by the applicant to prove these criteria were met, beyond the substantial equivalence argument.
§ 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.