(40 days)
- For the management of hypertrophic and keloid scars
- May prevent the formation of hypertrophic and keloid scar formation
- For use only on intact skin
- For application to hypertrophic and keloid scars as a means of reducing the size and erythema of scars resulting from bums, trauma and surgery
- The device is intended for the management of hypertrophic and keloid scars.
- The device may prevent the formation of hypertrophic and keloid scars.
- The product is indicated for use only on intact skin.
- For covering Hypertrophic and Keloid Scars as a means of reducing the size and erythema of scars resulting from burns, trauma and surgery.
CicaCare Scar Management Gel Sheet is a topical silicone gol sheet similar in indications and application to Rejuveness and Clinicel.
Cica Care Gel Sheet is packaged in a medical grade heat seal package. The product is manufactured by Smith and Nephew Medical Limited of Hull England. Ingredicats are procured from Dow Corning. This is the same formulation and manufacturing process as described in our document K935803. OTC distribution of the non-starile version is the only change from K935803.
The provided text is a 510(k) summary for the CicaCare Gel Sheet, an OTC scar management product. This document primarily focuses on demonstrating substantial equivalence to existing predicate devices (Rejuveness and Clinicel) for its indications for use. It does not contain information about specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The 510(k) summary states:
- Indications for Use:
- For the management of hypertrophic and keloid scars.
- May prevent the formation of hypertrophic and keloid scar formation.
- For use only on intact skin.
- For application to hypertrophic and keloid scars as a means of reducing the size and erythema of scars resulting from burns, trauma, and surgery.
- Substantial Equivalence Basis: Similarity in indications and application to existing products (Rejuveness and Clinicel), established OTC use of this type of non-sterile silicone gel sheet, and identical formulation and manufacturing process as described in a previous 510(k) (K935803).
Therefore, based on the provided text, I cannot answer most of the prompt's questions as the information is not present. The 510(k) process for this device relies on substantial equivalence to existing devices rather than new performance studies with specific acceptance criteria and detailed methodologies.
§ 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.