(141 days)
NEARLY NETOUCHTMY Stillcone Scar Reduction Sheets are Soft durable silicone sheets designed to be worn on the skin for linited periods of time to reduce the appearance of hyp scars.
RETOUCH™ Silicone Scar Reduction Sheets are soft, slightly adherent silicone gel sheets that are applied over healed hypertrophic and/or keloid scars. The sheets are not made of medical grade silicone and are not sterile. The sheets are rectangular and come in three sizes, 3.5 cm x 7 cm, 7 cm x 10.5 cm and 10.5 cm x 14 cm. They are approximately .125 of an inch thick. The customers will determine which size sheet is best for their own application. A sheet will not remove or eliminate the scar but will flatten and soften the scar tissue and help improve and regain the natural skin color. The sheets are not for use on an open wound, are not sterile but can be washed. They are to be temporarily used on old or new healed hypertrophic or keloid scars and can be cut to other shapes if necessary.
The provided document is a 510(k) summary for the RETOUCH™ Silicone Gel Pads/Scar Reduction Sheets, indicating FDA clearance for marketing. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process is based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical performance studies with acceptance criteria in the way you've described. The document largely focuses on device description, intended use, and the regulatory outcome (clearance).
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on this document. The document explicitly states:
- No acceptance criteria are mentioned.
- No specific study proving performance against acceptance criteria is described. The 510(k) process typically relies on literature, existing data for predicate devices, and sometimes bench testing or small user studies for safety and efficacy, but a detailed performance study with defined acceptance criteria and statistical analysis as described in points 2-9 of your request is not provided in this regulatory submission.
The document essentially states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This is the core of the 510(k) determination, which doesn't require the detailed performance study information you are asking for.
§ 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.