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K Number
K991968
Device Name
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
Manufacturer
SMITH & NEPHEW, INC.
Date Cleared
1999-07-30

(49 days)

Product Code
MDA
Regulation Number
878.4025
Type
Traditional
Panel
SU
Reference & Predicate Devices
K954413,K960254,K974380
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • 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 application to Hypertrophic and Keloid Scars as a means of reducing the size and erythema of scars resulting from burns, trauma and surgery.
Device Description

Cica-Care Roll-On Gel is a topical liquid silicone gel made from medical grade silicone. The gel is applied via roller-ball technology. As a result, the gel can be applied to awkward areas of the body. Cica-Care Roll-On Gel is available OTC and is non-sterile. The gel may also be recommended/specified by healthcare professionals for use in the management of scars.

AI/ML Overview

This document, K991968, is a 510(k) summary for Cica-Care Roll-On Gel. It outlines the product's description, indications for use, and a comparison to substantially equivalent predicate devices. However, it does not contain any information regarding specific acceptance criteria, performance data from a study, or details about the methodology of such a study.

Therefore, I cannot extract the requested information. The document focuses solely on establishing substantial equivalence based on product characteristics and indications for use compared to previously cleared devices, rather than presenting a performance study with acceptance criteria.

To answer your request, the provided text does not contain:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number and qualifications of experts for ground truth establishment.
  4. Adjudication method for the test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information about a standalone performance study.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

§ 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.