CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.

• 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: General & Plastic Surgery
• Reference & Predicate Devices: K954413 , K960254 , K974380
• Predicate For: N/A

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.

Summary

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K991968

510(k) Summary

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. Indications are:

• • 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.

Materials present in the product do not contra-indicate topical (skin/scar) applications. The components do not contain animal ingredients.

Substantially equivalent products are contained in the following matrix.

Product	510(K)
Kelocote Allied Bio-Medical Corp	K954413
Silgel Biosil Ltd.	K960254
RejuvenessRickmark InternationalCorp.	K974380
Clinicel Life MedicalSciences, Inc.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Jim Irvin Vice President of Regulatory Affairs Smith & Nephew, Inc. Wound Management Division 11775 Starkey Road Largo, Florida 33779-1970

Re: K991968

Trade Name: Cicacare Roll-on Gel-Scar Management Liquid Gel Regulatory Class: Unclassified Product Code: MDA Dated: June 9, 1999 Received: June 11, 1999

Dear Mr. Irvin:

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, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jim Irvin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K991968

Device Name:

CICACARE ROLL-ON GEL

Indications for 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Piccolo

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K991968

Prescription Use _

OR

Over-the Counter Use X

(Per 21CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.