(40 days)
No
The document describes a topical silicone gel sheet for scar management and makes no mention of AI or ML technology.
Yes
The intended use explicitly states that the device is "for the management of hypertrophic and keloid scars" and "reducing the size and erythema of scars resulting from bums, trauma and surgery," which are therapeutic claims.
No
The "Intended Use / Indications for Use" section states that the device is for the management and prevention of hypertrophic and keloid scars, and for reducing their size and erythema. There is no mention of the device performing any diagnostic function like detecting, identifying, or analyzing a medical condition.
No
The device description explicitly states it is a "topical silicone gel sheet" and mentions ingredients and manufacturing processes, indicating a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and prevention of hypertrophic and keloid scars on intact skin. This is a therapeutic and preventative application directly on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "topical silicone gel sheet." This is a physical product applied to the skin, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device falls under the category of a medical device used for wound care and scar management, applied externally to the body.
N/A
Intended Use / 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 bums, trauma and surgery
Product codes
MDA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a series of bold, black numbers and letters against a white background. The characters appear to be handwritten or drawn with a thick marker, giving them a somewhat irregular and bold appearance. The sequence of characters is 'KG91957'.
510k Summary for OTC version of CicaCare Gel Sheet
CicaCare Scar Management Gel Sheet is a topical silicone gol sheet similar in indications and application to Rejuveness and Clinicel. Respectively, Richmark International Corporation and Life Modical Sciences, Inc sell these products. The Indications for CiceCare include the following:
- 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
Materials present in the product do not contraindicate topical (skin'scar) applications. The components do not contain animal ingredients. Additionally, the OTC use of this type of nonsterile silicone gol shoot is established via other currently marketed OTC non-storile products.
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.
Signature
Date 7-6-99
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the symbol. The text is in all caps and is in a circular arrangement around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1999
Mr. Jim Irvin Vice President, Quality Assurance and Regulatory Affairs Smith & Nephew, Inc. Wound Management Division 11775 Starkey Road Largo, Florida 33773-4727
Re: K991957
Trade Name: Cicacare Management for Scars Regulatory Class: Unclassified Product Code: MDA Dated: June 8, 1999 Received: June 10, 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
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
3
510(k) Number (if known):
Image /page/3/Picture/1 description: The image shows a series of bold, black numbers and a letter, seemingly handwritten. The sequence reads 'K991957'. The characters are closely spaced and have a somewhat rough, uneven appearance, suggesting they were written quickly or with a thick marker.
Device Name:
CICACARE MANAGEMENT FOR SCARS
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 covering 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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K991957 |
Prescription Use _________________ OR Over-the Counter Use X(Per 21CFR 801.109)