Intended for the management of hypertrophic and keloid scars. May be used as prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.

Device Description

Curad® Scar Therapy is a semi-occlusive, flexible pad for the management of hypertrophic scars resulting from burns, surgery, or injuries, after complete healing. The device is also intended for management of keloid scars. It may be used as a prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring. It is intended for over-the-counter use.

Curad® Scar Therapy consists of an adhesive aliphatic polyurethane matrix. Embedded in this matrix are absorbent sodium polyacrylate particles. The product has a waterproof polyurethane film that is permeable to oxygen and water vapor.

The Curad® Scar Therapy pads are individually sealed in envelopes and packaged in cartons of 21 pads. The size of the pads is 7x4 cm. The pad is intended to be exchanged daily for a new pad, and may remain in place 24 hours a day. Treatment should consist of at least 12 hours a day for at least eight weeks.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Curad® Scar Therapy device, structured according to your request:

Device: Curad® Scar Therapy

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety (Biocompatibility, application to compromised/intact skin)	"The safety of this polyurethane pad for application to both compromised and intact skin has been demonstrated with biocompatibility studies and long-term use. Thus, Curad Scar Therapy, which is applied only to intact skin, does not raise new issues of safety." (Section VI - Summary of Substantial Equivalence)
Efficacy (Management and reduction of hypertrophic and keloid scars)	"Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars. Therefore, Curad Scar Therapy does not raise new issues of efficacy." (Section VI - Summary of Substantial Equivalence)
Substantial Equivalence to Predicate Devices (Composition/Technology)	"In terms of its composition or technological characteristics, Curad®Scar Therapy is identical, and therefore substantially equivalent, to Beiersdorf's Cutinova®thin Wound Dressing, cleared for marketing under 510(k) number K94-4581." and "Curad® Scar Therapy has the same intended use and principle of operation as, and is therefore also substantially equivalent to, the Mepiform product." (Section VI - Summary of Substantial Equivalence)

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample size used for the efficacy clinical studies or the data provenance (country of origin, retrospective/prospective). It only makes a general statement about "Clinical studies".

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical studies. Given the nature of scar assessment, it is likely that clinicians (e.g., dermatologists, plastic surgeons) would have been involved, but this is not specified.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. This device is a topical medical device, not an AI-powered diagnostic tool, so an MRMC study would generally not be applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical scar therapy pad and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

Based on "Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars," the ground truth for efficacy would likely be based on clinical assessment of scar appearance and characteristics by medical professionals. This could involve subjective ratings (e.g., Vancouver Scar Scale, patient satisfaction) or objective measurements (though not specified). It is not pathology or direct outcomes data in the sense of mortality or disease progression, but rather clinical improvement in a visible condition.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical scar therapy pad and does not involve AI or machine learning models that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary of Study Information Provided in the 510(k):

The 510(k) summary for Curad® Scar Therapy relies on demonstrating substantial equivalence to predicate devices (Cutinova®thin Wound Dressing and Mepiform Adherent Silicone Dressing).

Safety: Demonstrated through "biocompatibility studies and long-term use" of the device's polyurethane pad, claiming it "does not raise new issues of safety" since it's applied only to intact skin.
Efficacy: Stated that "Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars," implying a comparative clinical study against the Mepiform predicate. However, specific details about these clinical studies (e.g., sample size, methodology, endpoints, blinding) are not provided in this summary document. The submission is primarily focused on asserting equivalence rather than detailing the full clinical study report.

Summary

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K024057
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510(k) Summary Curad® Scar Therapy

I. General Information on the Submitter:

Name:	Beiersdorf Inc.
Address:	5801 Mariemont AvenueCincinnati, Ohio 45227
Telephone:	513.272.5060
Contact Person:	Mr. Richard Taylor
Date SummaryPrepared:	December 9, 2002

II. General Information on Device:

Proprietary name:	Curad® Scar Therapy
Classification:
Name:	Elastomer, silicone, for scar management
Common Name:	Scar management sheet, bandage, pad, patch, or material
Class:	Not classified

III. Predicate Devices:

Curad® Scar Therapy is substantially equivalent to the Cutinova®thin Wound Dressing (K94-4581) and the Mepiform Adherent Silicone Dressing for Scar Care (K97-4354).

IV. Description of the Device:

The Curad® Scar Therapy pads are individually sealed in envelopes and packaged in cartons of 21 pads. The size of the pads is 7x4 cm. The pad is intended to

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K024057
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be exchanged daily for a new pad, and may remain in place 24 hours a day. Treatment should consist of at least 12 hours a day for at least eight weeks.

Intended Use: V.

Curad® Scar Therapy is intended for the management of hypertrophic and keloid scars. It may be used as a prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.

VI. Summary of Substantial Equivalence

In terms of its composition or technological characteristics, Curad®Scar Therapy is identical, and therefore substantially equivalent, to Beiersdorf's Cutinova®thin Wound Dressing, cleared for marketing under 510(k) number K94-4581. The safety of this polyurethane pad for application to both compromised and intact skin has been demonstrated with biocompatibility studies and long-term use. Thus, Curad Scar Therapy, which is applied only to intact skin, does not raise new issues of safety.

Curad® Scar Therapy has the same intended use and principle of operation as, and is therefore also substantially equivalent to, the Mepiform product. Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars. Therefore, Curad Scar Therapy does not raise new issues of efficacy.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending upwards. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUN 1 8 2003

Beiersdorf, Inc. c/o Ms. Frances K. Wu Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, D.C. 20005-5929

Re: K024057

Trade/Device Name: Curad® Scar Therapy Regulatory Class: Unclassified Product Code: MDA Dated: April 2, 2003 Received: April 3, 2003

Dear Ms. Wu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Frances K. Wu

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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Page of of

510(k) Number (if known): K024057

Device Name: Curado Scar Therapy

Indications For Use:

Intended for the management of hypertrophic and keloid scars. May be used as prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K624057

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.