(191 days)
K94-4581, K97-4354
Not Found
No
The device description and intended use focus on a physical pad with specific material properties for scar management. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the "management of hypertrophic and keloid scars" and "prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring," indicating it treats a medical condition.
No.
The device is described as a therapy for managing and reducing scars, not as a tool for diagnosing medical conditions.
No
The device description clearly states it is a "semi-occlusive, flexible pad" consisting of an "adhesive aliphatic polyurethane matrix" with "absorbent sodium polyacrylate particles" and a "waterproof polyurethane film." This describes a physical, material-based medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The Curad® Scar Therapy is a physical pad applied externally to the skin for the management and prevention of scars. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for the management and prevention of scars, which is a physical treatment, not a diagnostic test.
Therefore, the Curad® Scar Therapy falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MDA
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.
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)
Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K94-4581, K97-4354
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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K024057
page 11/2
510(k) Summary Curad® Scar Therapy
I. General Information on the Submitter:
| Name: | Beiersdorf Inc. |
|---|---|
| Address: | 5801 Mariemont Avenue |
| Cincinnati, Ohio 45227 | |
| Telephone: | 513.272.5060 |
| Contact Person: | Mr. Richard Taylor |
| Date Summary | |
| Prepared: | 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:
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
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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.
2
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.
3
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
4
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