(93 days)
Coreleader Scar-D Silicone Sheeting is intended for use: for the management of closed hypertrophic and keloid scars.
Coreleader Scar-D silicone sheeting is a thin, soft and self-adhesive sheet made from medical grade silicone with a PU Foam/PU non-woven film backing paper and a non-silicone polyester release paper. It is able to hold moisture with adequate pressure on the scar. The sheets are rectangular and come in four sizes, 5 cm x 8 cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm. They are approximately 0.6 mm thick. The sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.
The provided text is a 510(k) summary for the "Coreleader Scar-D Silicone Sheeting." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document.
The document primarily describes the device's characteristics, intended use, and states that it is substantially equivalent to two predicate devices (BIODERMIS CORP., K003948, EPI-DERM SILICONE GEL SHEETING and SMITH & NEPHEW UNITED, INC., K935803, CICA-CARE SILICONE GEL SHEET). It does not contain information about a specific study designed to prove the device meets pre-defined acceptance criteria for its performance.
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K 111733
page 1 of 2
Chapter 5 510(K) Summary
SEP 2 2 2011
510(k) Summary
| Submitted by: | Coreleader Biotech Co., Ltd.19F, No. 100, Sec. 1, Sintai 5th Rd., Sijhih Dist., NewTaipei City, Taiwan (R.O.C), 22102Phone: +886-2-26968880FAX: +886-2-26968882 |
|---|---|
| Contact Person: | Teeming Tsao |
| Date Prepared: | May 25, 2011 |
| Proprietary Name: | Coreleader Scar-D Silicone Sheeting |
| Common Name: | Silicone Sheeting |
| Classification: | Unclassified |
| Classification Name: | Elastomer, silicone, for scar management |
| Predicate Device: | BIODERMIS CORP., K003948, EPI-DERM SILICONEGEL SHEETINGSMITH & NEPHEW UNITED, INC., K935803,CICA-CARE SILICONE GEL SHEET |
| Device Description: | Coreleader Scar-D silicone sheeting is a thin, soft andself-adhesive sheet made from medical grade silicone witha PU Foam/PU non-woven film backing paper and a non-silicone polyester release paper. It is able to hold moisturewith adequate pressure on the scar.The sheets are rectangular and come in four sizes, 5 cm x 8cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm.They are approximately 0.6 mm thick. The sheet maybe cut |
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K 11 1 733
Page 2 of 2
Chapter 5 510(K) Summary
or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.
Coreleader Scar-D Silicone Sheeting is intended for use in Intended Use: the management of closed hypertrophic and keloid scars.
Technological Characteristics:
Coreleader Scar-D Silicone Sheeting is a thin, soft and self-adhesive medical grade silicone dressing. It is able to hold moisture with adequate pressure on the scar. Properties of silicone have been observed to hydrate scar tissue, soften it, and therefore aid in reducing the healing time of scars.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Coreleader Biotech Co.. Lid. % Mr. lan Li 19 F, No. 100, Sec. 1, Sintai 500 Rd., Sijhih Dist.. New Taipei City Taiwan (R.O.C) 22102
SEP 2 2 2011
Re: K111733 Trade/Device Name: Scar-D Silicone Sheeting Regulation Number: 21 CFR 878.4025 Regulation Name: Silicone sheeting Regulatory Class: 1 Product Code: MDA Dated: August 16, 2011 Received: August 30. 2011
Dear Mr. Li:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 fisting (21
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Page 2 - Mr. Ian Li
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofie the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely your
For
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):K111733
Device Name: Coreleader Scar-D Silicone Sheeting
Indications for Use:
Coreleader Scar-D Silicone Sheeting is intended for use:
for the management of closed hypertrophic and keloid scars. ◆
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Division of Surgical. Orthopedic, and Restorative Devices
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510(k) Number K111733
§ 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.