(106 days)
Mepiform Adherent Silicone Dressing is intended for the management of both old and new hypertrophic and keloid scars. It can also be used as a prophylactic therapy on closed wounds which may prevent hypertrophic or keloid scarring.
The Mepiform Adherent Silicone Dressing for Scar Care consists of a silicone coated nonwoven bonded to an adhesive thermoplastic polyurethene film. The silicone dressing is protected by a low density polyethylene release film. The Mepiform dressing is individually sealed in a medical grade paper pouches and packaged in cartons of five (5) pouches each. The Mepiform dressings are available in two sizes: 5 cm x 7.5 cm (2" x 3") and 10 cm x 18 cm (4" x 7").
The provided text describes a 510(k) summary for a medical device called Mepiform Adherent Silicone Dressing for Scar Care. It outlines the device's purpose, components, and regulatory classification. However, the document does not contain any information about a study proving the device meets acceptance criteria.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device based on its intended use, technological characteristics, and safety profile (nontoxic, nonirritant, nonsensitizing in laboratory tests). It does not present results from a clinical trial or performance study that would typically include acceptance criteria and reported device performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided text.
The information given is primarily for regulatory clearance based on substantial equivalence, not a detailed performance study.
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MAR - 5 1998
510(k) SUMMARY
| Proprietary Name: | Mepiform |
|---|---|
| Common Name: | Adherent Silicone Dressing for Scar Care |
| Classification: | Unclassified |
| Submitter: | SCA Mölnlycke500 Baldwin TowerEddystone, PA 19022 |
| Contact Person: | Miguel A. NegronTel. 610-499-3383Fax. 610-499-3396 |
| Predicate Device: | Smith & Nephew Cica-Care™ Adhesive Gel Sheet |
Description:
The Mepiform Adherent Silicone Dressing for Scar Care consists of a silicone coated nonwoven bonded to an adhesive thermoplastic polyurethene film. The silicone dressing is protected by a low density polyethylene release film.
The Mepiform dressing is individually sealed in a medical grade paper pouches and packaged in cartons of five (5) pouches each. The Mepiform dressings are available in two sizes: 5 cm x 7.5 cm (2" x 3") and 10 cm x 18 cm (4" x 7").
Mepiform Adherent Silicone Dressing for Scar Care is intended for the management of both old and new hypertrophic and keloid scars. It can also be used as a prophylactic therapy on close wounds which may prevent hypertrophic or keloid scarring.
Mepiform Adherent Silicone Dressing for Scar Care have been shown in laboratory tests to be nontoxic, nonirritant, and nonsensitizing.
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Image /page/1/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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1998
Mr. Miguel A. Negron Manager, Requlatory Affairs & Quality Assurance North America SCA Molnlycke 500 Baldwin Tower Eddystone, Pennsylvania 19022
Re: K974354 Mepiform Adherent Silicone Dressing for Trade Name: Scar Care Regulatory Class: Unclassified Product Code: MDA February 18, 1998 Dated: February 19, 1998 Received:
Dear Mr. Negron:
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 reqistration, 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. Negron
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
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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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
510(k) Number: K974354 SCA Mölnlycke
Device Name: Mepiform Adherent Silicone Dressing for Scar Care
Indications for Use:
Mepiform Adherent Silicone Dressing is intended for the management of both old and new hypertrophic and keloid scars. It can also be used as a prophylactic therapy on closed wounds which may prevent hypertrophic or keloid scarring.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
. coley
(Division Sign-Off of General Restorative Devices 510(k) Num
לייני
SCA Mölnlycke
§ 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.