(90 days)
[Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids. Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.
[Trade Name] is a self-adhesive, fabric-backed, semi-disposable silicone sheet. The main component of the product is a proprietary material called Silon®. The basic Silon material is made from a blend of medical grade silicone and polytetrafluoroethylene ("PTFE") in the form of an interpenetrating polymer network. [Trade Name] is not sterile and does not contain antibiotics. [Trade Name] is not intended for use on open wounds. Each package of [Trade Name] contains 30 individual sheets (1.5" x 3"). Each sheet can be cut to fit the size of the scar or applied side-by-side, depending on the size of the scar.
This 510(k) submission does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. The document states "Performance Data: Not applicable" and primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and biocompatibility testing.
Therefore, I cannot provide the requested information.
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Pfizer Consumer Healthcare Pfizer Inc
201 Tabor Road
Morris Plains, NJ 07950 Tel 973 385 4909
K024160
page1/2
Consumer Healthcare
MAR 1 7 2003
510(k) SUMMARY 12.0
| Date Prepared: | December 16, 2002 |
|---|---|
| Applicant: | Warner-Lambert Company201 Tabor Rd.Morris Plains, NJ 07950Telephone: 973-385-5523Fax: 973-385-4300 |
| Contact Person: | John R. JacobsVice-President, Regulatory Affairs |
| Proprietary Name:Common Name:Classification Name:Product Code: | [Trade Name]Silicone Elastomer SheetingElastomer, Silicone, for Scar ManagementMDA |
| Predicate Devices: | Oleeva® Fabric (K982036), and (K023136)Bio Med Sciences, Inc.1111 Hamilton St.Allentown, PA 18101 |
| Description: | [Trade Name] is a self-adhesive, fabric-backed, semi-disposable silicone sheet. The main component of theproduct is a proprietary material called Silon®. Thebasic Silon material is made from a blend of medicalgrade silicone and polytetrafluoroethylene ("PTFE") inthe form of an interpenetrating polymer network( |
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December 16, 2002
[Trade Name] Silicone Sheeting [Trade Name] is not sterile and does not contain antibiotics. [Trade Name] is not intended for use on open wounds. Each package of [Trade Name] contains 30 individual sheets (1.5" x 3"). Each sheet can be cut to fit the size of the scar or applied side-by-side, depending on the size of the scar. [Trade Name] silicone sheeting is indicated for the Intended Use: management of hypertrophic scars and keloids. Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids. Technological [Trade Name] and the predicate devices are Characteristics: technologically and functionally identical. All devices have a skin-contacting surface of medical grade silicone with an internal matrix of PTFE, which increases the physical strength and durability of the product. In addition, [Trade Name] and the predicate devices have a non-skin contacting fabric backing, which makes the products convenient to wear under clothing. Performance Data: Not applicable Biocompatibility Testing: When tested according to the ISO 10993 guidelines, [Trade Name], was found to be non-sensitizing (Kligman Maximization); non-irritating (Intracutaneous Injection); and, non-cytotoxic (MEM Elution Cytotoxicity
510(k) Notification
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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 the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Public Health Service
MAR 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Warner-Lambert Company Dina Russello Director, Regulatory Affairs 201 Tabor Road Morris Plains, New Jersey 07950
Re: K024160
Trade/Device Name: Silicone Sheeting Regulation Name: Elastomer, silicone for scar management Regulatory Class: Unclassified Product Code: MDA Dated: December 16, 2002 Received: December 17, 2002
Dear Ms. Russello:
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
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Page 2 – Ms. Dina Russello
(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. 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Muriam C. Provost
for 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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STATEMENT OF INDICATIONS FOR USE 13.0
| 510(k) Number: | K024160 |
|---|---|
| Device Name: | [Trade Name] Silicone Sheeting |
| Indications for Use: | [Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids. |
| Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. | |
| [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurologicul Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
OR
Prescription Use (Per 21 CFR §801.109) Over-The-Counter Use
§ 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.