(90 days)
Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.
Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel backed by a polyester hook and loop fabric.
The provided 510(k) summary for the Implantech Associates Inc. "Gelzone" device does not contain a study that proves the device meets specific acceptance criteria in the manner of a performance study. This is a premarket notification where substantial equivalence to a predicate device is claimed, not a study demonstrating efficacy against defined metrics.
Therefore, most of the requested information (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) cannot be extracted from this document as no such study is presented.
The summary states:
"Efficacy
Gelzone's silicone layer is manufactured with silicone gel. This silicone layer is the same material used in the current Implantech Gel Sheeting and Conform Sheeting products. The manufacturer of the gel has an FDA Master File which includes information on their formulation, on manufacturing methods, testing, and toxicology information."
This indicates that the efficacy is primarily supported by the known properties of the silicone gel material and its prior use in substantially equivalent devices, rather than a new clinical study with specific acceptance criteria for the Gelzone product itself.
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FEB 0 7 2002
510(k) Summary
February 07, 2001 Date:
Manufacturer
Implantech Associates Inc. 2064 Eastman Ave. #101 Ventura, CA 93003
Telephone: (805) 339-9415 (805) 339-9414 Fax: Stephen Meade Contact:
Device Name Gelzone Common or Usual Name: Gel Sheeting Device Classification: Currently unclassified
Product Description
Gelzone is a soft, semi-occlusive, slightly adhesive silicone gel backed by a polyester hook and loop fabric.
Indication For Use
Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.
Substantial Equivalence
Gelzone is substantially equivalent to the Implantech's Gel Sheeting and Conform Sheeting cleared under 510(k) K964846 and K012419 respectively. Gelzone is also substantially equivalent to PMT's Amend™ Silicone Gel Sheeting cleared under 510(k) number K972597.
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277210) page ZofZ
Packaging and Labeling
Gelzone will be provided in various lengths, widths and colors and packaged in a box with see through window to permit potential users to see the device prior to purchase. Use instructions along with warnings, precautions and complications are displayed on the packaging and can be easily understood and followed by OTC users. The use of this product does not require instruction by a physician to insure adequate or safe use.
Efficacy
Gelzone's silicone layer is manufactured with silicone gel. This silicone layer is the same material used in the current Implantech Gel Sheeting and Conform Sheeting products. The manufacturer of the gel has an FDA Master File which includes information on their formulation, on manufacturing methods, testing, and toxicology information.
Date: Feb 07 2001
Stephen Meade RA/QA Manager, Implantech Associates, Inc.
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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus is a common symbol associated with medicine and healthcare.
Public Health Service
FEB 0 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Meade Regulatory Affairs/Quality Assurance Manager Implantech Associates, Inc. 2064 Eastman Avenue, Unit 101 Ventura, California 93003
Re: K013732 Trade/Device Name: Gelzone Regulatory Class: Unclassified Product Code: MDA Dated: November 5, 2001 Received: November 9, 2001
Dear Mr. Meade:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreases) 7 the enactment date of the Medical Device Amendments, or to conniner or nas nas nas 2011 ) 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 nean r lease of acrised that thermination that your device complies with other requirements of the Act that I Dri has made a assoc 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 - Mr. Stephen Meade
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough mating of substantial equivalence of your device to a legally prematicated 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 11 you dostro specific arrest 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 1 Frances of 301) 594-4659. Additionally, for question and advertising of Compliance at (301) 594-4639 of Compliance at (301) 594-4639. 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 Oiner general 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,
iriam 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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Implantech Associates, Inc.
13732
Gelzone 510(k) Submission
INDICATIONS FOR USE
Applicant: Implantech Associates, Inc.
510(k) Number (if known): N/A*
Device Name: Gelzone
Indications For Use:
Gelzone is indicated for use in the management of keloid and hypertrophic scars. Gelzone may also be used prophylactically to help retard the formation of such scars.
Musiam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K013732
(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
Over-the-Counter_ メ OR
§ 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.