(32 days)
KELOCOTE SCAR GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ASSOCIATED ERYTHEMA SECONDARY TO ANY TRAUMA CAUSING SCARS KELOCOTE LASER GEL: FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ERYTHEMA SECONDARY TO LASER RESURFACING
Kelocote Scar Gel and Kelocote Laser Gel are topical silicone elastomer products. Kelocote Gel is described as an amorphous paste with minimal to no elasticity or strength. Kelocote Gel in one form will contain Titanium Oxid or Zinc Oxide for color and concistency. Kelocote is manufactured from Applied Silicone's LSR-30 and or Nusil Technology's MED 4210 and 4211 Silicone Rubber MAF 612.
This document is a 510(k) premarket notification for a medical device called "Kelocote Scar Gel and Kelocote Laser Gel." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as a similar device already on the market and does not require premarket approval.
Based on the provided text, there is no acceptance criteria or study data presented in the format requested. The document primarily focuses on the device's intended use, physical properties, and packaging, along with the FDA's decision regarding its substantial equivalence.
Here's why the requested information cannot be extracted:
- Acceptance Criteria and Device Performance: The document states that Kelocote Scar Gel and Kelocote Laser Gel are "substantially equivalent" to Kelocote Gel of Allied Biomedical, which was in turn found "SE to PMT's Gel Sheeting." This is the basis for market clearance, not specific performance metrics or acceptance criteria for a new study. There are no tables of performance metrics.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Information: Since no new performance study is described, none of this information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details) is available in the provided text. The FDA's substantial equivalence determination rarely requires new clinical trials if equivalence can be demonstrated through other means (e.g., comparison to a predicate device's characteristics and historical use).
In summary, the document is an FDA clearance letter based on substantial equivalence, not a report of a performance study with acceptance criteria.
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OCT 2 1 1997
TAB G
510 (k) Summary
Substantial Equivalence:
Kelocote Scar Gel and Kelocote Laser Gel are topical silicone elastomer products that are substantially equivalent to Kelocote Gel of Allied Biomedical. Allied Biomedical's kelocote was found SE to PMT's Gel Sheeting.
Intended Use:
The intended use of Kelocote Scar and Kelocote Laser Gels are for . the management of hypertrophic scars and associated erythema which is commonly associated with scars in the first few months post trauma. Kelocote Scar Gel is applied in a very thin coat and the excess is wiped away. This forms a thin sheet on the skin which is very nearly invisible.
Physical and Chemical Properties:
Kelocote Gel is described as an amorphous paste with minimal to no elasticity or strength. Kelocote Gel in one form will contain Titanium Oxid or Zinc Oxide for color and concistency. Kelocote is manufactured from Applied Silicone's LSR-30 and or Nusil Technology's MED 4210 and 4211 Silicone Rubber MAF 612.
Package Description:
Packaging will consist of aluminum tubes of varying volumes from 1/6 ounce to 2 ounces. Tubes will be blind mouth with crimped ends. Tubes will be shipped individually or in boxes of 12 in corrugated protective outer boxes.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three heads or faces, represented by flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Kathy Hanson Richardson .Regulatory Affairs Hanson Medical Inc. 19325 58th Place N.E. Seattle, Washington 98155
OCT 2 1 1997
Re: K973572
Trade Name: Kelocote Scar Gel and Kelocote Laser Gel Regulatory Class: Unclassified Product Code: MDA Dated: September 10,1997 Received: September 19, 1997
Dear Ms. Richardson:
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 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 (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 requirements , 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 - Ms. Kathy Hanson Richardson
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.D.
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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510(k) Number (if known): K973572
Device Name: KELOCOTE SCAR_GEL, KELOCOTE LASER GEL
Indications For Use:
KELOCOTE SCAR GEL:
FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ASSOCIATED ERYTHEMA SECONDARY TO ANY TRAUMA CAUSING SCARS
KELOCOTE LASER GEL:
FOR THE MANAGEMENT OF HYPERTROPHIC SCARS AND KELOID SCARS AND ERYTHEMA SECONDARY TO LASER RESURFACING
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General Restorative Devices
| 510(k) Number | L973572 |
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Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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§ 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.