EPI-FOAM SILICONE SHEETING by BIODERMIS CORP.

I'm sorry, but the provided text does not contain the information needed to describe acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter for a device called "Epi-Foam Silicone Sheeting," indicating that it is substantially equivalent to a pre-existing device for the management of hypertrophic and keloid scars.

The letter does not include:

A table of acceptance criteria or reported device performance.
Details about a study, sample sizes, data provenance, ground truth establishment, or expert involvement.
Information on MRMC comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0 1999 JUN

Jeff S. Schleuning, Ph.D. General Manager Biodermis Corp. 3078 East Sunset Road, Suite #1 Las Vegas, Nevada 89120

Re: K991604 Trade Name: Epi-Foam Silicone Sheeting Regulatory Class: Unclassified Product Code: MDA Dated: April 15, 1999 Received: May 10, 1999

Dear Dr. Schleuning:

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 requirement, as set forth in the Quality System Regulation (OS) 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 - Jeff S. Schleuning, Ph.D.

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,

Jocolef

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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4400tl)	1	11	11
11		Company of	****

510(k) Number (if known):__K991604 K991604

Device Name:Epi-Foam Silicone Sheeting______________________________________________________________________________________________________________________________________

Indications For Use:

Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices	K991604
510(k) Number
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use X

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.