HYCURE ORAL / HYCURE ORAL SMART GEL by THE HYMED GROUP CORP.

The provided text is a letter from the FDA regarding a medical device, Hycure Oral/Hycure Oral Smart Gel, and discusses its regulatory classification, labeling limitations, and substantial equivalence.

It does not contain any information about acceptance criteria, device performance, studies, sample sizes, ground truth establishment, or expert involvement for a medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central graphic. The graphic consists of three stylized profiles of human faces, stacked one behind the other, with flowing lines suggesting hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Ms. Anita M. Petito Director The Hymed Group Corporation 1890 Bucknell Drive Bethlehem, Pennsylvania 18015

Re: K994339 Trade Name: Hycure Oral/Hycure Oral Smart Gel Regulatory Class: Unclassified Product Code: KGN Dated: December 15, 1999 Received: December 23, 1999
Dear Ms. Petito:

This letter corrects our substantially equivalent letter of March 22, 2000.

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 (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 and the following limitations:

This device may not be labeled for use on third degree burns.
This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.

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Page 2 - Ms. Anita M. Petito

This device may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (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 continue 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.

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Page 3 - Ms. Anita M. Petito

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K994339

Indications

For the management of oral wounds and sores, including:

Denture sores ·
Denture sores
Oral ulcers (non-infected or viral) ■
Oral dicorp (surgical wounds l
Suture sites 발
Burns l
Extraction sites 트
Surgical wounds 해
Traumatic wounds I

Susan Rume

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital, Intection
and General Hospital Devices 510(k) Number . 00

Regulation Number and Section

N/A