HYCURE

K955506 · The Hymed Group Corp. · KGN · Jan 17, 1996 · SU

Device Facts

• Record ID: K955506
• Device Name: HYCURE
• Applicant: The Hymed Group Corp.
• Product Code: KGN · SU
• Decision Date: Jan 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Device Story

HYCURE™ is a wound dressing device. It is applied topically to manage wounds. The device is intended for use by healthcare professionals in clinical settings. It functions as a physical barrier for wound protection. It does not accelerate healing, treat or cure wounds, or serve as artificial skin. It is not indicated for third-degree burns.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Wound dressing; physical barrier; non-implantable.

Submission Summary (Full Text)

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HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

MAR 19 2007

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

George D. Petito, Ph.D.
President
The Hymed Group Corporation
1890 Bucknell Drive
Bethlehem, Pennsylvania 18015

Re: K955506
Trade Name: HYCURE™
Regulatory Class: Unclassified
Product Code: KGN
Dated: December 22, 1995
Received: December 28, 1995

Dear Dr. Petito:

This letter corrects our substantially equivalent letter of January 17, 1996.

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:

1. This device may not be labeled for use on third degree burns.
2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
3. 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 – Dr. George D. Petito

4. 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 – Dr. George D. Petito

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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