GILTECH PLUS HYDROGEL SKIN DRESSING

K992094 · Giltech Plus, Inc. · NAE · Sep 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992094
• Device Name: GILTECH PLUS HYDROGEL SKIN DRESSING
• Applicant: Giltech Plus, Inc.
• Product Code: NAE · General, Plastic Surgery
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4022
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of. 1. Minor burns - Decubitus ulcers 2. - 3. Superficial lacerations, cuts and abrasions - 4. Postoperative incisions - Sunburn

Device Story

Hydrogel wound dressing; high water content provides high specific heat for cooling effect; manages minor burns, ulcers, lacerations, and incisions; applied topically to wound site; provides cooling relief; intended for wound management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrogel-based wound dressing; high water content; cooling properties via high specific heat.

Indications for Use

Indicated for management of minor burns, decubitus ulcers, superficial lacerations, cuts, abrasions, postoperative incisions, and sunburn.

Regulatory Classification

Identification

A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

Mr. William J. Giliam President Giltech Plus, Inc. P.O. Box 728 Milford, Pennsylvania 18337

Re: K992094

> Trade Name: Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: June 17, 1999 Received: June 21, 1999

Dear Mr. Giliam:

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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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 - Mr. William J. Giliam

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html",

Sincerely yours,

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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## "INDICATIONS FOR USE"

Page 1 of 1

510(k) Number (if known): K992094

Device Name: Giltech Plus Hydrogel Wound Dressing

Indications For Use:

Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of.

1. Minor burns

- Decubitus ulcers 2.
- 3. Superficial lacerations, cuts and abrasions
- 4. Postoperative incisions
- પં Sunburn

This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dcollepe

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)