STERILE HYDROGEL

K993119 · Dumex Medical Surgical Products, Ltd. · MGQ · Nov 23, 1999 · SU

Device Facts

• Record ID: K993119
• Device Name: STERILE HYDROGEL
• Applicant: Dumex Medical Surgical Products, Ltd.
• Product Code: MGQ · SU
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Hydrogel sterile dressing is for the wound management of partial and full thickness pressure ulcer, stasis ulcers, first & second degree burns, cuts, abrasions, irritations of the skin and skin condition associated with periostomal care.

Device Story

Sterile Hydrogel is a wound dressing designed for management of various skin wounds and irritations. It provides a moist environment to facilitate healing. Used in clinical or home settings for patients with pressure ulcers, stasis ulcers, burns, or minor skin trauma. Applied topically by clinicians or patients to the affected area to protect the wound bed and manage exudate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Sterile hydrogel-based wound dressing. Formulated for topical application to manage wound moisture. Non-implantable, single-use device.

Indications for Use

Indicated for wound management of partial and full thickness pressure ulcers, stasis ulcers, first and second degree burns, cuts, abrasions, skin irritations, and periostomal skin conditions.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1999

Mr. Sam Lakhani, M.S. Research and Development Manager Dumex Medical Surgical Products LTD 104 Shorting Road Scarborough, Ontario, Canada MIS 3S4

> K993119 Trade Name: Sterile Hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: September 17, 1999 Received: September 20, 1999

Dear Mr.Lakhani:

Re:

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 Ouality 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 -- Mr. Sam Lakhani, M.S.

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 vour 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,

Neil R.P. Ogden

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10. Indication For Use Statement:

510 (k) Number (If known): 4993119

Dumex Medical Surgical Products Ltd.

Device Name: Sterile Hydrogel

Indication for use:

Hydrogel sterile dressing is for the wound management of partial and full thickness pressure ulcer, stasis ulcers, first & second degree burns, cuts, abrasions, irritations of the skin and skin condition associated with periostomal care.

## (PLEASE DO NOT WRITE BELLOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center">PROF</div> <div align="center">(Division Sign-Off)</div> |
|---------------|------------------------------------------------------------------------------|
| | Division of General Restorative Devices |
| 510(k) Number | K993119 |

| Prescription Use<br>(Per 21 CFR 801.109) | | OR | Over-The-Counter-Use<br>(Optional Format 1-2-96) |
|------------------------------------------|--|----|--------------------------------------------------|
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