SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA

K991287 · Advanced Medical Solutions Group Plc · FRO · Jun 29, 1999 · SU

Device Facts

• Record ID: K991287
• Device Name: SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
• Applicant: Advanced Medical Solutions Group Plc
• Product Code: FRO · SU
• Decision Date: Jun 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Advanced Medical Solutions Group plc Spyrogel Hydrogel Wound and Burn Dressing SA is intended for OTC use on: Superficial wounds such as, minor cuts, lacerations and minor burns and scalds

Device Story

Spyrogel Hydrogel Wound and Burn Dressing SA is a sterile hydrogel dressing used for the management of superficial wounds. The device is supplied individually packaged in medical grade foil pouches. It is intended for over-the-counter (OTC) use by patients for minor cuts, lacerations, burns, and scalds. The dressing provides a protective barrier for the wound site. No specific clinical operation or healthcare provider interaction is required for application.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993-1. Sterilization validated per ISO 11137 Method 1 to achieve a Sterility Assurance Level (SAL) of 10^-6.

Technological Characteristics

Hydrogel wound dressing; sterile; gamma-irradiated; packaged in medical grade foil pouches. Sterilization validation per ISO 11137. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for OTC use on superficial wounds including minor cuts, lacerations, minor burns, and scalds.

Predicate Devices

• Intelligent film (K981753)

Reference Devices

• K982804

Submission Summary (Full Text)

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K991287

JUN 29 1999

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## Summary of Safety and Efficacy Summary of Advanced Medical Solutions Group plc Spyrogel® Hydrogel Wound and Burn Dressing SA

Manufacturer:

Telephone:

Classification:

Description:

Regulatory Affairs Contact:

Date Summary Presared:

Common or Usual Name:

Device Trade Name:

Advanced Medical Solutions ple Road Three, Winsford Industrial Estato Cheshire CW7 3PD, United Kingdom

Christopher Oakes, Mariayor

44 1606 863 500

April 13, 1999

Spyrogel® Hydrogel Wound and Burn Dressing SA.

Dressing, Wound and Burn, Hydrogel

Wound Dressings, currently unclassified by FDA.

Advanced Medical Sulutions Group plc Spyrogel® Hydrogel Wound and Rurn Dressing SA are supplied individually packaged in medical graum fuil pouches suitable for gamma irradiation. They are supplied to the market place as sterile dreasings.

The intelligent film is as comercially distrubuted in the USA under 510(k) (K981753) June 30, 1998.

The dressings are sterilized by gamma Irradiation. Isotron Laboratories provided Dose Mapping per ISO 11137, validation was undertaken in accordance with ISO 11137 Mothod 1. The verification dose required for a Sterllity Assurance Level (SAL) of 10-6 is 23.4 kGy. Starilization velidation data is on file at Isotron Laboratories.

Biooompatability tosting has boon performed in accordance with ISO10983-1 Biological Evaluation of Medical Devices -- Part 1 Guidance on Selection of Tests First Edition. Data and Safety evaluation is as that submitted with aiready sporoved 510(k)'s K881753 and K982804. No components or raw materials have changed therefore no resubmission of loxicily data its required.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 29 1999

Mr. Christopher Oakes Regulatory Affairs Manager Advanced Medical Solutions plc Road Three. Winsford Industrial Estate Cheshire CW7 3PD United Kingdom

K991287 Re:

> Trade Name: Spyrogel Hydrogel Wound and Burn Dressing Regulatory Class: Unclassified Product Code: MGP and MGQ Dated: April 13, 1999 Received: April 14, 1999

Dear Mr. Oakes:

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 (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. Christopher Oakes

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,

tocafo

-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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#### k991287 510(k) Number (if known):

Device name: Advanced Medical Solutions Group plc, Spyrogel Hydrogel Wound and Burn Dressing SA

Indications For Use:

Advanced Medical Solutions Group plc Spyrogel Hydrogel Wound and Burn Dressing SA is intended for OTC use on:

Superficial wounds such as, minor cuts, lacerations and minor burns and scalds

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

**OR Over The Counter Use**

*

(Optional Format 1-2-96)

Põllufto

Division Siyn-O Division of General Restorative Devi 510(k) Number -