ANTIMICROBIAL ALGINATE DRESSING

K024298 · Advanced Medical Solutions, Ltd. · FRO · Jun 30, 2003 · SU

Device Facts

• Record ID: K024298
• Device Name: ANTIMICROBIAL ALGINATE DRESSING
• Applicant: Advanced Medical Solutions, Ltd.
• Product Code: FRO · SU
• Decision Date: Jun 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Device Story

Antimicrobial Alginate Dressing is a sterile, non-woven wound dressing; composed of high G alginate, carboxymethylcellulose (CMC), and silver-coated nylon fibers. Device functions by absorbing wound exudate to maintain a moist healing environment; releases ionic silver upon moisture activation to provide antimicrobial protection for up to 3 days. Acts as a barrier to bacterial penetration to help reduce infection. Available in flat pads and rope formats; applied by clinicians to wound sites. Benefits include infection reduction and optimal healing environment.

Clinical Evidence

Bench testing only. Biocompatibility demonstrated per BSENISO 10993-1. In vitro testing demonstrated performance characteristics substantially equivalent to the predicate device.

Technological Characteristics

Sterile, non-woven pad; materials: high G alginate, carboxymethylcellulose (CMC), silver-coated nylon fibers. Principle: moisture-activated sustained release of ionic silver. Form factors: flat dressings (various sizes) and rope. Sterilization: gamma irradiation. Biocompatibility: BSENISO 10993-1.

Indications for Use

Indicated for patients with moderate to heavily exuding partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

Predicate Devices

• Acticoat Calcium Alginate Dressing (K002896)

Submission Summary (Full Text)

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024298 Page 1/3

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## SECTION 11.

## 510(k) SUMMARY.

JUN 3 0 2003

## General information.

This 510(k) is to provide notification of substantial equivalence for Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing, which is substantially equivalent to a currently marketed device intended for wound care.

| Submitted by: | Advanced Medical Solutions Ltd.,<br>Road Three,<br>Winsford Industrial Estate,<br>Winsford,<br>Cheshire,<br>CW7 3PD,<br>England |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. John Green<br>Quality Assurance and Regulatory Affairs Manager |
| Telephone: | 44 (0)1606 545612 |
| Fax: | 44 (0)1606 863600 |
| e-mail: | [e-mail] |
| Date prepared: | 12th December 2002 |
| Classification:<br>dressings | There is currently no classification for wound and burn |
| Trade name: | Antimicrobial Alginate Dressing |
| Common name: | Alginate Dressing |
| Predicate device: | K002896 Acticoat Calcium Alginate Dressing |
| Indications for use: | Advanced Medical Solutions Ltd's Antimicrobial Alginate<br>Dressing is an effective barrier to bacterial penetration. The<br>barrier functions of the dressing may help reduce infection in<br>moderate to heavily exuding partial and full-thickness<br>wounds including: pressure ulcers, venous ulcers, diabetic |

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K02 4 298 page 2/3

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Product description: Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing is a sterile, non-woven pad composed of a high G (quluronic acid) alginate, carboxymethylcellulose (CMC) and silver coated nylon fibres. The sustained release of silver creates a favourable environment by protecting the dressing from bacterial contamination. The dressing absorbs exudate, maintains a moist wound healing environment and allows intact removal.

> The dressing has a light grey appearance, and is available in various sizes (5cm x 5cm, 11cm x 11cm, 10cm x 20cm flat dressings and 2.5cm x 30.5cm rope). The flat dressings are packaged in pouches, and the rope is packaged in a blister pack.

Testing: The biocompatibility of Advanced Medical Solutions Ltd's Antimicrobial Alginate Dressing has been demonstrated in accordance with BSENISO 10993-1. Additional in vitro testing has demonstrated that the performance characteristics of the dressing are substantially equivalent to the predicate device.

Statement of substantial equivalence:

The materials from which the devices are manufactured are similar, and both devices are produced from calcium alginate and incorporate silver.

The Antimicrobial Alginate Dressing and the predicate device have the same intended use, and have almost identical indications for use, (e.g. pressure ulcers, venous ulcers, diabetic ulcers, traumatic and surgical wounds).

The Antimicrobial Alginate Dressing and the predicate device consist of absorbent materials, are provided sterile to the user, and both devices provide a sustained release of broad spectrum ionic silver, when activated by moisture, to provide an antimicrobial effect to protect the dressing from bacterial contamination for up to 3 days. Both devices provide an effective barrier to bacterial penetration. The barrier functions of both dressings may help reduce infection in moderate to heavily exuding partial and full-thickness wounds.

Both devices are biocompatible, exhibit absorbent properties. maintain a moist environment for optimal wound healing,

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permit intact removal and have the same recommended frequency of dressing changes.

Both devices have a similar range of product sizes, are available in flat dressing and rope variants, are sterilised by gamma irradiation, and have similar contraindications.

Although there are some minor differences between the devices these differences are minor and raise no new questions of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized symbol of three human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2003

Mr. John Green Quality Assurance and Regulatory Affairs Manager Advanced Medical Solutions Ltd. Road Three Winsford Industrial Estate Winsford, Cheshire CW7 3PD, England

Re: K024298

Trade/Device Name: Antimicrobial Alginate Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 9, 2003 Received: April 14, 2003

Dear Mr. Green:

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 application (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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.

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Page 2 - Mr. John Green

This letter will allow you to begin 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) NUMBER (IF KNOWN): K024298 Antimicrobial Alginate Dressing DEVICE NAME:

INDICATIONS FOR USE:

Advanced Medical Solutions Ltd's Antimicrobial Alginate. Dressing is an effective barrier to bacterial penetration, The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

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

Miriam C. Provost

eral, Restorative Division of Gen and Neurological Devices

510(k) Number K024298