SILVER ALGINATE II WOUND DRESSING by ADVANCED MEDICAL SOLUTIONS LIMITED

Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. . Odour reduction results from the antibacterial effect in the dressing. Silver Alginate II Dressing is an effective barrier to bacterial penetration. Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing. The dressing has an off-white appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm, 20cm x 30cm flat dressings; 2.7cm x 30cm and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat rope dressings are packaged in pouches and the flat rope and rope dressings are packaged in a blister pack.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Silver Alginate II Dressing." This submission is for a device modification and asserts substantial equivalence to previously cleared devices.

The information provided does not include a study that focuses on device performance in the context of acceptance criteria as one would typically find for an AI/ML medical device. Instead, the document discusses the biocompatibility and sterilization validation of the dressing, and its substantial equivalence to predicate devices based on comparable absorbency, silver release profile, and antimicrobial activity. There is no mention of an algorithm, AI, machine learning, or human reader studies.

Therefore, the requested information elements related to AI/ML device performance and associated studies (items 1 through 9) are not present in the provided text.

Here is a summary of what is available in the document, which primarily focuses on regulatory approval based on equivalence for a wound dressing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit - based on predicate device equivalence):
- Biocompatibility in compliance with BS EN ISO 10993-1.
- Sterilization validation in compliance with harmonized standards.
- Comparable absorbency to predicate devices.
- Comparable silver release profile to predicate devices.
- Comparable antimicrobial activity to predicate devices.
Reported Device Performance:
- "The biocompatibility of Advanced Medical Solutions Limited Silver Alginate II Dressing has been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1."
- "Sterilisation validation has been performed in compliance with harmonised standards."
- "Comparable absorbency, silver release profile and antimicrobial activity have been demonstrated."
- "The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing."
- "Odour reduction results from the antibacterial effect in the dressing."
- "Silver Alginate II Dressing is an effective barrier to bacterial penetration."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* This information is not provided in the document. The studies mentioned (biocompatibility, sterilization, absorbency, silver release, antimicrobial activity) are general test types for wound dressings, but specific sample sizes or data provenance are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* Not applicable as no expert-based ground truth for a test set (like an image review or clinical outcome assessment) is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
* No MRMC study was done, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For biocompatibility and sterilization, the "ground truth" would be compliance with specified international standards (BS EN ISO 10993-1 and unspecified harmonized standards for sterilization).
* For absorbency, silver release, and antimicrobial activity, the "ground truth" was established through in-vitro laboratory testing, with comparison to predicate devices. The specifics of these tests (e.g., control groups, reference methods) are not detailed but are implied to be standard in-vitro assessments for such dressings.

8. The sample size for the training set
* Not applicable, as this is not an AI/ML device and no training set is described.

9. How the ground truth for the training set was established
* Not applicable, as this is not an AI/ML device and no training set is described.

Summary

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K070581

JUL 1 3 2007

Section 11 – Traditional 510(k): Device Modification -Summary

This Traditional 510(k) Device Modification is to provide substantial equivalence for Advanced Medical Solutions Limited's Silver Alginate II Dressing, which is substantially equivalent to currently marketed devices intended for wound care. This product is already legally marketed as Silver Alginate II Dressing (unmodified device) and was previously cleared under 510(k) numbers K041316/K063173. Both submissions have been made by Advanced Medical Solutions Limited.

Submitted by: -	Advanced Medical Solutions LimitedRoad ThreeWinsford Industrial EstateWinsfordCheshireCW7 3PDUnited Kingdom
Contact:-	Mrs Claire RyanRegulatory Affairs Manager
Telephone: -	+44(0)1606 545569
Fax :-	+44(0)1606 863600
Email:-	Claire.ryan@admedsol.com
Date prepared:-	2nd February 2007
Classification :-	There is currently no classification for wound and burndressings.
Common Name :-	Silver Alginate II Dressing
Trade Names:-	Maxsorb Extra AgSeasorb AgInvacare Silver Alginate Dressing
Predicate devices:-	K041316 Silver Alginate II Dressing manufactured byAdvanced Medical SolutionsK013814 Aquacel Ag with hydrofibre manufactured byConVatec, A division of E.R Squibb and Sons LLC.K002896 Acticoat® manufactured by Smith & NephewLimited

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Directions for use: -Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds such as:

. Post-operative wounds
. Trauma wounds (dermal lesions, trauma injuries or incisions)
. Leg Ulcers
. Pressures Ulcers
Diabetic Ulcers ●
. Graft and donor sites
. Post-operative surgical wounds
1st and 2nd degree burns ●
Partial and Full Thickness wounds .

Silver Alginate II Dressing is indicated for external use only

Device Description: -Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. . Odour reduction results from the antibacterial effect in the dressing.

Silver Alginate II Dressing is an effective barrier to bacterial penetration.

Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing.

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	The dressing has an off-white appearance and is availablein various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm,10cm x 20cm, 20cm x 30cm flat dressings; 2.7cm x 30cmand 3cm x 44cm flat rope dressings; and 30cm x 2g ropedressings). The flat rope dressings are packaged in pouchesand the flat rope and rope dressings are packaged in ablister pack.
Testing:-	The biocompatibility of Advanced Medical SolutionsLimited Silver Alginate II Dressing has been demonstratedto be in compliance with the requirements of BS EN ISO10993-1. Sterilisation validation has been performed incompliance with harmonised standards.
Statement of: -SubstantialEquivalence	The Silver Alginate II Dressing is a non-woven calciumalginate dressing which is substantially equivalent inconstruction and/or performance to both Anticoat® CalciumAlginate Dressing and Aquacel Ag absorbent antimicrobialwound dressing predicate devices. Comparableabsorbency, silver release profile and antimicrobial activityhave been demonstrated.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or forms, arranged in a flowing, dynamic composition.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2007

Advanced Medical Solutions, Ltd % Ms. Claire Ryan Regulatory Affairs Manager Road Three, Winsford Industrial Estate Winsford, Cheshire, CW7 3PD United Kingdom

Re: K070581

Trade/Device Name: Silver Alginate II Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 20, 2007 Received: June 22, 2007

Dear Ms. Ryan:

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 - Ms. Claire Ryan

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K070581

Device Name: Silver Alginate II Dressing

Indications for Use:

Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:

Post-operative wounds .
Trauma wounds (dermal lesions, trauma injuries or incisions) .
Leg Ulcers .
Pressures Ulcers .
Diabetic Ulcers ◆
Graft and donor sites .
Post-operative surgical wounds .
1st and 2nd degree burns .
Partial and Full Thickness wounds .

Silver Alginate II Dressing is indicated for external use only

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evalua

(Division & Division of General, Restorative, and Neurological Devices

510(k) Number //
$$020551$$
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Regulation Number and Section

N/A