Silver Alginate IV Antimicrobial Wound 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 IV Antimicrobial Wound Dressing is indicated for external use only

Device Description

Silver Alginate IV Antimicrobial Wound Dressing is a sterile, non woven pad or rope/ribbon/filler composed of a high M (mannuronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (silver carbonate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the dressing forms a gel, which aids autolytic debridement, whilst maintaining a moist environment for optimal wound healing and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms, such as a Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Streptococcus and bw, merceas faecalis (VRE), Pseudomonas aeruginosa, Escherichia Doli, and fungi such as Candida albicans , over a period of up to twenty-one (21) days, based on in-vitro testing, and may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver Alginate IV Antimicrobial Wound Dressing is an effective barrier to bacterial penetration. The dressing has pale golden appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 10cm x 12cm, 15cm, 10cm x 20cm, 20cm x 20cm flat dressings; 2.7cm x 30cm room, 10cm x 12cm, 150m, 150mm x 2g rope dressings). The dressings are packaged in pouches.

AI/ML Overview

The provided text describes a 510(k) notification for a medical device, the Silver Alginate IV Antimicrobial Wound Dressing. This type of submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials to prove efficacy against acceptance criteria. Therefore, the document primarily details the basis for equivalence rather than specific acceptance criteria and a study proving performance against them.

Based on the provided information, I can answer some of your questions and note where the information is not available:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. For a 510(k) submission like this, the "acceptance criteria" are generally that the new device performs as well as or substantially equivalently to the predicate device in relevant tests (e.g., biocompatibility, sterilization, antimicrobial activity, absorption). The document states that the testing demonstrated compliance and substantial equivalence to predicate devices, implying these "acceptance criteria" were met.

Acceptance Criteria (Implied from 510(k))	Reported Device Performance
Biocompatibility in compliance with BS EN ISO 10993-1	Demonstrated to be in compliance
Sterilization validation in compliance with harmonized standards	Performed in compliance
Antimicrobial activity against specified microorganisms for up to 21 days	Achieved based on in-vitro testing. Protects the dressing from a broad spectrum of microorganisms (e.g., Staphylococcus aureus including MRSA, Pseudomonas aeruginosa, Candida albicans)
Absorption and gel formation characteristics similar to predicate devices	Forms a gel and aids autolytic debridement after absorbing wound fluid
Barrier to bacterial penetration	An effective barrier to bacterial penetration
Safety and Rationale for Use	Demonstrated to be safe and effective for the indications of use

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document mentions "in-vitro testing" for antimicrobial activity, but the specific number of samples or experimental replicates is not detailed.
Data Provenance: The manufacturing company is Advanced Medical Solutions Limited, located in the United Kingdom. The testing would presumably have been conducted in the UK or by contractors for AMS Ltd. The nature of the tests (biocompatibility, sterilization validation, in-vitro antimicrobial activity) indicates laboratory-based studies rather than human clinical trials. These would generally be considered prospective in design for the specific tests performed.

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)

This information is not applicable and therefore not provided. The "ground truth" concept is typically used in AI/ML studies where human experts classify data for model training and validation. For a medical device like a wound dressing, the "ground truth" for performance is established through standardized laboratory tests and validated methodologies (e.g., microbiology labs for antimicrobial activity, toxicology labs for biocompatibility). There is no mention of human experts interpreting raw test results as "ground truth" in the way it would be for an image classification task, for example.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this type of adjudication is relevant for expert-driven tasks, not for standardized laboratory performance testing of a wound dressing.

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. This is a medical device (wound dressing), not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant or discussed. The comparison is against predicate wound dressings to establish substantial equivalence, not against AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI product. The device itself is the "standalone" product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not directly applicable here. For the tests cited:

Biocompatibility: Ground truth is established by adherence to standards like BS EN ISO 10993-1, which involves specific laboratory assays (e.g., cytotoxicity, irritation, sensitization).
Sterilization Validation: Ground truth is adherence to harmonized standards, ensuring a specified sterility assurance level (SAL).
Antimicrobial Activity: Ground truth is established by validated in-vitro microbiological test methods demonstrating reduction or inhibition of microbial growth.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is used for this type of medical device.

Summary

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NOV 12 2008

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Section 6 -- Traditional 510(k) Notification: -Summary

This Traditional 510(k) notification is to provide substantial equivalence for Advanced Medical Solutions Limited's Silver Alginate IV Antimicrobial Wound Dressing, which is substantially equivalent to currently marketed devices intended for wound care.

Submitted by :-	Advanced Medical Solutions LimitedRoad ThreeWinsford Industrial EstateWinsford, CheshireCW7 3PDUnited Kingdom
Contact:-	Mrs Claire RyanRegulatory Affairs ManagerTelephone: + 44(0)1606 545569Fax:- + 44(0)1606 863600Email: claire.ryan@admedsol.com
Date prepared :-	14th February 2008
Common Name :-	Silver Alginate IV Antimicrobial Wound Dressing
Trade Names :-	Not yet defined
Classification Name :-	Dressing, Wound, Drug
Classification :-	Unclassified
Product Code :-	FRO

Legally marketed device(s) for substantial equivalence comparison:-

Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions.

Aquace! Ag with hydroffbre (Absorbent Antimicrobial Wound Dressing), 510(k) # K013814, manufactured by ConvaTec, A division of E.R Squibb and Sons LLC.

Device Description :-

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The silver ions protect the dressing from a broad spectrum of microorganisms, such as a Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Streptococcus and bw, merceas faecalis (VRE), Pseudomonas aeruginosa, Escherichia Doli, and fungi such as Candida albicans , over a period of up to twenty-one (21) days, based on in-vitro testing, and may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing.

Silver Alginate IV Antimicrobial Wound Dressing is an effective barrier to bacterial penetration.

The dressing has pale golden appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 10cm x 12cm, 15cm, 10cm x 20cm, 20cm x 20cm flat dressings; 2.7cm x 30cm room, 10cm x 12cm, 150m, 150mm x 2g rope dressings). The dressings are packaged in pouches.

Indications for use:

Silver Alginate IV Antimicrobial Wound Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as pressures ulcers, diabetic ulcers, leg ulcers, post-operative wounds, trauma wounds (dermal lesions, trauma injuries or incisions), arons, post-operative were were ical wounds, 1st and 2nd degree burns. Silver Alginate I V Antimicrobial Wound Dressing is indicated for external use only.

Manufacturing :-

Manufacturing.
Silver Alginate IV Antimicrobial Wound Dressing will be manufactured according to the product specification and under good manufacturing practices (GMP). A risk analysis has been product openituation and efailure mode during manufacturing. Manufacturing controls have performou to lections possessed to address the identified risk factors based on the criticality of the failure mode.

Advanced Medical Solutions Ltd meets all the established specifications prior to release to ensure the device is safe, effective and correctly labelled for its intended use.

Testing :-

The biocompatibility of Advanced Medical Solutions Limited Silver Alginate IV Antimicrobial The broompations' of read monstrated to be in compliance with the requirements of BS EN ISO 10993-1(Biological Evaluation of Medical Devices). Sterilisation validation has been performed in compliance with harmonised standards.

Statement of Substantial Equivalence:-

Statement of Substantial Equivalesting and antimicrobial activity for the Silver Alginate IV Antimicrobial Wound Dressing is substantially equivalent to the predicate devices; Silver Alginate II Dressing, 510(k) # K041316/K063173/K070581, manufactured by Advanced Medical Solutions and Aquacel Ag with hydrofibre (Absorbent Antimicrobial Wound Dressing), 510(k) # K013814, manufactured by ConvaTec, A division of E.R Squibb and Sons LLC. The biocompatibility and performance testing for the Silver Alginate IV Antimicrobial Wound Dressing has demonstrated that the device is safe and effective for the indications of use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 12 2008

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

Re: K080503

Trade/Device Name: Silver Alginate IV Antimicrobial Wound Dressing Regulatory Class: Unclassified Product Code: FRO . Dated: October 30, 2008 Received: November 3, 2008

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M. Millman

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):

Device Name: Silver Alginate IV Antimicrobial Wound Dressing

Indications for Use:

Silver Alginate IV Antimicrobial Wound 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 IV Antimicrobial Wound Dressing is indicated for external use only

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) 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 Evaluation (ODE)

Mark M. Millkenen

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K08050

Regulation Number and Section

N/A