Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:

Pressure ulcers
Leg ulcers
Diabetic ulcers
Graft and donor sites
Post-operative surgical wounds
Trauma wounds (dermal lesions, trauma injuries or incisions)
1st and 2nd degree burns
Abrasions and lacerations

Device Description

Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing. Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel. Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.

AI/ML Overview

The provided text is a 510(k) summary for a medical device modification, specifically for a Silver Antimicrobial Wound Gel. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not include specific acceptance criteria with quantifiable metrics (e.g., "device must achieve X% sensitivity or Y% specificity"). Instead, it focuses on demonstrating performance through qualitative statements and comparisons.

Therefore, for the requested table of acceptance criteria and device performance, I can only extract what is stated. For other sections, the information is largely absent based on a typical AI/software device study description.

Here's the analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a device modification for a wound care product, not an AI software), the "acceptance criteria" are not presented as numerical thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating antimicrobial barrier activity and acceptable wound healing performance compared to a predicate device and standard care.

Acceptance Criterion (Implied)	Reported Device Performance
In-vitro Antimicrobial Barrier Activity	Effective against: Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus brasiliensis (formerly Aspergillus niger) when they come into contact with the gel. Demonstrated by a seven-day log reduction evaluation test and preservative efficacy test (USP 33 <51> and European Pharmacopoeia Edition 6.6 section 5.1.3). The clinical implications of the in-vitro findings are unknown.
Biocompatibility	Compliant with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices).
In-vivo Wound Closure Rate (compared to predicate/control)	"The report findings showed that the rate of wound closure in receipt of Silver Antimicrobial Wound Gel showed no significant differences when compared to the Hydrogel and 'Wet to Dry' gauze treatment."
In-vivo Wound Adherence (compared to predicate/control)	"Wound site adherence...was not detected for the Silver Antimicrobial Wound Gel or Hydrogel at any point in the study" (significant in "Wet to Dry" gauze treated wounds). This indicates better performance than "Wet to Dry" gauze.
In-vivo Peri-wound Inflammation/Erythema	"Peri-wound inflammation/erythema was less frequently observed and less severe in Silver Antimicrobial Wound Gel and Hydrogel treated wounds than in similar control 'Wet to Dry gauze' treated wounds." This indicates better performance than "Wet to Dry" gauze.
In-vivo Adverse Effects	"No adverse effects were noted following the use of either of the Silver Antimicrobial Wound Gel or the Hydrogel 'dressings' investigated."
Substantial Equivalence to Predicate Device (K073197)	"The Silver Antimicrobial Wound Gel...is substantially equivalent to Advanced Medical Solutions Limited's Antimicrobial Wound Gel, 510(k) # K073197." This is the overarching acceptance criterion for the 510(k) submission. Demonstrated through the above testing, biocompatibility, and antimicrobial activity.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in terms of number of subjects or wounds for the in-vivo porcine study. It only mentions "an in-vivo porcine study."
Data Provenance: The in-vivo study was a porcine study (animal model). The country of origin for the data is not specified, but the applicant is based in the United Kingdom. It is a prospective study as it describes an assessment over time ("day 2 & 4 assessment points").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not mentioned. The in-vivo study involved direct observation and measurement of wound characteristics in a porcine model, rather than expert interpretation of images or clinical data for ground truth establishment in the way an AI medical device would.

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

Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in clinical image interpretation, not for direct observations in an animal model.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a wound care gel.

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

Not applicable. The device is a wound care gel, not an algorithm. Therefore, "standalone" performance in the context of AI is not relevant.

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

For the in-vivo study, the "ground truth" (or outcome measures) were direct observations of wound closure rate, wound site adherence, peri-wound inflammation/erythema, presence of debris, and adverse effects in a porcine model. These are direct physical measurements and observations.
For the in-vitro study, the ground truth was based on laboratory testing against specified microorganisms following recognized standards (USP 33 <51> and European Pharmacopoeia Edition 6.6 section 5.1.3).

8. The sample size for the training set

Not applicable. This is a medical device (wound gel), not a machine learning model. There is no "training set."

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

Not applicable. There is no "training set" for this device.

Summary

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K 110458
page 1 of 3

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

This Special 510(k) Device Modification is to provide substantial equivalence for the Advanced Medical Solutions Limited's Silver Antimicrobial Wound Gel, which is substantially equivalent to currently marketed devices intended for wound care. The Silver Antimicrobial Wound Gel was previously cleared under 510(k) # K073197. The submission was made by Advanced Medical Solutions Limited.

Submitted by:-	Advanced Medical Solutions LimitedPremier Park, 33 Road OneWinsford Industrial EstateWinsford, CheshireCW7 3RTUnited Kingdom
Contact:-	Mrs. Claire RyanRegulatory Affairs ManagerTelephone: + 44(0)1606 545569Fax: + 44(0)1606 863600Email: claire.ryan@admedsol.com
Date prepared:-	9th February 2011
Common Name:-	Silver Antimicrobial Wound Gel
Trade Names:-	Not yet defined
Classification Name:-	Dressing, wound, drug
Classification:-	Unclassified
Product Code:-	FRO

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

Advanced Medical Solutions Limited's Silver Antimicrobial Wound Gel, 510(k) # K073197.

Device Description :-

Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel .- , י גרנטער

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Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.

Indications for use :-

Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:

Pressure ulcers ●
Leg ulcers �
Diabetic ulcers .
. Graft and donor sites
Post-operative surgical wounds .
Trauma wounds (dermal lesions, trauma injuries or incisions) .
18 and 2nd degree burns
Abrasions and lacerations .

Contraindication and Precautions:-

Contraindication: Silver Antimicrobial Wound Gel should not be used on patients with a known sensitivity to Silver or Propylene glycol.

Caution: Frequent or prolonged use of this preparation may result in permanent discoloration of skin and mucous membranes.

Caution: Federal [US] Law restricts this device to sale by or on the order of a physician [or properly licensed practitioner].

Manufacturing:-

Silver Antimicrobial Wound Gel will be manufactured according to the product specification and under good manufacturing practices (GMP). A risk analysis has been performed to identify possible failure mode during manufacturing. Manufacturing controls have been developed and implemented 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.

In-vitro Testing :-

The antimicrobial barrier activities of the Silver Antimicrobial Wound Gel have been established by a seven day log reduction evaluation test and preservative efficacy test in accordance with the requirements of USP 33 <51> (Antimicrobial Effectiveness Testing) and European Pharmacopoeia Edition 6.6 section 5.1.3.

In-vitro testing has shown that Silver Antimicrobial Wound Gel is effective against the following broad spectrum of microorganisms; Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Streptoccus pyogenes, Pseudomonas aeruginosa, Escherichia coli and fungi such as Candida albicans and Aspergillus brasiliensis (formerly known as Aspergillus niger) when they come into contact with the gel. The clinical implications of the in-vitro findings are unknown.

The biocompatibility of the Advanced Medical Solutions Ltd Silver Antimicrobial Wound Gel has been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices).

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In-vivo Testing :-

Product performance has been established using an in-vivo porcine study. The study assessed the I roduct performance and compared the Silver Antimicrobial Wound Gel to that of a commercially available equivalent Hydrogel, manufactured by Advanced Medical Solutions which has a similar formulation to the Silver Antimicrobial Wound Gel but contains no silver compound (silver carbonate), and a "Wet to Dry" gauze dressing.

The report findings showed that the rate of wound closure in receipt of Silver Antimicrobial Wound The report imallige the !! Jo significant differences when compared to the Hydrogel and "Wet to Dry" gauze treatment.

Wound site adherence, though significant in "Wet to Dry" gauze treated wounds, was not detected for the Silver Antimicrobial Wound Gel or Hydrogel at any point in the study - a reflection of the gel structure of these two devices. The surface of wounds in receipt of Silver Antimicrobial Wound get structure of these two device debris in the form of dark-coloured granules at the day 2 & 4 assessment points; however such granules were not apparent at later time points.

Peri-wound inflammation/erythema was less frequently observed and less severe in Silver i cri-would inmanilations very Hydrogel treated wounds than in similar control "Wet to Dry gauze" treated wounds. No adverse effects were noted following the use of either of the Silver Antimicrobial Wound Gel or the Hydrogel "dressings" investigated.

Statement of Substantial Equivalence:-

Statement or Gabstan for as a stimicrobial activity for the modified Silver I he interestion for use, perisantially equivalent to Advanced Medical Solutions Limited's Antimicrobial Wound Gel, 510(k) # K073197. The biocompatibility, in-vivo study and performance testing for the Silver Antimicrobial Wound Gel has demonstrated that the device is safe and effective for the indications of use.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two main elements: a circular text element and an abstract symbol. The text element is arranged in a circle and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". To the right of the text is an abstract symbol that resembles a stylized bird or a human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Advanced Medical Solutions Limited % Mrs. Claire Ryan Premeir Park, 33 Road One Winsford Industrial Estate Winsford, Cheshire CW7 3RT United Kingdom

MAR 1 4 201

Re: K110458

Trade/Device Name: Silver Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: March 15, 2011 Received: March 18, 2011

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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mrs. Claire Ryan

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Pan 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

h11p://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vor Mark N. Melkerson

Director

· Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K110458
Page 1 of 1

Indications for Use

510(k) Number (if known): K 110458

Device Name: Silver Antimicrobial Wound Gel

Indications for Use:

Silver Antimicrobial Wound Gel is indicated under the medical supervision of a SINVE Animals of the management of dry to moderate exuding partial to full thickness wounds, such as:

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

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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kiac for WKM
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110458

Regulation Number and Section

N/A