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

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Silver Antimicrobial Wound Gel":

The document does not explicitly state numerical acceptance criteria in a table format for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to established in-vitro and in-vivo testing standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (a 510(k) for a wound gel), the "acceptance criteria" are more implicitly derived from demonstrating safety, efficacy, and substantial equivalence to existing predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Antimicrobial Barrier Activity (In-vitro)	Effective against Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptoccus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger when they come into contact with the gel. Demonstrated by 7-day log reduction and preservative efficacy test (USP 30 <51>).
Biocompatibility	Demonstrated to be in compliance with BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). No adverse effects noted in the in-vivo study.
Wound Closure Rate (In-vivo)	No statistically significant differences in the rate of wound closure when compared to a similar hydrogel (without silver) and "Wet to Dry" gauze.
Wound Site Adherence (In-vivo)	Not detected for the device, similar to the comparative Hydrogel, and significantly better than "Wet to Dry" gauze.
Peri-wound Inflammation/Erythema (In-vivo)	Less frequently observed and less severe than in "Wet to Dry gauze" treated wounds, similar to the comparative Hydrogel.
No Adverse Effects (In-vivo)	No adverse effects were noted following the use of the Silver Antimicrobial Wound Gel.
Manufacturing Quality	Manufactured according to product specification and Good Manufacturing Practices (GMP). Risk analysis performed and controls implemented.
Substantial Equivalence to Predicate Devices	The indication for use, performance testing, and antimicrobial activity are substantially equivalent to "Silver Shield™ Antimicrobial Skin and Wound Gel" (K062212) and "AcryDerm Silver Antimicrobial Wound Gel" (K011994, K070333).

2. Sample Size Used for the Test Set and Data Provenance

The document primarily references two types of testing for device performance:

In-vitro Testing:
- Sample Size: Not explicitly stated as a numerical count of "samples" for the antimicrobial tests. It mentions a "seven day log reduction evaluation test and preservative efficacy test in accordance with the requirements of USP 30 <51> (Antimicrobial Effectiveness Testing)." This implies standardized methodology with defined replicates, but not a specific "sample size" in terms of clinical cases.
- Data Provenance: Not specified, but generally, in-vitro tests are conducted in laboratory settings, likely within the UK or a qualified testing facility.
In-vivo Testing (Porcine Study):
- Sample Size: Not explicitly stated as a number of animals or wounds. The wording describes "an in-vivo porcine study" that assessed dressing performance and compared three treatment arms (Silver Antimicrobial Wound Gel, equivalent Hydrogel without silver, and "Wet to Dry" gauze). We cannot determine the exact sample size from the provided text.
- Data Provenance: The study was "in-vivo," using porcine subjects, implying a controlled animal study. The country of origin for the study is not mentioned. It is a prospective study as it involved applying the treatments and then assessing outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

In-vitro Testing: Not applicable in the context of "experts establishing ground truth." The ground truth for antimicrobial efficacy is derived from standardized laboratory tests with defined protocols (e.g., USP 30 <51> requirements).
In-vivo Testing (Porcine Study): Not explicitly stated. For animal studies, assessments would typically be performed by trained researchers or veterinary professionals. It does not mention a panel of "experts" in the context of radiologists or similar clinical specialties for establishing ground truth, as this is an animal study evaluating wound healing parameters.

4. Adjudication Method for the Test Set

In-vitro Testing: Not applicable. Results are quantitative measurements from lab tests.
In-vivo Testing (Porcine Study): Not specified. The document states "The report findings showed that..." suggesting data collection and analysis, but no explicit adjudication method (like 2+1 or 3+1 consensus) among multiple assessors for qualitative observations is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study typically involves multiple human readers evaluating medical images or cases with and without AI assistance to measure reader improvement. The provided document concerns a wound gel and its performance, not an AI-based diagnostic or assistive device for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of an algorithm's performance was not conducted. The device is a wound gel, which is a physical product, not a software algorithm. Its performance is intrinsic to its physical and chemical properties and how it interacts with wounds, not through an algorithm operating independently.

7. Type of Ground Truth Used

In-vitro Testing: Ground truth is established by standardized laboratory test results (e.g., log reduction of microbial counts for antimicrobial efficacy, compliance with ISO standards for biocompatibility).
In-vivo Testing (Porcine Study): Ground truth is based on direct observation and measurement of wound healing parameters in a controlled animal model. This includes wound closure rate, wound site adherence, peri-wound inflammation/erythema, and general absence of adverse effects.

8. Sample Size for the Training Set

Not applicable. This device is a wound care product, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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AUG 2 8 2008

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

This Traditional 510(k) notification is to provide substantial equivalence for Advanced Medical Solutions Limited's Silver Antimicrobial Wound Gel, 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:-	6th November 2007
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:-

Silver Shield™ Antimicrobial Skin and Wound Gel, 510(k) # K062212, manufactured by Anacapa Technologies, Inc., CA.

AcryDerm Silver Antimicrobial Wound Gel, 510(k) # K011994 and K070333, manufactured by AcryMed Inc., OR also distributed under the trade name SilvaSorb™ Gel, Silver Antimicrobial Wound Gel (Medline Industries, Inc.).

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.

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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.

KO73197 2 of 3

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)
1st 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 30 <51> (Antimicrobial Effectiveness Testing).

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 niger when they come into contact with the gel, The clinical implications of the in-vitro findings are unknown.

The biocompatibility of 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 dressing 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 Gel showed no statistically 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 Gel was found to include 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 Antimicrobial Wound Gel and 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:-

The indication for use, performance testing and antimicrobial activity for the Silver Antimicrobial Wound Gel is substantially equivalent to the predicate devices: Silver Shield™ Antimicrobial Skin and Wound Gel, 510(k) # K062212, manufactured by Anacapa Technologies, Inc., CA. and AcryDerm Silver Antimicrobial Wound Gel, 510(k) # KK011994 and K070333, manufactured by AcryMed Inc., OR also distributed under the trade name SilvaSorb™ Gel, Silver Antimicrobial Wound Gel (Medline Industries, Inc.). The biocompatibility 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 seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its head turned to the right, symbolizing vigilance and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

AUG 2 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073197

Trade/Device Name: Silver Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: August 12, 2008 Received: August 14, 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 N. 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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AUG 2 8 7008

16673197

p. I of

510(k) Number (if known): K073197

Device Name: Silver Antimicrobial Wound Gel

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 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) .
1 st and 2nd degree burns .
Abrasions and lacerations .

Prescription Use X AND/OR (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. Milken

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

KO 73199 510(k) Number

Regulation Number and Section

N/A