Under the supervision of a healthcare professional Surgical Silver Post Operative Dressing may be used in the management of post operative surgical wounds healing by primary intent, and as an effective barrier to bacterial penetration.

Device Description

The subject device, Surgical Silver Post Operative dressing, is a sterile dressing comprising of an absorbent non woven pad containing an ionic silver. This centered silver pad is secured between two layers of hydrocolloid; the outer hydrocolloid layer incorporates a breathable waterproof film. The inner layer of hydrocolloid forms a windowed self adhesive skin contact layer, which adheres to healthy skin, minimizes trauma on removal and assists in minimizing leakage. As wound fluid is absorbed the dressing forms a gel, this helps maintain a moist environment. A moist wound environment has been shown to be conducive for wound healing. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.

Based on in vitro performance data, the Surgical Silver Post Operative dressing provides a barrier to bacterial penetration through the dressing and the silver component prevents colonization and proliferation of bacteria within the dressing for up to 7 days.

Surgical Silver Post Operative dressings, when tested in-vitro have been demonstrated to be efficacious, achieving ≥4 log reduction within the dressing including multiple re-inoculations against three gram positive (MRSA, MRSE, VRE) bacteria, three gram negative bacteria ( Escherichia coli, Klebsiella pneumonia, Pseudomona areuginosa ) and yeast ( Candida albicans ) challenge organisms.

The dressings are supplied sterile (gamma irradiation) in a range of sizes between 14 in 2 to 49 in 2 .

AI/ML Overview

The device, Surgical Silver Post Operative Dressing, is subjected to various performance tests to demonstrate its substantial equivalence to the predicate device, AQUACEL® Ag Surgical dressings (K091034). The studies cited include in-vitro performance data, animal testing, and biological evaluation.

Here's an breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Bacterial Barrier / Silver Efficacy (In-vitro)	≥4 log reduction in bacterial colonization and proliferation within the dressing for up to 7 days, including multiple re-inoculations.	Achieved ≥4 log reduction within the dressing against 3 gram-positive bacteria (MRSA, MRSE, VRE), 3 gram-negative bacteria (Escherichia coli, Klebsiella pneumonia, Pseudomonas aeruginosa), and yeast (Candida albicans).
Total Fluid Handling	(Not explicitly stated, but implied to be comparable to predicate)	Performed, results led to a conclusion of substantial equivalence.
Absorbency over 7 days	(Not explicitly stated, but implied to be comparable to predicate)	Performed, results led to a conclusion of substantial equivalence.
Peel Adhesion	(Not explicitly stated, but implied to be comparable to predicate for securing dressing and minimizing trauma on removal)	Performed, results led to a conclusion of substantial equivalence.
Water Barrier	(Not explicitly stated, but implied to be effective)	Performed, results led to a conclusion of substantial equivalence.
Wound Healing in Porcine Model	No biologically relevant differences in local tissue effects and wound healing compared to predicate and negative control.	No biologically relevant differences amongst the test subjects (Surgical Silver Post Operative Dressing, AQUACEL® Ag Surgical dressing and a Negative Control) in terms of wound healing performance characteristics and local tolerance after wound creation.
Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Material Mediated Pyrogenicity, Implantation, Sub-acute/sub-chronic toxicity)	Meets the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) and is safe.	Demonstrated to meet the requirements of BS EN ISO 10993-1 and is safe.

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

Bacterial Barrier / Silver Efficacy: The sample size for the in-vitro tests is not explicitly stated in terms of the number of dressings or repetitions.
Wound Healing (Porcine Model): The document mentions "test subjects" in the porcine model, implying a number of animals were used, but the specific count is not provided.
Biocompatibility: The sample size for the various biocompatibility tests is not specified.
Data Provenance: The studies are described as in-vitro and animal testing, which are implicitly prospective studies designed to evaluate the device. The country of origin for the studies is not explicitly stated, but the manufacturer is Advanced Medical Solutions Ltd, based in the UK, suggesting the studies were likely conducted or overseen in the UK or by a contract research organization.

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

Bacterial Barrier / Silver Efficacy: The ground truth for bacterial efficacy (in-vitro) is established through standard microbiological testing protocols, which rely on validated laboratory methods and measurements (e.g., colony-forming unit counts). While experts perform these tests, a specific "number of experts" or their qualifications for establishing ground truth as in a clinical consensus review is not applicable in this context.
Wound Healing (Porcine Model): The evaluation involved "macroscopic and histopathological observations." Histopathological observations typically involve trained veterinary pathologists or equivalent experts. However, the exact number and qualifications of these experts are not provided.
Biocompatibility: These tests are conducted according to international standards (e.g., ISO 10993-1) by qualified toxicologists and laboratory personnel. The specific number and qualifications of experts are not detailed in this summary.

4. Adjudication method for the test set

Bacterial Barrier / Silver Efficacy: No explicit adjudication method is mentioned. The results would likely be based on quantitative measurements and statistical analysis against predefined thresholds.
Wound Healing (Porcine Model): "Macroscopic and histopathological observations" suggest subjective and objective assessments. However, no specific adjudication method like 2+1 or 3+1 for resolving discrepancies is described. Typically, a qualified pathologist's report would constitute the finding.

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

This section is not applicable as the device is a medical dressing and not an AI-powered diagnostic or decision support system that would involve human readers or an AI assistance component.

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

This section is not applicable as the device is a medical dressing and not an algorithm. The "standalone" performance here refers to the dressing's intrinsic properties.

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

Bacterial Barrier / Silver Efficacy: Ground truth is based on quantitative microbiological assays (e.g., direct enumeration of bacterial colonies) performed in-vitro.
Wound Healing (Porcine Model): Ground truth is established through macroscopic observation of wound healing progression and microscopic histopathological examination of tissue samples.
Biocompatibility: Ground truth is determined by the results of standardized biological tests according to ISO 10993-1, which assess cellular responses, systemic toxicity, and tissue reactions.

8. The sample size for the training set

This section is not applicable. The device is a medical dressing with performance evaluated through laboratory and animal studies, not a machine learning algorithm that requires a training set.

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

This section is not applicable for the same reasons as point 8.

Summary

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August 7, 2018

Advanced Medical Solutions Ltd. Rose Guang QA/RA Director Premier Park, 33 Road One, Winsford Industrial Estate Winsford, CW7 3RT Gb

Re: K180634

Trade/Device Name: Surgical Silver Post Operative Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 25, 2018 Received: July 2, 2018

Dear Rose Guang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180634

Device Name

Surgical Silver Post Operative Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K180634

Image /page/3/Picture/1 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue letter "A" with a swoosh extending from the right side. Below the logo, the text "Advanced Medical Solutions Ltd" is written in a blue sans-serif font.

Advanced Medical Solutions Limited Premier Park, 33 Road One Winsford Industrial Estate Cheshire. CW7 3RT. UK

510(k) Summary Statement

Submitted by:	Advanced Medical Solutions LtdPremier Park33 Road OneWinsford Industrial EstateWinsfordCheshireCW7 3RTTel: +44 1606 863500Fax: +44 1606 863600
Contact Person:	Rose Guang
Date of Summary:	07 August 2018
Trade Name:	Surgical Silver Post Operative Dressing
Common Name:	Surgical Cover Dressing
Classification Name:	Dressing, Wound, Drug
Classification:	Unclassified (Pre-amendment)
Classification Code:	Product code: FRO
Predicate Device(s):	AQUACEL® Ag Surgical dressings (K091034)

Image /page/3/Picture/5 description: The image shows two certification logos. The first logo on the left is the BSI (British Standards Institution) logo, which features the letters "bsi" above a heart shape, all enclosed within a circle. The second logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a checkmark, with the text "UKAS MANAGEMENT SYSTEMS" below it, and the number "003" at the bottom. The text "Certificate No. MD78010" is printed below the logos.

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Image /page/4/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh above the text. The text "Advanced Medical Solutions Ltd" is written in a blue sans-serif font and is located below the "A" symbol.

Device Description:	The subject device, Surgical Silver Post Operative dressing, is a sterile dressing comprising of an absorbent non woven pad containing an ionic silver. This centered silver pad is secured between two layers of hydrocolloid; the outer hydrocolloid layer incorporates a breathable waterproof film. The inner layer of hydrocolloid forms a windowed self adhesive skin contact layer, which adheres to healthy skin, minimizes trauma on removal and assists in minimizing leakage. As wound fluid is absorbed the dressing forms a gel, this helps maintain a moist environment. A moist wound environment has been shown to be conducive for wound healing. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.
	Based on in vitro performance data, the Surgical Silver Post Operative dressing provides a barrier to bacterial penetration through the dressing and the silver component prevents colonization and proliferation of bacteria within the dressing for up to 7 days.
	Surgical Silver Post Operative dressings, when tested in-vitro have been demonstrated to be efficacious, achieving ≥4 log reduction within the dressing including multiple re-inoculations against three gram positive (MRSA, MRSE, VRE) bacteria, three gram negative bacteria ( Escherichia coli, Klebsiella pneumonia, Pseudomona areuginosa ) and yeast ( Candida albicans ) challenge organisms.
	The dressings are supplied sterile (gamma irradiation) in a range of sizes between 14 in 2 to 49 in 2 .
Indication for Use:	Under the supervision of a healthcare professional Surgical Silver Post Operative Dressing may be used in the management of post operative surgical wounds healing by primary intent, and as an effective barrier to bacterial penetration.
Substantial Equivalence:	Surgical Silver Post Operative Dressing has substantially equivalent intended use, design, materials, labeling, and performance characteristics to the predicate device AQUACEL® Ag Surgical dressings (K091034).

Image /page/4/Picture/3 description: The image contains two logos. The logo on the left is the BSI (British Standards Institution) logo, which consists of the letters "bsi" above an inverted triangle, all enclosed in a circle. The logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which features a crown above the text "UKAS MANAGEMENT SYSTEMS" and the number "003" below. The text "Certificate No. MD78010" is located below the logos.

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Image /page/5/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a blue stylized "A" with a swoosh above the text. The text "Advanced Medical Solutions Ltd" is written in a blue sans-serif font and is located below the "A" symbol.

Technological characteristics:	Surgical Silver Post Operative Dressing is a one piece dressing design incorporating a central silver-containing absorbent pad which is efficacious within the dressing against three gram positive and 3 gram negative bacteria, and a yeast. Two skin friendly layers of hydrocolloid secure the central silver pad in place and provide a bacterial barrier. The inner of the two hydrocolloid layers provides adhesion to the peri- wound area, securing the dressing in place.
Performance Testing Summary:	Performance data submitted in support of this 510(k) included in-vitro and animal testing.
	Performance testing included total fluid handling, absorbency over 7 days, peel adhesion, and water and bacterial barrier.
	Surgical Silver Post Operative dressings, when tested in-vitro have been demonstrated to be efficacious, achieving ≥4 log reduction within the dressing including multiple re-inoculations against the following 3 gram negative bacteria, 3 gram positive bacteria and a yeast organisms:Methicillin-Resistant S. aureus (MRSA)Methicillin Resistant S. epidermidis (MRSE)Vancomycin-Resistant E. faecalis (VRE)Pseudomonas areuginosaEscherichia coliKlebsiella pneumoniaCandida albicans
	The results of performance testing demonstrate that Surgical Silver Post Operative Dressings are substantially equivalent to the predicate, AQUACEL® Ag Surgical dressings (K091034).
	A non-clinical GLP study was performed to evaluate the local tissue effects of Surgical Silver Post Operative Dressing on wound healing following repeated application to incisional full thickness dermal wounds in a porcine model. Tissues were evaluated by macroscopic and histopathological observations until robust tissue response and complete re-epithelisation occurred; this study demonstrated that there were no biologically relevant differences amongst the test subjects (Surgical Silver Post Operative Dressing, AQUACEL® Ag Surgical dressing and a Negative Control) in terms of wound healing

Image /page/5/Picture/3 description: The image contains two logos and a certificate number. The first logo is a circle with the letters "bsi." above a heart shape. The second logo is a square with a crown above the text "UKAS MANAGEMENT SYSTEMS" and the number "003" below. The certificate number is "MD78010".

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Image /page/6/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" inside of a circle. The text "Advanced Medical Solutions Ltd" is written in blue below the logo.

performance characteristics and local tolerance after wound creation.

Biological evaluation, conducted in accordance with "Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management process" demonstrates that Surgical Silver Post Operative Dressings meet the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) and is safe.

The following end points were assessed: Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Material Mediated Pyrogenicity, Implantation, and Sub-acute/sub-chronic toxicity.

Conclusion: Based on the information provided within this 510(k) submission, Advanced Medical Solutions Ltd. concludes that the proposed Surgical Silver Post Operative Dressing is substantially equivalent to the predicate device listed and does not raise different questions of safety or effectiveness compared to the predicate.

Image /page/6/Picture/6 description: The image contains two certification logos. The first logo on the left is the BSI (British Standards Institution) logo, which features the letters 'bsi' above a heart shape. The second logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a checkmark and the number '003' below. The text 'Certificate No. MD78010' is located at the bottom of the image.

Regulation Number and Section

N/A