Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Silverlon® Island Wound Dressing is indicated for the management of infected wounds', as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Island Wound Dressing may be used for the management of painful wounds' Silverlor® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.

1Clarified/New Indication, not previously included in this format under K984208.

Device Description

Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order):

· Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 - 1.0 um thick and contains approximately 1% silver oxide).

· Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
· Laver 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;

· Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and,

· layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner.

Laver 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.

AI/ML Overview

The provided text is a 510(k) summary for the Silverlon® Island Wound Dressing, a medical device. This document focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria in the manner typically seen for algorithmic devices. Therefore, much of the requested information regarding AI/algorithm performance studies is not directly applicable or available in this specific document.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria with reported device performance in the typical sense of a clinical trial for diagnostic or prognostic devices. Instead, the "acceptance criteria" for K122817 are implicitly defined by demonstrating substantial equivalence to predicate devices and meeting established safety and effectiveness standards for wound dressings.

Acceptance Criteria Category	Reported Device Performance (as demonstrated for Substantial Equivalence)
Biocompatibility	Silverlon® Island Dressings have been subjected to independent standard in vitro and in vivo biocompatibility tests, including cytotoxicity, sensitization and intracutaneous reactivity. All tests were performed in accordance with ISO 10993 Standard Series. (Results implied to be acceptable for safety).
Antimicrobial Effectiveness (Stability)	In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years, was conducted. (Results implied to be acceptable, demonstrating sustained antimicrobial properties).
Antimicrobial Susceptibility	Kirby-Bauer Standard Antimicrobial Susceptibility Test and ASTM E2315 Time Kill Assay for Antimicrobial Agents Report were conducted. (Results implied to be acceptable, demonstrating the silver's antimicrobial action).
Technological Characteristics Equivalence	Silverlon® Island Wound Dressing has substantially the same characteristics as AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383) and ACTICOAT FLEX 7 DRESSING (K083113) and has not changed from previously cleared Silverlon® Island Wound Dressing and Silverlon Pad (K984208). Any technological differences do not raise new questions of safety and effectiveness. (Demonstrated through comparison of materials, design, mechanism of action – silver release for antimicrobial effect, absorptive capacity, non-adherence).
Intended Use Equivalence	The device has the same intended use as the predicate devices: managing various wound types, including infected wounds, painful wounds, surgical incisions, and dermal ulcers, by providing an antimicrobial barrier, absorbing exudate, and maintaining a moist healing environment. (Demonstrated by comparing Indications for Use).
Safety and Effectiveness (No New Questions)	The technological characteristics and intended use are similar enough to predicate devices that no new questions of safety or effectiveness are raised. This is supported by product specifications, testing (biocompatibility, antimicrobial), and scientific studies. (Conclusion drawn from the submission, leading to substantial equivalence finding).

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

The document does not describe a "test set" in the context of an AI/algorithm evaluation. The studies mentioned are primarily pre-clinical (in vitro/in vivo biocompatibility) and in vitro (antimicrobial effectiveness).

Biocompatibility Studies: Specific sample sizes for cytotoxicity, sensitization, and intracutaneous reactivity tests are not provided, but these are standard tests performed according to ISO 10993. The provenance would be the testing laboratories that conducted these standard tests.
Antimicrobial Effectiveness: No specific sample size is given for the "accelerated stability testing for antimicrobial effectiveness" or "Kirby-Bauer Standard Antimicrobial Susceptibility Test." These are laboratory-based in vitro studies. The "Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report" would also be an in vitro lab study.

These are not clinical studies with human participants that would typically have a "test set" for performance evaluation in the way requested for AI.

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

This information is not applicable as there is no mention of a "test set" requiring expert ground truth in the context of an AI/algorithm evaluation in the provided summary. The studies are laboratory-based for material properties and antimicrobial activity.

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

This information is not applicable as there is no mention of a "test set" requiring adjudication or expert review in the provided summary.

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 such study was done. This document is for a traditional wound dressing, not an AI-powered device, and therefore MRMC studies or AI assistance are not relevant.

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

No such study was done. The device is a physical wound dressing and does not involve an algorithm.

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

For the studies mentioned:

Biocompatibility: Ground truth is established by standard ISO 10993 criteria for material safety.
Antimicrobial Effectiveness: Ground truth is based on established microbiological testing methods (e.g., Kirby-Bauer, ASTM E2315) and scientific principles of bacterial inhibition/kill.

8. The sample size for the training set

This is not applicable. The device is a physical wound dressing, not an AI/algorithmic device that requires a training set.

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

This is not applicable for the reasons stated above.

Summary

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SUMMARY STATEMENT (K122817)

5.0 510(k) Summary [As required by 21 CFR 807.92]

5.1. Submitted by

Argentum Medical, LLC 2571 Kaneville CT. Geneva, IL 60134 Phone 630.232.2507 Fax 630.232.8005

5.2. Contact person

C Richard Foster Argentum Medical, LLC 2571 Kaneville CT. Geneva, IL 60134 Phone 630.232.2507 Fax 630.232.8005 richfoster@silverlon.com

Walt Brittle, Regulatory Consultant (Application Correspondent) FDAImports.com, LLC 810 Landmark Drive, Suite 126 Glen Burnie, MD 27061 phone: (410) 220-2800 Fax: (443) 583-1464 wlbrittle@fdaimports.com

5.3. Date prepared

4/23/2014

5.4. Device trade name

Silverlon® Island Wound Dressing

5.5. Common name

Dressing, Wound, Drug

5.6. Classification name

Unclassified: Pre-Amendment 21 CFR Number: None Product code FRO

5.7. Substantially Equivalent Devices (Predicates):

Primary Predicate: AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383) cleared 05/02/2008

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SUMMARY STATEMENT (K122817), page 2.

Other predicates: ACTICOAT FLEX 7 DRESSING (K083113) cleared 07/22/2009 Silverlon Island Wound Dressing and Silverlon Island Pad (K984208) cleared 02/22/1999

5.8. Description of Device

Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order):

· Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
· Laver 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;

· Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and,

Under the direction of a healthcare professional. Silverlon® Island Wound Dressing may be used for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers) or traumatic wounds left to heal by secondary intent, and management of painful wounds.

Silverlon® Island Wound Dressing is indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon Island Wound Dressing is indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that, may be helpful in managing these wounds.

{2}------------------------------------------------

SUMMARY STATEMENT (K122817), page 3.

A majority of postoperative surgical incisions are sutured, stapled or glued and are covered with some form of dressing. This first dressing, frequently referred to as the primary dressing, acts to absorb drainage, maintain a clean environment and serve as a barrier against further trauma to the delicate incision surface. Careful selection of non-adherent, absorptive dressings that do not become incorporated within the incision serves greatly to reduce the potential of surgical incision injury, and reduce pain upon dressing change when the time comes for the initial dressing to be removed.

Silverlon® Island Wound Dressing can be used safely and effectively as primary dressings on surgical incisions which heal by primary intent.

Technological Characteristics ર .ે.

The technological characteristics have not changed from the previously cleared Silverlon® Island Wound Dressing and Silverlon Pad (K984208) cleared 02/22/1999. Silverlon® Island Wound Dressing has substantially the same characteristics as AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383) cleared 05/02/2008 and the primary wound contact layer has substantially the same technological characteristics as ACTICOAT FLEX 7 DRESSING (K083113).Any technological differences do not raise new questions of safety and effectiveness.

Indications for Use 5.10.

Silverlon® Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.

5.10.1. The Over-The-Counter Indications:

Local management of superficial wounds, minor burns, abrasions and lacerations.

5.10.2. Prescription Indications:

Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers).

Silverlon Island Wound Dressing is indicated for the management of infected wounds', as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Island Wound Dressing may be used for the management of painful wounds' Silverlon® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.

1 Clarified/New Indication, not previously included in this format under K984208.

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SUMMARY STATEMENT (K122817), page 4.

Silverlon® Island Wound Dressing may be used for the management of:

Management of painful wounds' Silverlon® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.

1 Clarified/New Indication. not previously included in this format under K984208.

Preclinical and Clinical Studies 5.11.

5.11.1 Silverlon® Island Dressings have been subjected to independent standard in vitro and in vivo biocompatibility tests, including cytotoxicity, sensitization and intracutaneous reactivity. All tests were performed in accordance with the International Organization (ISO) 10993 Standard Series for Biological Evaluation of Medical Devices.

5.11.2 In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years.

5.11.3 Kirby-Bauer Standard Antimicrobial Susceptibility Test.

5.11.4 Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report.

5.12. Performance Standards

No applicable performance standards have been established under Section 514 of the FD&C Act. In vitro testing, animal testing, and clinical investigations have been completed to demonstrate the safe and effectiveness of Silverlon Island Wound Dressing.

Substantial Equivalence 5.13.

Silverlon Dressings have the 1) same intended use, 2) same technological characteristics, and 3) do not raise new questions of safety or effectiveness to the predicates AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383), ACTICOAT FLEX 7 DRESSING (K083113) and several other secondary predicates; which are supported by product specifications, testing, and scientific studies. This is further reflected in the summary documents submitted by the predicate manufacturers (required by 21 CFR 807.92), labeled indications and directions for use of the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MI) 20993-0002

May 1. 2014

Argentum Medical. LLC % Mr. Walt Brittle FDAlmports.Com、LLC 810 Landmark Drive. Suite 126 Glen Burnie, Maryland 21061

Re: K122817

Trade/Device Name: Silverlon Island Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2014 Received: February 26, 2014

Dear Mr. Brittle:

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. 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 (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.

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Page 2 - Mr. Walt Brittle

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education 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 yours,

Binita S. Ashar S 2014.05.01 16:32:20 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting 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): K 122817

Device Name: Silverlon® Island Wound Dressings

Silverlon® Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.

The Over-The-Counter Indications:

Local management of superficial wounds, minor burns, abrasions and lacerations.

1Clarified/New Indication, not previously included in this format under K984208.

Prescription Use (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)

Jivoung Dang -S

Page 1 of

Regulation Number and Section

N/A