Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pu 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, arterial ulcers, diabetic ulcers).

Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are 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 and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process.

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

Device Description

Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order): The Silverlon® Wound Pad dressings are comprised of Layers 1 - 4, they are not supplied with Layer 5 (adhesive tape layer).

∑ 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 µ m thick and contains approximately 1% silver oxide).
2 Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
∑ Layer 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;
2 Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below;
Σ 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. The Silverlon® Wound Pad dressings do not have a tape layer.

All materials are biocompatible per irritation, sensitization and cytotoxicity testing results.

Layer 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 provide 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.

Under the direction of a healthcare professional, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings 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, arterial ulcers, diabetic ulcers) or traumatic wounds left to heal by secondary intent, and management of painful wounds.

AI/ML Overview

The provided document describes the Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing and their substantial equivalence to a predicate device (K122817). However, it does not contain a detailed study proving that the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as typically requested for AI/ML device evaluations.

Instead, the document focuses on regulatory approval (510(k)) based on substantial equivalence to a previously cleared device. The "acceptance criteria" discussed are primarily related to safety and effectiveness demonstrated through biocompatibility and antimicrobial testing, rather than performance metrics for a diagnostic or AI device.

Here's a breakdown of the information available, and what is not present based on your query:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from document context)	Reported Device Performance (from document context)
Safety:
* Biocompatibility (irritation, sensitization, intracutaneous reactivity)	All tests performed in accordance with ISO 10993 Standard Series for Biological Evaluation of Medical Devices. All materials are biocompatible per irritation, sensitization, and cytotoxicity testing results.
* No new questions of safety compared to predicate device K122817	The technological characteristics have not changed from the previously cleared Silverlon® Island Wound Dressing (K122817). The minor changes in design (presence/absence of tape layer) do not influence technological differences, implying no new safety concerns.
Effectiveness:
* Antimicrobial Effectiveness (long-term)	In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years.
* Antimicrobial Susceptibility	Kirby-Bauer Standard Antimicrobial Susceptibility Test performed.
* Antimicrobial Activity (Time Kill)	Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report performed. Layer 1 delivers antimicrobial silver ions, killing wound bacteria and providing an antimicrobial barrier.
* Maintenance of moist wound healing environment	The moist wound healing environment and control of wound bacteria within the dressing may help reduce the risk of wound infection and support the body's healing process. This dressing absorbs high amounts of wound fluid.
* Pain reduction during dressing changes	Non-adherent wound contact layer reduces pain during dressing changes; evaporation of moisture in the dressing may soothe the wound.
* No new questions of effectiveness compared to predicate device K122817	The technological characteristics have not changed from the previously cleared Silverlon® Island Wound Dressing (K122817). The minor changes in design (presence/absence of tape layer) do not influence technological differences, implying no new effectiveness concerns. The device has the same intended use and technological characteristics as the predicate.

Information NOT Available in the Document:

The nature of these questions suggests an AI/ML device, which this document does not describe. The information below is thus not found in the provided text.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no "test set" for performance evaluation of an AI algorithm is mentioned. The tests are in vitro (antimicrobial, and stability) and in vivo (biocompatibility) laboratory tests.
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)
- Not applicable. Ground truth for an AI algorithm is not established in this context. The "truth" for biocompatibility is whether the device causes adverse biological reactions; for antimicrobial effectiveness, it's the measured killing of microbes. These are determined by standard laboratory protocols.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- Not applicable. This is not an AI/ML device related to human interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests involved refers to established scientific methodologies and standards. For biocompatibility, it's the absence of toxic or irritating effects as per ISO 10993. For antimicrobial activity, it's the measured reduction in microbial load according to standards like Kirby-Bauer and ASTM E2315.
The sample size for the training set
- Not applicable. This is not an AI/ML device with a training set.
How the ground truth for the training set was established
- Not applicable.

Conclusion:

The document is a 510(k) premarket notification letter and summary for a medical dressing, not an AI/ML device. It demonstrates substantial equivalence to a predicate device primarily through technical specifications, biocompatibility testing, and in vitro antimicrobial effectiveness tests. No clinical studies were deemed necessary for this submission. Therefore, most of the specific questions about AI/ML device evaluation criteria (test sets, ground truth experts, MRMC studies, training data) are not addressed by the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.

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

November 7, 2014

Argentum Medical, LLC Mr. C. Richard Foster Director of Quality and Regulatory Affairs 2571 Kaneville Court Geneva. Illinois 60134

Re: K143001

Trade/Device Name: Silverlon® Island Dressing and Silverlon® Wound Pad Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 16, 2014 Received: October 17, 2014

Dear Mr. Foster:

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

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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 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/Resourcesfor You/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,

David Krause -S

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

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Argentum Medical. The logo consists of a blue square with a white "A" inside, and the words "Argentum Medical" are written in a light gray font to the right of the square. The logo is simple and modern, and the colors are clean and professional.

APPENDIX F: Silverlon Island Wound Dressing - Wound Pad Dressing Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143001

Device Name

Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing

Indications for Use (Describe)

Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.

The Over-The-Counter Indications:

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

Rx Use

Type of Use (Select one or both, as applicable)
XJ Prescription Use (Part 21 CFR 801 Subpart D)	X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/3 description: The image contains the logo for Argentum Medical. The logo consists of a blue square with a white "A" inside, and the words "Argentum Medical" in a light gray font to the right of the square. The "A" in the square has a shadow effect.

2571 Kaneville Court Geneva, IL 60134

PH: (630) 232.2507 TF: (888) 551-0188

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

5.3. Date prepared

10/16/2014

5.4. Device trade name

Silverlon® Island Dressing Silverlon® Wound Pad Dressing

5.5. Common name

Dressing, Wound, Drug

5.6. Classification name

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

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5.7. Substantially Equivalent Devices (Predicates):

Predicate:

SILVERLON ISLAND WOUND DRESSING (K122817)

5.8. Description of Device

∑ 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 µ m thick and contains approximately 1% silver oxide).
2 Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
∑ Layer 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;
2 Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below;
Σ 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. The Silverlon® Wound Pad dressings do not have a tape layer.

All materials are biocompatible per irritation, sensitization and cytotoxicity testing results.

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Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are 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 Dressings and Silverlon® Wound Pad Dressings are 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.

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 aqainst further trauma to the delicate incision surface. Careful selection of nonadherent, 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 Dressings and Silverlon® Wound Pad Dressings can be used safely and effectively as primary dressings on surgical incisions which heal by primary intent.

5.9. Technological Characteristics

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 µm thick and contains approximately 1% silver oxide. Layer 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.

5.10. Indications for Use

Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-laver, sterile, non-adherent, antimicrobial barrier wound dressings.

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 and Silverlon® Wound Pad 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 full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers, diabetic ulcers).

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5.11. Preclinical and Clinical Studies

Silverlon® Island Dressing 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 Standard 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 vears.

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. Summary of Technological Characteristics of device compared to predicate device

The technological characteristics have not changed from the previously cleared Silverlon® lsland Wound Dressing (K122817) cleared 05/01/2014. Antimicrobial activity due to the Silverlon® pad is not affected. The Silverlon® Island Wound Dressings has a tape layer supplied with the dressing and Silverlon® Wound Pad Dressings is supplied without the tape layer. The minor changes in design do not influence the technological differences, so there are no new questions of safety and effectiveness.

5.13 Summary of Nonclinical testing

No applicable performance standards have been established under Section 514 of the FD&C Act. In vitro testing has been completed to demonstrate the safety and effectiveness of Silverlon Island Wound Dressing and Silverlon® Wound Pad Dressings.

Summary of Clinical testing 5.14

No clinical testing was necessary.

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Image /page/7/Picture/0 description: The image shows the logo for Argentum Medical. The logo consists of a blue square with a white line running diagonally across it, forming an "A" shape. To the right of the square is the text "Argentum Medical" in a light gray, sans-serif font.

5.15 Substantial Equivalence

Silverlon Island Wound Dressing (with a tape layer) and the Silverlon® Wound Pad Dressing (pad without a tape layer) have the 1) same intended use, 2) same technological characteristics, and 3) does not raise new questions of safety or effectiveness to the predicate device, Silverlon Island Wound Dressing, cleared in K122817. This is reflected in labeled indications and directions for use of the predicate device.

Image /page/7/Picture/5 description: The image shows the logo for Silverlon. The logo is in a gray rounded rectangle. Below the logo, the words "safe, strong, simple" are written in a smaller font.

Regulation Number and Section

N/A