K Number

Device Name

Manufacturer

ARGENTUM MEDICAL

Date Cleared

2014-08-28

(77 days)

Product Code

FRO

Regulation Number

N/A

Type

Special

Panel

General & Plastic Surgery

Reference & Predicate Devices

K122817

Predicate For

N/A

Intended Use

Silverlon® Island Wound Dressing 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.

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, 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 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):

• 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 2 is a polyethylene film used to bond the nylon substrate to the pad layer (Layer 3);
Layer 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 (Layer 5) described below; and,

· Laver 5 is a tape layer comprised of a widely used, commercially available foam tape component with natural color that is coated with a non-latex medical grade acrylic adhesive on the skin-contacting side. The side of the dressing away from the body is covered by a medical grade polyurethane film that is bonded to the foam membrane by an acrylic adhesive.

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 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 describes a medical device, the Silverlon® Island Wound Dressing, and its regulatory clearance (K141573) based on substantial equivalence to a predicate device (K122817). This document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo clinical study data for acceptance criteria.

Therefore, the information requested about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI/software-based devices is not applicable to this type of regulatory submission and device.

Here's an explanation based on the provided text, addressing why most of the requested information cannot be found:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The 510(k) summary does not set specific numerical acceptance criteria for performance metrics in the way one would for a diagnostic or AI device. Instead, it asserts that the device is "substantially equivalent" to a predicate device. The performance is assessed by confirming that its changed design (a new tape layer) maintains the same technological characteristics and does not raise new questions of safety or effectiveness compared to the predicate.
The document states: "The technological characteristics have not changed from the previously cleared Silverlon® Island Wound Dressing (K122817)... The minor changes in design do not influence the technological differences, so there are no new questions of safety and effectiveness."
It also lists "In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years," "Kirby-Bauer Standard Antimicrobial Susceptibility Test," and "Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report" as tests performed. These tests confirm properties of the dressing (like antimicrobial efficacy and stability), but specific "acceptance criteria" against which these were measured are not explicitly stated in this summary.

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

Not Applicable. This is a medical dressing, not a diagnostic or AI device that would have a "test set" of data in the sense of patient images or clinical data for performance evaluation.
The tests performed are "in vitro" and "in vivo biocompatibility tests," and "antimicrobial susceptibility tests." The sample sizes for these laboratory tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is typically for clinical data, which was not the primary basis of this submission.

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

Not Applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic devices (e.g., radiologists interpreting images). This device is a wound dressing. The "ground truth" for its properties would be established through laboratory methods and chemical/biological assays, not expert interpretation of clinical cases.

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

Not Applicable. Adjudication methods are used to resolve discrepancies among expert readers in clinical studies, primarily for diagnostic devices. This concept does not apply to the evaluation of a wound dressing.

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:

Not Applicable. This is a physical wound dressing and not an AI device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant.

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

Not Applicable. This is a wound dressing, not an algorithm or AI.

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

Not Applicable in the typical sense for AI/diagnostic devices. For this wound dressing, the "ground truth" is derived from:
- Biocompatibility testing: Conformance to ISO 10993 standards (cytotoxicity, sensitization, intracutaneous reactivity).
- Antimicrobial effectiveness testing: In vitro accelerated stability, Kirby-Bauer, and ASTM E2315 Time Kill Assay.
- The "truth" is established by these standardized laboratory and material tests, not clinical outcomes data for this specific 510(k) beyond proving substantial equivalence.

8. The sample size for the training set:

Not Applicable. This is a wound dressing, not an AI device that requires a training set.

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

Not Applicable. As related to point 8, there is no training set for this device.

In summary: The provided document is a 510(k) summary for a wound dressing, which focuses on demonstrating "substantial equivalence" to a predicate device, primarily through non-clinical (laboratory and material) testing and a comparison of technological characteristics. The questions posed are largely relevant to the evaluation of AI/diagnostic software devices and are therefore not addressed in this specific regulatory filing for a wound dressing.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined figures that suggest human profiles.

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

August 28, 2014

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

Re: K141573

Trade/Device Name: Silverlon Island Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 11, 2014 Received: August 12, 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 forth in the quality systems (OS) 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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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

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) K141573

Device Name

Silverlon® Island Wound Dressing

Indications for Use (Describe)

Silverlon® Island Wound Dressing 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.

Prescription Indications:

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:

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510(k) Summary

Image /page/4/Picture/3 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 blue font to the right of the square. The logo is simple and modern, and the colors are clean and professional.

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

08/25/2014

55.4. 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):

Predicate: SILVERLON ISLAND WOUND DRESSING (K122817)

Image /page/4/Picture/22 description: The image contains 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.

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Image /page/5/Picture/2 description: The image shows the text "510(k) Summary" in a large, bold, blue font. The text is centered and appears to be the title or heading of a document. The background is plain white.

Image /page/5/Picture/3 description: The image contains the logo for Argentum Medical. The logo consists of a blue square with a white "A" inside of it. To the right of the logo is the text "Argentum Medical" in a light gray font.

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 (Layer 3);
Layer 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 (Layer 5) described below; and,

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

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, arterial 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.

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

Image /page/5/Picture/17 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.

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Image /page/6/Picture/1 description: The image shows the logo for Argentum Medical. The logo consists of a blue square with a white "A" inside of it. To the right of the square is the text "Argentum Medical" in a light gray font.

510(k) Summary

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Argentum Medical

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.

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 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:

The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations.

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, arterial ulcers, diabetic ulcers).

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

Image /page/6/Picture/18 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.

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Image /page/7/Picture/3 description: The image contains the logo for Argentum Medical. The logo consists of a blue square with a white stylized "A" inside. To the right of the logo, the text "Argentum Medical" is written in a light gray sans-serif font.

Preclinical and Clinical Studies 5.11.

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® Island Wound Dressing (K122817) cleared 05/01/2014. The tape laver adheres to the body in the same manner as the predicate. Antimicrobial is not affected. 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.

5.14 Summary of Clinical testing

No clinical testing was necessary.

5.15 Substantial Equivalence

Silverlon Island Wound Dressing with new tape layer has 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/17 description: The image shows the logo for SILVERLON. The logo is in a silver color and is set against a white background. Below the logo, the words "safe, strong, simple" are written in a smaller font.

Regulation Number and Section

N/A