Prescription Indications:
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), 1st and 2nd degree burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites.

Silverlon® 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® Dressings may help reduce the risk of wound infection and support the body's healing process.

Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Burn Contact Dressings is a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.

Device Description

Silverlon® Wound Contact, Burn Contact Dressings are sterile, porous, non-adherent, knitted nylon plated with 99% elemental silver and 1% silver oxide. Silverlon® Wound Contact, Burn Contact Dressings 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.

The Silverlon® Wound Contact, Burn Contact Dressings are used as the primary wound contact layer and is placed under reticulated foam, gauze, or other wound fillers. Silverlon® Wound Contact, Burn Contact Dressings are non-adherent, wound care dressings designed to be used up to seven (7) days.

AI/ML Overview

The provided document is a 510(k) premarket notification for Silverlon® Wound Contact, Burn Contact Dressings. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than to prove safety and effectiveness through new clinical studies against specific acceptance criteria. This means the information typically sought for device acceptance criteria and study outcomes (like those for AI/ML devices) is not directly present in this type of regulatory submission.

Here's a breakdown based on the information available:

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

This document does not contain specific acceptance criteria with corresponding device performance metrics in the way a study for a novel device or AI/ML algorithm would. The device, Silverlon® Wound Contact, Burn Contact Dressings, is seeking clearance based on substantial equivalence to predicate devices (K023612, K073213, K122817).

Instead, the submission focuses on demonstrating:

Same intended use: "Local management of superficial wounds, minor burns, abrasions and lacerations" (OTC) and for various partial and full-thickness wounds (Prescription) up to 7 days, including infected and painful wounds.
Same technological characteristics: Composed of knitted nylon fiber substrate coated with metallic silver, delivering antimicrobial silver ions when activated by moisture, acting as a barrier, and permitting oxygen/fluid passage.
No new questions of safety or effectiveness: Supported by biocompatibility testing and antimicrobial efficacy testing, showing it performs similarly to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on non-clinical (in vitro) testing and comparison to predicate devices, not human subject testing with a test set.

3. 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 a test set is not established in this type of submission.

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

Not applicable. There is no test set or human reader adjudication involved.

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 not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

For the non-clinical tests conducted, the "ground truth" would be established by:

Biocompatibility: Established ISO 10993 standards and methodologies (cytotoxicity, sensitization, intracutaneous reactivity).
Antimicrobial effectiveness: Standardized in vitro tests like Kirby-Bauer Standard Antimicrobial Susceptibility Test and ASTM E2315 Time Kill Assay for Antimicrobial Agents Report. The "ground truth" here is the measured bacterial reduction or inhibition according to the test standards.

8. The sample size for the training set

Not applicable. There is no AI/ML model or training set discussed in this document.

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

Not applicable. There is no AI/ML model or training set discussed in this document.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this 510(k) submission):

The "study" in this context is a collection of non-clinical (in vitro) tests and a demonstration of substantial equivalence.

Biocompatibility Testing: In vitro and in vivo biocompatibility tests were conducted according to ISO 10993 standards, covering cytotoxicity, sensitization, and intracutaneous reactivity. The successful completion of these tests demonstrates the device is biologically safe for its intended use, meeting the implicit acceptance criteria of being non-toxic and non-irritating.
Antimicrobial Effectiveness Testing: In vitro tests were performed including:
- Accelerated stability testing for antimicrobial effectiveness on samples aged to the equivalent of 5 years.
- Kirby-Bauer Standard Antimicrobial Susceptibility Test.
- ASTM E2315 Time Kill Assay for Antimicrobial Agents Report.
  These tests demonstrate the sustained ability of the silver in the dressing to provide an antimicrobial barrier and reduce bacterial growth within the dressing, thereby supporting the proposed indications related to managing infected wounds and reducing infection risk. The acceptance criteria for these tests would be defined by the specific standards, e.g., a certain percentage reduction in bacterial count for the time kill assay, or specific zones of inhibition for Kirby-Bauer. The report states these tests were conducted to demonstrate safety and effectiveness.
Comparison to Predicate Devices: The core of the K150256 submission is a comparison against legally marketed predicate devices (K023612, K073213, K122817). The "study" concludes that there are "no technological differences" or "minor technological differences that do not raise new questions of safety and effectiveness." This comparison, along with the specified in vitro testing, is the primary means of demonstrating that the device meets the implicit acceptance criteria for safety and effectiveness that were established for the predicate devices.

Key takeaway for this specific document: This 510(k) submission seeks regulatory clearance by demonstrating equivalence to existing devices through non-clinical testing and comparison, rather than through a clinical study with explicit performance acceptance criteria typical for novel devices or AI/ML. No clinical studies were conducted for this premarket notification.

Summary

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

April 30, 2015

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

Re: K150256

Trade/Device Name: Silverlon "Wound Contact, Burn Contact Dressings Regulatory Class: Unclassified Product Code: FRO Dated: January 30, 2015 Received: February 3, 2015

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/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,

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

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

Indications for Use

510(k) Number (if known)

K150256

Device Name

Silverlon® Wound Contact, Burn Contact Dressings

Indications for Use (Describe)

Silverlon® Wound Contact, Burn Contact Dressings are comprised of a single layer of knitted nylon fiber substrate coated with metallic silver.

The Over-The-Counter Indications:

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

Prescription Indications:

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), 1st and 2nd degree burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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." FORM FDA 3881 (8/14) Page 1 of 1

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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

12/11/2014

5.4. Device trade name

Silverlon® Wound Contact Dressings, Silverlon® Burn Contact Dressings

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):

K023612; Silverlon® Antimicrobial Barrier Wound Contact Dressing, Antimicrobial Barrier Burn Wrap Dressing, Antimicrobial Barrier Burn Contact Dressing, SilverlonB Acute Burn Glove K073213; TheraBond Antimicrobial Barrier Systems K122817; Silverlon® Island Wound Dressing 2015-01-30

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5.8. Description of Device

Technological Characteristics 5.9.

Silverlon® Wound Contact, Burn Contact Dressings are composed of a single layer of woven nylon fiber substrate plated with metallic silver. The dressing facilitates the body's wound healing process by:

. covering the wound and acting as a barrier to the ingress of foreign objects;
. providing silver ions for an antimicrobial effect in the dressing: and,
permitting the passage of oxygen and fluids to the wound.

5.9.1. How the device functions

Silverlon® Wound Contact, Burn Contact Dressings deliver 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 for bacterial penetration of the dressing which may help reduce infection.

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

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

Indications for Use 5.10.

Silverlon® Wound Contact, Burn Contact Dressings are comprised of a single layer of knitted nylon fiber substrate coated with metallic silver.

5.10.1. The Over-The-Counter Indications:

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

5.10.2. Prescription Indications:

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds, surgical wounds (donor and graft sites, incisions), 1st and 2nd degree burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites.

5.11. Preclinical and Clinical Studies

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Silverlon® Dressings have been tested to independent standards for biocompatibility. In vitro and in vivo biocompatibility tests were conducted. These included cytotoxicity, sensitization and intracutaneous reactivity, per the guidance of International Standard Organization (ISO) 10993 Standard Series for Biological Evaluation of Medical Devices. Other in vitro testing included the following:

In vitro accelerated stability testing for antimicrobial effectiveness on . samples aged to the equivalent of 5 years.
. Kirby-Bauer Standard Antimicrobial Susceptibility Test.
. ASTM E2315 Time Kill Assay for Antimicrobial Agents Report.

Summary of Technological Characteristics of device compared to predicate device 5.12.

There is no technological difference between the subject devices and the Silverlon® Barrier Wound Contact, Burn Wrap, Burn Contact, Burn Glove Dressing, The technological characteristics have not changed from the previously cleared K023612; Silverlon® Barrier Wound Contact, Burn Wrap, Burn Contact, Burn Glove Dressing. Therefore the subject device also remains unchanged from the cleared predicate K073213; TheraBond Antimicrobial Barrier Systems. The Silverlon® Wound Contact, Burn Contact Dressings have the same technological characteristics cleared in other Silverlon® dressings' 510(k)s including K122817; Silverlon® Island Wound Dressing. .Any technological differences are minor and do not raise 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® Wound Contact, Burn Contact Dressings.

The metallic silver provides antimicrobial protection of the dressing. When the dressing is exposed to moisture in the form of water, water vapor, blood, saline, and other forms of liguid it produces silver ions to minimize/reduce the growth of bacteria within the dressing. Antimicrobial effectiveness in the dressing was addressed in separate in-vitro laboratory evaluations using licensed commercial reference laboratories.

Summary of Clinical testing 5.14

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No clinical studies were conducted to support this premarket notification.

Substantial Equivalence 5.15

Based on the information presented above it is concluded that the Silverlon® Wound Contact and Burn Contact Dressings have the 1) same intended use, 2) same technological characteristics, and 3) do not raise new questions of safety or effectiveness to the listed predicates. This is further reflected in the summary documents submitted by the predicate manufacturers (required by 21 CFR 807.92) and labeled indications.

Image /page/7/Picture/6 description: The image shows the logo for SILVERLON. The logo is in a silver rounded rectangle with the word "SILVERLON" in white letters. Below the logo is the phrase "safe, strong, simple" in a smaller font.

Regulation Number and Section

N/A