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), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites.

Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.

Silverlon® Wound Contact, Burn Contact 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® Wound Contact, Burn Contact 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, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

Device Description

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

Silverlon Wound Contact, Burn Contact Dressings are used as the primary wound contact layer and is placed under reticulated foam, gauze, or other wound dressings. 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) summary for the Silverlon® Wound Contact, Burn Contact Dressings. It describes the device, its indications for use, and a nonclinical (animal) study conducted to support an expanded indication.

Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

The document describes a non-inferiority study performed on Gottingen minipigs. The acceptance criteria are based on a "non-inferiority margin" for a "histopathology composite score."

Acceptance Criteria	Reported Device Performance
Non-Inferiority Margin: 1.5 points (or 10% of maximum possible score of 15) for the total histopathology composite score. The subject device is considered non-inferior if its score is not substantially worse than the standard of care.	Moderate Partial Thickness (DD) Injuries: Mean composite histopathology score for the subject device was 0.36 points higher than standard of care.
	Superficial Partial Thickness (SD) Injuries: Mean composite histopathology score for the subject device was 0.01 points higher than standard of care.
Conclusion:	The study demonstrated that the Silverlon Wound Contact, Burn Contact Dressing is non-inferior to standard of care for both moderate and superficial partial thickness mustard-induced vesicant injuries. For DD injuries, this was demonstrated when changed every 7 days, and for SD injuries, when changed every 4 days.

Explanation of Performance:
Since a higher histopathology score is implicitly better (as the device score was higher than the standard of care and still met non-inferiority), the device performed as well as or slightly better than the standard of care, falling within the pre-defined non-inferiority margin.

Study Details

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

Sample Size: 165 Gottingen minipigs.
Data Provenance: Nonclinical study, animal data (Gottingen minipigs). The study was a GLP (Good Laboratory Practice) nonclinical study.

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):

The document does not specify the number or qualifications of experts used to establish the ground truth (histopathology scores). It only mentions that the primary endpoint was the "histopathology composite score." Typically, a pathologist would be responsible for such assessments, but no details are provided here.

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

The document does not describe any expert adjudication method for the histopathology scores. It only refers to a "histopathology composite score," which implies a single score derived from the histological examination.

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. This was a nonclinical (animal) study comparing the wound dressing to standard of care. It was not an MRMC study and did not involve human readers or AI assistance.

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

No. This was a nonclinical study of a physical wound dressing device. It does not involve an algorithm or AI.

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

The primary endpoint (ground truth) was a histopathology composite score of dermal wounds. This suggests a pathology-based assessment.

8. The sample size for the training set:

Not applicable. This was a nonclinical study of a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there was no training set.

Summary

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July 18, 2019

Argentum Medical, LLC Aftab Ahmad Director, Quality and Regulatory Affairs 2571 Kaneville CT Geneva, Illinois 60134

Re: K190343

Trade/Device Name: Silverlon Wound Contact, Burn Contact Dressings Regulatory Class: Unclassified Product Code: FRO Dated: April 17, 2019 Received: April 19, 2019

Dear Aftab Ahmad:

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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Cynthia Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190343

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.

Over-The Counter Indications:

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

Prescription Indications:

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

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 4: 510(k) Summary

Image /page/3/Picture/2 description: The image shows the logo for Argentum Medical. The logo consists of a blue square with a white "A" inside, followed by the text "Argentum Medical" in a light gray sans-serif font. 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

4.0 510(k) Summary

[As required by 21 CFR 807.92]

4.1. Submitted by

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

4.2. Contact Person

Aftab Ahmad Argentum Medical, LLC 2571 Kaneville CT. Geneva, IL 60134 Phone 630.232.2507 Fax 630.232.8005 aahmad(@silverlon.com

4.3. Date Prepared

July 18, 2019

4.4. Device Trade Name

Silverlon® Wound Contact, Burn Contact Dressings

4.5. Common Name

Dressing, Wound, Drug

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4.6. Classification Name

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

4.7. Substantially Equivalent Device (Predicate Device):

Silverlon Wound Contact, Burn Contact Dressings (K150256)

4.8. Device Description

4.9. Technological Characteristics

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. .

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.

4.10. Technological Characteristics Compared to Predicate Device

Silverlon Wound Contact, Burn Contact Dressings have the same technological characteristics as the predicate device. The expanded indications for use has no impact on the product design or technological characteristics.

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4.10. Indications for Use

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

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, surgical wounds (donor and graft sites, incisions), first and second degree thermal 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 Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.

Silverlon Wound Contact, Burn Contact 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 Wound Contact, Burn Contact 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 are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.

4.11. Indications for Use Compared to Predicate Device

Silverlon® Wound Contact, Burn Contact Dressings shares the same intended use and nearly the same indications for use as the predicate device, although the subject device revises the indications for use to clarify first and second degree thermal burns and expands the indications for use to include use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting, defined as:

· Decontaminated: a mustard vapor injury that has received sufficient debridement to remove all traces of the mustard agent.

· Stable: a mustard vapor injury that has not become deeper or larger during the preceding 2-4 davs.

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· Unroofed: a mustard vapor injury in which debridement of all appropriate blisters has been performed.

This modification does not result in a new intended use in comparison to the predicate device, and the submitted testing demonstrates that Silverlon Wound Contact, Burn Contact Dressings are substantially equivalent to the predicate device in terms of performance.

4.12. Summary of Bench Testing

No bench studies were conducted to support this premarket notification.

4.13. Summary of Animal Testing

A GLP nonclinical study was conducted comparing use of the subject device and standard of care on vesicant-induced sulfur mustard injuries in 165 Gottingen minipigs. Superficial partial thickness (SD) and moderate partial thickness (DD) depth wounds were induced by sulfur mustard vapor followed by wet-to-wet debridement 48 hours post-injury and daily thereafter for 7 days. The wounds were then covered for 30 days with either the subject device or standard of care followed by 7 days of no wound coverage. The primary endpoint for the study was the histopathology composite score (total score of up to 15) of dermal wounds obtained at the end of the study (Study Day 46). The non-inferiority margin for the total histopathology score is 1.5 (or 10% of maximum possible score). In the DD depth injuries, those covered with the subject device had a mean composite histopathology score 0.36 points higher than those covered with standard of care. In the SD depth injuries, those covered with the subject device had a mean composite histopathology score 0.01 points higher than those covered with standard of care. Dressing moistening was performed three times daily with the subject device and once daily with standard of care. The study demonstrated that the Silverlon Wound Contact, Burn Contact Dressing is non-inferior to standard of care when it is changed every 7 days on moderate partial thickness depth decontaminated stable unroofed mustard-induced vesicant injuries not requiring skin grafting on Gottingen minipigs. The study also demonstrated that the Silverlon Wound Contact Burn Contact Dressing is noninferior to standard of care when it is changed every 4 days on superficial thickness depth decontaminated stable unroofed mustard-induced vesicant injuries not requiring skin grafting on Gottingen minipigs. There were no device-related adverse events during the study. The results of this study demonstrated that the new indication does not raise different questions of safety and effectiveness and does not significantly increase any concerns of safety or effectiveness in comparison to use of the wound dressings on the other specified burn types in the predicate labeling.

Summary of Clinical Testing 4.14.

No clinical studies were conducted to support this premarket notification.

Substantial Equivalence 4.14.

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Based on the information presented above and further detailed within this premarket notification, Silverlon Wound Contact, Burn Contact Dressings are substantially equivalent to the predicate device. Silverlon Wound Contact, Burn Contact Dressings have the same intended use and same technological characteristics as the predicate device, and do not raise different questions of safety or effectiveness in comparison to the predicate device.

Regulation Number and Section

N/A