(154 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical efficacy of a silver-coated wound dressing, with no mention of AI or ML technology.
Yes
The device is indicated for local management of various wounds, including partial and full thickness wounds, burns, and ulcers, and provides an antimicrobial barrier and supports healing, which are therapeutic functions.
No
This device is a wound dressing designed for treatment and management of wounds, not for diagnosis. It provides an antimicrobial barrier and helps with pain management and moist wound healing.
No
The device description clearly states it is a physical dressing comprised of knitted nylon fiber substrate coated with metallic silver, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for the local management of various types of wounds and burns. This is a topical application for direct contact with the body.
- Device Description: The description details the physical composition and function of the dressing, which is to provide an antimicrobial barrier and a moist wound healing environment. This is a therapeutic and protective function applied externally.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.
The device is a wound care product, not a diagnostic tool.
N/A
Intended Use / 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 (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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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:
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.
| 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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3
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
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.
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.
6
· 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.