(86 days)
Not Found
No
The document describes a silver-coated wound dressing and its antimicrobial properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as a wound and burn dressing that uses silver to provide an antimicrobial barrier, manage infected wounds, and support the healing process, which are all therapeutic functions.
No
The device is a wound dressing designed for management and treatment of wounds, not for diagnosis.
No
The device description clearly states it is a physical dressing made of knitted nylon fiber 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Silverlon® Wound Contact, Burn Contact Dressings are topical dressings applied directly to wounds and burns. Their function is to provide an antimicrobial barrier and a moist healing environment.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It interacts directly with the wound surface.
- Intended Use: The intended use is for the local management of wounds and burns, not for diagnosing conditions based on biological samples.
Therefore, the Silverlon® Wound Contact, Burn Contact Dressings fall under the category of wound care dressings, not in vitro diagnostics.
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.
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.
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.
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 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.
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.
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® Dressing can be used safely and effectively as primary dressings on surgical incisions which heal by primary intent.
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)
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.
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.
No clinical studies were conducted to support this premarket notification.
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.
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
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
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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 a stylized human profile, composed of three interconnected lines or shapes.
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
1
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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Image /page/2/Picture/0 description: The image contains the logo for Argentum Medical. The logo consists of a blue square with a white stylized letter "A" inside. To the right of the square is the text "Argentum Medical" in a light gray sans-serif font.
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)
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.
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.
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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Image /page/3/Picture/0 description: The image contains the logo for Argentum Medical. The logo consists of a blue square with a white line running diagonally across it, resembling the letter 'A'. To the right of the square is the text "Argentum Medical" in a light gray sans-serif font. The text is aligned horizontally with the square, creating a clean and professional look.
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, along with the company name "Argentum Medical" in a light gray font. The logo is simple and modern, with a focus on the company's name.
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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Image /page/4/Picture/0 description: The image contains 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, with a focus on the company name.
5.8. Description of Device
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.
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
5
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.
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 soothe the wound.
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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Image /page/7/Picture/0 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" are written in a light gray font to the right of the square. The logo is simple and professional.
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.