(21 days)
Not Found
No
The device description and performance studies focus on the physical properties and antimicrobial effectiveness of the wound dressing, with no mention of AI or ML technology.
Yes
The device is described as a "wound dressing" intended for "local management of superficial wounds, minor burns, abrasions and lacerations" (OTC) and for various complex wounds under the supervision of a healthcare professional, with features like "antimicrobial barrier" and supporting "the body's healing process." These descriptions align with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a wound dressing designed for managing wounds and providing an antimicrobial barrier, not for identifying, monitoring, or predicting diseases or medical conditions.
No
The device description clearly outlines a physical wound dressing composed of multiple material layers, including fabric, film, and adhesive. It is a tangible product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing" for the "local management of superficial wounds, minor burns, abrasions and lacerations" and various types of ulcers and surgical wounds. This describes a device applied externally to the body to manage wounds.
- Device Description: The description details the physical layers of the dressing and how it functions as a wound covering and antimicrobial barrier. It does not mention any components or processes that involve testing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition.
The device is a wound dressing, which is a type of medical device used for wound care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Rx Use
Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pu 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 Dressings and Silverlon® Wound Pad 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® Island Wound Dressing and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressing's non-adherent wound contact layer 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® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order): The Silverlon® Wound Pad dressings are comprised of Layers 1 - 4, they are not supplied with Layer 5 (adhesive tape layer).
- 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 described below;
- 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 the outer polyester fabric described below;
- and,
- Layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner. The Silverlon® Wound Pad dressings do not have a tape layer.
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 provide 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.
Under the direction of a healthcare professional, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings 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.
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
Under the supervision of a healthcare professional (for Rx Use)
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® 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.
In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years.
Kirby-Bauer Standard Antimicrobial Susceptibility Test.
Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report.
No clinical testing was necessary.
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/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 bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2014
Argentum Medical, LLC Mr. C. Richard Foster Director of Quality and Regulatory Affairs 2571 Kaneville Court Geneva. Illinois 60134
Re: K143001
Trade/Device Name: Silverlon® Island Dressing and Silverlon® Wound Pad Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 16, 2014 Received: October 17, 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
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/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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing
Indications for Use (Describe)
Silverlon® Island Wound Dressing and Silverlon® Wound Pad Dressing are multi-layer, sterile, non-adherent, antimicrobial barrier wound dressings.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Rx Use
Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pu 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 Dressings and Silverlon® Wound Pad 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® Island Wound Dressing and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| XJ Prescription Use (Part 21 CFR 801 Subpart D) | X 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."
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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, and the words "Argentum Medical" in a light gray font to the right of the square. The "A" in the square has a shadow effect.
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
10/16/2014
5.4. Device trade name
Silverlon® Island Dressing Silverlon® Wound Pad Dressing
5.5. Common name
Dressing, Wound, Drug
5.6. Classification name
Unclassified: Pre-Amendment 21 CFR Number: None Product code: FRO
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5.7. Substantially Equivalent Devices (Predicates):
Predicate:
SILVERLON ISLAND WOUND DRESSING (K122817)
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): The Silverlon® Wound Pad dressings are comprised of Layers 1 - 4, they are not supplied with Layer 5 (adhesive tape layer).
- ∑ 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 µ m thick and contains approximately 1% silver oxide).
- 2 Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
- ∑ Layer 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;
- 2 Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below;
- Σ and,
- ∑ Layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner. The Silverlon® Wound Pad dressings do not have a tape layer.
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 provide 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.
Under the direction of a healthcare professional, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings 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.
5
Silverlon® Island Wound Dressings and Silverlon® Wound Pad 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® Island Wound Dressings and Silverlon® Wound Pad 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.
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® Island Wound Dressings and Silverlon® Wound Pad Dressings 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 and Silverlon® Wound Pad Dressing are multi-laver, sterile, non-adherent, antimicrobial barrier wound dressings.
5.10.1. The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
5.10.2. Prescription Indications:
Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad 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 full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, diabetic ulcers, diabetic ulcers).
6
Silverlon® Island Wound Dressings and Silverlon® Wound Pad 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® Island Wound Dressing and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds, Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
5.11. Preclinical and Clinical Studies
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® lsland Wound Dressing (K122817) cleared 05/01/2014. Antimicrobial activity due to the Silverlon® pad is not affected. The Silverlon® Island Wound Dressings has a tape layer supplied with the dressing and Silverlon® Wound Pad Dressings is supplied without the tape layer. 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 and Silverlon® Wound Pad Dressings.
Summary of Clinical testing 5.14
No clinical testing was necessary.
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5.15 Substantial Equivalence
Silverlon Island Wound Dressing (with a tape layer) and the Silverlon® Wound Pad Dressing (pad without a tape layer) have 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.
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