(77 days)
Not Found
No
The device description focuses on the physical layers and materials of the wound dressing, and there is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for local management of superficial wounds, burns, abrasions, lacerations, and various types of ulcers, which are conditions that therapeutic devices are designed to treat or alleviate. The dressing also provides an antimicrobial barrier and helps reduce the risk of wound infection, supporting the body's healing process.
No.
The Silverlon® Island Wound Dressing is described as a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing intended for wound management, not for diagnosis. Its functions include providing an antimicrobial barrier, absorbing exudate, and promoting a moist healing environment, which are all therapeutic or supportive actions, not diagnostic ones.
No
The device description clearly outlines a physical, multi-layer wound dressing with specific material compositions and physical properties. It is a tangible product, not software.
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 Description and Intended Use: The description and intended use clearly indicate that the Silverlon® Island Wound Dressing is a topical wound dressing applied directly to the wound surface. It functions as an antimicrobial barrier, absorbs exudate, and provides a moist healing environment. It does not involve testing samples taken from the body.
The device is a wound dressing, which is a type of medical device used for wound management, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Silverlon Island Wound Dressing is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Prescription Indications:
Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin 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 Dressing is 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 may help reduce the risk of wound infection and support the body's healing process.
Silverlon Island Wound Dressing may be used for the management of painful wounds, Silverlor Island Wound 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
FRO
Device Description
Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order):
• 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 (Layer 3);
- 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 (Layer 5) described below; and,
· Laver 5 is a tape layer comprised of a widely used, commercially available foam tape component with natural color that is coated with a non-latex medical grade acrylic adhesive on the skin-contacting side. The side of the dressing away from the body is covered by a medical grade polyurethane film that is bonded to the foam membrane by an acrylic adhesive.
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 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.
Under the direction of a healthcare professional, Silverlon® Island Wound Dressing 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.
Silverlon® Island Wound Dressing is 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 is 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 against further trauma to the delicate incision surface. Careful selection of non-adherent, 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 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
Under the supervision of a healthcare professional
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined figures that suggest human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Argentum Medical Mr. Richard C. Foster Director of Quality and Regulatory Affairs 2571 Kaneville Court Geneva, Illinois 60134
Re: K141573
Trade/Device Name: Silverlon Island Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 11, 2014 Received: August 12, 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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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
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
2
Indications for Use
510(k) Number (if known) K141573
Device Name
Silverlon® Island Wound Dressing
Indications for Use (Describe)
Silverlon® Island Wound Dressing is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Prescription Indications:
Under the supervision of a healthcare professional Silverlon® Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin 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 Dressing is 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 may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressing may be used for the management of painful wounds, Silverlor® Island Wound 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
മി Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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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:
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510(k) Summary
Image /page/4/Picture/3 description: The image shows 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 blue font to the right of the square. 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
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
08/25/2014
55.4. Device trade name
Silverlon® Island Wound Dressing
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):
Predicate: SILVERLON ISLAND WOUND DRESSING (K122817)
Image /page/4/Picture/22 description: The image contains the logo for SILVERLON. The logo is in a gray rounded rectangle. Below the logo, the words "safe, strong, simple" are written in a smaller font.
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Image /page/5/Picture/2 description: The image shows the text "510(k) Summary" in a large, bold, blue font. The text is centered and appears to be the title or heading of a document. The background is plain white.
Image /page/5/Picture/3 description: The image contains the logo for Argentum Medical. The logo consists of a blue square with a white "A" inside of it. To the right of the logo is the text "Argentum Medical" in a light gray font.
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):
• 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 (Layer 3);
- 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 (Layer 5) described below; and,
· Laver 5 is a tape layer comprised of a widely used, commercially available foam tape component with natural color that is coated with a non-latex medical grade acrylic adhesive on the skin-contacting side. The side of the dressing away from the body is covered by a medical grade polyurethane film that is bonded to the foam membrane by an acrylic adhesive.
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 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.
Under the direction of a healthcare professional, Silverlon® Island Wound Dressing 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.
Silverlon® Island Wound Dressing is 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 is 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
Image /page/5/Picture/17 description: The image shows the logo for SILVERLON. The logo is in a gray rounded rectangle. Below the logo, the words "safe, strong, simple" are written in a smaller font.
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Image /page/6/Picture/1 description: The image shows the logo for Argentum Medical. The logo consists of a blue square with a white "A" inside of it. To the right of the square is the text "Argentum Medical" in a light gray font.
510(k) Summary
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Argentum Medical
against further trauma to the delicate incision surface. Careful selection of non-adherent, 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 Dressing 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 is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.
5.10.1. The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
5.10.2. Prescription Indications:
The Over-The-Counter Indications: Local management of superficial wounds, minor burns, abrasions and lacerations.
Under the supervision of a healthcare professional Silverlon® Island Wound 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 fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).
Silverlon® Island Wound Dressing is 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 may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressing may be used for the management of painful wounds, Silverlon® Island Wound Dressing's non-adherent wound contact laver reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
Image /page/6/Picture/18 description: The image shows the logo for SILVERLON. The logo is in a gray rounded rectangle. Below the logo, the words "safe, strong, simple" are written in a smaller font.
7
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Image /page/7/Picture/3 description: The image contains the logo for Argentum Medical. The logo consists of a blue square with a white stylized "A" inside. To the right of the logo, the text "Argentum Medical" is written in a light gray sans-serif font.
Preclinical and Clinical Studies 5.11.
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® Island Wound Dressing (K122817) cleared 05/01/2014. The tape laver adheres to the body in the same manner as the predicate. Antimicrobial is not affected. 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.
5.14 Summary of Clinical testing
No clinical testing was necessary.
5.15 Substantial Equivalence
Silverlon Island Wound Dressing with new tape layer has 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.
Image /page/7/Picture/17 description: The image shows the logo for SILVERLON. The logo is in a silver color and is set against a white background. Below the logo, the words "safe, strong, simple" are written in a smaller font.