(287 days)
Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.
Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven pad composed of a calcium (and sodium) alginate and a silver nylon contact layer. The dressing is available in various sizes ( 2" x 2", 4.2", 4.25" x 4.25", 4" x 8", 8" x 12", and a %" x 12" rope) and packaged in Tyvek pouches. The release of silver ions provides an antimicrobial barrier, which protects the dressing from microbial colonization. The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.
The provided text describes a 510(k) summary for the Silverlon™ CA Calcium Alginate Dressing. However, it does not contain the acceptance criteria or the study details that you've requested.
The document focuses on:
- Device Identification: Name, submitter, contact information.
- Predicate Device: Claims equivalence to prior Silverlon products and other marketed alginate dressings.
- Device Description: Sterile, non-woven calcium alginate pad with a silver nylon contact layer for antimicrobial barrier and exudate absorption.
- Intended Use/Indications: For moderate to heavy exudating partial and full-thickness wounds (pressure ulcers, venous ulcers, diabetic ulcers, donor/graft sites, traumatic/surgical wounds, 1st and 2nd-degree burns). External use only.
- Technological Characteristics Comparison: States silver content and alginate amount per square inch are identical to the predicate device.
- Performance Data: Mentions non-clinical studies showing good balance of tolerability and safety. These studies are:
- Systemic Injection Test in Mice
- Cytotoxicity - Agar Diffusion
- Primary Dermal Irritation in Rabbits
- FDA Clearance Letter: Confirms substantial equivalence determination based on the 510(k) submission.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them because it is not present in the given text.
The document only details non-clinical safety and tolerability tests (Systemic Injection, Cytotoxicity, Dermal Irritation) which are part of demonstrating safety, but not specific performance acceptance criteria for its indicated uses (e.g., wound healing rates, infection reduction rates) or clinical study results to prove those.
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510(k) Summary
Summary Information 6.1
Submitter's Name and Address 6.1.1
OCT - 6 2006
Argentum LLC 240 81st Street Willowbrook, IL 60527
Contact person and telephone number:
Thomas Miller Telephone: (708) 927-9398 Telefax: (630) 986-4401 E-mail: temiller@aol.com
Device Name 6.1.2
Silverlon™ CA Calcium Alginate Dressing-Antimicrobial Silver
Identification of predicate device substantial equivalence is being claimed 6.1.3
Equivalence is being claimed for prior Silverlon products distributed by Argentum Equivatence is being Claimed Ter proc. Arivate dressings ADRI -K011618; Westaim Medical, DBC and Advanced Medical Solutions - K041316
Device Description 6.1.4
Silverlon™ CA Advanced Antimicrobial Alginate Dressing, is a sterile, non-woven Silverlon - CA Advanced Anamieranic acid) alginate and a silver nylon contact layer. pad composed or a right nr (indicious sizes ( 2" x 2", 4.2", 4.25" x 4.25", 4" x 8", 8" x 12", and a %" x 12" rope) and packaged in Tyvek pouches. The release of silver ions provides an antimicrobial barrier, which protects the dressing from Shver 1013 provides . The dressing absorbs exudates, maintains a moist wound environment and allows for intact removal.
September 26, 2006 Replaces version dated August 8, 2006
Page 1 of 2
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6.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended.
As described in the product label -
Indications
Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.
6.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device
Silver content is identical to the predicate device. Alginate amount per square inch is identical to the predicate device.
6.2 Assessment of Performance Data
Non-clinical studies showed good balance of tolerability and safety. Three studies were conducted:
- � Systemic Injection Test in Mice
- . Cytotoxicity - Agar Diffusion
- Primary Dermal Irritation in Rabbits .
September 26, 2006 Replaces version dated August 8, 2006
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract eagle or bird-like figure.
Public Health Service
OCT - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Argentum Medical, LLC % Clementi-King, Ltd. William A. Clementi, Pharm.D., F.C.P. 8 Tower Bridge, Suite 1045 161 Washington Street Conshohocken, Pennsylvania 19428
Re: K053590
Trade/Device Name: Silverton™ CA Antimicrobial Calcium Alginate Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 10, 2006 Received: August 14, 2006
Dear Dr. Clementi:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 mav 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); good manufacturing practice requirements as set 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.
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Page 2 - William A. Clementi, Pharm.D., F.C.P.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buchner
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053590
Silverlon™ CA Antimicrobial Calcium Alginate Dressing Device Name:
Indications for Use:
Silverlon™ CA Advanced Antimicrobial Alginate Dressing is an effective barrier to microbial penetration for moderate to heavy exudating partial and fullthickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 200 degree burns. Silverlon™ CA Advanced Antimicrobial Dressing is indicated for external use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Huem
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K053590
263
N/A