SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV

{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 featuring three stylized human profiles facing to the right, with flowing lines suggesting movement or connection. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 12, 2014 Argentum Medical, LLC Mr. C. Richard Foster Director of Quality and Regulatory Affairs 2571 Kaneville Court Geneva. Illinois 60134 Re: K141033 Trade/Device Name: Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 8, 2014 Received: August 11, 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 {1}------------------------------------------------ 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 (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 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) K141033 ### Device Name Silverlon® Fenestrated Wound Contact Dressings: - Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing Indications for Use (Describe) Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic}, partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for negative pressure wound therapy (NPWT), the NPWT system is indicated for patients who benefit from wound management therapy via the application of negative pressure wound of fluids and excess exudates, infectious material, and tissue debris which may promote wound healing. It provides a non-adherent, conformable, antimicrobial barrier and may help reduce infection when placed under reticulated foam, gauze, or other wound fillers. Silverlon® Fenestrated Wound Contact Dressings may be cut or overlapped to fit any wound size. 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." {3}------------------------------------------------ # Al Appendix-9: 510(k) Summary 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. To the right of the logo is the text "Argentum Medical" in a light gray sans-serif font. 2571 Kaneville Court Geneva, IL 60134 PH: (630) 232.2507 TF: (888) 551-0188 #### 5. 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 #### 5.3. Date prepared 09/08/2014 #### 5.4. Device trade name(s) Silverlon® Fenestrated Wound Contact Dressing Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing #### 5.5. Common name Negative pressure antimicrobial wound contact layer dressing Image /page/3/Picture/18 description: The image contains the logo for SILVERLON. The logo is in a silver rounded rectangle. Below the logo, the words "safe, strong, simple" are written in a smaller font. {4}------------------------------------------------ #### 5.6. Classification name Powered suction pump (accessory) #### Substantially Equivalent Devices (Predicates): 5.7. K050261; V.A.C. GranuFoam Silver Protection Dressing K041642; V.A.C. GranuFoam™ Silver Dressing K080275; Kalypto Medical's NPD 1000 (Wound Dressing Set ) K981299; Silverlon Contact Wound Dressing (1 and 4 Layer) K122817; SILVERLON ISLAND WOUND DRESSING #### 5.8. Description of Device Silverlon® Fenestrated Wound Contact Dressings-Models Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are sterile, porous, non-adherent, knitted with 99% elemental silver and 1% silver oxide. The dressings may promote wound healing via assisting the removal of fluids, including body fluids, wound exudates and infectious materials. The Silverlon® Fenestrated Wound Contact Dressing 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® Fenestrated Wound Contact Dressings are used as the primary wound contact layer for NPWT dressing sets and is placed under reticulated foam, gauze, or other wound fillers. Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing are non-adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to seven (7) days. Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing is a non- adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to three (3) days. Image /page/4/Picture/10 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. {5}------------------------------------------------ #### 5.9. Technological Characteristics Silverlon® Fenestrated Wound 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 (e.g. foam particles, etc.): - providing an antimicrobial effect in the dressing: . - permitting the passage of oxygen and fluids to the wound; and, ● - . permitting the removal under vacuum of wound exudate from the wound (negative pressure wound therapy). ### 5.9.1. How the device functions Silverlon® Fenestrated Wound Contact Dressing functions as an antimicrobial barrier preventing materials and microbes in the dressing set from entering the wound. Silverlon® Fenestrated Wound Contact Dressing 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 for bacterial penetration of the dressing which may help reduce infection. Bench testing using simulated wound exudate demonstrate the porous single layer structure of the dressing allows substantially the same amount of fluid removal when compared to NPWT dressing sets currently on the market. The metallic silver functions as an antimicrobial in the dressing. When the dressing is exposed to moisture in the form of water, water vapor, blood, saline, and other forms of liquids it releases silver ions that are responsible for the antimicrobial effect. Antimicrobial effectiveness in the dressing was addressed in separate in-vitro laboratory evaluations using licensed commercial reference laboratories. ### 5.10. Indications for Use Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Aq™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for negative pressure wound therapy (NPWT), the NPWT system is indicated for patients who benefit from wound management therapy via the application of negative pressure wound therapy for removal of fluids and Image /page/5/Picture/13 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. {6}------------------------------------------------ excess exudates, infectious material, and tissue debris which may promote wound healing. It provides a non-adherent, conformable, antimicrobial barrier and may help reduce infection when placed under reticulated foam, gauze, or other wound fillers. Silverlon® Fenestrated Wound Contact Dressings may be cut or overlapped to fit any wound size. # 5.11. Preclinical Clinical Studies Silverlon® Fenestrated Wound Contact Dressing has 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. # 5.12. Summary of Technological Characteristics of Device compared to Predicate Device There is NO technological difference between the subject device and the Silverlon Island dressing. The only technological difference between the V.A.C. GranuFoam dressing and the subject device is that the predicate has the silver-coated nylon adhered to a substrate, while the subject device is simply the silver-coated nylon without the substrate. The other predicate devices also have very similar technological characteristics. ### 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® Fenestrated Wound Contact Dressing. Bench testing using simulated wound exudate demonstrated that the porous single layer structure of the dressing allows substantially the same amount of fluid removal when compared to NPWT dressing sets currently on the market. 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 liquid it produces silver ions to minimize/reduce the growth of bacteria within the Image /page/6/Picture/13 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}------------------------------------------------ dressing. Antimicrobial effectiveness in the dressing was addressed in separate in-vitro laboratory evaluations using licensed commercial reference laboratories. #### 5.14 Summary of Clinical testing No clinical studies were conducted to support premarket notification.. # 5.15. Substantial Equivalence Based on the information presented above it is concluded that the Silverlon® Fenestrated Wound 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/7 description: The image shows the logo for Silverlon. The logo is in a silver rounded rectangle. The word "SILVERLON" is in white letters inside the rectangle. Below the rectangle, the words "safe, strong, simple" are written in a smaller font.