← Product Code FRO · K141603 # Ultra Silver Dressings (K141603) _Milliken Healthcare Products, LLC · FRO · Oct 22, 2014 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K141603 ## Device Facts - **Applicant:** Milliken Healthcare Products, LLC - **Product Code:** FRO - **Decision Date:** Oct 22, 2014 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). ## Device Story ULTRA Silver Dressing is a sterile, single-use wound care dressing for moist wound management. Device consists of 4 layers: occlusive synthetic top layer, polyurethane foam layer, hot-melt adhesive, and silver-containing knitted composite fabric (silver sodium hydrogen zirconium phosphate). Applied by clinicians to manage various acute and chronic wounds. Silver component provides antimicrobial properties. Dressing manages wound moisture and conforms to wound site. Benefits include protection and antimicrobial environment for healing. No clinical testing conducted; substantial equivalence based on non-clinical performance testing. ## Clinical Evidence No clinical testing was conducted to support this submission. ## Technological Characteristics 4-layer sterile dressing: occlusive synthetic top layer, polyurethane foam, hot-melt adhesive, and silver-coated polyester/nylon/lycra knitted composite fabric. Antimicrobial agent: silver sodium hydrogen zirconium phosphate. Thickness >= 4.0 mm. Sterilization: Gamma irradiation (25 kGy). Packaging: Tyvek/Film medical pouch. ## Predicate Devices - AFM Ultra Ag Dressings ([K093188](/device/K093188.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. 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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 22, 2014 Milliken Healthcare Products, LLC % Dr. Gordon Macfarlane Aptiv Solutions Incorporated 62 Forest Street, Suite 300 Marlborough, Massachusetts 01752 Re: K141603 Trade/Device Name: ULTRA Silver Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 3, 2014 Received: October 6, 2014 Dear Dr. Macfarlane: 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K141603 Device Name ULTRA Silver Dressing Indications for Use (Describe) The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). 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) ### 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) 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}------------------------------------------------ # ULTRA SILVER DRESSINGS ## 510(K) SUMMARY (per 21CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm) #### SPONSOR/MANUFACTURER 1. Milliken Healthcare Products, LLC 920 Milliken Road, M-207 Spartanburg, SC 29303 | Contact Person: | Brian J. Lindsay | |-----------------|------------------| | Telephone: | 864-503-1323 | Date Prepared: 26 August 2014 Consultant/Contact: Aptiv Solutions 62 Forest Street, Suite 300 Marlborough, MA 01752 Primary Contact: Gordon MacFarlane, PhD, RAC Telephone: 919-873-8962 #### 2. DEVICE NAME | Trade Name | ULTRA Silver Dressings | |---------------------|-------------------------------------------| | Common Name | Wound Dressing | | Classification Name | Dressing, Wound, Drug (Product Code: FRO) | #### 3. PREDICATE DEVICE AFM Ultra Ag Dressings (K093188) #### 4. DEVICE DESCRIPTION The ULTRA Silver Dressings are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 4 layers, each performing a specific function; an occlusive synthetic top layer, a polyurethane foam layer, a hot-melt adhesive and a layer of a silver-containing knitted composite fabric. {4}------------------------------------------------ #### 5. INDICATIONS FOR USE The ULTRA Silver Dressings are indicated for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). ### SUMMARY OF TECHNICAL CHARACTERISTICS COMPARED TO THE PREDICATE 6. DEVICE The subject of this Special 510(k) is a modification of the AFM Ultra Ag Dressings that was previously cleared on February 17, 2010 under Premarket Notification Number K093188. There are no changes to the fundamental design and technology characteristics. The only change proposed is a modification of the materials in the non-patient contacting layers of the dressing. This modification includes the absorbent foam material, the high MVTR film layer and the hot-melt adhesive that binds the wound contact layer to the foam layer. No modification is being made to the patient contacting component or to the silver component. ### 7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE Validation activities to support the use of the ULTRA Silver Dressings consisted of four main elements: - Biocompatibility Testing ● - Validation of Antimicrobial Effectiveness - Sterility Validation ● - . Fluid Management Performance Testing of the ULTRA Silver Dressings has demonstrated that the wound dressing fulfills prospectively defined performance criteria and that the modification system meets user needs. #### SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE 8. No clinical testing was conducted to support this submission. #### SUMMARY OF OTHER INFORMATION 9. No other information is available. {5}------------------------------------------------ #### 10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed ULTRA Silver Dressings and the predicate AFM Ultra Ag Dressings lead to a conclusion of substantial equivalence between the proposed and predicate device. A side-by-side comparison of the predicate device and the proposed device is provided in the table below. | Product Characteristics | ULTRA Silver Dressings | AFM Ultra Ag Dressings (K093188) | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Management of Partial- to Full Thickness Acute and Chronic Wounds | Same | | Fabric Layer (Wound Contact) | Silver coated polyester/nylon/lycra | Same | | Indications | The ULTRA Silver Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). | The AFM Ultra Ag Dressings are indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic). | | Antimicrobial Components | Silver sodium hydrogen zirconium phosphate | Same | | Moisture Management Properties | Yes | Yes | | Conformable | Yes | Yes | | Multiple Day Use? | Yes | Yes | | Thickness | $\ge 4.0 mm$ | $\ge 5.5 mm$ | | Porous Fabric Layer | Yes | Yes | | Biocompatible | Yes | Yes | | Contra-Indications | Known allergy to silver | Same | | Packaging | Tyvek/Film Medical Pouch | Same | | Sterilization | Gamma Irradiation (25 kGy) | Same | # Comparison of ULTRA Silver Dressings to Predicate AFM Ultra AG Dressings --- **Source:** [https://fda.innolitics.com/device/K141603](https://fda.innolitics.com/device/K141603) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com