Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border

Q: Who is the manufacturer of Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

Winner Medical Co., Ltd. filed the 510(k) submission for Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border (K191819).

Q: What is the FDA product code for Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

FRO. as a Class U device in the SU panel.

Q: What is the regulatory pathway for Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

Biatain Silicone Ag Foam Dressings (K120828); Biatain Ag Foam Dressing (K100218).

Q: Who can help prepare an FDA 510(k) submission like Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K191819 · Winner Medical Co., Ltd. · FRO · May 14, 2020 · SU

Device Facts

Record ID	K191819
Device Name	Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
Applicant	Winner Medical Co., Ltd.
Product Code	FRO · SU
Decision Date	May 14, 2020
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns.

Device Story

Sterile, single-use antimicrobial wound dressing; contains silver compounds (0.25-0.35mg/cm2) within polyurethane foam layer. Absorbs wound exudate; releases silver ions in presence of wound fluid to reduce bacterial colonization within dressing; maintains moist wound environment. Four configurations: non-adhesive, adhesive, silicone-contact, and silicone-border. Applied by clinicians or patients to wound site; provides barrier protection via vapor-permeable, waterproof polyurethane film backing. Benefits include exudate management, bacterial reduction, and atraumatic removal. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only. In vitro testing demonstrated antibacterial effectiveness for up to 7 days. Biocompatibility testing performed per ISO 10993-5, -7, -10, -11. Packaging integrity verified via ASTM F88/F88M-15 and ASTM F1929-15.

Technological Characteristics

Materials: Polyurethane film, silver-containing polyurethane foam, super absorbent fiber, non-woven fabrics, silicone gel, acrylic adhesive. Energy: None. Connectivity: None. Sterilization: EtO (ISO 11135-1:2014) or Irradiation (ISO 11137-2:2013). Form factor: Pad/dressing in various sizes.

Indications for Use

Indicated for management of moderately to highly exuding wounds including leg/foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, and 1st/2nd degree burns.

Predicate Devices

Biatain Silicone Ag Foam Dressings (K120828)
Biatain Ag Foam Dressing (K100218)

Related Devices

K223359 — LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing · Huizhou Foryou Medical Devices Co., Ltd. · Dec 21, 2023
K221754 — Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) · Winner Medical Co., Ltd. · Jan 17, 2023
K140954 — LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING · Huizhou Foryou Medical Devices Co., Ltd. · Mar 23, 2015
K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) · Huizhou Foryou Medical Devices Co., Ltd. · Nov 13, 2024
K160022 — LUOFUCON Silicone Ag foam dressing · Huizhou Foryou Medical Devices Co., Ltd. · Aug 17, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. May 14, 2020 Winner Medical Co., Ltd. Dan Wang, Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen City, Guangdong Province, 518109, China # Re: K191819 Trade/Device Name: Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border Regulatory Class: Unclassified Product Code: FRO Dated: June 27, 2019 Received: July 5, 2019 # Dear Dan Wang: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191819 #### Device Name Ag Foam Dressing Non-Adhesive; Ag Foam Dressing Adhesive; Silicone Ag Foam Dressing; Silicone Ag Foam Dressing with Border. #### Indications for Use (Describe) The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns. 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}------------------------------------------------ ## 510(k) Summary - This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K191819 - 1. Date Prepared: 05/14/2020 ## 2. Submitter Identification ## Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China Contact Person: Dan Wang Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email:wangdan@winnermedical.com ## 3. Identification of Proposed Device Trade/Proprietary Name: Ag Foam Dressing Non-Adhesive Ag Foam Dressing Adhesive Silicone Ag Foam Dressing Silicone Ag Foam Dressing with Border Common name: Antimicrobial dressing ## Regulatory Information Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery; ## 4. Identification of Predicate Device Primary Predicate Device: 510(k) Number: K120828 {4}------------------------------------------------ Product Name: Biatain Silicone Ag Foam Dressings Secondary Predicate Device: 510(k) Number: K100218 Product Name: Biatain Ag Foam Dressing #### 5. Device Description It is a sterile, single-use dressing, the foam layer contain about 0.25-0.35mg/cm2 silver. The dressing absorbs wound exudate and releases silver ions within the dressing in the presence of wound fluid to help reduce bacterial colonization of the dressing. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The proposed devices are available in four configurations: The basic configuration, Ag Foam Dressing Non-adhesive, consist of a top layer (Vapor permeable and waterproof polyurethane film); a soft, absorbing polyurethane (PU) antimicrobial foam contain silver compounds adhered to the top film with acrylic adhesive. The film backing has the same area as the polyurethane foam layer. The is available in different sizes. A second adhesive configuration, Ag Foam Dressing Adhesive, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A thin non-woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a release liner (covered on the foam pad and top film border part). The product line is available in different sizes. A third adhesive configuration, Silicone Ag Foam Dressing, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated laminate of acrylic adhesive/polyurethane film/silicone gel, where the acrylic adhesive adheres to the top film, and the silicone gel is for skin adherence); a release liner covers on the silicone gel. The product line is available in different sizes. {5}------------------------------------------------ A forth adhesive configuration, Silicone Ag Foam dressing with Border, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A supper absorbent fiber pad, a thin non-woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a wound contact layer (Perforated silicone gel adhered to the center layer and top film); a release liner (covered on the silicone gel). The dressing has light yellow or light brown appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro. Silicone Ag Foam Dressing and Silicone Ag Foam Dressing with Border are sterilized and sold directly to users after sterilized by EtO using conditions validated following ISO 11135-1: 2014. Ag Foam Dressing Non-adhesive and Ag Foam Dressing Adhesive are sterilized and sold directly to users after sterilized by irradiation using conditions validated following ISO 11137-2: 2013. ## 6. Intended Use Statement The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns. #### 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity. {6}------------------------------------------------ - ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals. - ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization. - ISO 10993-11:2017 Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity. - ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials. - ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration USP <85> Bacterial Endotoxins Test ## 8. Clinical Test Conclusion No clinical study is included in this submission. ## 9. Substantially Equivalent (SE) Comparison Silver Foam Dressing is compared with the following Predicate Device in terms of intended use, mechanism, material, and performance. K120828, Biatain Silicone Ag Foam Dressings, Manufactured by Coloplast A/S. K100218, Biatain Ag Foam Dressings, Manufactured by Coloplast A/S. The following table shows similarities and differences of use, design, material, and processing methods between propoesd device and two predicate devices. These data came from commercially product labeling and 510(k) summary. | Item | Proposed Device | Primary Predicate Device (K120828) | Secondary Predicate Device (K100218) | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FRO | FRO | FRO | | Class | Unclassified | Unclassified | Unclassified | | | | | | | Intended Use | The proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, traumatic and surgical wounds, donor sites, 1st and 2nd degree burns. | Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree bumns, donor sites, post operative wounds and skin abrasions. | Biatain Ag Foam Adhesive & Non-Adhesive Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions. Biatain Ag Foam Non-Adhesive Dressings are additionally indicated for diabetic foot ulcers. | | Mechanism | Polyurethane foam and super absorbent fiber pad for absorbing liquid; Silver compounds present in the foam for reducing bacteria colonization in the dressing; Silicone soft contact layer for self-adhesive; Backing film for waterproof. | Same | Same | | Material | Polyurethane film , polyurethane foam containing silver, super absorbent fiber, non- woven fabrics, Silicone, Release liner | Polyurethane film , Polyurethane foam containing silver, Silicone contact layer, Release liner | Polyurethane foam containing silver, Polyurethane film Release liner | | Antibacterial Duration | 7 days | 7 days | 7 days | | Single Use | Yes | Yes | Yes | | Sterilization | Ag Foam Dressing Non-Adhesive & Ag Foam Dressing Adhesive sterilization | Sterilization by: EtO SAL: 10-6 | Sterilization by: Irradiation SAL: 10-6 | | | Silicone Ag Foam Dressing & Silicone Ag Foam Dressing with Border sterilization byEtO. SAL: 10-6 | | | | Biocompatibility | Biocompatibility in accordance to 10993- 1(breached or compromised surfaces with prolonged contact(>24h to 30d)) | Biocompatibility in accordance to 10993- 1(breached or compromised surfaces with prolonged contact(>24h to 30d)) | Biocompatibility in accordance to 10993- 1(breached or compromised surfaces with prolonged contact(>24h to 30d)) | Table 1 Comparison of intended use and Technological Characteristics {7}------------------------------------------------ {8}------------------------------------------------ The proposed device has same intended use, and similar technological characteristics to the predicate device. In order to address the questions raised from differences in technological characteristics, biocompatibility tests according to 10993-1 were conducted. These are no new questions of the safety and efficacy raised. ## 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.