← Product Code FRO · K181315 # Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing (K181315) _Winner Medical Co., Ltd. · FRO · Feb 14, 2019 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K181315 ## Device Facts - **Applicant:** Winner Medical Co., Ltd. - **Product Code:** FRO - **Decision Date:** Feb 14, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use It is intended for use as primary or secondary dressings for exuding wounds, surgical incisions, lacerations, abrasions, first and second degree burns, wound packing, donor sites, catheter sites, I.V. sites and central lines. Also may be used for securement of primary dressing. The antimicrobial activity of the PHMB and benzalkonium chloride in dressing helps resist bacterial colonization within the dressing. ## Device Story Antimicrobial sponge dressings (gauze, super sponge, non-woven) impregnated with PHMB and benzalkonium chloride; designed to resist bacterial colonization within dressing for up to 7 days; used as primary or secondary dressing for exuding wounds, surgical incisions, burns, and catheter sites; applied by healthcare professionals; provides broad-spectrum antimicrobial effect against Gram-positive/negative bacteria and fungi; reduces bacterial load in dressing; benefits patient by inhibiting bacterial growth at wound site. ## Clinical Evidence No clinical data. Bench testing only, including in vitro antimicrobial efficacy (4 log reduction) and biocompatibility testing per ISO 10993 standards. ## Technological Characteristics Materials: Gauze, fluff gauze, or non-woven fabric impregnated with PHMB and benzalkonium chloride. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 10993-5, -6, -7, -10, -11; ASTM F88/F88M-15; ASTM F1929-15; USP <85>. ## Predicate Devices - PolyPlex Wound Dressing ([K160872](/device/K160872.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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 14, 2019 Winner Medical Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China Re: K181315 Trade/Device Name: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 4, 2019 Received: January 7, 2019 Dear Diana Hong: 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/cfpmn/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 {1}------------------------------------------------ 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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Lixin Liu-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) K181315 #### Device Name Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing. ## Indications for Use (Describe) It is intended for use as primary or secondary dressings for exuding wounds,surgical incisions, abrasions, first and second degree burns, wound packing, donor sites, catheter sites, I. V. sites and central lines. Also may be used for securement of primary dressing. The antimicrobial activity of the PHMB and benzalkonium chloride in dressing helps resist bacterial colonization within the dressing. | 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}------------------------------------------------ ## Tab#7 510(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: K181315 - 1. Date of Preparation: 04/08/2018 - 2. Sponsor Identification ## Winner Medical Co., Ltd Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China Establishment Registration Number: 9616433 Contact Person: Dan Wang Position: Engineer Tel: +86-755 28138888 Fax:+86-755 28134588 Email:wangdan@winnermedical.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net - 4. Identification of Proposed Device Trade Name: Antimicrobial gauze sponge dressing Antimicrobial super sponge dressing Antimicrobial non-woven sponge dressing {4}------------------------------------------------ ## Regulatory Information Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery; Indications for Use Statement: It is intended for use as primary or secondary dressings for exuding wounds, surgical incisions, lacerations, abrasions, first and second degree burns, wound packing, donor sites, catheter sites, I.V. sites and central lines. Also may be used for securement of primary dressing. The antimicrobial activity of the PHMB and benzalkonium chloride in dressing helps resist bacterial colonization within the dressing. ### Device Description The proposed devices are available in three configurations, which are Antimicrobial gauze sponge dressing. Antimicrobial super sponge dressing and Antimicrobial non-woven sponge dressing. All of them consist of (1) a dressing (base material) and (2) anti-microbial agent. For each configuration, it is available in several models, which are different in size and quantity of anti-microbial agent. The product can achieve board spectrum antimicrobial effect within the dressing for Gram-Bacteria and Fungi. It has been shown to have 4 log bacterial reduction in vitro against includes: Staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomona aeruginosa and Bacillus subtilis, Streptococcus pyogenes, Serratia marcescens, Aspergillus niger. The effective inhibition of bacteria within the dressing is 7 days. - న్. Identification of Predicate Device Predicate Device 510(k) Number: K160872 Product Name: PolyPlex Wound Dressing - 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as 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. {5}------------------------------------------------ - > 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. - > SO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation - > ISO 10993-11:2006 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 - A USP <85> Bacterial Endotoxins Test - 7. Clinical Test Conclusion No clinical study is included in this submission. - Substantially Equivalent (SE) Comparison 8. | Item | Proposed Device
K181315 | Predicate Device
K160872 | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FRO | Same | | Regulation
Number | NA | Same | | Intended Use | The Antimicrobial gauze sponge
dressing / Antimicrobial super sponge
dressing / Antimicrobial non-woven
sponge dressing are intended to use as
primary or secondary dressings for
exuding wounds, surgical incisions,
lacerations, abrasions, first and second
degree burns, wound packing, donor
sites, catheter sites, I.V. sites and central
lines. Also may be used for securement
of primary dressing. The antimicrobial
activity of the PHMB and
benzalkonium chloride in dressing
helps resist bacterial colonization
within the dressing. | Under the management of a healthcare
professional, Poly Plex Wound Dressing
is intended for the management of first
and second degree bums, venous stasis
ulcers, diabetic ulcers, partial and full
thickness wounds, donor sites, post
surgical incisions, trauma wounds, and
abrasions. It can be used during wound
dressing changes to soften encrusted
wound dressings . | | Single Use | Yes | Yes | ## Table 1 Comparison of Technology Characteristics {6}------------------------------------------------ | Antimicrobial | Polyhexamethylene Biguanide HCl
(PHMB)
Benzalkonium chloride (BKC) | Same | |------------------|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Sterilization | EO Sterilization | Unknown | | SAL | 10-6 | Unknown | | Material | Gauze rolls / Fluff gauze rolls /
Non-woven rolls,
Polyhexamethylene Biguanide HCl
(PHMB)
Benzalkonium chloride (BKC) | petrolatum-based emulsion,
Polyhexamethylene Biguanide (PHMB)
Benzalkonium Chloride (BZK) | | Biocompatibility | Comply with ISO 10993-5, ISO
10993-10, ISO 10993-6 and ISO
10993-11. | Comply with ISO 10993 | #### Substantially Equivalent (SE) Conclusion 9. Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices. --- **Source:** [https://fda.innolitics.com/device/K181315](https://fda.innolitics.com/device/K181315) **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