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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing). It describes a submission to the FDA seeking clearance based on substantial equivalence to a predicate device.

The document does not describe a study conducted to prove the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would. Instead, it focuses on non-clinical tests to demonstrate compliance with standards and substantial equivalence to a predicate device.

Therefore, many of the requested categories for the acceptance criteria and study that proves the device meets them cannot be answered from this document because they are not applicable to the type of submission described (a 510(k) for a dressing, not an AI/ML diagnostic device). Specifically, there is no mention of an algorithm, AI, human readers, ground truth establishment for a test set, or training set details.

However, I can extract information related to the acceptance criteria as described by standard compliance and the comparison to the predicate device.

Here's a breakdown of the information that can be extracted or deduced from the provided document, addressing the structure of your request where applicable, and indicating when information is not available:

1. A table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the format of a clinical performance target (e.g., sensitivity/specificity thresholds) or a statistical endpoint for a trial. Instead, the "performance" discussed is compliance with established standards and similar characteristics to a predicate device.

Acceptance Criteria Category/Standard	Reported Device Performance
Biocompatibility:
ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity)	Complies with ISO 10993-5 (Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity)
ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization)	Complies with ISO 10993-10 (Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization)
ISO 10993-6:2016 (Tests for local effects after implantation)	Complies with ISO 10993-6 (Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation)
ISO 10993-11:2006 (Tests For Systemic Toxicity)	Complies with ISO 10993-11 (Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity)
Sterilization Residuals:
ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals)	Complies with ISO 10993-7 (Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals)
Packaging Integrity:
ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials)	Complies with ASTM F88/F88M-15 (Standard Test Method for Seal Strength of Flexible Barrier Materials)
ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)	Complies with ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)
Bacterial Endotoxins:
USP <85> Bacterial Endotoxins Test	Complies with USP <85> Bacterial Endotoxins Test
Antimicrobial Activity (in vitro):	Achieved 4 log bacterial reduction in vitro against: Staphylococcus aureus, Escherichia coli, Candida albicans, Pseudomonas aeruginosa, Bacillus subtilis, Streptococcus pyogenes, Serratia marcescens, Aspergillus niger. Effective inhibition within dressing for 7 days.
In vitro bacterial reduction (e.g., 4 log reduction against specific organisms)
Sterility Assurance Level (SAL):	SAL of 10^-6
Sterility Assurance Level
Substantial Equivalence to Predicate Device (K160872):	Demonstrated Substantially Equivalent (SE) for: Product Code (FRO), Regulation Number (NA), Intended Use (similar wound types, antimicrobial activity), Single Use (Yes), Antimicrobial Agents (PHMB, Benzalkonium chloride/BZK), and Biocompatibility (ISO 10993).
Equivalence in Product Code, Regulatory Number, Intended Use, Single Use, Active Agents, Material, Sterilization method, Biocompatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided as there was no "test set" in the context of an algorithm or diagnostic performance study. The studies mentioned are non-clinical lab tests for material properties, sterilization, and biocompatibility. Details like sample sizes for these specific lab tests are generally found in the full test reports, which are not part of this summary document. Data provenance details are also not stated for these non-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. There was no "ground truth" to be established by experts for a diagnostic performance test, as this device is a wound dressing and not a diagnostic AI/ML tool.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. No adjudication method was used for a test set, as this is not a diagnostic device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. No MRMC study was performed as this is a medical device clearance for a wound dressing, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. There is no algorithm associated with this wound dressing device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided. There was no "ground truth" established in the context of diagnostic performance. The "truth" for this device's performance comes from compliance with recognized standards (e.g., ISO, ASTM, USP) and laboratory assays for antimicrobial activity.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for this device, as it is not an AI/ML algorithm.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no "training set" for this device, as it is not an AI/ML algorithm.

Summary

{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)

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
1. 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

1. 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

1. 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

న్. Identification of Predicate Device
Predicate Device 510(k) Number: K160872 Product Name: PolyPlex Wound Dressing
1. 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
1. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 8.

Item	Proposed DeviceK181315	Predicate DeviceK160872
Product Code	FRO	Same
RegulationNumber	NA	Same
Intended Use	The Antimicrobial gauze spongedressing / Antimicrobial super spongedressing / Antimicrobial non-wovensponge dressing are intended to use asprimary or secondary dressings forexuding wounds, surgical incisions,lacerations, abrasions, first and seconddegree burns, wound packing, donorsites, catheter sites, I.V. sites and centrallines. Also may be used for securementof primary dressing. The antimicrobialactivity of the PHMB andbenzalkonium chloride in dressinghelps resist bacterial colonizationwithin the dressing.	Under the management of a healthcareprofessional, Poly Plex Wound Dressingis intended for the management of firstand second degree bums, venous stasisulcers, diabetic ulcers, partial and fullthickness wounds, donor sites, postsurgical incisions, trauma wounds, andabrasions. It can be used during wounddressing changes to soften encrustedwound 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, ISO10993-10, ISO 10993-6 and ISO10993-11.	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.

Regulation Number and Section

N/A