Silver Alginate Dressing (Prescription use) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

OTC:

Antibacterial Alginate Wound Dressing (OTC use) is first aid to help in minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns.

Device Description

It is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent. The dressing absorbs wound exudate and release silver ions within the dressing in the presence of wound fluid to help reduce bacteria within the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The alginate material contains silver which inhibits bacteria growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Staphylococcus aureus, Bacillus subtilis, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus (VRE), Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae for up to seven days.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Silver Alginate Dressing / Antibacterial Alginate Wound Dressing." This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria, as no such clinical study was submitted or detailed in this document.

However, I can extract information related to non-clinical testing and comparison to a predicate device, which are the bases for this 510(k) clearance.

Here's an analysis of the provided text, focusing on the available information:

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

Since no clinical study with acceptance criteria for clinical performance is presented, I will summarize the non-clinical tests and the comparison to the predicate device as presented in the document.

Non-Clinical Test/Characteristic	Acceptance Criteria (Implied by compliance with standard)	Reported Device Performance (K202982)	Comparison to Predicate (K172554)
Biocompatibility	Complies with ISO 10993-5, -6, -10, -11	Complies with ISO 10993-5, -6, -10, -11	Same
Seal Strength	Complies with ASTM F88/F88M-15	Complies with ASTM F88/F88M-15	Not explicitly compared
Seal Leaks	Complies with ASTM F1929-15	Complies with ASTM F1929-15	Not explicitly compared
Bacterial Endotoxins	Complies with USP <85>	Complies with USP <85>	Not explicitly compared
Antibacterial Duration	N/A (in vitro shown up to 7 days)	7 days (in vitro protected against bacteria)	Same (7 days)
Free Swell Absorption Capacity	N/A (value compared to predicate)	14.2 g/g	Similar (Predicate: 13.8 g/g)
Sterilization	N/A (SAL: 10^-6)	Gamma irradiation, SAL: 10^-6	Same (Radiation, SAL: 10^-6)
Intended Use	N/A (comparison to predicate)	As stated for Rx and OTC applications	Same
Mechanism	N/A (comparison to predicate)	Alginate for absorption, silver for bacteria reduction	Same
Material	N/A (comparison to predicate)	Alginate and silver	Same
Single Use	N/A (comparison to predicate)	Yes	Yes

Explanation: For a 510(k) submission, "acceptance criteria" for non-clinical tests are generally met by demonstrating compliance with recognized standards. The document states that "The test results demonstrated that the proposed device complies with the following standards," which implies that meeting these standards served as the acceptance criteria for those specific tests. For comparative characteristics, "acceptance" is based on demonstrating substantial equivalence to the predicate device, meaning the differences do not raise new questions of safety or effectiveness.

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

The document does not provide details on sample sizes for the non-clinical tests (e.g., number of dressings tested for absorption capacity, or specific biological evaluation tests). It also does not specify the country of origin of the data or whether it was retrospective or prospective. The non-clinical tests are typically laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as no clinical study or expert-adjudicated test set is described. The "ground truth" for non-clinical tests is established by adhering to the methodology and results specified in the referenced international and national standards (e.g., ISO, ASTM, USP).

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

This information is not applicable as no clinical study or expert-adjudicated test set is described.

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. The device is a wound dressing, not an AI-powered diagnostic or interpretive tool. No MRMC study was conducted or is relevant here.

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

This information is not applicable. The device is a wound dressing, not an algorithm.

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

For the non-clinical tests, the "ground truth" is determined by the specific testing methodologies and measurable outcomes defined by international and national standards (e.g., ISO for biocompatibility, ASTM for packaging integrity, USP for endotoxins). For the antibacterial efficacy, it's based on in vitro laboratory testing demonstrating inhibition of bacterial growth within the dressing.

8. The sample size for the training set:

This information is not applicable as no AI/machine learning component or training set is mentioned for this device.

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

This information is not applicable as no AI/machine learning component or training set is mentioned for this device.

Summary

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October 19, 2021

Winner Medical Co., Ltd. Haoyuan He Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, Guangdong 518109 China

Re: K202982

Trade/Device Name: Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) Regulatory Class: Unclassified Product Code: FRO Dated: December 14, 2020 Received: December 21, 2020

Dear Haoyuan He:

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

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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 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,

Lixin Liu, PhD 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202982

Device Name

Silver Alginate Dressing (Prescription use), Antibacterial Alginate Wound Dressing (OTC use)

Indications for Use (Describe)

Prescription:

OTC:

Antibacterial Alginate Wound Dressing (OTC use) is first aid to help in minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns.

Type of Use (Select one or both, as applicable)
For Fire Control/Life Safety Use	For Non-Fire Control/Life Safety Use

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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: K202982

1. Date of Submission: September 25, 2020

2. Submitter 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: Haoyuan He

Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email: hyhe@winnermedical.com

3. Identification of Proposed Device

Trade/Proprietary Name: Silver Alginate Dressing (Prescription use) Antibacterial Alginate Wound Dressing (OTC use) Common name: Silver Alginate Wound Dressing

Regulatory Information

Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery;

4. Identification of Predicate Device

Predicate Device: 510(k) Number: K172554

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Product Name: LUOFUCON® Extra Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Wound Dressing (OTC Use) Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.

5. Device Description

6. Intended Use Statement

Prescription:

Silver Alginate Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

OTC:

Antibacterial Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

7. Non-Clinical Test Conclusion

Non clinical tests were conducted. The test results demonstrated that the proposed device complies with the following standards:

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ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-6:2016 Biological Evaluation of Medical Devices- Part 6: Tests for local effects after implantation.
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. Comparison of Technological Characteristics With The Predicate Device

Silver Alginate Dressing (Rx only)/ Antibacterial Alginate Wound Dressing (OTC) is compared with the following Predicate Device in terms of intended use, mechanism, material, and performance.

K172554. LUOFUCON® Extra Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Wound Dressing (OTC Use), Manufactured by Huizhou Foryou Medical Devices Co., Ltd.

The following table shows similarities and differences of intended use, mechanism, material, and performance between proposed device and its predicate devices. These data came from commercially product labeling and 510(k) summary.

Item	Subject Device (K202982)	Predicate Device (K172554)	Comparison
Product Code	FRO	FRO	NA
Class	Unclassified	Unclassified	NA

Intended Use	Prescription:Silver Alginate Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.OTC:Antibacterial Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.	Prescription:LUOFUCON® Extra Silver Alginate Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, and graft and donor sites.OTC:LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.	Same
Mechanism	Alginate for absorbing liquid, silver present in the alginate for reducing bacteria in the dressing.	Alginate for absorbing liquid, silver present in the alginate for reducing bacteria colonization in the dressing.	Same
Material	Alginate and silver	Alginate and silver	Same
Antibacterial Duration	7 days	7 days	Same
Single Use	Yes	Yes	Same
Sterilization	Gamma irradiationSAL:10-6	RadiationSAL:10-6	Same
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))	Same
Free Swell Absorption Capacity	14.2g/g	13.8g/g	Similar

Table 1 Comparison of Intended use, Design and Technological Characteristics

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The proposed device is compared to the predicate device with respect to intended use, mechanism, material, antibacterial capacity, single use, biocompatibility, free swell absorption capacity. According to the comparison information, most of the characteristics of proposed device are the same as the predicate, one is different, but none of them will raise different questions of safety or effectiveness.

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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.

Regulation Number and Section

N/A