K Number
K202982
Device Name
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
Date Cleared
2021-10-19

(384 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Prescription: 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.
More Information

Not Found

No
The device description and performance studies focus on the material properties and antibacterial efficacy of the dressing, with no mention of AI or ML.

No
The device is a wound dressing that absorbs exudate and helps maintain a moist environment for healing while inhibiting bacterial growth. It is not designed to treat a disease or condition in a therapeutic manner beyond supporting the natural healing process.

No

This device is a wound dressing designed for healing, not for diagnosing medical conditions. It absorbs wound exudate and releases silver ions to reduce bacteria, which are therapeutic actions, not diagnostic ones.

No

The device description clearly states it is a sterile, single-use dressing composed of physical materials (calcium alginate and silver antibacterial agent), indicating it is a hardware-based medical device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is a wound dressing for managing various types of wounds. This is a topical application for direct interaction with the wound surface.
  • Device Description: The description details the composition and mechanism of action of the dressing, which involves absorbing exudate and releasing silver ions within the dressing to reduce bacteria within the dressing. This is a local effect on the wound environment, not a diagnostic test performed on a sample taken from the body.
  • Lack of Diagnostic Activity: There is no mention of the device being used to analyze a sample (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
  • Performance Studies: The performance studies listed are related to biocompatibility, seal strength, and bacterial endotoxins, which are typical for wound dressings and medical devices that come into contact with the body, not for diagnostic tests.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

Prescription:
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.

Product codes (comma separated list FDA assigned to the subject device)

FRO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wounds (postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites, minor abrasions, minor lacerations, minor scrapes, minor scalds and minor burns)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical tests were conducted. 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.
  • 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 Bacterial Endotoxins Test
    No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K172554

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

N/A

0

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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

1

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:

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.

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

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.

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:

5

  • 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 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.

ItemSubject Device (K202982)Predicate Device (K172554)Comparison
Product CodeFROFRONA
ClassUnclassifiedUnclassifiedNA
Intended UsePrescription:
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
MechanismAlginate 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
MaterialAlginate and silverAlginate and silverSame
Antibacterial Duration7 days7 daysSame
Single UseYesYesSame
SterilizationGamma irradiation
SAL:10-6Radiation
SAL:10-6Same
BiocompatibilityBiocompatibility 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 Capacity14.2g/g13.8g/gSimilar

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.