OTC Use: Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns. Prescription Use: Under the supervision of a healthcare professional. Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow: Partial thickness (second degree) burns; Pressure ulcers (partial and full thickness); Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Diabetic foot ulcers; Surgical wounds that heal by primary intent such as dermatological and surgical incisions; Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites: Traumatic wounds.

Device Description

Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). A moist wound environment supports the body's healing process. The silver antimicrobial may help reduce bacterial colonization within the dressing for up to 7 days. The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.

AI/ML Overview

This document describes the Silver Gelling Fiber Dressing's acceptance criteria and how it was proven to meet them.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance metrics in a numerical sense; rather, it focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests and a comparison of characteristics. The performance is largely demonstrated by meeting established standards and showing comparable properties to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Complied with ISO 10993-5:2009 (Tests For In Vitro Cytotoxicity), ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization), ISO 10993-11:2017 (Tests For Systemic Toxicity), and ISO 10993-1 (breached or compromised surfaces with prolonged contact (>24h to 30d)). No biologically relevant differences in local tolerance after wound creation were observed in a porcine study compared to the predicate device.
Sterility & Packaging Integrity	Sterilized by gamma radiation using conditions validated following ISO 11137-2:2013. Complied with ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials), ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration), and USP <85> (Bacterial Endotoxins Test).
Antibacterial Activity	Demonstrated ≥ 4 log-reduction of four gram-positive bacteria (Vancomycin-resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus, Methicillin-resistant Staphylococcus aureus (MRSA)) and four gram-negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days, as assessed by AATCC 100-2012 (Antibacterial Finishes on Textile Materials: Assessment of). Also matches the predicate device’s stated antibacterial duration of 7 days.
Wound Healing Performance (In vivo)	A porcine wound healing study demonstrated no biologically relevant differences between the Silver Gelling Fiber Dressing and the predicate device (AQUACEL® Ag Hydrofiber Dressing) in terms of wound healing performance characteristics.
Functional Characteristics (Absorbency, Gel Formation, Moist Environment)	"The dressing absorbs wound fluid and creates a soft, conformable gel, which maintains a moist wound environment to support the healing process." (Matches predicate device's described function).
Material Composition	Composed of sodium carboxymethylcellulose and 1.2% ionic silver, matching the predicate device.
Intended Use (OTC & Prescription)	The indications for use are substantially equivalent to the predicate device, with some minor wording variations for specific wound types.
Principle of Operation	The dressing absorbs wound fluid and creates a soft, conformable gel, maintaining a moist wound environment, with silver ions reducing bacterial colonization within the dressing. (Matches predicate).

2. Sample Size Used for the Test Set and Data Provenance:

Biocompatibility Tests (ISO 10993 series): The document does not specify exact sample sizes for these in vitro and in vivo (systemic toxicity) tests. The standards themselves typically outline sample size requirements. Provenance is not explicitly stated but these are laboratory tests following international standards.
Sterility & Packaging Integrity Tests (ASTM, USP): No specific sample sizes are mentioned, but these are standard laboratory tests. Provenance not specified.
Antibacterial Activity (AATCC 100-2012): No specific sample size is mentioned in terms of the number of dressings tested, but it describes testing against "four gram-positive bacteria" and "four gram-negative bacteria." Provenance not specified but these are in vitro laboratory tests.
Porcine Wound Healing Study: The document refers to "the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing)." It does not specify the number of porcine subjects used. This is an animal study, not human data. The provenance of the animals or the location of the study is not specified. All studies appear to be retrospective in the context of the 510(k) submission, meaning they were completed prior to the submission.

There is no test set of human subjects/patients for clinical performance evaluation mentioned in this submission. The "test set" for performance evaluation is primarily in vitro and animal models.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The study is for a medical dressing and focuses on non-clinical performance and substantial equivalence to a predicate device. There is no expert-established ground truth in the context of diagnostic or interpretive accuracy, as would be relevant for an AI/CADe device. The "ground truth" for the non-clinical tests is established by the methods outlined in international and national standards (e.g., cell viability in cytotoxicity tests, bacterial counts in antimicrobial tests).

4. Adjudication Method for the Test Set:

Not applicable, as there is no human-interpreted test set requiring adjudication in this context. The non-clinical tests directly measure physical, chemical, or biological properties against established standards or compare them to a control/predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not an AI/CADe device, and no MRMC study was conducted or is relevant for this type of medical dressing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an AI/algorithm-based device. The "device" is a physical wound dressing. The tests performed are "standalone" in the sense that they assess the intrinsic properties and performance of the dressing itself without human intervention in its function.

7. The Type of Ground Truth Used:

Biocompatibility: Established by standardized methods measuring cellular response (cytotoxicity, irritation, sensitization) and systemic effects. For the porcine study, the ground truth was the wound healing characteristics observed in the animal model.
Sterility & Packaging Integrity: Established by adherence to validated sterilization methodologies and standardized tests for seal strength and integrity, and bacterial endotoxins.
Antibacterial Activity: Established by measuring the log-reduction of specific challenge organisms according to the AATCC 100-2012 standard.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

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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.

January 14, 2022

Winner Medical Co., Ltd. Haoyuan He Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, Guangdong 51809 China

Re: K210466

Trade/Device Name: Silver Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 17, 2021 Received: September 27, 2021

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Julie Morabito, 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

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Indications for Use

510(k) Number (if known)

Device Name Silver Gelling Fiber Dressing

Indications for Use (Describe)

Prescription Use:

Under the supervision of a healthcare professional. Silver Gelling Fiber Dressing may be used for the management of moderate to heavily exuding chronic and acute wounds as follow:

· Partial thickness (second degree) burns;
· Pressure ulcers (partial and full thickness);
· Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
· Diabetic foot ulcers;
· Surgical wounds that heal by primary intent such as dermatological and surgical incisions;
· Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites:
· Traumatic wounds

OTC Use:

Silver Gelling Fiber Dressing may be used for the management of:

· Minor Abrasions
· Minor Lacerations
Minor cuts
Minor scalds and burns

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: K210466
1. Date of Submission: February 9, 2021

2. Submitter Identification

Winner Medical Co., Ltd.

Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China

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 Gelling Fiber Dressing Common name: Wound or Burn 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: K080383 Product Name: AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING Manufacturer: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C

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5. Device Description

The dressings are supplied sterile in a range of sizes, ranging in area from 25cm2 to 600cm². All dressings have the exactly the same material, chemical, and physical properties and are different only in size.

All dressings are sterilized and sold after sterilization by gamma radiation using conditions validated following ISO 11137-2:2013.

6. Indications for use

OTC Use:

Silver Gelling Fiber Dressing may be used for the management of:

Minor Abrasions
Minor Lacerations
Minor cuts
Minor scalds and burns

Prescription Use:

Under the supervision of a healthcare professional. Silver Gelling Fiber Dressing may be used for the management of wounds as follow:

· Partial thickness (second degree) burns;
Pressure ulcers (partial and full thickness);
· Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Diabetic foot ulcers;
Surgical wounds that heal by primary intent such as dermatological and surgical incisions;

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· Surgical wounds left to heal by secondary intention such as dehisced surgical incisions and donor sites;

• Traumatic wounds

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.

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

AATCC 100-2012 Antibacterial Finishes on Textile Materials: Assessment of

Silver Gelling Fiber Dressing in vitro testing has demonstrated ≥ ≥ 4 log-reduction of four gram positive bacteria (Vancomycin- resistant enterococcus (VRE), Bacillus subtilis, Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus (MRSA)), four gram negative bacteria (Serratia marcescens, Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumonia) challenge organisms within the dressing for up to 7 days.

A porcine wound healing study was carried out to evaluate the silver cytotoxicity of subject device. The study demonstrated that there were no biologically relevant differences between the test subjects (Silver Gelling Fiber Dressing, and a Control AQUACEL® Ag Hydrofiber Dressing) in terms of wound healing performance characteristics and local tolerance after wound creation.

8. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

Silver Gelling Fiber Dressing is compared with the following Predicate Device in terms of intended use, principle of operation, material, technology, characteristics and performance. K080383, AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing Manufactured by ConvaTec.

The following table shows comparison between proposed device and predicate devices. These data came from commercially product labeling and 510(k) summary.

Item	Proposed Device	Predicate Device(K080383)
Product Code	FRO	FRO
Class	Unclassified	Unclassified
Indication forUse	Over-the-Counter Use:	Over-the-Counter Use:
	Silver Gelling Fiber Dressing may beused for the management of:	AQUACEL® Hydrofiber® WoundDressing may be used for:
	• Minor abrasions	• Abrasions
	• Minor lacerations	• Lacerations
	• Minor cuts	• Minor cuts
	• Minor scalds and burns	• Minor scalds and burns
	Prescription Use:	Prescription Use:
	Under the supervision of a healthcareprofessional:	Under the supervision of a healthcareprofessional:
	Silver Gelling Fiber Dressing may beused for the management of woundsas follows:	AQUACEL® Ag Hydrofiber Dressingmay be used for the management of:
	• Partial thickness (second degree)burns;	• Wounds as an effective barrier tobacterial penetration of the dressing asthis may help reduce infection;
	• Pressure ulcers (partial and fullthickness);	• Partial thickness (second degree)burns;
	• Leg ulcers (venous stasis ulcers,arterial ulcers and leg ulcers of mixedetiology);	• Diabetic foot ulcers, leg ulcers(venous stasis ulcers, arterial ulcersand leg ulcers of mixed etiology) andpressure ulcers/sores (partial & fullthickness);
	• Diabetic foot ulcers;
	• Surgical wounds that heal byprimary intent such as dermatologicaland surgical incisions;	• Surgical wounds left to heal bysecondary intention such as dehiscedsurgical incisions;

							Table 1 Comparison of Intended use, Design and Technological Characteristics

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	• Surgical wounds left to heal bysecondary intention such as dehiscedsurgical incisions and donor sites;• Traumatic wounds	• Surgical wounds that heal byprimary intent such as dermatologicaland surgical incisions (e.g., orthopedicand vascular);• Traumatic wounds;• Wounds that are prone to bleedingsuch as wounds that have beenmechanically or surgically debridedand donor sites;• Oncology wounds with exudate suchas fungoides-cutaneous tumors,fungating carcinoma, cutaneousmetastasis, Kaposi's sarcoma andangiosarcoma;• Management of painful wounds;• Infected Wounds;
Principle of	The dressing absorbs wound fluid	The dressing absorbs wound fluid and
operation	and creates a soft, conformable gel,	creates a soft, conformable gel, which
	which maintains a moist wound	maintains a moist wound environment
	environment to support the healing	to support the healing process. Silver
	process. Silver ionic present in the	ionic present in the fiber for reducing
	fiber for reducing bacteria	bacteria colonization in the dressing.
	colonization in the dressing.
Material	Composed of sodium	Composed of sodium
components	carboxymethylcellulose and 1.2%	carboxymethylcellulose
	ionic silver	(Hydrofiber™) and 1.2% ionic silver
	Silver impregnated sodium	Silver impregnated sodium
	carboxymethylcellulose fibers	carboxymethylcellulose fibers
Technology	needled together to non-woven pad	needled together to non-woven pad
	or ribbon	or ribbon
Characteristics	• Sterile	• Sterile
	• Absorbs exudate (including	• Absorbs exudate (including bacteria)
	bacteria)
	• Forms a soft conformable gel	• Forms a soft conformable gel
	• The silver in the dressing kills	• The silver in the dressing kills
	bacteria held in the dressing	bacteria held in the dressing
	• May require a secondary dressing	• May require a secondary dressing

Antibacterial	7 days	7 days
Duration
Single Use	Yes	Yes
Sterilization	Radiation	Radiation

Biocompatibility	Biocompatibility in accordance to10993-1(breached or compromisedsurfaces with prolonged contact(>24hto 30d))	Biocompatibility in accordance to10993-1(breached or compromisedsurfaces with prolonged contact(>24hto 30d))

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The proposed device has same intended use, materials of construction, principle of operation, technology and characteristics to the predicate device.

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