K Number

Device Name

Extra Silver Gelling Fiber Dressing

Manufacturer

Winner Medical Co., Ltd.

Date Cleared

2022-12-21

(191 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

Prescription Use: Under the supervision of a healthcare professional. Extra 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: Extra Silver Gelling Fiber Dressing may be used for the management of: Minor Abrasions, Minor Lacerations, Minor cuts, Minor scalds and burns.

Device Description

Extra Silver Gelling Fiber Dressing is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose (CMC) fibers, strengthening fibers 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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K210466

Reference Devices

K121275

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

Yes
The device is intended for the management of chronic and acute wounds, including burns, ulcers, and surgical wounds, and is described as supporting the body's healing process and reducing bacterial colonization, which are therapeutic functions.

Diagnostic

Explanation: The device is a wound dressing designed for therapeutic purposes (managing wounds, absorbing exudate, maintaining a moist environment, and reducing bacterial colonization) rather than for identifying or analyzing medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical dressing composed of fibers and silver, which is a hardware component.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use clearly states the device is for the management of various types of wounds. This is a topical application for wound care, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The description details a wound dressing that absorbs fluid and creates a gel. This is a physical barrier and absorbent material, not a diagnostic reagent or instrument.
Performance Studies: The performance studies focus on the physical properties of the dressing (absorbency, tensile strength) and its antimicrobial activity within the dressing. These are relevant to wound care, not diagnostic testing.
Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, urine, tissue, etc.) or providing information for diagnosis.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

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

FRO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use: Under the supervision of a healthcare professional.

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 to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, ASTM F88/F88M-15, ASTM F1929-15, USP , AATCC 100-2012. Extra 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. Biocompatibility testing was conducted in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO - 10993: 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and test results meet the requirements. No clinical study is included in this submission.

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

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.

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.

K210466

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.

K121275

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

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

December 21, 2022

Winner Medical Co., Ltd. Mingni Liu Regulator Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, Guangdong 518109 China

Re: K221720

Trade/Device Name: Extra Silver Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 25, 2022 Received: November 25, 2022

Dear Mingni Liu:

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 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,

Julie A. Morabito -S

Julie Morabito, Ph.D. 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

Indications for Use

510(k) Number (if known) K221720

Device Name

Extra Silver Gelling Fiber Dressing

Indications for Use (Describe)

Prescription Use:

Under the supervision of a healthcare professional. Extra 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:

Extra 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)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

The assigned 510(k) Number: K221720

1. Date of Submission: December 14, 2022

2. Submitter Identification

Winner Medical Co., Ltd.

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

Contact Person: Mingni Liu

Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email: 2346@winnermedical.com

3. Identification of Proposed Device

Trade/Proprietary Name: Extra 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

Predicate Device: 510(k) Number: K210466 Product Name: Silver Gelling Fiber Dressing Manufacturer: Winner Medical Co., Ltd. Reference Device: 510(k) Number: K121275 Product Name: AQUACEL™ Ag EXTRATM Hydrofiber™ Dressing with Silver and Strengthening Fiber Manufacturer: ConvaTec Inc.

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:

Extra 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. Extra 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;

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

• Traumatic wounds

The indications for use are identical to the primary predicate device (K210466).

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications.

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

8. Clinical Test Conclusion

No clinical study is included in this submission.

9. Technological Characteristics Comparison

Extra Silver Gelling Fiber Dressing has the same intended use and indications for use as the predicate device but has an additional tensile strength performance than the predicate device. This is achieved by addition strengthening fibers. The differences in the composition and technology, as detailed below, is explained by the addition of strengthening fibers in the proposed device as compared to the predicate device. There are no differences in operation and directions for use between Extra Silver Gelling Fiber Dressing and the predicate device.

Table 1 Comparison of Intended use, Design and Technological Characteristics

Item	Proposed Device	Predicate Device (K210466)	Comparison
------	-----------------	----------------------------	------------

| Product

Code	FRO	FRO	Equivalent
Class	Unclassified	Unclassified	Equivalent
Indication
for Use	Over-the-Counter 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;
• Surgical wounds left to heal by
secondary intention such as
dehisced surgical incisions and
donor sites;
• Traumatic wounds	Over-the-Counter 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;
• Surgical wounds left to heal
by secondary intention such as
dehisced surgical incisions and
donor sites;
• Traumatic wounds	Equivalent
Principle
of
operation	The dressing absorbs wound fluid
and creates a soft, conformable gel,
which maintains a moist wound
environment to support the healing
process. Silver ionic present in the
fiber for reducing bacteria
colonization in the dressing.	The dressing absorbs wound
fluid and creates a soft,
conformable gel, which
maintains a moist wound
environment to support the
healing process. Silver ionic
present in the fiber for
reducing bacteria colonization
in the dressing.	Equivalent

| Material
componen
ts | Composed of sodium
carboxymethylcellulose,
strengthening fibers (polyester
thread) and ionic silver | Composed of sodium
carboxymethylcellulose and
ionic silver | Similar |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Technolog
y | Silver impregnated sodium
carboxymethylcellulose fibers
needling together and stitch
bonded with polyester thread to
non-woven pad or ribbon; | Silver impregnated sodium
carboxymethylcellulose
fibers needling together to
non-woven pad or ribbon | Similar |
| Characteri
stics | • Sterile
• Absorbs exudate (including
bacteria)
• Forms a soft conformable gel
• The silver in the dressing kills
bacteria held in the dressing
• May require a secondary dressing | • Sterile
• Absorbs exudate (including
bacteria)
• Forms a soft conformable
gel
• The silver in the dressing
kills bacteria held in the
dressing
• May require a secondary
dressing | Equivalent |
| Antibacter
ial
Duration | 7 days | 7 days | Equivalent |
| Single Use | Yes | Yes | Equivalent |
| Sterilizati
on | Gamma Radiation | Gamma Radiation | Equivalent |
| Biocompa
tibility | 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)) | Equivalent |

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

10. Non-Clinical Testing - Performance

Mechanical testing was conducted for this submission. Absorbency performance is equivalent to the predicate device; tensile strength performance is superior to the predicate device due to the addition strengthening fibers design modification.

Extra Silver Gelling Fiber Dressing in vitro testing has demonstrated > 4 logreduction 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.

11. Non-Clinical Testing – Biocompatibility

Biocompatibility testing was conducted for this submission in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO - 10993: 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and test results meet the requirements.

12. Conclusions

The proposed device and the predicate device underwent evaluation that demonstrates substantial equivalence in the intended use of each device, biocompatibility, safety, efficacy, environment of use, and the principles of operation. Therefore, the proposed device demonstrates substantial equivalence to the predicate device.