Silver Gelling Fiber Dressing

K210466 · Winner Medical Co., Ltd. · FRO · Jan 14, 2022 · SU

Device Facts

• Record ID: K210466
• Device Name: Silver Gelling Fiber Dressing
• Applicant: Winner Medical Co., Ltd.
• Product Code: FRO · SU
• Decision Date: Jan 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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

Device Story

Silver Gelling Fiber Dressing; non-woven pad or ribbon composed of sodium carboxymethylcellulose and 1.2% ionic silver. Absorbs wound exudate; transforms into soft, conformable gel; maintains moist wound environment; facilitates autolytic debridement. Ionic silver provides antimicrobial effect within dressing for up to 7 days. Used in clinical or home settings; applied by healthcare professionals or patients. Output is physical wound coverage and exudate management; aids healing process by reducing bacterial colonization. Sterile, single-use device.

Clinical Evidence

No clinical study included. Bench testing only: biocompatibility (ISO 10993-5, -10, -11), seal strength (ASTM F88/F88M-15), package integrity (ASTM F1929-15), and antimicrobial efficacy (AATCC 100-2012) demonstrating ≥ 4 log-reduction of gram-positive and gram-negative bacteria. Porcine wound healing study confirmed no biologically relevant differences in healing or local tolerance compared to predicate.

Technological Characteristics

Non-woven pad/ribbon of sodium carboxymethylcellulose and 1.2% ionic silver. Needled fiber construction. Sterile (gamma radiation per ISO 11137-2:2013). Single-use. Biocompatible per ISO 10993-1. Dimensions 25cm² to 600cm².

Indications for Use

Indicated for management of moderate to heavily exuding chronic and acute wounds (burns, pressure/leg/diabetic ulcers, surgical/traumatic wounds) under professional supervision, and minor abrasions, lacerations, cuts, and scalds/burns for OTC use.

Predicate Devices

• AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] Email: [e-mail]

#### 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

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.

### 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 for<br>Use | Over-the-Counter Use: | Over-the-Counter Use: |
| | Silver Gelling Fiber Dressing may be<br>used for the management of: | AQUACEL® Hydrofiber® Wound<br>Dressing 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 healthcare<br>professional: | Under the supervision of a healthcare<br>professional: |
| | Silver Gelling Fiber Dressing may be<br>used for the management of wounds<br>as follows: | AQUACEL® Ag Hydrofiber Dressing<br>may be used for the management of: |
| | • Partial thickness (second degree)<br>burns; | • Wounds as an effective barrier to<br>bacterial penetration of the dressing as<br>this may help reduce infection; |
| | • Pressure ulcers (partial and full<br>thickness); | • Partial thickness (second degree)<br>burns; |
| | • Leg ulcers (venous stasis ulcers,<br>arterial ulcers and leg ulcers of mixed<br>etiology); | • Diabetic foot ulcers, leg ulcers<br>(venous stasis ulcers, arterial ulcers<br>and leg ulcers of mixed etiology) and<br>pressure ulcers/sores (partial & full<br>thickness); |
| | • Diabetic foot ulcers; | |
| | • Surgical wounds that heal by<br>primary intent such as dermatological<br>and surgical incisions; | • Surgical wounds left to heal by<br>secondary intention such as dehisced<br>surgical incisions; |

| | | | | | | | Table 1 Comparison of Intended use, Design and Technological Characteristics |
|--|--|--|--|--|--|--|------------------------------------------------------------------------------|
| | | | | | | | |

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| | • Surgical wounds left to heal by<br>secondary intention such as dehisced<br>surgical incisions and donor sites;<br>• Traumatic wounds | • Surgical wounds that heal by<br>primary intent such as dermatological<br>and surgical incisions (e.g., orthopedic<br>and vascular);<br>• Traumatic wounds;<br>• Wounds that are prone to bleeding<br>such as wounds that have been<br>mechanically or surgically debrided<br>and donor sites;<br>• Oncology wounds with exudate such<br>as fungoides-cutaneous tumors,<br>fungating carcinoma, cutaneous<br>metastasis, Kaposi's sarcoma and<br>angiosarcoma;<br>• Management of painful wounds;<br>• 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 to<br>10993-1(breached or compromised<br>surfaces with prolonged contact(>24h<br>to 30d)) | Biocompatibility in accordance to<br>10993-1(breached or compromised<br>surfaces with prolonged contact(>24h<br>to 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.