PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border

K192463 · Winner Medical Co., Ltd. · FRO · May 14, 2020 · SU

Device Facts

• Record ID: K192463
• Device Name: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border
• Applicant: Winner Medical Co., Ltd.
• Product Code: FRO · SU
• Decision Date: May 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The proposed devices are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

Device Story

Sterile, single-use antimicrobial wound dressings; polyurethane foam containing 0.5% (w/w) Polyhexamethylene Biguanide (PHMB) to resist bacterial colonization; microporous hydrophilic structure absorbs exudate; maintains moist healing environment. Four variants: non-adhesive, adhesive, silicone-contact, and silicone-contact with border. Silicone variants use perforated silicone gel for wound contact. Vapor-permeable, waterproof polyurethane film backing. Used in clinical settings for wound management. PHMB effective against bacterial colonization for up to 7 days. Benefits include exudate management and antimicrobial protection within the dressing.

Clinical Evidence

No clinical study included. Evidence based on bench testing: biocompatibility (ISO 10993-5, -7, -10, -11), seal strength (ASTM F88/F88M-15), package integrity (ASTM F1929-15), bacterial endotoxins (USP <85>), and antimicrobial effectiveness (modified AATCC 100) demonstrating 7-day efficacy.

Technological Characteristics

Materials: Polyurethane film, polyurethane foam with 0.5% PHMB, perforated silicone gel, super absorbent fiber, non-woven fabrics. Dimensions: Various. Connectivity: None. Sterilization: EtO (ISO 11135:2014) for silicone variants; irradiation (ISO 11137-2:2013) for non-silicone variants. Standards: ISO 10993 series, ASTM F88/F88M-15, ASTM F1929-15, USP <85>.

Indications for Use

Indicated for management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 1st and 2nd degree burns, dermatologic disorders, and trauma wounds; also for use as secondary or cover dressing for packed wounds.

Predicate Devices

• PHMB Foam Wound Dressing (K181197)

Submission Summary (Full Text)

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May 14, 2020

Winner Medical Co., Ltd. Dan Wang Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, 518109CN

## Re: K192463

Trade/Device Name: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border Regulatory Class: Unclassified Product Code: FRO Dated: April 10, 2020 Received: April 14, 2020

# Dear Dan Wang:

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

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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 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.

Anjana Jain, 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) K192463

#### Device Name

PHMB Foam Dressing Non-Adhesive; PHMB Foam Dressing Adhesive; Silicone PHMB Foam Dressing; Silicone PHMB Foam Dressing with Border.

#### Indications for Use (Describe)

The proposed devices are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

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

| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
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| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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### K192463 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: K192463

- 1. Date of Submission: 09/04/2019
#### 2. Submitter Identification

#### Winner Medical_Co., Ltd.

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

Contact Person: Dan Wang

Position: Regulatory Affairs Specialist

Tel: [phone] Fax: [phone] Email:[e-mail]

### 3. Identification of Proposed Device

Trade/Proprietary Name: PHMB Foam Dressing Non-Adhesive PHMB Foam Dressing Adhesive Silicone PHMB Foam Dressing Silicone PHMB Foam Dressing with Border Common name: Antimicrobial 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

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510(k) Number: K181197

Product Name: PHMB Foam Wound Dressing

### 5. Device Description

The subject devices are sterile, single-use dressings, the polyurethane foam contain about 0.5% (w/w) Polyhexamethylene Biguanide (PHMB), an agent that is intended to resist bacterial colonization within the dressing. The foam in the dressings has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.

Based on in vitro performance data, the PHMB Foam Wound Dressings have demonstrated to be effective against colonization and proliferation of bacteria within the dressing for up to 7 days.

The proposed device in this submission consists of four variants:

The basic one, PHMB Foam Dressing Non-adhesive, consist of a film backing laminated of acrylic adhesive (Vapor permeable and waterproof polyurethane film); a soft, absorbing polyurethane (PU) antimicrobial foam contain PHMB adhered to the top film with acrylic adhesive. The film backing has the same size with the polyurethane foam layer. The product line is available in different sizes.

A second adhesive variant, PHMB Foam Dressing Adhesive, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A thin non-woven and absorbent polyurethane antibacterial foam pad containing PHMB adhered to the top film, and the top film remained with a border); a release liner (covered on the foam pad and top film border part). The product line is available in different sizes.

A third adhesive variant, Silicone PHMB Foam Dressing, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing PHMB adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel. The product line is available in different sizes.

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A forth adhesive variant, Silicone PHMB Foam Dressing with Border, consists of a top layer (Vapor permeable and waterproof polyurethane film); a center layer (A supper absorbent fiber pad, a thin non-woven and absorbent polyurethane antibacterial foam pad containing PHMB adhered to the top film, and the top film remained with a border); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner (covered on the silicone gel).

Silicone PHMB Foam Dressing and Silicone PHMB Foam Dressing with Border are sterilized by EtO using conditions validated following ISO 11135: 2014.

PHMB Foam Dressing Non-adhesive and PHMB Foam Dressing Adhesive are sterilized by irradiation using conditions validated following ISO 11137-2: 2013.

#### 6. Intended Use Statement

The proposed devices are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions , lacerations , 1st and 2nd degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

#### 7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specification s 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 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization.

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- ISO 10993-11:2017 Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity.
- A.STM 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. Substantially Equivalent (SE) Comparison

The proposed devices are compared with the following Predicate Device in terms of intended use, mechanism, material, specifications, and performance.

K181197, PHMB Foam Wound Dressing, Manufactured by Advanced Medical Solutions Ltd.

The following table shows similarities and differences of use, design, material, and processing between the subject device and the predicate device.

These data came from commercially product labeling and 510(k) summary.

| Item | Proposed Devices | Predicate Device<br>(K181197) | Substantial<br>Equivalence |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Product Code | FRO | FRO | SE |
| Class | Unclassified | Unclassified | SE |
| Intended Use | The proposed devices are<br>indicated for use in the<br>management of post-surgical<br>incisions, pressure sores,<br>venous stasis ulcers, diabetic<br>ulcers, donor sites, abrasions ,<br>lacerations, 1st and 2nd degree<br>burns, dermatologic disorders,<br>other wounds inflicted by<br>trauma and, as a secondary | PHMB Foam Wound<br>Dressings are indicated for use<br>in the management of post-<br>surgical incisions, pressure<br>sores, venous stasis ulcers,<br>diabetic ulcers, donor sites,<br>abrasions, lacerations, 1st and<br>2nd degree burns,<br>dermatologic disorders, other<br>wounds inflicted by trauma | SE |
| | cover dressing for | and, as a secondary dressing or | |
| | packed wounds. | cover dressing for packed wounds. | |
| Mechanism | Polyurethane foam and super absorbent fiber pad for absorbing liquid;<br>PHMB present in the foam for reducing bacteria<br>colonization in the dressing;<br>Silicone soft contact layer for self-adhesive;<br>Backing film for vapor permeable and waterproof. | Polyurethane foamfor absorbing liquid;<br>PHMB present in the foam for reducing bacteria colonization in the dressing;<br>Clear polyurethane wound contact layer with acrylic adhesive for self-adhesive;<br>Backing film for vaporpermeable and waterproof. | SE |
| Material | Polyurethane film, polyurethane foam contain PHMB, release liner, some with super absorbent fiber, non - woven fabrics or | Polyurethane film, Polyurethane foam containing PHMB,<br>Clear polyurethane with acrylic adhesive | No new questions of safety or effectiveness raised. |
| Antimicrobial<br>Effectiveness | Reduction of Staphylococcus aureus, Escherlchia coli, Candida albicans, Pseudomona aeruginosa, MRSA, VRE, Klebsiella | Reduction of MRSA, MRSE, VRE, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumonia, Candida albicans, Rhodotorula mucilaginosa > 4 log | SE |
| Antibacterial<br>Duration | 7days | 7days | SE |
| Single Use | Yes | Yes | SE |
| Sterilization | PHMB Foam Dressing Non- Adhesive,<br>PHMB Foam Dressing Adhesive sterilized by irradiation;<br>Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border | Irradiation | |
| Biocompatibility | Biocompatibility in accordance to 10993-1(breached or compromised surfaces with prolonged | Biocompatibility in accordance to 10993-1(breached or compromised surfaces with | |
| | | prolonged contact(>24h to<br>30d)) | |

Table 1 Comparison of intended use and Technological Characteristics

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The proposed device has the same intended use, and similar technological characteristics to the predicate device. In order to address the questions raised from differences in technological characteristics, biocompatibility tests according to 10993-1 and antimicrobial effectiveness s tests according to modified AATCC 100 were conducted. These are no new questions of the safety and efficacy raised.

#### 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.