Who is the manufacturer of PHMB Wound Dressing?

Winner Medical Co., Ltd. filed the 510(k) submission for PHMB Wound Dressing (K221532).

What is the FDA product code for PHMB Wound Dressing?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for PHMB Wound Dressing?

510(k) clearance (submission type: Traditional).

What are the predicate devices for PHMB Wound Dressing?

PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (K192463); Poly FIT™+ Absorbing Antimicrobial Dressings (OTC), Poly FIT™+ High Absorbing Antimicrobial Dressings (OTC) (K121522).

Who can help prepare an FDA 510(k) submission like PHMB Wound Dressing?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PHMB Wound Dressing

K221532 · Winner Medical Co., Ltd. · FRO · Jan 30, 2023 · SU

Device Facts

Record ID	K221532
Device Name	PHMB Wound Dressing
Applicant	Winner Medical Co., Ltd.
Product Code	FRO · SU
Decision Date	Jan 30, 2023
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Prescription Use: PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. OTC Use: For Over-the-Counter Use, PHMB Wound Dressing is used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.

Device Story

Sterile wound dressing; absorbs wound exudates; contains 0.2% PHMB to resist bacterial colonization within dressing for up to 7 days. Two configurations: Island Wound Dressing (polyester viscose non-woven backing, acrylic adhesive, absorbent pad, PET film) and Pad Wound Dressing (absorbent pad, PET film). Used in clinical or home settings; applied by healthcare professionals or patients. Acts as physical barrier and antimicrobial agent; reduces bacterial colonization; supports wound healing. No active electronic components or software.

Clinical Evidence

No clinical data. Bench testing only. Antimicrobial effectiveness demonstrated via modified AATCC 100 method showing ≥4 log-reduction of eight challenge organisms (VRE, B. subtilis, S. aureus, MRSA, S. marcescens, P. aeruginosa, E. coli, K. pneumonia) for up to 7 days.

Technological Characteristics

Materials: Polyester viscose non-woven, acrylic adhesive, 100% cotton absorbent pad, PET film. Principle: Absorbent pad with 0.2% (w/w) PHMB. Form factor: Island and Pad configurations. Sterilization: Ethylene Oxide (ISO 11135:2014). Standards: ISO 10993-5, -6, -7, -10, -11; 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, first/superficial second degree burns, dermatologic disorders, trauma wounds, and as secondary/cover dressing for packed wounds. OTC use indicated for minor abrasions, lacerations, cuts, scalds, and burns.

Predicate Devices

PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border (K192463)
Poly FIT™+ Absorbing Antimicrobial Dressings (OTC), Poly FIT™+ High Absorbing Antimicrobial Dressings (OTC) (K121522)

Related Devices

K191819 — Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border · Winner Medical Co., Ltd. · May 14, 2020
K133775 — EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING · Exciton Technologies, Inc. · Mar 26, 2014
K201016 — LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) · Huizhou Foryou Medical Devices Co., Ltd. · Jan 28, 2021
K192463 — PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border · Winner Medical Co., Ltd. · May 14, 2020
K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing · Winner Medical Co., Ltd. · Jan 13, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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 is in blue and includes the agency's name, "U.S. Food & Drug Administration." January 30, 2023 Winner Medical Co., Ltd. Yi Fu Regulatory Affairs Specialist 660 Bulong Road, Longhua District Shenzhen, China Re: K221532 Trade/Device Name: PHMB Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 14, 2023 Received: January 17, 2023 Dear Yi Fu: 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 {1}------------------------------------------------ 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 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221532 Device Name PHMB Wound Dressing # Indications for Use (Describe) Prescription Use: PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stass ulcers, diabetic ulcers, donor sites, abrasions, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. #### OTC Use: For Over-the-Counter Use, PHMB Wound Dressing is used for minor lacerations, minor lacerations, minor cuts, minor scalds, and minor 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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: __K221532 - 1. Date of Submission: January 26th, 2023 # 2. Submitter Identification ### Winner Medical Co., Ltd. Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China Contact Person: Yi Fu Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email: 3911 @winnermedical.com ### 3. Identification of Proposed Device Trade/Proprietary Name: PHMB Wound Dressing Common name: Antibacterial Wound 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: K192463 Product Name: PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive Silicone PHMB Foam Dressing Silicone PHMB Foam Dressing with Border Manufacturer: Winner Medical Co., Ltd. {4}------------------------------------------------ Secondary Predicate Device: K121522 Product Name: Poly FIT™+ Absorbing Antimicrobial Dressings (OTC) Poly FITTM+ High Absorbing Antimicrobial Dressings (OTC) Manufacturer: PolyRemedy, Inc. #### 5. Device Description The proposed device PHMB Wound Dressing is a sterile wound dressing. It is used as a primary or secondary dressing to absorb wound exudates. Based on in vitro testing, the antibacterial agent PHMB in dressing helps to resist bacterial colonization within the dressing for up to 7 days. The proposed device is available in two configurations, The first one, PHMB Island Wound Dressing with acrylic adhesive, consists of a polyester viscose non-woven backing layer coated with acrylic adhesive as the top layer, a center soft absorbent pad which is made of non-woven fabric containing 0.2 % PHMB and it is laminated with the PET film, and a release liner covers on the top adhesive layer border part. The second one, PHMB Pad Wound Dressing, only consists of a soft absorbent pad containing 0.2 % PHMB and the non-woven absorbent pad is laminated with the PET film. The PHMB Island Wound Dressings with acrylic adhesive are supplied in a range of sizes within the range from 25 cm² to 400 cm², while for PHMB Pad Wound Dressings are supplied in a range of sizes within the range from 25 cm². For each configuration, it has exactly the same materials, chemicals, and physical properties and are different only in size. All variants of proposed device, PHMB Wound Dressing, are sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014. #### 6. Intended Use Statement Prescription Use: PHMB Wound Dressings are indicated for use in the management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, first and superficial second degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. {5}------------------------------------------------ # OTC Use: For Over-the-Counter Use, PHMB Wound Dressing is used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns. #### 7. Non-Clinical Test Conclusion Non-clinical tests were conducted to verify that the proposed device met all design specifications and 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 10993-6:2016 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after implantation. - 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. - 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-NF:2021 <85> Bacterial Endotoxins Test PHMB Wound 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. This testing was performed using a modified AATCC 100 method. {6}------------------------------------------------ ## 8. Clinical Test Conclusion No clinical study is included in this submission. #### 9. Substantially Equivalent (SE) Comparison The subject devices are compared with the following Predicate Devices in terms of intended use, mechanism, material, specifications, and performance. These data came from commercially product labeling and 510(k) summary. Note: There are four available configurations in PHMB Foam Dressing (K192463). For SE comparison, the configuration-PHMB Foam Dressing Adhesive is mainly used in SE comparison, particularly in material components, technology, principle of operation, sizes and performance characteristics. This configuration, PHMB Foam Dressing Adhesive, of the primary predicate device is chosen because the dressing structure of proposed device (PHMB Island Wound Dressing) is most similar to PHMB Foam Dressing Adhesive configuration. PHMB Pad Wound Dressing is exactly the same as the absorbent pad contained in the PHMB Island Wound Dressing with acrylic adhesive. | Item | Subject Device K221532 | Primary Predicate Device K192463 | Secondary Predicate Device K121522 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FRO | FRO | FRO | | Class | Unclassified | Unclassified | Unclassified | | Intended Use | Prescription Use: PHMB Wound Dressings are indicated for use in the management of post- surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, first and superficial second degree burns, | Prescription Use: PHMB Foam Dressing 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 | Prescription Use: Under the supervision of a healthcare professional, PolyFITTM + Absorbing Antimicrobial Dressings and PolyFITTM + High Absorbing Antimicrobial Dressings may be used for the management of:PolyFITTM + Absorbing Antimicrobial Dressings are intended as | | | dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. Over-the-Counter Use: For Over-the-Counter Use, PHMB Wound Dressing is used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns. | inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds. | effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFITTM + Absorbing Antimicrobial Dressings are for use as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone, for 3rd degree burns or for dry wounds. Over-the-Counter Use: For Over-the-Counter Use, PolyFITTM+ Absorbing Antimicrobial Dressings and PolyFITTM+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns. | | Material components | Polyester viscose non- woven fabrics layer with acrylic adhesive; | For PHMB Foam Dressing Adhesive, the dressing contains: Polyurethane top layer | Fibers containing polyethylene oxide (PEO), polyethylene-co- vinly-alcohol (EVOH), | | | | | | | | 100% cotton absorbent pad; PHMB; PET film; Release liner. | with acrylic adhesive; Thin non-woven fabrics layer; Polyurethane foam absorbent pad; PHMB; Release liner. | polycaprolactone (PCL) and PHMB. | | Technology | Absorbent pad is made of cotton which is impregnated with 0.2% (w/w) PHMB | Absorbent pad is made of a thin non-woven and polyurethane foam impregnated with 0.5% (w/w) PHMB | Dressing is made of gelling fibers which is embedded with 0.3% PHMB | | Characteristics | • Absorbent pad laminated with PET film absorbs exudates • PHMB resists bacterial colonization within the dressing • Island model has adhesive border for self-adhesive | • Absorbent foam pad absorbs exudates • PHMB resists bacterial colonization within the dressing • Island model has adhesive border for self-adhesive | • Fibers absorbs exudates • PHMB inhibits microbial proliferation within the dressing and reduce microbial penetration through the dressing. | | Principle of operation | Absorbent pad for absorbing liquid; PHMB presents in the center absorbent pad to resist bacterial colonization within the dressing; | Polyurethane foam pad for absorbing liquid; PHMB presents in the center absorbent foam pad to resist bacterial colonization within the dressing; | Fiber for absorbing liquid; PHMB embedded in the fibers ensures that when bacteria come in contact with PHMB molecule the outer cell wall of the bacteria is disrupted. | | Model | Island Model and Pad Model | Island Model and Pad Model | NA | | Antibacterial Effectiveness | ≥4 Log reduction | ≥4 Log reduction | Not publicly available | | Antibacterial Duration | 7 days | 7 days | Not publicly available | | Single use | Yes | Yes | Yes | | Sterilization | EtO Sterilization | PHMB Foam Dressing Adhesive sterilized by Gamma irradiation | Not publicly available | | Bio- compatibility | Biocompatibility in accordance to 10993-1 | Biocompatibility in accordance to 10993-1 | Biocompatibility in accordance to 10993-1 | Table 1. Comparison of Intended use, Design and Technological Characteristics {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the subject devices are determined to be Substantially Equivalent (SE) to the predicate devices.