← Product Code FRO · K231564 # Skin and Wound Cleanser (K231564) _Winner Medical Co., Ltd. · FRO · Nov 10, 2023 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K231564 ## Device Facts - **Applicant:** Winner Medical Co., Ltd. - **Product Code:** FRO - **Decision Date:** Nov 10, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Prescription Use: Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, venous ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. Over-The-Counter: Skin and Wound Cleanser for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor abrasions, minor lacerations and minor burns. ## Device Story Clear, colorless aqueous solution containing purified water, PHMB, undecylenamidopropyl betaine, allantoin, and citric acid. Applied via spray or squeeze bottle to wounds; fluid movement mechanically removes foreign material, dirt, and debris. PHMB acts as an antimicrobial preservative to inhibit microbial growth (e.g., E. coli, P. aeruginosa, S. aureus, MRSA, VRE) within the solution during storage. Used in clinical settings under professional supervision or by patients for OTC management of minor wounds. Benefits include wound cleansing, debridement, and maintenance of a moist wound environment to support healing. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-5, -6, -10, -11) and antimicrobial effectiveness testing (USP <51>) against E. coli, P. aeruginosa, S. aureus, C. albicans, A. niger, MRSA, and VRE. ## Technological Characteristics Aqueous solution; non-sterile; pH-balanced with citric acid. Ingredients: purified water, PHMB, undecylenamidopropyl betaine, allantoin, citric acid. Density: 0.9–1.0 g/ml at 20°C. Application via spray or squeeze bottle. Biocompatible per ISO 10993 standards. ## Predicate Devices - NAWAlution Skin and Wound Cleanser ([K141660](/device/K141660.md)) ## Reference Devices - Prontosan Wound Irrigation Solution ([K161623](/device/K161623.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. November 10, 2023 Winner Medical Co., Ltd. Mingni Liu Regulatory Affairs Specialist Winner Industrial Park. No. 660 Bulong Road. Longhua District Shenzhen, Guangdong 518109 China Re: K231564 Trade/Device Name: Skin and Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: July 10, 2023 Received: October 10, 2023 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ equirements, the Quality System (QS) regulation (21 CFR Part Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Yu-chieh Chiu -S Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231564 Device Name Skin and Wound Cleanser # Indications for Use (Describe) Prescription Use: Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. #### OTC Use: Skin and Wound Cleanser for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, minor abrasions, minor lacerations 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}------------------------------------------------ ## Tab #6 510(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: K231564 1.Date of Submission:May 31, 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: 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: Skin and Wound Cleanser Common name: Wound wash Solution #### 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: K141660 Product Name: NAWAlution Skin and Wound Cleanser Manufacturer: NAWA Heilmittel GmbH {4}------------------------------------------------ Reference Device: 510(k) Number: K161623 Product Name: Prontosan Wound Irrigation Solution Manufacturer: B. Braun Medical Inc #### 5.Device Description The proposed devices, Skin and Wound Cleanser, is a clear, colorless solution that is intended for wound management including cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze).The solution of Skin and Wound Cleanser contains purified water, PHMB, undecylenamidopropyl betaine, and trace ingredients (allantoin, citric acid). During the application of product, fluid moving across the wound aids in the removal of foreign objects such as dirt and debris. Skin and Wound Cleanser solution contains PHMB, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus niger, Methicillinresistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterocccus faecalis (VRE) to maintain quality of the product during storage of the wound cleansing solution. ## 6. Intended Use Statement ## Prescription Use: Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, venous ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. ## Over-The-Counter: Skin and Wound Cleanser for over-the-counter use is intended for cleansing wounds and moistening absorbent wound dressings for the management of minor abrasions, minor lacerations and minor burns. {5}------------------------------------------------ ## 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 10993-6:2016 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after implantation. 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. USP <51> Antimicrobial Effectiveness Testing Preservative efficiency testing was conducted with the proposed device according to USP <51> category 2. The proposed device was tested against the following microorganism: Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, Aspergillus niger, Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococcus faecalis (VRE). The test results demonstrated the effectiveness of Skin and Wound Cleanser to inhibit the growth of microorganisms within the wound cleansing solution. ## 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 Devices in terms of intended use, principle of operation, material components, specifications, and performance. These data came from commercially product labeling and 510(k) summary. - Predicate Device, K141660, NAWAlution Skin and Wound Cleanser, Manufactured by NAWA Heilmittel GmbH. - Reference Device, K161623, Prontosan Wound Irrigation Solution, Manufactured by B. Braun Medical Inc. {6}------------------------------------------------ The following table shows comparison between the proposed device and predicate devices in terms of intended use, performance, material components, principle of operation and etc. Based on the comparison and analysis, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices. | Item | Proposed Device
K231564 | Predicate Device
K141660 | Reference Device
K161623 | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FRO | FRO | FRO | | Class | Unclassified | Unclassified | Unclassified | | Intended Use | Prescription Use:
Skin and Wound Cleanser
for prescription use is
intended for use under the
supervision of healthcare
professionals for cleansing,
moistening, debriding, and
removal of foreign material
including microorganisms
and debris from wounds,
including acute and chronic
dermal lesions, such as
Stage I-IV pressure ulcers,
venous ulcers, leg ulcers,
diabetic foot ulcers, post-
surgical wounds, first and
second degree burns,
grafted and donor sites. It
is also intended for
moistening absorbent | Prescription Use:
NAWAlution for
prescription use is intended
for use under the
supervision of healthcare
professionals for cleansing,
moistening, debriding, and
removal of foreign material
including microorganisms
and debris from wounds,
including acute and chronic
dermal lesions, such as
Stage I-IV pressure ulcers,
venous ulcers, leg ulcers,
diabetic foot ulcers, post-
surgical wounds, first and
second degree burns,
grafted and donor sites. It
is also intended for
moistening absorbent | Prescription Use:
Prontosan Wound
Irrigation Solution is
intended for cleaning
wounds and for
moistening and
lubricating absorbent
wound dressings for
ulcers, burns, post-
surgical wounds and
abrasions. | | | | Table 1 Comparison of Intended use, Design and Technological Characteristics | | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------| | | | | | | | | | | | | | | | | | wound dressings and
cleaning minor cuts, minor
burns, superficial abrasions
and minor irritations of the
skin.

Over-The-Counter Use:
Skin and Wound Cleanser
for over-the-counter use is
intended for cleansing
wounds and moistening
absorbent wound dressings
for the management of
minor cuts, minor
abrasions, minor
lacerations and minor
burns. | wound dressings and
cleaning minor cuts, minor
burns, superficial abrasions
and minor irritations of the
skin.

Over-The-Counter Use:
NAWAlution for over-the-
counter use is intended for
cleansing wounds and
moistening absorbent
wound dressings for the
management of minor cuts,
abrasions, lacerations and
minor burns. | | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | | Appearance | Clear, colorless solution | Clear, colorless solution | Clear, colorless solution | | Application
method | Spray bottle;
Squeeze bottle | Spray bottle (50 mL (1.8
fluid oz.) – OTC);
Spray bottle (8 fluid oz.
(237 mL) or 16 fluid oz.
(473 mL) - Rx) | Tube applicator;
Spray bottle | | Characteristics | Aqueous | Aqueous | Aqueous | | Density
(at 20°C) | 0.9 – 1.0 g/ml | 0.9 – 1.0 g/ml | 0.9 – 1.0 g/ml | | Materials | Purified water, PHMB,
Undecylenamidopropyl | Purified water,
Cocamidopropylbetaine,
Zinc Chloride, PHMB, | Purified water, PHMB,
Undecylenamidopropyl
Betaine | | | Betaine, Trace ingredients
(allantoin, citric acid) | Hydrochloric acid, Trace
Element | | | Sterility | Non-sterile | Non-sterile | Sterile | {7}------------------------------------------------ {8}------------------------------------------------ ## 10.Conclusion Skin and Wound Cleanser is comparable to the predicate device in formulation, manufacturing, packaging and intended use. Winner believes the predicate and subject devices to be substantially equivalent --- **Source:** [https://fda.innolitics.com/device/K231564](https://fda.innolitics.com/device/K231564) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com