(163 days)
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.
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.
The provided document is an FDA 510(k) summary for a medical device called "Skin and Wound Cleanser." It outlines the regulatory submission, identity of the device, identification of predicate devices, device description, intended use, and non-clinical test conclusions.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical tests performed to ensure the device meets design specifications and is substantially equivalent to predicate devices. The acceptance criteria are implicitly tied to compliance with the standards listed and the successful demonstration of the specified performance.
| Acceptance Criteria (Implicit from Standards/Tests) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: | |
| ISO 10993-5:2009 (Cytotoxicity) | Device complies with the standard |
| ISO 10993-6:2016 (Local Effects after Implantation) | Device complies with the standard |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | Device complies with the standard |
| ISO 10993-11:2017 (Systemic Toxicity) | Device complies with the standard |
| Antimicrobial Effectiveness: | |
| USP <51> Antimicrobial Effectiveness Testing | Effectiveness to inhibit growth of microorganisms (E. coli, P. aeruginosa, S. aureus, C. albicans, A. niger, MRSA, VRE) within the wound cleansing solution. |
| Physical/Chemical Characteristics: | |
| Appearance: Clear, colorless solution | Clear, colorless solution |
| Application method: Spray/Squeeze bottle | Spray bottle; Squeeze bottle (matches predicate) |
| Characteristics: Aqueous | Aqueous |
| Density (at 20°C): 0.9 – 1.0 g/ml | 0.9 – 1.0 g/ml |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (e.g., number of replicates, number of animals, etc.) used for each non-clinical test. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Data Provenance: Not explicitly stated in terms of country of origin but refers to established international (ISO) and US (USP) standards. The tests are presented as being conducted by the applicant, Winner Medical Co., Ltd. The study appears to be a prospective non-clinical study specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable (N/A) as the tests conducted are non-clinical, laboratory-based analyses (biological evaluation and antimicrobial effectiveness), rather than studies requiring human expert interpretation or a "ground truth" derived from expert consensus. The "ground truth", in this context, is the quantitative or qualitative outcome specified by the respective ISO or USP standard, assessed by laboratory personnel.
4. Adjudication Method for the Test Set:
- This information is N/A for the same reasons as point 3. The non-clinical tests are evaluated against predefined criteria in the standards, not through adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This type of study is typically for image-based diagnostic or prognostic devices involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is N/A as the device is a "Skin and Wound Cleanser," which is a physical solution, not a software algorithm or an AI device.
7. The type of ground truth used:
- The "ground truth" for the non-clinical tests is derived from established scientific standards and methodologies. For example:
- Biocompatibility: The "ground truth" is determined by observing cellular responses (cytotoxicity), tissue reactions (local effects, irritation), and systemic effects in laboratory models, as per the guidelines and endpoints defined in the ISO 10993 series.
- Antimicrobial Effectiveness: The "ground truth" is measured by the reduction in microbial population over time, in comparison to specified log reductions or absence of growth criteria as defined by USP <51> for various microorganisms.
8. The Sample Size for the Training Set:
- This question is N/A as the device is a physical wound cleanser and does not involve a "training set" in the context of machine learning or AI. The non-clinical tests are performed on the device itself.
9. How the Ground Truth for the Training Set was Established:
- This question is N/A for the same reasons as point 8.
In summary, the K231564 submission relies on non-clinical, laboratory-based testing to demonstrate conformance to recognized standards for biocompatibility and antimicrobial effectiveness, establishing substantial equivalence to predicate devices, rather than clinical studies or AI algorithm performance evaluations.
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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).
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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
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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)
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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
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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.
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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.
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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 DeviceK231564 | Predicate DeviceK141660 | Reference DeviceK161623 |
|---|---|---|---|
| Product Code | FRO | FRO | FRO |
| Class | Unclassified | Unclassified | Unclassified |
| Intended Use | Prescription Use:Skin and Wound Cleanserfor prescription use isintended for use under thesupervision of healthcareprofessionals for cleansing,moistening, debriding, andremoval of foreign materialincluding microorganismsand debris from wounds,including acute and chronicdermal lesions, such asStage I-IV pressure ulcers,venous ulcers, leg ulcers,diabetic foot ulcers, post-surgical wounds, first andsecond degree burns,grafted and donor sites. Itis also intended formoistening absorbent | Prescription Use:NAWAlution forprescription use is intendedfor use under thesupervision of healthcareprofessionals for cleansing,moistening, debriding, andremoval of foreign materialincluding microorganismsand debris from wounds,including acute and chronicdermal lesions, such asStage I-IV pressure ulcers,venous ulcers, leg ulcers,diabetic foot ulcers, post-surgical wounds, first andsecond degree burns,grafted and donor sites. Itis also intended formoistening absorbent | Prescription Use:Prontosan WoundIrrigation Solution isintended for cleaningwounds and formoistening andlubricating absorbentwound dressings forulcers, burns, post-surgical wounds andabrasions. |
| Table 1 Comparison of Intended use, Design and Technological Characteristics | |||
|---|---|---|---|
| wound dressings andcleaning minor cuts, minorburns, superficial abrasionsand minor irritations of theskin.Over-The-Counter Use:Skin and Wound Cleanserfor over-the-counter use isintended for cleansingwounds and moisteningabsorbent wound dressingsfor the management ofminor cuts, minorabrasions, minorlacerations and minorburns. | wound dressings andcleaning minor cuts, minorburns, superficial abrasionsand minor irritations of theskin.Over-The-Counter Use:NAWAlution for over-the-counter use is intended forcleansing wounds andmoistening absorbentwound dressings for themanagement of minor cuts,abrasions, lacerations andminor burns. | ||
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible |
| Appearance | Clear, colorless solution | Clear, colorless solution | Clear, colorless solution |
| Applicationmethod | Spray bottle;Squeeze bottle | Spray bottle (50 mL (1.8fluid 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,UndecylenamidopropylBetaine |
| Betaine, Trace ingredients(allantoin, citric acid) | Hydrochloric acid, TraceElement | ||
| Sterility | Non-sterile | Non-sterile | Sterile |
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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
N/A