Rx Indications: Under the supervision of a healthcare professional, Microcyn Antimicrobial Skin and Wound Cleanser is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

OTC Indications for Use: Microcyn Antimicrobial Skin and Wound Cleanser is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Device Description

The Microcyn Antimicrobial Skin and Wound Cleanser is a clear hypotonic solution that aids in the mechanical removal of debris and foreign material from the application site. It is also for the management of skin abrasions, lacerations, irritation, cuts, and wounds.

AI/ML Overview

The provided text describes a 510(k) summary for the Microcyn Antimicrobial Skin and Wound Cleanser, which sought to demonstrate substantial equivalence to predicate devices. This type of submission does not typically involve a device that requires performance against specific clinical acceptance criteria in the same way a novel AI algorithm might. Instead, the focus is on showing that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested details, such as human-in-the-loop studies, AI training/test sets, and expert adjudication, are not applicable to this type of medical device submission.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present:

1. A table of acceptance criteria and the reported device performance:

Since this is a substantial equivalence determination for a wound cleanser, the "acceptance criteria" are not defined as specific diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they relate to demonstrating similar technological characteristics, safety, and effectiveness to predicate devices. The "reported device performance" is primarily about meeting various bench and biocompatibility testing standards and showing comparable properties to the predicate devices.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Microcyn Antimicrobial Skin and Wound Cleanser)
Intended Use Equivalence	Rx Indications: Cleansing, irrigation, moistening, debridement and removal of foreign material/debris from exudating wounds, acute and chronic dermal lesions (Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, 1st & 2nd degree burns, abrasions, minor irritations, diabetic foot ulcers, ingrown toe nails, grafted/donor sites, exit sites). Also for moistening/lubricating wound dressings and use with wound irrigating devices. OTC Indications: Management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. (Matches predicate devices K090206 and K171727).
Technological Characteristics Equivalence	Ingredients: Water, sodium chloride, hypochlorous acid, sodium hypochlorite (Matches K090206, similar to K171727 which also includes sodium sulfate, monobasic sodium phosphate). Sterility Claim: Non-sterile (Matches both predicates). Mechanism of Action: Dirt, debris, foreign material mechanically removed by fluid action (Matches both predicates). Delivery System: Aqueous Solution (Matches both predicates). Shelf Life: 24 months (Compared to 24 months for K090206 and 12 months for K171727).
Biocompatibility	Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
Bench Testing	Package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC) testing performed. USP <51> testing used for preservative effectiveness against various compendia organisms and other bacteria (P. aeruginosa, E. coli, S. aureus, C. albicans, A. niger, S. epidermidis, P. acnes, Proteus mirabilis, S. marcescens, MRSA, VRE, A.baumannii).

2. Sample size used for the test set and the data provenance:

Not Applicable. This is a wound cleanser, not a diagnostic device relying on a "test set" of patient data for performance evaluation in the context of AI. The performance data consists of laboratory bench tests and biocompatibility studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. See point 2.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not Applicable. Ground truth in the context of AI or complex diagnostic accuracy is not relevant here. The "ground truth" for this device's efficacy and safety relies on established scientific methods for evaluating chemical composition, microbiological effectiveness, physical properties (pH, osmolality), and biocompatibility.

8. The sample size for the training set:

Not Applicable. This is not an AI algorithm; there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

In summary: The provided document is a 510(k) premarket notification for a wound care product. The "study" demonstrating that the device meets "acceptance criteria" primarily refers to biocompatibility testing and bench testing (e.g., chemical properties, microbiological preservative efficacy, shelf-life testing) to show that the device is safe, performs as intended, and is substantially equivalent to existing predicate devices. It does not involve clinical studies with patient data, AI algorithms, or expert ground truthing as would be seen for diagnostic software.

Summary

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November 21, 2017

Sonoma Pharmaceuticals, Inc. Brian Martin VP Regulatory 1129 N. McDowell Boulevard Petaluma, California 94954

Re: K172622

Trade/Device Name: Microcyn Antimicrobial Skin and Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: August 29, 2017 Received: September 1, 2017

Dear Brian Martin:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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

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803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172622

Device Name

Microcyn Antimicrobial Skin and Wound Cleanser

Indications for Use (Describe)

OTC Indications for Use: Microcyn Antimicrobial Skin and Wound Cleanser is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

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

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

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510(k) SUMMARY

The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

I. SUBMITTER

Sonoma Pharmaceuticals, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551 Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: August 29, 2017

II. DEVICE

Name of Device: Microcyn Antimicrobial Skin and Wound Cleanser Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline Wound Dressing Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO

III. PREDICATE DEVICE

Puracyn Skin and Wound Cleanser with Preservatives manufactured by Sonoma Pharmaceuticals (K090206)

Hydrocleanse Antimicrobial Skin and Wound Cleanser manufactured by Sonoma Pharmaceuticals (K171727)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

Rx Indications for Use:

Under the supervision of a healthcare professional, Microcyn™ Antimicrobial Skin and Wound Cleanser is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.

Sonoma Pharmaceuticals. Inc. K172622 Microcyn Antimicrobial Skin and Wound Cleanser 510(k) Summary

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OTC Indications for Use:

Microcyn™ Antimicrobial Skin and Wound Cleanser is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Submitter/Holder	Proposed Device: MicrocynAntimicrobial Skin andWound Cleanser SonomaPharmaceuticals, Inc.	Predicate Device: K090206Puracyn Skin and WoundCleanser with PreservativesSonoma Pharmaceuticals, Inc.	Predicate Device: K171727Hydrocleanse Antimicrobial Skinand Wound Care Solution SonomaPharmaceuticals, Inc.
Indications forUse	Rx Indications:Under the supervision of a healthcareprofessional, Microcyn™Antimicrobial Skin and WoundCleanser is intended for thecleansing, irrigation, moistening,debridement and removal of foreignmaterial including debris fromexudating wounds, acute and chronicdermal lesions including stage I-IVpressure ulcers, stasis ulcers, diabeticulcers, post-surgical wounds, first-and second-degree burns, abrasions,minor irritations of the skin, diabeticfoot ulcers, ingrown toe nails,grafted/donor sites and exit sites. It isalso intended for use to moisten andlubricate wound dressings and for usewith devices intended to irrigatewounds.OTC Indications:Microcyn™ Antimicrobial Skin andWound Cleanser is intended for OTCuse in the management of skinabrasions, lacerations, minorirritations, cuts, and intact skin.	Rx Indications:Puracyn Skin and Wound Cleanser withPreservatives is intended to be used byhealth care professional in themanagement via debridement of woundssuch as stage I-IV pressure ulcers, partialand full thickness wounds, diabetic footulcers, post- surgical wounds, first andsecond degree burns, grafted and donorsites.OTC Indications:Puracyn™ Skin and Wound Cleanserwith preservatives is intended for OTCuse for the management of skin abrasions,lacerations, minor irritations, cuts, andintactskin.	Rx Indications:Under the supervision of a healthcareprofessional, Hydrocleanse™Antimicrobial Skin and Wound CareSolution is intended for the cleansing,irrigation, moistening, debridement andremoval of foreign material and debrisfrom exudating wounds, acute andchronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabeticulcers, post- surgical wounds, first- andsecond-degree bums, abrasions, minorirritations of the skin, diabetic footulcers, ingrown toe nails, grafted/donorsites and exit sites. It is also intended foruse to moisten and lubricate wounddressings and for use with devices toirrigate wounds.OTC Indications:For management of minor skinabrasions, minor lacerations, minorirritations, minor cuts, minor burns andintact skin.
Technology	Ingredients: Water, sodium chloride,hypochlorous acid, sodiumhypochlorite	Ingredients: Water, sodium chloride,hypochlorous acid, sodium hypochlorite	Ingredients: Water, sodium sulfate,monobasic sodium phosphate, sodiumchloride, hypochlorous acid, sodiumhypochlorite
SterilityClaim	Non-sterile	Same	Same
Mechanism ofAction	Dirt debris and foreign material aremechanically removed by the actionof the fluid moving across the woundor device.	Same	Same
DeliverySystem	Aqueous Solution	Same	Same
Shelf Life	24 months	Same	12 months

Sonoma Pharmaceuticals, Inc.

K172622 Microcyn Antimicrobial Skin and Wound Cleanser 510(k) Summary

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation for the Microcyn Antimicrobial Skin and Wound Cleanser was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

Bench Testing

The following tests were performed to support the performance of Microcyn Antimicrobial Wound Care Solution: package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC). USP <51> testing was used to support preservative effectiveness of the product with the compendia organisms: P. aeruginosa (ATCC 9027), E. coli (ATCC 8739), S. aureus (ATCC 6538), C. albicans (ATCC 10231), A. niger (ATCC 16404) - and the following bacteria in solution: S. epidermidis (ATCC 12228), P acnes (ATCC 6919), Proteus mirabilis (ATCC- 29906), S. marcescens (ATCC-13880), antibiotic resistant Methicillin-Resistant S. aureus (MRSA) (ATCC-BAA-1708), Vancomycin- resistant E. faecalis (VRE) (ATCC-BAA2320), and A.baumannii (ATCC 19606).

VIII. CONCLUSION

Microcyn Antimicrobial Skin and Wound Cleanser is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Puracyn Skin and Wound Cleanser with Preservatives manufactured by Sonoma Pharmaceuticals, Inc. (K090206) and Hydrocleanse Antimicrobial Skin and Wound Care Solution manufactured by Sonoma Pharmaceuticals (K171727). Therefore, the Microcyn Antimicrobial Skin and Wound Cleanser is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A