Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus Antimicrobial Wound Care Solution 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 Plus Antimicrobial™ Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Device Description

The Microcyn Plus Antimicrobial Wound Care Solution 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. The solution is supplied in glass bottles with lined caps with a pH range of 3.5 - 6.0. Ingredients: water, sodium chloride, hypochlorous acid.

AI/ML Overview

The provided text describes a 510(k) summary for the Microcyn Plus Antimicrobial Wound Care Solution, which evaluates its substantial equivalence to predicate devices. This type of submission relies on demonstrating similarity to already legally marketed devices rather than conducting a full clinical study to prove efficacy, especially for Class I or II devices where such extensive studies might not be required.

Therefore, the information regarding acceptance criteria and performance is focused on bench testing and biocompatibility to prove the device's similarity and safety, rather than a clinical trial with human subjects, AI performance metrics, or complex ground truth establishment.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in the way one might expect for an AI/diagnostic device. Instead, the performance data provided are primarily for bench testing to ensure the new device functions similarly to the predicate devices and meets safety standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility:	Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Specific results are not detailed, but compliance is stated).
Package Integrity:	Bench tested. (Results are not detailed).
Visual Inspection:	Bench tested. (Results are not detailed).
Osmolality:	Bench tested. (Results are not detailed).
pH:	Bench tested. (pH range is 3.5 - 6.0, as stated in Device Description).
Free Available Chlorine (FAC):	Bench tested. (Results are not detailed).
Preservative Effectiveness (USP <51>):	Used to support preservative effectiveness with compendia organisms and specific bacteria: Proteus mirabilis, Serratia marcescens, MRSA, VRE, and Acinetobacter baumannii. (Results are not detailed, but effectiveness is supported).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable or not provided in the context of this 510(k) summary. The testing described is laboratory-based bench testing and biocompatibility assessments, not a clinical trial with a "test set" of patient data.

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

This information is not applicable or not provided. Since there isn't a "test set" of clinical data requiring expert review for ground truth, this aspect is not part of the submission. The ground truth for chemical and physical properties comes from established scientific methods and readings.

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

This information is not applicable or not provided. There is no clinical test set requiring adjudication.

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

This information is not applicable. The device is a wound care solution, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to this submission.

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

This information is not applicable. The device is not an algorithm or AI.

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

The "ground truth" for the tests performed is based on established laboratory standards, chemical analysis, and microbiological testing methodologies. For example:

Biocompatibility: Adherence to ISO standards and FDA guidelines.
pH, Osmolality, FAC: Instrumental measurements against known chemical standards.
Preservative Effectiveness: Standardized microbiological challenge tests (USP <51>) against recognized microbial strains.

8. The sample size for the training set

This information is not applicable or not provided. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The development and formulation of the solution would involve iterative testing, but not in the sense of a machine learning training set size.

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

This information is not applicable or not provided. As above, there is no "training set" for an AI algorithm. The development of the solution would rely on scientific principles and established chemical and biological testing methods for quality control and formulation, rather than a labeled "ground truth" for training an algorithm.

Summary

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November 15, 2017

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

Re: K172851

Trade/Device Name: Microcyn Plus Antimicrobial Wound Care Solution Regulatory Class: Unclassified Product Code: FRO Dated: September 19, 2017 Received: September 20, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K172851

Device Name

Microcyn Plus Antimicrobial Wound Care Solution

Indications for Use (Describe)

OTC Indications for Use: Microcyn Plus Antimicrobial™ Wound Care Solution 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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ல் 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: June 8, 2017

II. DEVICE

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

PREDICATE DEVICE III.

Microcyn Plus Wound Care Solution manufactured by Sonoma Pharmaceuticals (K161034) Hydrocleanse Antimicrobial Skin and Wound Care Solution manufactured by Sonoma

Pharmaceuticals, Inc. (K171727)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE Rx

Indications for Use:

Under the supervision of a healthcare professional, Microcyn Plus™ Antimicrobial Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign

Sonoma Pharmaceuticals, Inc.

K172851 Microcyn Plus Antimicrobial Wound Care Solution 510(k) Summary

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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 seconddegree 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:

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

Submitter/Holder	Proposed Device:Microcyn Plus AntimicrobialWound Care Solution -SonomaPharmaceuticals, Inc.	Predicate Device: K161034Micorcyn Plus Skin and WoundCare CleanserSonoma Pharmaceuticals, Inc.	Predicate Device: K171727Hydrocleanse AntimicrobialSkin and Wound CareSolution SonomaPharmaceuticals,Inc.
IndicationsforUse	Rx Indications:Under the supervision of ahealthcare professional, MicrocynPlus Antimicrobial Wound CareSolution is intended for thecleansing, irrigation, moistening,debridement and removal of foreignmaterial and debris from exudatingwounds, acute and chronic dermallesions including stage I-IV pressureulcers, stasis ulcers, diabetic ulcers,post-surgical wounds, first- andsecond-degree burns, abrasions,minor irritations of the skin, diabeticfoot ulcers, ingrown toe nails,grafted/donor sites and exit sites. Itis also intended for use to moistenand lubricate wound dressings andfor use with devices intended toirrigate wounds.OTC Indications:Microcyn Plus Antimicrobial WoundCare Solution is intended for OTCuse in the management of minor skinabrasions, lacerations, minorirritations, cuts, and intact skin.	Rx Indications:Under the supervision of a healthcareprofessional, Microcyn Plus is intendedfor the cleansing, irrigation, moistening,debridement and removal of foreignmaterial including microorganisms anddebris from exudating wounds, acuteand chronic dermal lesions includingstage 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 isalso intended for use to moisten andlubricate wound dressings and for usewith devices intended to irrigatewounds.OTC Indications:Microcyn Plus is intended for use in themanagement of skin abrasions,lacerations, minor irritations, cuts, andintact skin.	Rx Indications:Under the supervision of ahealthcare professional,HydrocleanseTM AntimicrobialSkin and Wound Care Solution isintended for the cleansing,irrigation, moistening,debridement and removal offoreign material and debris fromexudating wounds, acute andchronic dermal lesions includingstage I-IV pressure ulcers, stasisulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minorirritations of the skin, diabetic footulcers, ingrown toe nails,grafted/donor sites and exit sites.It is also intended for use tomoisten and lubricate wounddressings and for use with devicesto irrigate wounds.OTC Indications for Use:OTC HydrocleanseTMAntimicrobial Skin and WoundCare Solution is intended for OTCuse in the management of skinabrasions, lacerations,minor irritations, cuts, andintact skin.
SterilityClaim	Non-sterile	Same	Same
Mechanismof Action	Dirt debris and foreign material aremechanically removed by the actionof the fluid moving across the woundor device.	Same	Same
DeliverySystem	Aqueous Solution containing: Water,sodium chloride, hypochlorous acid	Aqueous Solution containing: Water,sodium chloride, hypochlorous acid	Aqueous Solution containing:Water, sodium sulfate, sodiumphosphate, sodium chloride,hypochlorous acid
Shelf Life	24 months	Same	12 months

Sonoma Pharmaceuticals, Inc.

K172851 Microcyn Plus Antimicrobial Wound Care Solution 510(k) Summary

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

PERFORMANCE DATA

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

Biocompatibility Testing

The biocompatibility evaluation for the Microcyn Plus Antimicrobial Wound Care Solution 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 Plus 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 and the following bacteria in solution, Proteus mirabilis (ATCC - 25933), Serratia marcescens (ATCC-8100), antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC-43300). Vancomycin- resistant Enterococcus faecalis (VRE) (ATCC-700221), and Acinetobacter baumannii (ATCC 19606).

VII. CONCLUSION

Microcyn Plus Antimicrobial Wound Care Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Microcyn Plus Wound Care Solution manufactured by Sonoma Pharmaceuticals. Inc. (K161034) and Hydrocleanse Antimicrobial Skin and Wound Care Solution manufactured by Sonoma Pharmaceuticals (K171727). Therefore, the Microcyn Plus Antimicrobial Wound Care Solution is substantially equivalent to the predicate devices.

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K172851

Regulation Number and Section

N/A