Rx Indication: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborthea and sebortheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

OTC Indications for Use: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.

Device Description

The Alevicyn SG Antimicrobial Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer. Ingredients: Water, sodium lithium magnesium fluorosilicate, dimethicone, sodium phosphate, sodium bicarbonate, sodium chloride, sodium sulfate, with hypochlorous acid and sodium hypochlorite as gel preservatives.

AI/ML Overview

The document provided describes a 510(k) Premarket Notification for the Alevicyn SG Antimicrobial Gel. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on showing equivalence through comparison and specific performance data, rather than detailing a direct study to "prove acceptance criteria" in the way one might for a novel device.

However, I can extract the acceptance criteria (specifications) and reported performance data based on the provided "Performance Data" section.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specification)	Reported Device Performance
Biocompatibility:
Cytotoxicity	Met (Evaluated in accordance with FDA guidance and ISO 10993-1)
Irritation	Met (Evaluated in accordance with FDA guidance and ISO 10993-1)
Sensitization	Met (Evaluated in accordance with FDA guidance and ISO 10993-1)
Toxicological Risk	Met (Toxicological risk assessment conducted to support prolonged use)
Bench Testing:
Visual Inspection	Meets specification (Opaque, colorless semi-viscous gel, slightly chlorinated odor)
pH	Meets specification
Viscosity	Meets specification
Free Available Chlorine (FAC)	Meets specification
Antimicrobial Preservative Effectiveness	Meets specification (Effective against Proteus mirabilis, Serratia marcescens, antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA), and Acinetobacter baumannii while on the shelf, conforming to USP <51>)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any of the biocompatibility or bench tests. It also does not specify the country of origin or whether the data was retrospective or prospective. The nature of these tests (e.g., in-vitro toxicology, chemical property testing) typically involves lab-based experiments rather than human clinical trials with "test sets" in the traditional sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided in the document. For device submissions based on predicate equivalence and bench/biocompatibility testing, the "ground truth" is established by adherence to recognized standards (e.g., ISO 10993-1, USP <51>) and internal specifications for chemical and physical properties. There are no "experts" establishing ground truth in the context of clinical interpretation, as would be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to resolve discrepancies in diagnoses or assessments, particularly for AI image interpretation. The studies described here are laboratory-based performance and safety evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI vs. Without AI Assistance

This information is not applicable and not provided. MRMC studies are relevant for evaluating diagnostic imaging systems (often AI-powered) where human readers interpret cases. The Alevicyn SG Antimicrobial Gel is a topical medical device, not an imaging or diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable and not provided. "Standalone performance" refers to the performance of an algorithm without human intervention, again typically for AI-driven diagnostic tools. This device is not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by:

Adherence to recognized international standards like ISO 10993-1 ("Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process").
FDA biocompatibility guidance (issued June 16, 2016).

For bench testing, the ground truth is established by:

Internal specifications defined for pH, viscosity, FAC.
Adherence to recognized pharmacopeial standards like USP <51> for antimicrobial preservative effectiveness.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical product (gel) and does not involve AI or machine learning models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, for the same reason as above (no AI/ML training set).

Summary

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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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 1, 2017

Sonoma Pharmaceuticals, Inc. Brian Martin Director of Regulatory Affairs and Quality Control 1129 N. McDowell Boulevard Petaluma, California 94954

Re: K171935

Trade/Device Name: Alevicyn SG Antimicrobial Gel Regulatory Class: Unclassified Product Code: FRO Dated: November 2, 2017 Received: November 3, 2017

Dear Mr. 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 mediation-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) K171935

Device Name Alevicyn SG Antimicrobial Gel

Indications for Use (Describe)

Rx Indications: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborthea and sebortheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

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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Image /page/3/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is a stylized flower or star-like design with teal and gray colors. The company name "Sonoma" is written in gray, and the word "PHARMACEUTICALS" is written in teal below it.

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: November 28, 2017

II. DEVICE

Name of Device: Alevicyn SG Antimicrobial Gel Common or Usual Name: Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO

III. PREDICATE DEVICE

Alevicyn SG Antipruritic Gel (K152945) manufactured by Sonoma Pharmaceuticals, Inc. Puracyn Plus Antimicrobial Gel (K150799), manufactured by Innovacyn, Inc.

IV. REFERENCE DEVICE Alevicyn SG Gel (K143590) manufactured by Sonoma Pharmaceuticals, Inc.

DEVICE DESCRIPTION V.

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Image /page/4/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a circular design made up of interconnected teal and gray shapes on the left. To the right of the design is the word "Sonoma" in gray, with the word "PHARMACEUTICALS" in teal underneath.

VI. INDICATIONS FOR USE

Rx Indication: Alevicyn SG Antimicrobial Gel is intended to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. Alevicyn SG Antimicrobial Gel is indicated to manage and relieve the burning, itching, erythema, scaling, and pain experienced with various types of dermatoses, including atopic dermatitis, radiation dermatitis, seborrhea and seborrheic dermal irritation, sores, injuries, and ulcers of dermal tissue in addition to moistening and lubricating absorbent wound dressings. The Alevicyn SG Antimicrobial Gel may also be used to manage partial or full thickness wounds such as first and second degree burns, stage I -IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), and trauma wounds. Alevicyn SG Antimicrobial Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

OTC Indications: Alevicyn SG Antimicrobial Gel is intended for OTC use to relieve itch and pain from minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.

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Image /page/5/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of several curved lines that form a flower-like pattern. The company name is written in a sans-serif font, with the word "Sonoma" in a larger font than the word "Pharmaceuticals."

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.

Submitter/Holder	Proposed Device:Alevicyn SG Antimicrobial Gel,Sonoma Pharmaceuticals	Predicate Device:K152945 - RxAlevicyn SG Gel,Sonoma Pharmaceuticals	Predicate Device:K150799Puracyn Plus AntimicrobialHydroGel	Reference Device:K143590 - OTCAlevicyn SG Gel,Sonoma Pharmaceuticals
PrescriptionIndicationsforUse	Rx Indication: Alevicyn SGAntimicrobial Gel is intended tomoisten the wound bed and facilitateautolytic debridement of acute andchronic dermal lesions. Alevicyn SGAntimicrobial Gel is indicated tomanage and relieve the burning,itching, erythema, scaling, and painexperienced with various types ofdermatoses, including atopicdermatitis, radiation dermatitis,seborrhea and seborrheic dermatitis,dermal irritation, sores, injuries, andulcers of dermal tissue in addition tomoistening and lubricating absorbentwound dressings. The Alevicyn SGAntimicrobial Gel may also be used tomanage partial or full thicknesswounds such as first and seconddegree burns, stage I - IV pressureulcers, diabetic and stasis ulcers,abrasions and skin irritations, surgicalwounds (donor and graft sites,incisions), and trauma wounds.Alevicyn SG Antimicrobial Gel helpsto relieve dry waxy skin bymaintaining a moist wound & skinenvironment, which is beneficial to thehealing process.	Rx Indication: Under thesupervision of a healthcareprofessional, Alevicyn SG Gel isintended to manage and relievethe burning, itching, erythema,scaling, and pain experiencedwith various types of dermatoses,including atopic dermatitis,radiation dermatitis, andseborrhea and seborrheicdermatitis. The Alevicyn SG Gelmay also be used to relieve thepain of first and second degreeburns. Alevicyn SG Gel helps torelieve dry, waxy skin bymaintaining a moist wound &skin environment, which isbeneficial to the healing process.	Rx Indication: Puracyn® PlusAntimicrobial HydrogelProfessional Formula isintended for use by healthcareprofessionals to moisten thewound bed and facilitateautolytic debridement of acuteand chronic dermal lesions, asindicated below. Puracyn®Plus Antimicrobial HydrogelProfessional Formula relievesitch and pain associated withdermal irritation, sores, injuriesand ulcers of dermal tissue inaddition to moistening andlubricating absorbent wounddressings. Puracyn® PlusAntimicrobial HydrogelProfessional Formula isindicated for the managementof partial or full thicknesswounds such as 1st and 2nddegree burns, stage I - IVpressure ulcers, diabetic andstasis ulcers, abrasions and skinirritations, surgical wounds(donor and graft sites,incisions), trauma wounds, andvarious dermatoses includingatopic dermatitis	Rx Indication: Alevicyn SG Gelis intended to manage and relievethe burning, itching and painexperienced with various types ofdermatoses, including radiationdermatitis and atopic dermatitis.The Alevicyn SG Gel may also beused to relieve the pain of firstand second degree burns.Alevicyn SG Gel helps to relievedry waxy skin by maintaining amoist wound & skin environment.which is beneficial to the healingprocess.
Submitter/Holder	Proposed Device:Alevicyn SG Antimicrobial Gel,	Predicate Device:K152945 - Rx	Predicate Device:K150799	Reference Device:K143590 - OTC
	Sonoma Pharmaceuticals	Alevicyn SG Gel,Sonoma Pharmaceuticals	Puracyn Plus AntimicrobialHydroGel	Alevicyn SG Gel,Sonoma Pharmaceuticals
OTCIndicationsfor Use	OTC Indication: Alevicyn SGAntimicrobial Gel is intended for OTCuse to relieve itch and pain from minorskin irritations, minor cuts, exit sites,minor lacerations, minor abrasions andminor burns, including sunburns.Hydrogel is also intended to moistenand lubricate absorbent wounddressings and moisten the wound bed.A moist wound and skin environmentfacilitates autolytic debridement and isbeneficial to wound management andthe healing process.	None	OTC Indication: Puracyn®Plus Duo-Care™Antimicrobial Wound & SkinHydrogel is intended for OTCuse to relieve itch and painfrom minor skin irritations,minor cuts, exit sites, minorlacerations, minor abrasionsand minorburns, including sunburns.Hydrogel is also intended tomoisten and lubricateabsorbent wound dressings andmoisten the wound bed. Amoist wound and skinenvironment facilitatesautolytic debridement and isbeneficial to woundmanagement and the healingprocess.	OTC Indication: Alevicyn SG Gelis intended to relieve the burningand itching associated with manycommon types of skin irritation,lacerations, abrasions, and minorburns. Alevicyn SG AntipruriticGel is also indicated for themanagement of irritation and painfrom minor burns, includingsunburn.
Mechanismof Action	Skin emollient and moisturizer	Same	Same	Same
DeliverySystem	Bottle, Spray Gel	Same	Bottle - Twist Top	Same
Description	Appearance: Opaque Colorless semiviscous gelOdor: Slightly Chlorinated	Same	Same	Same
Submitter/Holder	Proposed Device:Alevicyn SG Antimicrobial Gel,Sonoma Pharmaceuticals	Predicate Device:K152945 – RxAlevicyn SG Gel,Sonoma Pharmaceuticals	Predicate Device:K150799Puracyn Plus AntimicrobialHydroGel	Reference Device:K143590 – OTCAlevicyn SG Gel,Sonoma Pharmaceuticals
Ingredients	Water, sodium lithium magnesiumfluorosilicate, dimethicone, sodiumphosphate, sodiumbicarbonate, sodium chloride, sodiumsulfate, with hypochlorous acid andsodium hypochloriteas gel preservatives.	Same	Electrolyzed water,Lithium Magnesium,Sodium Silicate,Phosphates,Sodium Bicarbonate,Sodium Chloride,Sodium Sulfate,Hypochlorous Acid(0.01%),Sodium Hypochlorite	Same
	SterilityClaim	Non-sterilePreserved/Conforming to USP <51>	Same	Non Sterile	Same
		Shelf Life	24 months	Same	2 years

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Image /page/6/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a stylized flower-like design on the left, with the word "Sonoma" in a gray sans-serif font to the right. Below "Sonoma" is the word "PHARMACEUTICALS" in a smaller, teal-colored font. The flower-like design is made up of teal and gray shapes arranged in a circular pattern.

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Image /page/7/Picture/0 description: The image contains the logo for Sonoma Pharmaceuticals. The logo consists of a circular design on the left and the company name on the right. The circular design is made up of interlocking shapes in shades of gray and teal, forming a flower-like pattern around a central white space. To the right of the circular design, the word "Sonoma" is written in a gray, sans-serif font, with the word "PHARMACEUTICALS" written in a smaller, teal font directly below it.

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Image /page/8/Picture/0 description: The image shows the logo for Sonoma Pharmaceuticals. The logo consists of a geometric design on the left and the company name on the right. The geometric design is a circular shape made up of intersecting curved lines in gray and teal. The company name "Sonoma" is in gray, and the word "PHARMACEUTICALS" is in teal below it.

VIII. PERFORMANCE DATA

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

Biocompatibility Testing

The biocompatibility evaluation for the Alevicyn SG Antimicrobial Gel was conducted in accordance with the FDA biocompatibility guidance issued on June 16, 2016 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. The Alevicyn SG Antimicrobial Gel was evaluated for cytotoxicity, irritation, sensitization. In addition, a toxicological risk assessment was conducted to support the prolonged use of the device.

Bench Testing

The following tests were performed to support the performance of Alevicyn SG Antimicrobial Gel: visual inspection, pH, viscosity, Free Available Chlorine (FAC) and Antimicrobial Preservative Effectiveness Testing against the following bacteria in the gel while on the shelf: Proteus mirabilis, Serratia marcescens, antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA), and Acinetobacter baumannii. The Alevicyn SG Antimicrobial Gel meets specification and performance characteristics and is substantially equivalent to the predicate devices.

IX. CONCLUSION

Alevicyn SG Antimicrobial Gel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to Alevicyn SG Gel (K152945), and Puracyn Plus Antimicrobial Gel (K150799). Therefore, the Alevicyn SG Antimicrobial Gel is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A