Rx Indication: Under the supervision of a health care professional, Alevicyn SG 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, and sebortheic dermatitis. Alevicyn SG Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Gel helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Device Description

The Alevicyn SG Gel is an opaque gel, slightly chlorinated odor, low viscosity spray gel. The product has a pH range of 5.5-7.0 and a viscosity target of 500-5000 cP and will be supplied in polyethylene terephthalate (PET) round-bottles with polypropylene (PP) screw-top closure and a finger pump sprayer.

AI/ML Overview

This document describes a 510(k) premarket notification for the Alevicyn SG Antipruritic Gel. The device is a topical gel indicated for managing and relieving various dermatoses symptoms and pain from burns. The approval is based on substantial equivalence to predicate devices, and the provided text does not include a study demonstrating how the device meets specific acceptance criteria for performance metrics via a clinical trial measuring efficacy outcomes.

Instead, the provided information focuses on biocompatibility testing and bench testing to support the substantial equivalence claim. Since no clinical study on performance outcomes (e.g., reduction in itching, pain, erythema) is presented, I cannot provide details on acceptance criteria and a study that proves the device meets them in the way typically associated with human-in-the-loop or standalone AI performance studies.

Here's an assessment based on the available text:

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

The document does not specify quantitative acceptance criteria for clinical performance (e.g., a specific percentage reduction in itching or pain). The acceptance criteria mentioned are related to manufacturing specifications and safety/biocompatibility.

Acceptance Criteria Type	Acceptance Criteria	Reported Device Performance
Biocompatibility	In accordance with 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 ISO 10993-1 ("Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process").	The biocompatibility evaluation for the Alevicyn SG Gel was conducted in accordance with these standards. The solution is considered a breached/compromised surface device with limited contact, and thus implied to meet the standards for its intended use category. (Specific results like "no cytotoxicity observed" are not detailed, but compliance is stated).
Bench Testing	Meets specifications and performance characteristics.	The following tests were reviewed: package integrity, visual inspection, pH, and Free Available Chlorine (FAC). The Alevicyn SG Gel meets specification and performance characteristics. (Specific numerical ranges or results for each test are not provided, only the statement of compliance).
Substantial Equivalence	Demonstrated equivalence to predicate devices in intended use, technological characteristics, safety, and effectiveness.	Alevicyn SG Gel is determined to be substantially equivalent to Alevicyn SG Gel (K143590), TL Triseb Cream (K121134), Dermiseb Cream (K123724), and Loutrex Topical Cream (K120730).

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 provided in the document. The document refers to "Biocompatibility Testing" and "Bench Testing" but does not specify the sample sizes (e.g., number of test subjects or samples of the gel) or the provenance of any data used for these tests. There is no mention of a human clinical test set for performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The ground truth for biocompatibility and bench testing would be established by laboratory standards and measurements, not by expert consensus in a clinical context.

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

This information is not applicable/provided. Adjudication methods are typically relevant for clinical studies where subjective assessments might be made (e.g., by multiple readers). The tests described (biocompatibility, bench testing) are objective laboratory tests.

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/provided. This device is a topical gel, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness is not relevant.

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

This information is not applicable/provided. This device is a topical gel, not an algorithm.

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

For Biocompatibility Testing, the "ground truth" is defined by the International Standard ISO 10993-1 and FDA Blue Book Memorandum #G95-1. These are standardized methodologies and criteria for evaluating biological responses to medical devices.

For Bench Testing (package integrity, visual inspection, pH, Free Available Chlorine), the "ground truth" is established by predefined product specifications and validated analytical methods in a laboratory setting.

8. The sample size for the training set

This information is not applicable/provided. The device is a gel, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided. As above, there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2015

Oculus Innovative Sciences Incorporated Mr. Brian Martin Director of Regulatory Affairs and Quality Control 1129 North Mcdowell Boulevard Petaluma, California 94954

Re: K152945

Trade/Device Name: Alevicyn SG Antipruritic Gel Regulatory Class: Unclassified Product Code: FRO Dated: October 5, 2015 Received: October 6, 2015

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. Iisting 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 (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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -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) K152945

Device Name Alevicyn SG Antipruritic Gel

Indications for Use (Describe)

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/1 description: The image shows the logo for Oculus Innovative Science. The logo features the word "OCULUS" in bold, black letters. Above the word, there are three overlapping golden ellipses. Below the word "OCULUS", the words "Innovative Science" are written in a smaller font.

1 510(k) SUMMARY

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

I. SUBMITTER

Oculus Innovative Sciences. 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: October 5, 2015

II. DEVICE

Name of Device: Alevicyn SG Antipruritic Gel Common or Usual Name: Antipruritic Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO

III. PREDICATE DEVICE

Alevicyn SG Gel (K143590) manufactured by Oculus Innovative Sciences, Inc., TL Triseb Cream (K121134), manufactured by Trigen Laboratories, Inc., Dermiseb Cream (K123724) manufactured by IGI Laboratories, Inc., and Loutrex Topical Cream (K120730) manufactured by Acella Pharmaceuticals, LLC

IV. DEVICE DESCRIPTION

INDICATIONS FOR USE V.

Rx Indication: Under the supervision of a health care professional, Alevicyn SG 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, and seborrhea and seborrheic dermatitis. Alevicyn SG Gel may be also used to relieve the pain of first and second degree burns. Alevicyn SG Gel helps to relieve dry

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Image /page/4/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo consists of a stylized golden graphic above the word "OCULUS" in bold, black letters. Below "OCULUS" is the text "Innovative Science" in a smaller, non-bold font.

waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

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Image /page/5/Picture/0 description: The image shows the alphanumeric string "K152945" in a simple, sans-serif font. The characters are uniformly sized and spaced, with a clear distinction between the letter "K" and the numerical digits that follow. The text is presented in black against a white background, ensuring high contrast and readability.

Image /page/5/Picture/1 description: The image shows the logo for Oculus Innovative Sciences. The logo features the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Sciences" in a smaller font underneath. Above the word "OCULUS" is a graphic of three overlapping circles in a gold color. The logo is simple and modern, and the colors are clean and professional.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Submitter/Holder	Proposed Device:Alevicyn SG Antipruritic GelOculus Innovative Sciences	Predicate Device:K143590Alevicyn SG Gel,Oculus InnovativeSciences	Predicate Device:K121134TL Triseb Cream,Trigen Laboratories,Inc.	Predicate Device:K123724Dermiseb Cream,IGI Laboratories, Inc.	Predicate Device:K120730Loutrex Topical Cream,Acella Pharmaceuticals,LLC
Indications forUse	Rx Indication: Alevicyn SG Gel isindicated to manage and relievethe burning, itching, erythema,scaling, and pain experiencedwith various types of dermatoses,including atopic dermatitis,radiation dermatitis, andseborrhea and seborrheicdermatitis. Alevicyn SG Gel maybe also used to relieve the pain offirst and second degree burns.Alevicyn SG Gel helps to relievedry waxy skin by maintaining amoist wound & skin environment,which is beneficial to the healingprocess.	Rx Indication: AlevicynSG Antipruritic Gel isindicated to manage andrelieve the burning,itching and painexperienced with varioustypes of dermatoses,including radiationdermatitis and atopicdermatitis. Alevicyn SGAntipruritic Gel may bealso used to relieve thepain of first and seconddegree burns. AlevicynSG Antipruritic Gelhelpsto relieve dry waxy skinby maintaining a moistwound & skinenvironment, which isbeneficial to the healingprocess.OTC Indication:Alevicyn SG AntipruriticGel is intended to relievethe burning and itchingassociated with many	Rx Indication: Underthe supervision of ahealthcare professional,TL Triseb Cream isindicated to manage andrelieve the signs andsymptoms of seborrheaand seborrheicdermatitis such asitching, erythema,scaling and pain. TLTriseb Cream helpsrelieve dry waxy skinby maintaining a moistwound and skinenvironment, which isbeneficial to the healingprocess.	Rx Indication: Under thesupervision of ahealthcare professional,Dermiseb Cream isindicated to manage andrelieve the signs andsymptoms of seborrheaand seborrheic dermatitissuch as itching,erythema, scaling andpain. Dermiseb Creamalso aids to relieve dry,waxy skin bymaintaining a moistwound and skinenvironment. A moistwound and skinenvironment isbeneficial to the healingprocess.	Rx Indication: LoutrexTopical Cream is indicatedto manage and relieve thesigns and symptoms ofseborrhea and seborrheicdermatitis such as itching,erythema, scaling andpain. Loutrex TopicalCream helps relieve dry,waxy skin by maintaininga moist wound and skinenvironment, which isbeneficial to the healingprocess.
Submitter/Holder	Proposed Device:Alevicyn SG Antipruritic GelOculus Innovative Sciences	Predicate Device:K143590Alevicyn SG Gel,Oculus InnovativeSciences	Predicate Device:K121134TL Triseb Cream,Trigen Laboratories,Inc.	Predicate Device:K123724Dermiseb Cream,IGI Laboratories, Inc.	Predicate Device:K120730Loutrex Topical Cream,Acella Pharmaceuticals,LLC
		common types of skinirritation, lacerations,abrasions, and minorburns. Alevicyn SGAntipruritic Gel is alsoindicatedfor the management ofirritation and pain fromminor burns, includingsunburn.
Mechanism ofAction	Skin barrier emollient andmoisturizer	Same	Water based Emollient	Water based Emollient	Water based Emollient
DeliverySystem	Bottle, Spray Gel	Same	Tube	Tube	Tube
PhysicalCharacteristics	Appearance: Opaque Colorlesssemi viscous gelOdor: Slightly Chlorinated	Same	Appearance: Off WhiteCreamOdor: Fragrance Free	Appearance: Off WhiteCreamOdor: Fragrance Free	Appearance: OffWhite/Yellow CreamOdor: Fragrance Free
Sterility Claim	Non-sterilePreserved/Conforming to USP<51>	Same	Non Sterile	Non Sterile	Non Sterile
Shelf Life	24 months	Same	>1 year	>1 year	>1 year
Source	Sponsor/Manufacturer	Sponsor/Manufacturer	Labeling	Labeling	Labeling

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Image /page/6/Picture/0 description: The image shows the text "K152945" in a simple, sans-serif font. The text is black against a white background. The characters are evenly spaced and clearly legible.

Image /page/6/Picture/1 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized gold-colored graphic above the company name. The text "OCULUS" is in a bold, sans-serif font, and below it, in a smaller font, is the text "Innovative Sciences."

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Image /page/7/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized, abstract design of interconnected golden rings above the company name. The text "OCULUS" is in bold, black letters, and below it, in smaller font, are the words "Innovative Science".

VII. PERFORMANCE DATA

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

Biocompatibility Testing

The biocompatibility evaluation for the Alevicyn SG Gel 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. The solution is considered a breached/compromised surface device with limited contact.

Bench Testing

The following tests were reviewed to support the performance of Alevicyn SG Gel: package integrity, visual inspection, pH, Free Available Chlorine (FAC). The Alevicyn SG Gel meets specification and performance characteristics and is substantially equivalent to the predicate device.

VIII. CONCLUSION

Alevicyn SG Gel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to Alevicyn SG Gel (K143590), TL Triseb Cream (K121134), Dermiseb Cream (K123724), and Loutrex Topical Cream (K120730). Therefore, the Oculus Alevicyn SG Gel is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A