Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Device Description

Microcyn® Scar Management HydroGel is a translucent, silicone oil containing hydrogel which is intended for the management of old and new scars including hypertrophic and keloid scarring, on scars resulting from general surgical procedures, as well as trauma wounds, and burns. The product is intended to be applied to intact skin. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The mixture of hypochlorous acid and sodium hypochlorite act as a preservative in the non-sterile product to inhibit microbial growth during storage and repeat use. The preservative is identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient based on the

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called Microcyn® Scar Management HydroGel. This is a Class I device and the submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, not to prove that the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device would.

Therefore, many of the requested categories (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for this device.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria or performance metrics in terms of sensitivity, specificity, F1-score, etc., as would be common for AI/ML devices. Instead, the "acceptance criteria" for this submission are fundamentally about demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, safety, and effectiveness.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Meets specification and performance characteristics	"The Microcyn® Scar Management HydroGel meets specifications and performance characteristics"
Biocompatible according to ISO-10993	"Biocompatibility Testing... confirmed that the device meets the applicable requirements... and is biocompatible."
Well-tolerated in study population	"The Microcyn® Scar Management HydroGel was well tolerated in the study population"
Efficacy indicates substantial equivalence to predicate device	"efficacy results indicate substantial equivalence to the predicate device, Kelo-cote® Scar Gel."
Does not raise new safety and efficacy concerns	"The Microcyn® Scar Management HydroGel does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed."
Substantially equivalent in intended use, technological characteristics, safety, and effectiveness to predicates (Kelo-Cote Topical™ Gel and Beau Rx Scar Care Gel)	"The Microcyn® Scar Management HydroGel is substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the Kelo-Cote Topical™ Gel and Beau Rx Scar Care Gel."

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

Sample Size: Not specified for any "test set" in the context of an AI/ML device evaluation. The document mentions a "study population" for clinical testing, but the specific number of participants is not provided.
Data Provenance: Not specified. It's a clinical study, likely prospective, but no details on country of origin are given.

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

Number of Experts: Not applicable. This type of submission does not involve "ground truth" derived by experts for diagnostic or AI/ML performance evaluation. The clinical study would have assessed outcomes based on standard clinical evaluations.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Not applicable. There's no "test set" or adjudication process described for establishing ground truth as understood in AI/ML validation studies.

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 device is a topical hydrogel, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used:

Not applicable in the context of AI/ML validation. For the clinical study, efficacy would likely be based on clinical assessments of scar appearance, symptoms, and physician/patient satisfaction, typically compared to the predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable.

Summary

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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.

510(k) Owner

Oculus Innovative Sciences, Inc. 1129 North McDowell Blvd. Petaluma, CA 94954 Phone: (707) 283-0550 Fax: (707) 283-0551

NOV 15 2013

Official Contact

Brian W. Martin Director of Regulatory Affairs and Quality. Control

Device Information

Trade or Proprietary Name:	Microcyn® Scar Management HydroGel
Common Name:	Silicone Scar Gel
Classification Name:	Elastomer, Silicone, for Scar Management
Regulation:	Class 1 per 21CFR §878.4025
Product Code(s)	PFP
Legally marketed device(s)to which equivalence isclaimed:	Kelo-Cote Topical™ Gel manufactured by Advanced Bio-Technologies, cleared for distribution via 510(k) K002488
	Beau Rx Scar Care Gel currently marketed as Atopiclair®manufactured by Beau Rx Solutions, LLC, cleared fordistribution via 510(k) K083718
Reason for 510(k)submission	New Device
Device Description	Microcyn® Scar Management HydroGel is a translucent, siliconeoil containing hydrogel which is intended for the management ofold and new scars including hypertrophic and keloid scarring, onscars resulting from general surgical procedures, as well astrauma wounds, and burns. The product is intended to be appliedto intact skin. The product is preserved with a unique mixture ofhypochlorous acid and sodium hypochlorite generated through aproprietary process. The mixture of hypochlorous acid andsodium hypochlorite act as a preservative in the non-sterileproduct to inhibit microbial growth during storage and repeat use.The preservative is identified by the Center for Drug Evaluationand Research (CDER) as an inactive ingredient based on the
Intended Use	Rx INDICATIONS: Under the supervision of a health careprofessional, Microcyn® Scar Management HydroGel is intendedfor the management of old and new hypertrophic and keloidscarring on scars resulting from burns, general surgicalprocedures and trauma wounds.OTC INDICATIONS: Microcyn® Scar Management HydroGelis intended for the management of old and new hypertrophic andkeloid scarring on scars resulting from burns, general surgicalprocedures and trauma wounds.
Performance Testing	The Microcyn® Scar Management HydroGel meets specificationand performance characteristics and is substantially equivalent tothe predicate device.
Biocompatibility Testing	Biocompatibility Testing of the Microcyn® Scar ManagementHydroGel confirmed that the device meets the applicablerequirements of the Blue Book Memorandum G95-1 entitled Useof International Standards ISO-10993 Biological Evaluation ofMedical Devices and is biocompatible.
Clinical Testing	The Microcyn® Scar Management HydroGel was well toleratedin the study population and efficacy results indicate substantialequivalence to the predicate device, Kelo-cote® Scar Gel.
Safety and Effectiveness	The Microcyn® Scar Management HydroGel does not raise anynew safety and efficacy concerns when compared to a similardevice already legally marketed.
Substantial Equivalence(SE) Rationale	The Microcyn® Scar Management HydroGel is substantiallyequivalent in intended use, technological characteristics, safety,and effectiveness to the Kelo-Cote Topical™ Gel and Beau RxScar Care Gel. Therefore, the Microcyn® Scar ManagementHydroGel is substantially equivalent to the predicate devices.
Submitted by:	Brian W. MartinDirector of Regulatory Affairs and Quality Control

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Date Submitted:

ﺔ ﺍﻟﻘﺪﻡ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ

11/13/2013

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

November 15, 2013

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

Rc: K131672

Trade/Device Name: Microcyn™ Scar Management HydroGel Regulation Number: 21 CFR 878.4025 Regulation Name: Elastomer, Silicone, for Scar Management Regulatory Class: Class I Product Code: PFP Dated: September 24. 2013 Received: October 1, 2013

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 (reporting of medical

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Page 2 - Mr. Brian W. Martin

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

David Krause -S

for Mark N. Melkerson

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510{k} Number (if known) K131672

Device Name

Microcyn® Scar Management HydroGel

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY . . . . . . · . ..

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Regulation Number and Section

§ 878.4025 Silicone sheeting.

(a)
Identification. Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.