Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms 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 bums, 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: Microcyn Plus is intended for use in the management of skin abrasions, minor irritations, cuts, and intact skin.

Device Description

The Oculus Microcyn Plus Wound Care Solution is a colorless, slightly chlorinated odor, clear aqueous solution for moistening of wound dressings, wound debridement, and use with devices intended for wound irrigation with a pH range of 3.5 - 6.0. The solution will be supplied in 40mL glass vials with Teflon lined closures.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets these criteria in the format requested.

The document is a 510(k) summary for a medical device (Microcyn Plus Wound Care Solution) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria through a detailed clinical or comparative effectiveness study.

Here's what can be extracted from the text related to performance, but it does not fulfill all the requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity)	Met through testing in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
Physical/Chemical Performance (package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume)	Meets specification and performance characteristics.
Microbiological Purity (USP <51> and USP<61>)	Meets specification and performance characteristics.

Missing Information for this Section: The document does not specify quantitative acceptance criteria (e.g., "pH must be between X and Y") for most tests, only that the device "meets specification and performance characteristics."

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

Test Set Sample Size: Not specified for any of the performance tests (biocompatibility, bench testing).
Data Provenance: Not specified. These appear to be laboratory tests conducted on the device itself, rather than human or animal studies with specific geographical or temporal provenance.

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

Not applicable. The tests performed are laboratory-based and do not involve expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

Not applicable. The tests are laboratory measurements, not subjective evaluations 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:

No MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported. This device is a wound care solution, not an AI diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

For biocompatibility: Adherence to recognized international standards and FDA guidance for biological evaluation.
For bench testing (physical/chemical/microbiological): Adherence to predefined specifications and USP standards.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

Summary of what the document confirms regarding device performance:

The document primarily states that the Microcyn Plus Wound Care Solution underwent various laboratory tests to establish its safety and performance characteristics, specifically:

Biocompatibility Testing: Conducted according to FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Tests included Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity. The device is considered a "breached/compromised surface device with limited contact."
Bench Testing: Performed to assess package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume, USP <51> (Antimicrobial Effectiveness Testing), and USP <61> (Microbial Enumeration Tests).

The conclusion is that the Microcyn Plus Wound Care Solution "meets specification and performance characteristics and is substantially equivalent to the predicate device." However, concrete numerical acceptance criteria and the detailed methodology for proving those criteria for each test are not explicitly provided in this 510(k) summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

August 19, 2016

Oculus Innovative Sciences Mr. Brian Martin Director of Regulatory Affairs and Quality Control 1129 N. McDowell Boulevard Petaluma, CA 94954

Re: K161034

Trade/Device Name: Microcyn Plus Wound Care Solution Regulatory Class: Unclassified Product Code: FRO Dated: July 5, 2016 Received: July 13, 2016

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 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.

{1}------------------------------------------------

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/Resourcesfor You/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 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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K161034

Device Name Microcyn Plus Solution

Indications for Use (Describe)

Rx Indications:

Under the supervision of a healthcare professional, Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms 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 bums, 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:

Microcyn Plus is intended for use in the management of skin abrasions, minor irritations, cuts, and intact skin.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized gold-colored graphic above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Science" in a smaller, lighter font.

1 510(k) SUMMARY

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

SUBMITTER I.

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: August 11, 2016

II. DEVICE

Name of Device: Oculus Microcyn Plus Wound Care Solution Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline, Wound Dressing Regulatory Class: Unclassified Product Code: FRO

III. PREDICATE DEVICE

Oculus Hydrocleanse (K141012) and Vashe Wound Care Solution manufactured by Puricore (K131848).

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

Rx Indications:

Under the supervision of a healthcare professional. Microcyn Plus is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized graphic of three overlapping golden rings, resembling an atom. Below the graphic, the word "OCULUS" is written in bold, black letters. Underneath "OCULUS", the words "Innovative Science" are written in a smaller, lighter font.

including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree bums, 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:

Microcyn Plus is intended for use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Science" in a smaller font underneath. Above the word "OCULUS" is a graphic of three overlapping ellipses, which are gold in color. The background of the image is white.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Submitter/Holder	Proposed Device:Microcyn Plus SolutionOculus Innovative Sciences	Predicate Device: K141012Hydrocleanse Wound CareSolutionOculus Innovative Sciences	Predicate Device: K131848Vashe Wound SolutionPuricore Inc.
IndicationsforUse	Rx Indications:Under the supervision of ahealthcare professional, MicrocynPlus is intended for the cleansing,irrigation, moistening, debridementand removal of foreign materialincluding microorganisms and debrisfrom exudating wounds, acute andchronic dermal lesions includingstage I-IV pressure ulcers, stasisulcers, diabetic ulcers, post-surgicalwounds, first- and second-degreebums, abrasions, minor irritations ofthe skin, diabetic foot ulcers,ingrown toe nails, grafted/donor sitesand exit sites. It is also intended foruse to moisten and lubricate wounddressings and for use with devicesintended to irrigate wounds.OTC Indications:Microcyn Plus is intended for use inthe management of skin abrasions,lacerations, minor irritations, cuts,and intact skin.	Rx Indications:Under the supervision of a healthcareprofessional, Hydrocleanse TM Solutionis intended for the cleansing, irrigation,moistening, debridement and removalof foreign material includingmicroorganisms and debris fromexudating wounds, acute and chronicdermal lesions including stage I-IVpressure 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 intendedfor use to moisten and lubricate wounddressings and for use with devicesintended to irrigate wounds.OTC Indications:Hydrocleanse TM Solution is intendedfor OTC use in the management of skinabrasions, lacerations, minor irritations,cuts, and intact skin.	Rx Indications: Under thesupervision of healthcareprofessionals, Vashe WoundSolution is intended forcleansing, irrigating,moistening, debridement andremoval of foreign materialincluding microorganisms anddebris from exudating and/ordirty wounds, acute andchronic dermal lesions, such asStage I-IV pressure ulcers,stasis ulcers, diabetic ulcers,post-surgical wounds, first andsecond degree burns, abrasions,minor irritations of the skin,diabetic foot ulcers, ingrowntoe nails, grafted and donorsites, and exit sites. It is alsointended for moistening andlubricating absorbent wounddressings.
SterilityClaim	Non-sterile	Same	Same
Mechanismof Action	Dirt debris and foreign material aremechanically removed by the actionof the fluid moving across thewound. Provides moisture andrehydration.	Dirt debris and foreign material aremechanically removed by the action ofthe fluid moving across the wound.	The mechanism of fluidmoving across the wound aidsin the physical removal offoreign objects, foreign debrisand exudate from a wound.
DeliverySystem	Aqueous Solution	Aqueous Solution	Aqueous Solution

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the text 'K161034' in a clear, sans-serif font. The text is presented in a dark blue color, which contrasts with the white background. The letters and numbers are evenly spaced and easily readable. The overall impression is clean and straightforward.

Image /page/6/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized golden swirl of three overlapping circles above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the tagline "Innovative Science" in a smaller, lighter font.

VII. PERFORMANCE DATA

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

Biocompatibility Testing

The biocompatibility evaluation for the Microcyn Plus 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.

Testing Completed: Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity

Bench Testing

The following tests were performed to support the performance of Microcyn Plus Wound Care Solution: package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume, USP <51> and USP<61>. The Microcyn Plus Wound Care Solution meets specification and performance characteristics and is substantially equivalent to the predicate device.

CONCLUSION VIII.

Microcyn Plus Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Hydrocleanse Wound Solution manufactured by Oculus Innovative Sciences (K141012) and Vashe Wound Care Solution manufactured by Puricore (K131848). Therefore, the Microcyn Plus Solution is substantially equivalent to the predicate devices.

Regulation Number and Section

N/A