Microcyn Plus Wound Care Solution

K161034 · Oculus Innovative Sciences · FRO · Aug 19, 2016 · SU

Device Facts

• Record ID: K161034
• Device Name: Microcyn Plus Wound Care Solution
• Applicant: Oculus Innovative Sciences
• Product Code: FRO · SU
• Decision Date: Aug 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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 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 Story

Microcyn Plus is a clear, aqueous wound care solution; pH 3.5-6.0. Used for cleansing, irrigation, moistening, and debridement of wounds. Applied by healthcare professionals or patients (OTC). Mechanism: mechanical removal of debris and foreign material via fluid flow; provides moisture/rehydration. Supplied in 40mL glass vials with Teflon-lined closures. Benefits: aids wound management by removing microorganisms and debris, maintaining moist environment. No complex electronics or software.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (cytotoxicity, irritation, sensitization, systemic toxicity). Bench testing included package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume, and USP <51>/<61> testing.

Technological Characteristics

Aqueous solution; pH 3.5-6.0. Supplied in 40mL glass vials with Teflon-lined closures. Non-sterile. Mechanism: mechanical irrigation/debridement. No electronic components, software, or energy sources.

Indications for Use

Indicated for cleansing, irrigation, moistening, and debridement of exudating wounds, acute/chronic dermal lesions (stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, 1st/2nd degree burns, abrasions, minor skin irritations, diabetic foot ulcers, ingrown toe nails, grafted/donor sites, exit sites) and for moistening/lubricating wound dressings. OTC use for skin abrasions, minor irritations, cuts, and intact skin.

Predicate Devices

• Oculus Hydrocleanse (K141012)
• Vashe Wound Care Solution (K131848)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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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: [phone] Fax: [phone]

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.

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.

#### 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

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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.

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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/<br>Holder | Proposed Device:<br>Microcyn Plus Solution<br>Oculus Innovative Sciences | Predicate Device: K141012<br>Hydrocleanse Wound Care<br>Solution<br>Oculus Innovative Sciences | Predicate Device: K131848<br>Vashe Wound Solution<br>Puricore Inc. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for<br>Use | Rx Indications:<br>Under the supervision of a<br>healthcare professional, Microcyn<br>Plus is intended for the cleansing,<br>irrigation, moistening, debridement<br>and removal of foreign material<br>including microorganisms and debris<br>from exudating wounds, acute and<br>chronic dermal lesions including<br>stage I-IV pressure ulcers, stasis<br>ulcers, diabetic ulcers, post-surgical<br>wounds, first- and second-degree<br>bums, abrasions, minor irritations of<br>the skin, diabetic foot ulcers,<br>ingrown toe nails, grafted/donor sites<br>and exit sites. It is also intended for<br>use to moisten and lubricate wound<br>dressings and for use with devices<br>intended to irrigate wounds.<br>OTC Indications:<br>Microcyn Plus is intended for use in<br>the management of skin abrasions,<br>lacerations, minor irritations, cuts,<br>and intact skin. | Rx Indications:<br>Under the supervision of a healthcare<br>professional, Hydrocleanse TM Solution<br>is intended for the cleansing, irrigation,<br>moistening, debridement and removal<br>of foreign material including<br>microorganisms and debris from<br>exudating wounds, acute and chronic<br>dermal lesions including stage I-IV<br>pressure ulcers, stasis ulcers, diabetic<br>ulcers, post-surgical wounds, first- and<br>second-degree bums, abrasions, minor<br>irritations of the skin, diabetic foot<br>ulcers, ingrown toe nails, grafted/donor<br>sites and exit sites. It is also intended<br>for use to moisten and lubricate wound<br>dressings and for use with devices<br>intended to irrigate wounds.<br>OTC Indications:<br>Hydrocleanse TM Solution is intended<br>for OTC use in the management of skin<br>abrasions, lacerations, minor irritations,<br>cuts, and intact skin. | Rx Indications: Under the<br>supervision of healthcare<br>professionals, Vashe Wound<br>Solution is intended for<br>cleansing, irrigating,<br>moistening, debridement and<br>removal of foreign material<br>including microorganisms and<br>debris from exudating and/or<br>dirty wounds, acute and<br>chronic dermal lesions, such as<br>Stage I-IV pressure ulcers,<br>stasis ulcers, diabetic ulcers,<br>post-surgical wounds, first and<br>second degree burns, abrasions,<br>minor irritations of the skin,<br>diabetic foot ulcers, ingrown<br>toe nails, grafted and donor<br>sites, and exit sites. It is also<br>intended for moistening and<br>lubricating absorbent wound<br>dressings. |
| Sterility<br>Claim | Non-sterile | Same | Same |
| Mechanism<br>of Action | Dirt debris and foreign material are<br>mechanically removed by the action<br>of the fluid moving across the<br>wound. Provides moisture and<br>rehydration. | Dirt debris and foreign material are<br>mechanically removed by the action of<br>the fluid moving across the wound. | The mechanism of fluid<br>moving across the wound aids<br>in the physical removal of<br>foreign objects, foreign debris<br>and exudate from a wound. |
| Delivery<br>System | Aqueous Solution | Aqueous Solution | Aqueous Solution |

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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.