DERMACYN WOUND CARE

K060113 · Oculus Innovative Sciences, Inc. · FRO · Feb 22, 2006 · SU

Device Facts

• Record ID: K060113
• Device Name: DERMACYN WOUND CARE
• Applicant: Oculus Innovative Sciences, Inc.
• Product Code: FRO · SU
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Dermacyn™ Wound Care is intended for moistening absorbent wound dressings and for debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.

Device Story

Dermacyn Wound Care is a liquid wound cleansing solution. It functions via mechanical action of fluid moving across the wound surface to moisten dressings and remove foreign objects, dirt, and debris from dermal wounds. The device is provided in various bottle sizes, optionally with a trigger spray. It is intended for use in clinical or home settings to aid in wound management and cleaning. The healthcare provider or patient applies the solution to the wound site to facilitate debridement and cleaning, potentially benefiting the patient by maintaining a moist wound environment and removing contaminants.

Clinical Evidence

Non-clinical testing only. Biocompatibility and performance testing were conducted to confirm safety and effectiveness.

Technological Characteristics

Liquid wound cleansing solution. Mechanical action via fluid irrigation. Supplied in various bottle sizes with optional trigger spray. No electronic components or software.

Indications for Use

Indicated for moistening absorbent wound dressings and cleaning/debriding acute and chronic dermal lesions including Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, and minor skin irritations.

Predicate Devices

• Allclenz™ Cleanser; Healthpoint Medical (K965120)
• CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. (K022670)

Submission Summary (Full Text)

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Premarket Notification for Dermacyn Wound Care Traditional 510(k) January 13, 2006

Koco113

### Appendix 6

2/22/06

## 510(k) Summary of Dermacyn™ Wound Care

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R 807.92. |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Oculus Innovative Sciences<br>1129 North McDowell Blvd.<br>Petaluma, CA 94954 |
| Contact Person | Tammy Atwood Quality Assurance Manager<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | January 13, 2006 |
| Trade Name | Dermacyn™ Wound Care |
| Common Name | Wound Cleanser |
| Classification Name | Liquid Bandage |
| Predicate Device | Allclenz™ Cleanser; Healthpoint Medical K965120, Mar. 21st, 1997<br>CarraKlenz Wound Cleanser; Carrington Laboratories, Inc. K022670, Oct.<br>17th, 2002 |
| Description | The subject device is a wound cleansing solution that is intended for the<br>moistening and debriding of dermal wounds. The mechanical action of<br>fluid moving across the wound provides for the mechanism of action and<br>aids in the removal of foreign objects such as dirt and debris. The subject<br>device is offered in various bottle sizes with and without a trigger spray. |
| Indications for Use | Dermacyn™ Wound Care is intended for moistening absorbent wound<br>dressings and for debriding and cleaning acute and chronic dermal lesions,<br>such as Stage I-IV pressure ulcers, statis ulcers, diabetic ulcers, post-<br>surgical wounds, first and second degree burns, abrasions and minor<br>irritations of the skin. |
| Substantial Equivalence | The product is similar in function and intended use to Allclenz and<br>CarraKlenz/Ultraklenz Wound Cleansers manufactured by Healthpoint<br>Medical and Carrington Laboratories, Inc., respectively, and includes<br>among its labeled uses the cleansing of wounds and removal of foreign<br>material from dermal wounds. |
| Non-clinical Performance | Non-clinical testing was conducted to confirm the safe and effective<br>performance of Dermacyn™ Wound Care. Non-clinical testing also<br>demonstrated the biocompatibility of the subject device. |
| Conclusion | Dermacyn™ Wound Care is substantially equivalent to the currently<br>cleared and marketed Allclenz and CarraKlenz/Ultraklenz Wound<br>Cleansers. |

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Oculus Innovative Sciences, Inc. considers this application to be confidential and not subject to disclosure without the express written consent of the applicant.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with curved lines forming the faces and necks. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Oculus Innovative Sciences, Inc. c/o Ms. Tammy Atwood Manager, Quality Assurance 1129 N. McDowell Blvd. Petaluma, California 94954

Re: K060113

Trade/Device Name: Dermacyn™ Wound Care Regulatory Class: Unclassified Product Code: FRO Dated: January 13, 2006 Received: January 17, 2006

Dear Ms. Atwood:

This letter corrects our substantially equivalent letter of February 22, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 9 rotty premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule, to regarly manatised provice American of the Federal Food. Drug commerce prof to May 20, 1970, the enastinone with the provisions of the Federal Food, Drug, devices that have been reclassified in accessaries approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a president of the Act. The and Cosment Act (Act) that do not require approvine the general controls provisions of the Act. The You may, merelore, market the device, sucject to increases for annual registration, listing of
general controls provisions of the Act include requirements for annual registra general controls provisions of the receinentals requirements.
devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mho child cases in personations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlis: Existing increase of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may
1 be louid in the Code of Peacharters)
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 Please be advised that FDA s issualice of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies with one must that FDA nas made a determination that your are rose overpress. You must or any Peteral statures and regulations daministers or registration and listing (21 l
comply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, monation readies requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sectroni CFR Part 807); labeling (21 CFR Part 800); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the electroni forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Atwood

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Mark H Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# KO60113 f. 1.42

Premarket Notification for Dermacyn Wound Care Traditional 510(k) February 17, 2006

#### Appendix 5 - Revised

#### Statement of Indication for Use

510(k) Number: K060113

Device Name: Dermacyn™ Wound Care

Indications for Use:

Dermacyn™ is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.

Prescription Use (Per 21 CFR 801.109) OR Over-The Counter Use X

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)
EQMDE

Division Sign-Division of General. Rastorative, and Neurological Devices

KO60113 519(k) Number_

Oculus Innovative Sciences, Inc. considers this application to be confidential and not subject to disclosure without the express written consent of the applicant.