DERMACYN WOUND IRRIGATION

K042729 · Oculus Innovative Sciences, Inc. · FRO · May 17, 2005 · SU

Device Facts

• Record ID: K042729
• Device Name: DERMACYN WOUND IRRIGATION
• Applicant: Oculus Innovative Sciences, Inc.
• Product Code: FRO · SU
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Dermacyn™ Wound Cleanser is intended for moistening and debriding 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 Cleanser is a topical solution for cleansing dermal wounds. Mechanism of action relies on mechanical fluid movement across the wound surface to facilitate removal of foreign objects, dirt, and debris. Device is supplied in various bottle sizes for clinical or home use. Healthcare providers or patients apply the solution to moisten and debride lesions; this process aids in wound bed preparation and cleaning, potentially supporting the healing environment.

Clinical Evidence

Bench testing only. Non-clinical testing confirmed safe and effective performance; pre-clinical testing demonstrated biocompatibility.

Technological Characteristics

Wound cleansing solution. Mechanical action via fluid irrigation. No electronic components, software, or energy sources. Biocompatible formulation.

Indications for Use

Indicated for patients with 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 (K965120)
• CarraKlenz Wound Cleanser (K022670)

Submission Summary (Full Text)

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| 510(k) Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of 21 C.F.R §<br>807.92. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Oculus Innovative Sciences<br>1129 North McDowell Blvd.<br>Petaluma, CA 94954 |
| Contact Person | Theresa Mitchell<br>QA/RA VicePresident<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | September 30th, 2004 |
| Trade Name | Dermacyn™ Wound Cleanser |
| Common Name | Wound Cleanser |
| Classification Name | Solution, saline (wound dressing) |
| Predicate Device | Allclenz™ Cleanser; Healthpoint Medical K965120, Mar. 21st, 1997<br>CarraKlenz Wound Cleanser; Carrington Laboratories, Inc.<br>K022670, Oct. 17th, 2002 |
| Description | The subject device is a wound cleansing solution that is intended for<br>the cleansing of dermal wounds. The mechanical action of fluid<br>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<br>subject device is offered in various bottle sizes. |
| Indications for Use | Dermacyn™ Wound Cleanser is intended for moistening and<br>debriding acute and chronic dermal lesions, such as Stage I-IV<br>pressure ulcers, statis ulcers, diabetic ulcers, post-surgical wounds,<br>first and second degree burns, abrasions and minor irritations of the<br>skin. |
| Substantial Equivalence | The product is similar in function and intended use to Allclenz and<br>CarraKlenz Wound Cleansers manufactured by Healthpoint Medical<br>and Carrington Laboratories, Inc. and includes among its labeled<br>uses the cleansing of wounds and removal of foreign material from<br>dermal wounds. |
| Non-clinical<br>Performance | Non-clinical testing was conducted to confirm the safe and effective<br>performance of Dermacyn™ Wound Cleanser. Pre-clinical testing<br>also demonstrated the biocompatibility of the subject device. |
| Conclusion | Dermacyn™ Wound Cleanser is substantially equivalent to the<br>currently cleared and marketed Allclenz and CarraKlenz Wound<br>Cleansers |

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

Oculus Innovative Sciences, Inc.
Dermacyn™ Wound Cleanser_____________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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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 and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

MAR 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Zachary J. Woodson OA/RA Consultant Oculus Innovative Sciences, Inc. 1129 North McDowell Boulevard Petaluma, California 94954

Re: K042729 Trade/Device Name: Dermacyn™ Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: February 8, 2005 Received: February 9, 2005

Dear Mr. Woodson:

This letter corrects our substantially equivalent letter of May 17, 2005.

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 -- Mr. Zachary J. Woodson

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 promance noticated 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 if you a 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 other general so 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.

Mark N. Millman

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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K042729

## Indications for Use

510(k) Number (if known):

Device Name: Dermacyn™ Wound Cleanser

Dermacyn Wound Cleanser is intended for moistening and Indications for Use: debriding 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.

**Prescription Use** ✗ AND/OR **Over-The-Counter Use**
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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. Vision of Ganetal, RestoreBir .nd Neurological | Durines

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