MICROCYN WOUND CARE DRESSING

K041161 · Oculus Innovative Sciences, Inc. · FRO · May 3, 2005 · SU

Device Facts

• Record ID: K041161
• Device Name: MICROCYN WOUND CARE DRESSING
• Applicant: Oculus Innovative Sciences, Inc.
• Product Code: FRO · SU
• Decision Date: May 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For use in moistening and lubricating absorbent wound dressings for traumatic wounds, cuts, abrasions and minor burns.

Device Story

Dermacyn™ Wound Dressing is a topical solution supplied in an 8-ounce polyethylene bottle for multi-use. It is applied by clinicians or patients to moisten and lubricate absorbent wound dressings used on traumatic wounds, cuts, abrasions, and minor burns. The solution functions as a wound dressing aid to maintain a moist environment, facilitating wound management. It is intended for prescription use.

Clinical Evidence

Bench testing only. Non-clinical performance testing was conducted to compare the device to 0.9% sterile saline. Preclinical testing demonstrated the biocompatibility of the device.

Technological Characteristics

The device is a topical solution packaged in an 8-ounce polyethylene bottle. It is a non-sterile or sterile (as indicated by context of saline comparison) liquid wound dressing aid. No complex electronics, software, or energy sources are utilized.

Indications for Use

Indicated for moistening and lubricating absorbent wound dressings for patients with traumatic wounds, cuts, abrasions, and minor burns.

Predicate Devices

• Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v Sodium Chloride

Submission Summary (Full Text)

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K041161

## MAY - 3 2005

| 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 | Zachary Woodson<br>QA/RA Manager<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | February 1st, 2005 |
| Trade Name | Dermacyn™ Wound Dressing |
| Common Name | Topical Solution |
| Classification Name | Solution, Wound Dressing |
| Predicate Device | Saljet Single Dose Sterile Saline Topical Solution, 0.9% w/v<br>Sodium Chloride |
| Description | The subject device is an 8 ounce polyethylene bottle containing<br>Dermacyn™ Wound Care Dressing intended for multi-use. |
| Indications for Use | For use in moistening and lubricating absorbent wound dressings for<br>traumatic wounds, cuts, abrasions and minor burns. |
| Substantial Equivalence | The product is similar in function and intended use to Saljet Single<br>Dose Sterile Saline Topical Solution manufactured by Winchester<br>Laboratories LL and includes among its labeled uses for moistening<br>and lubricating absorbent wound dressing. |
| Non-clinical<br>Performance | Non-clinical testing was conducted to confirm the safe and effective<br>performance of Dermacyn™ Wound Care Dressing as compared to<br>0.9% sterile saline. Preclinical testing also demonstrated the<br>biocompatibility of the subject device. |
| Conclusion | The Dermacyn™ Wound Care Dressing is substantially equivalent<br>to the currently cleared and marketed Saljet Single Dose Sterile<br>Saline Topical Solution, 0.9% w/v Sodium Chloride. |

## 510(k) Summary of the Dermacyn™ Wound Dressing

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2007

Mr. Zachary J. Woodson QA/RA Manager Oculus Innovative Science, Inc. 1129 North McDowell Boulevard Petaluma, CA 94954

Re: K041161

Trade Name: Dermacyn™ Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 1, 2005 Received: February 2, 2005

Dear Mr. Woodson:

This letter corrects our substantially equivalent letter of May 3, 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 (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 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.

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Page 2 – Mr. Zachary J. Woodson

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.

This letter will allow you to continue 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/dsma/dsmamain.html

Sincerely yours,

pol Dolo R Del Ansitol

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

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K041161

## Indications for Use

510(k) Number (if known): K041161

Device Name: Dermacyn™ Wound Dressing

Dermacyn™ Wound Dressing is intended for use in moistening and Indications for Use: Delinacyn - Wound Dressings for traumatic wounds, cuts, abrasions and minor burns.

X Prescription Use _ (Part 21 CFR 801 Subpart D)

: "

AND/OR

Over-The-Counter Use _ (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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