← Product Code FRO · K042729 # DERMACYN WOUND IRRIGATION (K042729) _Oculus Innovative Sciences, Inc. · FRO · May 17, 2005 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K042729 ## Device Facts - **Applicant:** Oculus Innovative Sciences, Inc. - **Product Code:** FRO - **Decision Date:** May 17, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **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. ## Predicate Devices - Allclenz™ Cleanser ([K965120](/device/K965120.md)) - CarraKlenz Wound Cleanser ([K022670](/device/K022670.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ | 510(k) Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21 C.F.R §
807.92. | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Oculus Innovative Sciences
1129 North McDowell Blvd.
Petaluma, CA 94954 | | Contact Person | Theresa Mitchell
QA/RA VicePresident
Tel: (707) 559-7234
Fax: (707) 283-0551
E-mail: tmitchell@oculusis.com | | 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
CarraKlenz Wound Cleanser; Carrington Laboratories, Inc.
K022670, Oct. 17th, 2002 | | Description | The subject device is a wound cleansing solution that is intended for
the cleansing of dermal wounds. The mechanical action of fluid
moving across the wound provides for the mechanism of action and
aids in the removal of foreign objects such as dirt and debris. The
subject device is offered in various bottle sizes. | | Indications for 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. | | Substantial Equivalence | The product is similar in function and intended use to Allclenz and
CarraKlenz Wound Cleansers manufactured by Healthpoint Medical
and Carrington Laboratories, Inc. and includes among its labeled
uses the cleansing of wounds and removal of foreign material from
dermal wounds. | | Non-clinical
Performance | Non-clinical testing was conducted to confirm the safe and effective
performance of Dermacyn™ Wound Cleanser. Pre-clinical testing
also demonstrated the biocompatibility of the subject device. | | Conclusion | Dermacyn™ Wound Cleanser is substantially equivalent to the
currently cleared and marketed Allclenz and CarraKlenz Wound
Cleansers | ## 510(k) Summary of Dermacyn™ Wound Cleanser Oculus Innovative Sciences, Inc. Dermacyn™ Wound Cleanser_____________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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 {3}------------------------------------------------ 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) . . Vision of Ganetal, RestoreBir .nd Neurological | Durines Page 1 of *_*_ --- **Source:** [https://fda.innolitics.com/device/K042729](https://fda.innolitics.com/device/K042729) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com