← Product Code FRO · K141012 # HYDROCLEANSE WOUND CARE SOLUTION (K141012) _Oculus Innovative Sciences · FRO · Aug 8, 2014 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K141012 ## Device Facts - **Applicant:** Oculus Innovative Sciences - **Product Code:** FRO - **Decision Date:** Aug 8, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Rx Indications: Under the supervision of a healthcare professional, Hydrocleanse™ Solution 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: Hydrocleanse™ Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. ## Device Story Hydrocleanse Wound Care Solution is a clear, aqueous, slightly chlorinated-odor solution; pH range 4.0-5.8. Used for wound cleansing, irrigation, debridement, and moistening of dressings. Applied by healthcare professionals in clinical settings or by patients for OTC use on minor skin irritations. Supplied in PET bottles with PP closures and sprayers. Acts as a topical wound cleanser to remove debris and microorganisms; facilitates wound healing environment. No complex processing or electronic components. ## Clinical Evidence Bench testing only. Biocompatibility testing confirmed compliance with ISO-10993 standards. ## Technological Characteristics Aqueous solution, pH 4.0-5.8. Materials: Polyethylene terephthalate (PET) bottles, polypropylene (PP) screw-top closure and sprayer. Non-electronic, chemical-based wound cleanser. ## Predicate Devices - Primary Care Solutions Sterile Water and Sterile Saline ([K082330](/device/K082330.md)) - Vashe Wound Therapy Solution ([K093697](/device/K093697.md), [K123072](/device/K123072.md)) - Vashe Wound Solution ([K131848](/device/K131848.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}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 8, 2014 Oculus Innovative Sciences Mr. Brian W. Martin Director of Regulatory Affairs Quality Control 1129 North McDowell Boulevard Petaluma, California 94954 Re: K141012 Trade/Device Name: Hydrocleanse Wound Care Solution Regulatory Class: Unclassified Product Code: FRO Dated: May 9, 2014 Received: May 12, 2014 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K141012 Device Name Oculus Hydrocleanse Wound Care Solution #### Indications for Use (Describe) OTC INDICATIONS: Hydrocleanse™ Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. Rx INDICATIONS: Under the supervision of a healthcare professional, Hydrocleanse™ Solution 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. #### Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # Jiyoung Dang -S This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized golden swirl above the word "OCULUS" in bold, black letters. Below "OCULUS" is the text "Innovative Sciences" in a smaller, lighter font. ## 9.0 510(k) SUMMARY The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92. | 510(k) Owner
Oculus Innovative Sciences, Inc.
1129 North McDowell Blvd.
Petaluma, CA 94954
Phone: (707) 283-0550
Fax: (707) 283-0551 | Official Contact
Brian W. Martin
Director of Regulatory Affairs and Quality
Control | |-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Information
Trade or Proprietary
Name: | Oculus Hydrocleanse Wound Care Solution | | Common Name: | Wound Cleanser | | Classification Name: | Solution, Saline, Wound Dressing | | Regulation: | Unclassified | | Product Code(s) | FRO | | Legally marketed
device(s) to which
equivalence is claimed: | Primary Care Solutions Sterile Water and Sterile Saline (K082330),
Vashe Wound Therapy Solution (K093697, K123072), and Vashe
Wound Solution (K131848) | | Reason for 510(k)
submission | New Device | | Device Description | The Oculus Hydrocleanse 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 4.0 - 5.8. The
solution will be supplied in polyethylene terephthalate (PET)
round-bottles with polypropylene (PP) screw-top closure and
sprayer. | | Intended Use | Rx Indications: Under the supervision of a healthcare professional,
Hydrocleanse™ Solution 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, 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 als
intended for use to moisten and lubricate wound dressings and for
use with devices intended to irrigate wounds. | | | OTC Indications: OTC Hydrocleanse™ Solution is intended for
OTC use in the management of skin abrasions, lacerations, minor
irritations, cuts, and intact skin. | | Performance Testing | The Oculus Hydrocleanse Wound Care Solution meets
specification and performance characteristics and is substantially
equivalent to the predicate devices. | | Biocompatibility
Testing | Biocompatibility Testing of the Oculus Hydrocleanse Wound Care
Solution confirmed that the device meets the applicable
requirements of the Blue Book Memorandum G95-1 entitled Use
of International Standards ISO-10993 Biological Evaluation of
Medical Devices and is biocompatible. | | Safety and
Effectiveness | The Oculus Hydrocleanse Wound Care Solution does not raise any
new safety and efficacy concerns when compared to a similar
device already legally marketed. | | Substantial
Equivalence (SE)
Rationale | The Oculus Hydrocleanse Wound Care Solution is
substantially equivalent in intended use, technological
characteristics, safety, and effectiveness to the Primary Care
Solutions Sterile Water and Sterile Saline and Vashe Wound
Therapy Solution. Therefore, the Oculus Hydrocleanse
Wound Care Solution is substantially equivalent to the
predicate devices. | | Submitted by: | Brian W. Martin
Director of Regulatory Affairs and Quality Control | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Sciences. The logo features a stylized gold-colored graphic above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Sciences" in a smaller font size. Date Submitted: April 18, 2014 --- **Source:** [https://fda.innolitics.com/device/K141012](https://fda.innolitics.com/device/K141012) **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