(109 days)
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.
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.
The provided text describes the submission of a 510(k) premarket notification for the "Hydrocleanse Wound Care Solution." This document is a regulatory filing with the FDA and primarily focuses on establishing substantial equivalence to previously approved devices. It does not contain information about a specific study designed to prove the device meets acceptance criteria in the way a diagnostic or AI-powered device would.
The "Performance Testing" section states: "The Oculus Hydrocleanse Wound Care Solution meets specification and performance characteristics and is substantially equivalent to the predicate devices."
The "Biocompatibility Testing" section states: "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."
Based on the provided text, I cannot describe acceptance criteria and a study proving the device meets those criteria in the context of a diagnostic or AI device (e.g., sensitivity, specificity, accuracy, etc.) because this is a wound care solution, and the document is a regulatory submission for premarket notification, not a clinical trial report.
Here's an analysis based on what is available, along with explanations for missing information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics like sensitivity, specificity, or accuracy, which are typical for diagnostic devices. Instead, the "performance" is described qualitatively as meeting specifications and being substantially equivalent to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence | Meets specification and performance characteristics and is substantially equivalent to the predicate devices. |
| Biocompatibility | Confirmed to meet applicable requirements of Blue Book Memorandum G95-1 (ISO-10993) and is biocompatible. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document doesn't describe a "test set" in the context of evaluating a diagnostic algorithm. The "testing" referred to (Performance and Biocompatibility) would have involved laboratory studies on the solution itself, rather than clinical data from human subjects in the sense of a test set for a diagnostic or AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Ground truth establishment for a test set is not applicable to this type of device and regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for studies involving human interpretation or challenging cases, not for the type of testing described for a wound care solution.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was mentioned or implied. This type of study is specific to medical imaging or diagnostic AI, not to a wound care solution.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such standalone performance evaluation was mentioned or implied. This is a characteristic of AI or diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic or AI devices (e.g., confirmed pathology) is not explicitly detailed. For biocompatibility, the "ground truth" would be compliance with ISO standards. For "performance characteristics," it would refer to the physical, chemical, and biological properties of the solution meeting pre-defined specifications.
8. The sample size for the training set
This information is not provided. A "training set" is relevant for machine learning algorithms, which is not applicable to this wound care solution.
9. How the ground truth for the training set was established
This information is not provided as there is no training set mentioned.
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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.
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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
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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
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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) OwnerOculus Innovative Sciences, Inc.1129 North McDowell Blvd.Petaluma, CA 94954Phone: (707) 283-0550Fax: (707) 283-0551 | Official ContactBrian W. MartinDirector of Regulatory Affairs and QualityControl |
|---|---|
| Device InformationTrade or ProprietaryName: | Oculus Hydrocleanse Wound Care Solution |
| Common Name: | Wound Cleanser |
| Classification Name: | Solution, Saline, Wound Dressing |
| Regulation: | Unclassified |
| Product Code(s) | FRO |
| Legally marketeddevice(s) to whichequivalence is claimed: | Primary Care Solutions Sterile Water and Sterile Saline (K082330),Vashe Wound Therapy Solution (K093697, K123072), and VasheWound 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 ofwound dressings, wound debridement, and use with devicesintended for wound irrigation with a pH range of 4.0 - 5.8. Thesolution will be supplied in polyethylene terephthalate (PET)round-bottles with polypropylene (PP) screw-top closure andsprayer. |
| 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 includingmicroorganisms and debris from exudating wounds, acute andchronic dermal lesions including stage I-IV pressure ulcers, stasisulcers, diabetic ulcers, post-surgical wounds, first- and second- |
| degree bums, abrasions, minor irritations of the skin, diabetic footulcers, ingrown toe nails, grafted/donor sites and exit sites. It is alsintended for use to moisten and lubricate wound dressings and foruse with devices intended to irrigate wounds. | |
| OTC Indications: OTC Hydrocleanse™ Solution is intended forOTC use in the management of skin abrasions, lacerations, minorirritations, cuts, and intact skin. | |
| Performance Testing | The Oculus Hydrocleanse Wound Care Solution meetsspecification and performance characteristics and is substantiallyequivalent to the predicate devices. |
| BiocompatibilityTesting | Biocompatibility Testing of the Oculus Hydrocleanse Wound CareSolution confirmed that the device meets the applicablerequirements of the Blue Book Memorandum G95-1 entitled Useof International Standards ISO-10993 Biological Evaluation ofMedical Devices and is biocompatible. |
| Safety andEffectiveness | The Oculus Hydrocleanse Wound Care Solution does not raise anynew safety and efficacy concerns when compared to a similardevice already legally marketed. |
| SubstantialEquivalence (SE)Rationale | The Oculus Hydrocleanse Wound Care Solution issubstantially equivalent in intended use, technologicalcharacteristics, safety, and effectiveness to the Primary CareSolutions Sterile Water and Sterile Saline and Vashe WoundTherapy Solution. Therefore, the Oculus HydrocleanseWound Care Solution is substantially equivalent to thepredicate devices. |
| Submitted by: | Brian W. MartinDirector of Regulatory Affairs and Quality Control |
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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
N/A