OTC: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions. lacerations, minor irritations. cuts, and intact skin.

Professional Use: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended to be used by health care professionals in the management via debridement of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

Device Description

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is a clear hypotonic solution that aids in the mechanical removal of the debris and foreign material from the application site. Dirt debris and foreign material are mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). The device also contains antimicrobial agents that inhibit the growth of microorganisms. Oculus Puracyn™ Skin and Wound Cleanser with Preservatives will be supplied in High Density Polyethylene (HDPE) bottles of various volumes with dosing inserts and caps as described in Section 11.3.

AI/ML Overview

The provided text describes a 510(k) summary for the Oculus Puracyn™ Skin and Wound Cleanser with Preservatives. This is a medical device submission, and as such, the "acceptance criteria" and "device performance" are typically related to proving substantial equivalence to a predicate device and demonstrating safety and effectiveness through laboratory (in-vitro) and potentially animal (in-vivo) studies, rather than clinical studies with human readers or AI algorithms.

Therefore, many of the requested elements (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone algorithm performance, and sample size for training set) are not applicable in this context.

Here's the information derived from the provided text, adapted for the nature of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Need)	Reported Device Performance (Means of Demonstration)
Safety: Device is biocompatible, non-cytotoxic, and non-sensitizing.	Established through biocompatibility testing, in-vitro cytotoxicity testing, and sensitization testing in animal species. Mucosal irritation testing in two animal species also performed.
Mechanical Removal of Debris: Aids in the mechanical removal of debris and foreign material.	Demonstrated by in-vitro studies showing the action of the fluid moving across the wound bed or application site.
Antimicrobial Effectiveness: Inhibits the growth of commonly found microorganisms, including antibiotic-resistant strains and fungi.	In-vitro time-kill testing utilizing USP Antimicrobial Effectiveness <51> prescribed organisms and additional resistant bacterial strains (MRSA, VRE, Acinetobacter baumannii, etc.) and fungi (Candida albicans, Aspergillus niger). Results indicate inhibition and reduction of high concentrations of microorganisms to undetectable levels.
Stability: Product remains stable over its intended shelf life.	Stability study demonstrating the product is stable for at least 24 months when stored at room temperature.
Substantial Equivalence: Similar in function and intended use to a legally marketed predicate device, and does not raise new questions of safety and effectiveness.	Comparison to Anasept™ Antimicrobial Skin and Wound Cleanser (K073547), demonstrating similar intended use, and the provision of safety and effectiveness data as noted above.
Manufacturing Quality: Manufactured under good manufacturing practices.	Manufactured under cGMPs, with process validation completed and manufacturing controls implemented.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of this device. The "test set" refers to microorganisms and animal subjects used in laboratory and animal studies, not human clinical participants for evaluating an AI algorithm.
- For antimicrobial effectiveness, multiple strains of bacteria and fungi were tested as per USP<51> and additional clinical relevance.
- For biocompatibility, animal species were used for sensitization and irritation testing.
Data Provenance: The studies were conducted in-vitro (laboratory) and in-vivo (animal) as a part of the device's premarket submission. The specific location or institution where these studies were performed is not detailed, nor is the country of origin explicitly stated, but it's part of a US FDA submission. The studies are prospective in the sense they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context refers to established scientific methods and standards (e.g., USP <51> for antimicrobial effectiveness, ISO standards for biocompatibility) and the experimental results against those standards, rather than expert consensus on medical images or diagnoses. The studies are performed by qualified laboratory personnel following established protocols.

4. Adjudication method for the test set

Not applicable. Adjudication is typically for resolving discrepancies in expert interpretations of clinical data. For laboratory and animal studies, results are typically determined by direct measurement or observation against defined scientific criteria.

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. This device is not an AI diagnostic tool and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a solution for wound cleansing, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device can be understood as:

Established Scientific Standards: Performance against recognized standards like USP Antimicrobial Effectiveness <51> for microbiology.
Biocompatibility Standards: Results of biocompatibility, cytotoxicity, and sensitization tests in animal models, demonstrating non-harmful interaction with biological systems.
Chemical/Physical Properties: In-vitro demonstrations of mechanical removal action and stability over time.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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JUN - 2 2009

5.0 510(K) SUMMARY

5.1 Sponsor Information

Company Information:	Oculus Innovative Sciences, Inc.1135 North McDowell Blvd.Petaluma, CA 94954(707) 559-2445(707) 283-0551
Contact Information:	Antoinette DouglasDirector, Regulatory Affairs and QualityAssurancePhone: (707) 559-2445Fax: (415) 462-5163Email: adouglas@oculusis.com
Date of Preparation:	May 2009

5.2 Device Information

Device Trade Name:	Oculus Puracyn™ Skin and Wound Cleanser withPreservatives
Common Name:	Wound cleanser
Classification Name:	Dressing, wound and drug
Device Class:	Unclassified
Device Code:	FRO
Advisory Panel :	TBD

5.3 Identification of Legally Marketed Device for Substantial Equivalence Comparison

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is substantially equivalent to the following cleared predicate device:

Anasept™ Antimicrobial Skin and Wound Cleanser manufactured by Anacapa Technologies, cleared for distribution under 510(k) K073547.

5.4 Device Description

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mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). The device also contains antimicrobial agents that inhibit the growth of microorganisms. Oculus Puracyn™ Skin and Wound Cleanser with Preservatives will be supplied in High Density Polyethylene (HDPE) bottles of various volumes with dosing inserts and caps as described in Section 11.3.

Intended Use ર્સ્ડ

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended for over-the counter (OTC) and professional use as follows:

OTC: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions. lacerations, minor irritations. cuts, and intact skin.

These indications are similar to that of the predicate device (Anasept™ Antimicrobial Skin and Wound Cleanser) cleared on April 23, 2008.

5.6 Device Technological Characteristics

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is a clear. hypotonic liquid that helps in the mechanical removal of the debris and foreign material from the application site. Dirt, debris and foreign materials are mechanically removed by the action of the fluid (Wound Cleanser) moving across the wound bed or application site. Oculus Puracyn™ Skin and Wound Cleanser with Preservatives contains broad spectrum antimicrobial agents (sodium hypochlorite and hypochlorous acid) that inhibit the growth of bacteria such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, including antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) and Acinetobacter baumannii that are commonly found in wound bed as well as fungi such as Candida albicans and Aspergillus niger.

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Manufacturing:

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives will be manufactured under the guidelines of current Good Manufacturing Practices (cGMPs) and according to the established manufacturing, quality and product specifications. Process validation has been completed for this device and filling process parameters have been qualified. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode. Established cGMPs will assure that the device manufactured at Oculus Innovative Sciences meet all the established specifications prior to release and is safe and effective for its intended use.

Performance Testing:

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives has been subjected to in-vitro and in-vivo studies to demonstrate that the device is safe and effective for the indications for use. One series of time kill testing was performed utilizing the test organisms prescribed in the USP Antimicrobial Effectiveness <51> such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, Aspergillus niger and additional bacterial strains, such as, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE), Proteus mirabilis, Serratia marcescens and Acinetobacter baumannii that are commonly found in wound bed. All test results indicate that the product is capable of inhibiting the growth of bacteria and reducing high level concentrations of microorganisms (107 organisms /gram of product) to undetectable levels. The results of the stability study demonstrate that the product is stable for at least 24 months when stored at room temperature.

5.7 Substantial Equivalence Discussion/ Conclusion

Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is similar in function and has the same intended use as the predicate device Anasept™ Antimicrobial Skin and Wound Cleanser (Anacapa Technologies), legally marketed under 5109(k) K073547 as a dressing wound or drug.

The safety evaluation meets the requirements as detailed by USP and ISO. Safety has been established through biocompatibility testing, in-vitro Cytotoxicity testing and sensitization testing in species of animal and mucosal irritation in two species

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of animal. The mechanical mechanism of action and antimicrobial effectiveness have been demonstrated by in-vitro studies.

On the basis of the information presented in this application, Oculus Innovative Sciences concludes that Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is safe and effective for its use and is substantially equivalent to the predicate device as it has the same intended use as the predicate; and has different technological characteristics and the information submitted to FDA which does not raise new questions of safety and effectiveness; and demonstrates that the device is at least as safe and effective as the legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oculus Innovative Sciences, Incorporation % Ms. Antoinette Douglas Associate Director, Regulatory Affairs & Quality 1135 North McDowell Boulevard Petaluma, California 94954

Re: K090206

Trade/Device Name: Oculus Puracyn Skin and Wound Cleanser with Preservatives Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Product Code: FRO

JUN - 2 2009

Dated: May 13, 2009 Received: May 15, 2009

Dear Ms. Douglas:

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 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

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Page 2- Ms. Antoinette Douglas

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological

Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, 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;

M. N. Mulla

Mark N. Melkerson Division of Surgical, Orthopedic · and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K090206

Oculus Puracyn Skin and Wound Cleanser with Preservatives Device Name:

Indications For Use:

OTC:

Oculus Puracyn Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Prescription Use:

Oculus Puracyn Skin and Wound Cleanser with Preservatives is intended to be used by health care professionals in the management, via debridement of wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Ove r-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)

Daniel Kranesterllexm

(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K090206

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Regulation Number and Section

N/A