(125 days)
Not Found
No
The device description and performance studies focus on the chemical and mechanical properties of a wound cleanser, with no mention of AI or ML.
Yes.
The device is intended for the management and debridement of wounds, including various types of ulcers and burns, and aids in the mechanical removal of debris and inhibits microorganism growth, which are therapeutic actions.
No
The device is a wound cleanser, intended for mechanical removal of debris and foreign material from wounds and for inhibiting the growth of microorganisms, not for diagnosing a condition.
No
The device description clearly states it is a "clear hypotonic solution" supplied in "High Density Polyethylene (HDPE) bottles," indicating it is a liquid product with physical packaging, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management and debridement of skin and wounds. This involves applying the product directly to the body surface.
- Device Description: The device is a liquid cleanser applied topically.
- Lack of Diagnostic Purpose: The device is used for cleaning and inhibiting microbial growth on wounds, not for diagnosing a disease or condition based on in vitro examination of specimens from the human body.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device is applied to the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, wounds (Stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites), abrasions, lacerations, minor irritations, cuts.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter (OTC) and professional use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
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 of animal. The mechanical mechanism of action and antimicrobial effectiveness have been demonstrated by in-vitro studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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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 Douglas
Director, Regulatory Affairs and Quality
Assurance
Phone: (707) 559-2445
Fax: (415) 462-5163
Email: adouglas@oculusis.com |
| Date of Preparation: | May 2009 |
5.2 Device Information
| Device Trade Name: | Oculus Puracyn™ Skin and Wound Cleanser with
Preservatives |
|----------------------|---------------------------------------------------------------|
| 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
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
1
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.
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.
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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K090206
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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 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.
4
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
5
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
6
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
Page 1 of
510(k) Number K090206
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