(128 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a wound care solution, with no mention of AI or ML technologies.
Yes
The device is intended for "cleansing, irrigation, moistening, debridement and removal of foreign material including microorganisms and debris from exudating wounds, acute and chronic dermal lesions," which are all therapeutic actions.
No
The intended uses described are for cleansing, irrigation, moistening, debridement, and removal of foreign material from wounds, as well as for managing skin abrasions, minor irritations, and cuts. These are therapeutic and wound management actions, not diagnostic ones. Nothing in the provided text indicates that the device is used to identify or determine the nature of a disease or condition.
No
The device description clearly states it is an "aqueous solution" supplied in "glass vials," indicating it is a physical substance and not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being for the cleansing, irrigation, moistening, and debridement of wounds and skin lesions. These are all external applications and treatments.
- Device Description: The description details a solution for external wound care.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the external management and treatment of wounds and skin.
N/A
Intended Use / Indications for Use
Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus 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: Microcyn Plus is intended for use in the management of skin abrasions, minor irritations, cuts, and intact skin.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Oculus Microcyn Plus 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 3.5 - 6.0. The solution will be supplied in 40mL glass vials with Teflon lined closures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional (for Rx indications)
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)
Biocompatibility Testing: The biocompatibility evaluation for the Microcyn Plus was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The solution is considered a breached/compromised surface device with limited contact. Testing Completed: Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity.
Bench Testing: The following tests were performed to support the performance of Microcyn Plus Wound Care Solution: package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume, USP and USP. The Microcyn Plus Wound Care Solution meets specification and performance characteristics and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 19, 2016
Oculus Innovative Sciences Mr. Brian Martin Director of Regulatory Affairs and Quality Control 1129 N. McDowell Boulevard Petaluma, CA 94954
Re: K161034
Trade/Device Name: Microcyn Plus Wound Care Solution Regulatory Class: Unclassified Product Code: FRO Dated: July 5, 2016 Received: July 13, 2016
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 (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.
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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K161034
Device Name Microcyn Plus Solution
Indications for Use (Describe)
Rx Indications:
Under the supervision of a healthcare professional, Microcyn Plus 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:
Microcyn Plus is intended for use in the management of skin abrasions, minor irritations, cuts, and intact skin.
| Type of Use (Select one or both, as applicable) |
|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized gold-colored graphic above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the text "Innovative Science" in a smaller, lighter font.
1 510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
SUBMITTER I.
Oculus Innovative Sciences. Inc. 1129 North McDowell Blvd. Petaluma, CA 94954
Phone: (707) 283-0550 Fax: (707) 283-0551
Contact Person: Brian W. Martin, Director of Regulatory Affairs and Quality Control Date Prepared: August 11, 2016
II. DEVICE
Name of Device: Oculus Microcyn Plus Wound Care Solution Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline, Wound Dressing Regulatory Class: Unclassified Product Code: FRO
III. PREDICATE DEVICE
Oculus Hydrocleanse (K141012) and Vashe Wound Care Solution manufactured by Puricore (K131848).
DEVICE DESCRIPTION IV.
The Oculus Microcyn Plus 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 3.5 - 6.0. The solution will be supplied in 40mL glass vials with Teflon lined closures.
V. INDICATIONS FOR USE
Rx Indications:
Under the supervision of a healthcare professional. Microcyn Plus 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
4
Image /page/4/Picture/0 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized graphic of three overlapping golden rings, resembling an atom. Below the graphic, the word "OCULUS" is written in bold, black letters. Underneath "OCULUS", the words "Innovative Science" are written in a smaller, lighter font.
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 also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications:
Microcyn Plus is intended for use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
5
Image /page/5/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features the word "OCULUS" in a bold, sans-serif font, with the words "Innovative Science" in a smaller font underneath. Above the word "OCULUS" is a graphic of three overlapping ellipses, which are gold in color. The background of the image is white.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
| Submitter/
Holder | Proposed Device:
Microcyn Plus Solution
Oculus Innovative Sciences | Predicate Device: K141012
Hydrocleanse Wound Care
Solution
Oculus Innovative Sciences | Predicate Device: K131848
Vashe Wound Solution
Puricore Inc. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for
Use | Rx Indications:
Under the supervision of a
healthcare professional, Microcyn
Plus 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 also intended for
use to moisten and lubricate wound
dressings and for use with devices
intended to irrigate wounds.
OTC Indications:
Microcyn Plus is intended for use in
the management of skin abrasions,
lacerations, minor irritations, cuts,
and intact skin. | Rx Indications:
Under the supervision of a healthcare
professional, Hydrocleanse TM 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 also intended
for use to moisten and lubricate wound
dressings and for use with devices
intended to irrigate wounds.
OTC Indications:
Hydrocleanse TM 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 healthcare
professionals, Vashe Wound
Solution is intended for
cleansing, irrigating,
moistening, debridement and
removal of foreign material
including microorganisms and
debris from exudating and/or
dirty wounds, acute and
chronic dermal lesions, such as
Stage I-IV pressure ulcers,
stasis ulcers, diabetic ulcers,
post-surgical wounds, first and
second degree burns, abrasions,
minor irritations of the skin,
diabetic foot ulcers, ingrown
toe nails, grafted and donor
sites, and exit sites. It is also
intended for moistening and
lubricating absorbent wound
dressings. |
| Sterility
Claim | Non-sterile | Same | Same |
| Mechanism
of Action | Dirt debris and foreign material are
mechanically removed by the action
of the fluid moving across the
wound. Provides moisture and
rehydration. | Dirt debris and foreign material are
mechanically removed by the action of
the fluid moving across the wound. | The mechanism of fluid
moving across the wound aids
in the physical removal of
foreign objects, foreign debris
and exudate from a wound. |
| Delivery
System | Aqueous Solution | Aqueous Solution | Aqueous Solution |
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Image /page/6/Picture/0 description: The image shows the text 'K161034' in a clear, sans-serif font. The text is presented in a dark blue color, which contrasts with the white background. The letters and numbers are evenly spaced and easily readable. The overall impression is clean and straightforward.
Image /page/6/Picture/1 description: The image shows the logo for Oculus Innovative Science. The logo features a stylized golden swirl of three overlapping circles above the word "OCULUS" in a bold, sans-serif font. Below "OCULUS" is the tagline "Innovative Science" in a smaller, lighter font.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Microcyn Plus was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, " May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The solution is considered a breached/compromised surface device with limited contact.
Testing Completed: Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity
Bench Testing
The following tests were performed to support the performance of Microcyn Plus Wound Care Solution: package integrity, visual inspection, pH, Free Available Chlorine (FAC), fill volume, USP and USP. The Microcyn Plus Wound Care Solution meets specification and performance characteristics and is substantially equivalent to the predicate device.
CONCLUSION VIII.
Microcyn Plus Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Hydrocleanse Wound Solution manufactured by Oculus Innovative Sciences (K141012) and Vashe Wound Care Solution manufactured by Puricore (K131848). Therefore, the Microcyn Plus Solution is substantially equivalent to the predicate devices.