(56 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 the cleansing, irrigation, moistening, and debridement of various acute and chronic dermal lesions and wounds, which are therapeutic actions aimed at managing and healing conditions.
No
The device is a wound care solution intended for cleansing, irrigation, moistening, and debridement of wounds, not for diagnosis.
No
The device is a liquid solution intended for wound care, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the solution is for the cleansing, irrigation, moistening, debridement, and removal of foreign material and debris from wounds and skin lesions. It is applied directly to the body surface (skin and wounds).
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Mechanism of Action: The device's description and intended use indicate a topical application for wound management and skin care. It does not involve the analysis of biological specimens in vitro.
Therefore, the Microcyn Plus Antimicrobial Wound Care Solution falls under the category of a topical wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus Antimicrobial Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material 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 burns, 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 for Use: Microcyn Plus Antimicrobial™ Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Product codes
FRO
Device Description
The Microcyn Plus Antimicrobial Wound Care Solution is a clear hypotonic solution that aids in the mechanical removal of debris and foreign material from the application site. It is also for the management of skin abrasions, lacerations, irritation, cuts, and wounds. The solution is supplied in glass bottles with lined caps with a pH range of 3.5 - 6.0. Ingredients: water, sodium chloride, hypochlorous acid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal (skin)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional supervision for Rx indications; OTC use for other 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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing: The biocompatibility evaluation for the Microcyn Plus Antimicrobial Wound Care Solution 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.
Bench Testing: The following tests were performed to support the performance of Microcyn Plus Antimicrobial Wound Care Solution: package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC). USP testing was used to support preservative effectiveness of the product with the compendia organisms and the following bacteria in solution, Proteus mirabilis (ATCC - 25933), Serratia marcescens (ATCC-8100), antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC-43300). Vancomycin- resistant Enterococcus faecalis (VRE) (ATCC-700221), and Acinetobacter baumannii (ATCC 19606).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
November 15, 2017
Sonoma Pharmaceuticals, Inc. Brian Martin VP Regulatory 1129 N. McDowell Boulevard Petaluma, California 94954
Re: K172851
Trade/Device Name: Microcyn Plus Antimicrobial Wound Care Solution Regulatory Class: Unclassified Product Code: FRO Dated: September 19, 2017 Received: September 20, 2017
Dear Brian 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 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
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K172851
Device Name
Microcyn Plus Antimicrobial Wound Care Solution
Indications for Use (Describe)
Rx Indications: Under the supervision of a healthcare professional, Microcyn Plus Antimicrobial Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material 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 burns, 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 for Use: Microcyn Plus Antimicrobial™ Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
ல் 510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
I. SUBMITTER
Sonoma Pharmaceuticals, 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: June 8, 2017
II. DEVICE
Name of Device: Microcyn Plus Antimicrobial Wound Care Solution Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline Wound Dressing Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
PREDICATE DEVICE III.
Microcyn Plus Wound Care Solution manufactured by Sonoma Pharmaceuticals (K161034) Hydrocleanse Antimicrobial Skin and Wound Care Solution manufactured by Sonoma
Pharmaceuticals, Inc. (K171727)
IV. DEVICE DESCRIPTION
The Microcyn Plus Antimicrobial Wound Care Solution is a clear hypotonic solution that aids in the mechanical removal of debris and foreign material from the application site. It is also for the management of skin abrasions, lacerations, irritation, cuts, and wounds. The solution is supplied in glass bottles with lined caps with a pH range of 3.5 - 6.0. Ingredients: water, sodium chloride, hypochlorous acid.
V. INDICATIONS FOR USE Rx
Indications for Use:
Under the supervision of a healthcare professional, Microcyn Plus™ Antimicrobial Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign
Sonoma Pharmaceuticals, Inc.
K172851 Microcyn Plus Antimicrobial Wound Care Solution 510(k) Summary
4
material including debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first- and seconddegree burns, 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 for Use:
OTC Microcyn Plus™ Antimicrobial Wound Care Solution is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
| Submitter/
Holder | Proposed Device:
Microcyn Plus Antimicrobial
Wound Care Solution -Sonoma
Pharmaceuticals, Inc. | Predicate Device: K161034
Micorcyn Plus Skin and Wound
Care Cleanser
Sonoma Pharmaceuticals, Inc. | Predicate Device: K171727
Hydrocleanse Antimicrobial
Skin and Wound Care
Solution Sonoma
Pharmaceuticals,
Inc. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for
Use | Rx Indications:
Under the supervision of a
healthcare professional, Microcyn
Plus Antimicrobial Wound Care
Solution is intended for the
cleansing, irrigation, moistening,
debridement and removal of foreign
material 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 burns, 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 Antimicrobial Wound
Care Solution is intended for OTC
use in the management of minor skin
abrasions, lacerations, minor
irritations, cuts, and intact skin. | 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 burns,
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,
HydrocleanseTM Antimicrobial
Skin and Wound Care Solution is
intended for the cleansing,
irrigation, moistening,
debridement and removal of
foreign material 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 burns, 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
to irrigate wounds.
OTC Indications for Use:
OTC HydrocleanseTM
Antimicrobial Skin and Wound
Care Solution is intended for OTC
use in the management of skin
abrasions, lacerations,
minor irritations, cuts, and
intact skin. |
| 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
or device. | Same | Same |
| Delivery
System | Aqueous Solution containing: Water,
sodium chloride, hypochlorous acid | Aqueous Solution containing: Water,
sodium chloride, hypochlorous acid | Aqueous Solution containing:
Water, sodium sulfate, sodium
phosphate, sodium chloride,
hypochlorous acid |
| Shelf Life | 24 months | Same | 12 months |
Sonoma Pharmaceuticals, Inc.
K172851 Microcyn Plus Antimicrobial Wound Care Solution 510(k) Summary
5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Microcyn Plus Antimicrobial Wound Care Solution 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.
Bench Testing
The following tests were performed to support the performance of Microcyn Plus Antimicrobial Wound Care Solution: package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC). USP testing was used to support preservative effectiveness of the product with the compendia organisms and the following bacteria in solution, Proteus mirabilis (ATCC - 25933), Serratia marcescens (ATCC-8100), antibiotic resistant Methicillin-Resistant Staphylococcus aureus (MRSA) (ATCC-43300). Vancomycin- resistant Enterococcus faecalis (VRE) (ATCC-700221), and Acinetobacter baumannii (ATCC 19606).
VII. CONCLUSION
Microcyn Plus Antimicrobial Wound Care Solution is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Microcyn Plus Wound Care Solution manufactured by Sonoma Pharmaceuticals. Inc. (K161034) and Hydrocleanse Antimicrobial Skin and Wound Care Solution manufactured by Sonoma Pharmaceuticals (K171727). Therefore, the Microcyn Plus Antimicrobial Wound Care Solution is substantially equivalent to the predicate devices.
6