(81 days)
Not Found
No
The summary describes a topical skin and wound cleanser and does not mention any AI or ML capabilities.
Yes
The device is described as a skin and wound cleanser intended for various wound management purposes, including cleansing, irrigation, and debridement, which are therapeutic actions.
No
The device is a wound cleanser intended for mechanical removal of debris and foreign material from wounds, primarily for cleaning and managing skin abrasions, lacerations, and cuts. It does not perform any diagnostic function.
No
The device description clearly states it is a "clear hypotonic solution," indicating it is a liquid product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use of the Microcyn Antimicrobial Skin and Wound Cleanser clearly indicate that it is a topical solution applied directly to the skin and wounds for cleansing, irrigation, and debridement. It is used externally on the body, not on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Microcyn Antimicrobial Skin and Wound Cleanser falls under the category of a topical medical device for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Rx Indications: Under the supervision of a healthcare professional, Microcyn Antimicrobial Skin and Wound Cleanser 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 Antimicrobial Skin and Wound Cleanser 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 Antimicrobial Skin and Wound Cleanser 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, dermal lesions, foot, toe nails, grafted/donor sites, exit sites.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional supervision for Rx indications; OTC use for self-management.
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: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1.
Bench Testing: Performed to support the performance of Microcyn Antimicrobial Wound Care Solution. Tests included: package integrity, visual inspection, osmolality, pH, Free Available Chlorine (FAC). USP testing was used to support preservative effectiveness of the product with compendia organisms (P. aeruginosa (ATCC 9027), E. coli (ATCC 8739), S. aureus (ATCC 6538), C. albicans (ATCC 10231), A. niger (ATCC 16404)) and additional bacteria in solution (S. epidermidis (ATCC 12228), P acnes (ATCC 6919), Proteus mirabilis (ATCC- 29906), S. marcescens (ATCC-13880), antibiotic resistant Methicillin-Resistant S. aureus (MRSA) (ATCC-BAA-1708), Vancomycin- resistant E. faecalis (VRE) (ATCC-BAA2320), and A.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
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November 21, 2017
Sonoma Pharmaceuticals, Inc. Brian Martin VP Regulatory 1129 N. McDowell Boulevard Petaluma, California 94954
Re: K172622
Trade/Device Name: Microcyn Antimicrobial Skin and Wound Cleanser Regulatory Class: Unclassified Product Code: FRO Dated: August 29, 2017 Received: September 1, 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 (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.
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
1
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
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
Enclosure
2
Indications for Use
510(k) Number (if known) K172622
Device Name
Microcyn Antimicrobial Skin and Wound Cleanser
Indications for Use (Describe)
Rx Indications: Under the supervision of a healthcare professional, Microcyn Antimicrobial Skin and Wound Cleanser 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 Antimicrobial Skin and Wound Cleanser 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) |
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3
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: August 29, 2017
II. DEVICE
Name of Device: Microcyn Antimicrobial Skin and Wound Cleanser Common or Usual Name: Wound Cleanser Classification Name: Solution, Saline Wound Dressing Regulatory Class: Unclassified, Pre-amendment status Product Code: FRO
III. PREDICATE DEVICE
Puracyn Skin and Wound Cleanser with Preservatives manufactured by Sonoma Pharmaceuticals (K090206)
Hydrocleanse Antimicrobial Skin and Wound Cleanser manufactured by Sonoma Pharmaceuticals (K171727)
IV. DEVICE DESCRIPTION
The Microcyn Antimicrobial Skin and Wound Cleanser 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.
V. INDICATIONS FOR USE
Rx Indications for Use:
Under the supervision of a healthcare professional, Microcyn™ Antimicrobial Skin and Wound Cleanser is intended for the cleansing, irrigation, moistening, debridement and removal of foreign 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 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.
Sonoma Pharmaceuticals. Inc. K172622 Microcyn Antimicrobial Skin and Wound Cleanser 510(k) Summary
4
OTC Indications for Use:
Microcyn™ Antimicrobial Skin and Wound Cleanser is intended for OTC use in the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Submitter/
Holder | Proposed Device: Microcyn
Antimicrobial Skin and
Wound Cleanser Sonoma
Pharmaceuticals, Inc. | Predicate Device: K090206
Puracyn Skin and Wound
Cleanser with Preservatives
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™
Antimicrobial Skin and Wound
Cleanser is intended for the
cleansing, irrigation, moistening,
debridement and removal of foreign
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 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™ Antimicrobial Skin and
Wound Cleanser is intended for OTC
use in the management of skin
abrasions, lacerations, minor
irritations, cuts, and intact skin. | Rx Indications:
Puracyn Skin and Wound Cleanser with
Preservatives is intended to be used by
health care professional 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.
OTC Indications:
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. | Rx Indications:
Under the supervision of a healthcare
professional, Hydrocleanse™
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 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 to
irrigate wounds.
OTC Indications:
For management of minor skin
abrasions, minor lacerations, minor
irritations, minor cuts, minor burns and
intact skin. |
| Technology | Ingredients: Water, sodium chloride,
hypochlorous acid, sodium
hypochlorite | Ingredients: Water, sodium chloride,
hypochlorous acid, sodium hypochlorite | Ingredients: Water, sodium sulfate,
monobasic sodium phosphate, sodium
chloride, hypochlorous acid, sodium
hypochlorite |
| 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 | Same | Same |
| Shelf Life | 24 months | Same | 12 months |
Sonoma Pharmaceuticals, Inc.
K172622 Microcyn Antimicrobial Skin and Wound Cleanser 510(k) Summary
5
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the Microcyn Antimicrobial Skin and Wound Cleanser 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 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: P. aeruginosa (ATCC 9027), E. coli (ATCC 8739), S. aureus (ATCC 6538), C. albicans (ATCC 10231), A. niger (ATCC 16404) - and the following bacteria in solution: S. epidermidis (ATCC 12228), P acnes (ATCC 6919), Proteus mirabilis (ATCC- 29906), S. marcescens (ATCC-13880), antibiotic resistant Methicillin-Resistant S. aureus (MRSA) (ATCC-BAA-1708), Vancomycin- resistant E. faecalis (VRE) (ATCC-BAA2320), and A.baumannii (ATCC 19606).
VIII. CONCLUSION
Microcyn Antimicrobial Skin and Wound Cleanser is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Puracyn Skin and Wound Cleanser with Preservatives manufactured by Sonoma Pharmaceuticals, Inc. (K090206) and Hydrocleanse Antimicrobial Skin and Wound Care Solution manufactured by Sonoma Pharmaceuticals (K171727). Therefore, the Microcyn Antimicrobial Skin and Wound Cleanser is substantially equivalent to the predicate devices.