Who is the manufacturer of Microcyn Plus Antimicrobial Wound Care Solution?

Sonoma Pharmaceuticals, Inc. filed the 510(k) submission for Microcyn Plus Antimicrobial Wound Care Solution (K172851).

What is the FDA product code for Microcyn Plus Antimicrobial Wound Care Solution?

FRO. as a Class U device in the SU panel.

What is the regulatory pathway for Microcyn Plus Antimicrobial Wound Care Solution?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Microcyn Plus Antimicrobial Wound Care Solution?

Microcyn Plus Wound Care Solution (K161034); Hydrocleanse Antimicrobial Skin and Wound Care Solution (K171727).

Who can help prepare an FDA 510(k) submission like Microcyn Plus Antimicrobial Wound Care Solution?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Microcyn Plus Antimicrobial Wound Care Solution

K172851 · Sonoma Pharmaceuticals, Inc. · FRO · Nov 15, 2017 · SU

Device Facts

Record ID	K172851
Device Name	Microcyn Plus Antimicrobial Wound Care Solution
Applicant	Sonoma Pharmaceuticals, Inc.
Product Code	FRO · SU
Decision Date	Nov 15, 2017
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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.

Device Story

Microcyn Plus Antimicrobial Wound Care Solution is a clear, hypotonic aqueous solution containing water, sodium chloride, and hypochlorous acid. It functions as a wound cleanser to mechanically remove debris and foreign material from wound sites via fluid irrigation. The device is supplied in glass bottles and is intended for use by healthcare professionals in clinical settings or by patients for OTC management of minor skin conditions. By irrigating the wound, the solution aids in debridement and moistening, which supports wound management and dressing maintenance. It does not involve electronic components, software, or complex algorithms.

Clinical Evidence

Bench testing only. No clinical data provided. Performance supported by biocompatibility testing per ISO 10993-1 and bench testing including package integrity, visual inspection, osmolality, pH, and Free Available Chlorine (FAC) analysis. Preservative effectiveness verified via USP <51> against various organisms including MRSA, VRE, and Acinetobacter baumannii.

Technological Characteristics

Clear hypotonic aqueous solution; pH 3.5-6.0. Ingredients: water, sodium chloride, hypochlorous acid. Non-sterile. Supplied in glass bottles with lined caps. Mechanical action via fluid irrigation. Shelf life: 24 months.

Indications for Use

Indicated for cleansing, irrigation, moistening, and debridement of exudating wounds, acute/chronic dermal lesions (stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first/second-degree burns, abrasions, minor skin irritations, diabetic foot ulcers, ingrown toe nails, grafted/donor sites, exit sites) and for OTC management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Predicate Devices

Microcyn Plus Wound Care Solution (K161034)
Hydrocleanse Antimicrobial Skin and Wound Care Solution (K171727)

Related Devices

K161034 — Microcyn Plus Wound Care Solution · Oculus Innovative Sciences · Aug 19, 2016
K233399 — Microdacyn Wound Care Solution · Sonoma Pharmaceuticals, Inc. · Sep 13, 2024
K100948 — HYPO CLENZ WOUND WASH MODEL 100 PPM · Nevoa Life Sciences, LLC · Feb 2, 2011
K141012 — HYDROCLEANSE WOUND CARE SOLUTION · Oculus Innovative Sciences · Aug 8, 2014
K213514 — Spectricept Skin and Wound Cleanser · Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc. · Jan 13, 2023

Submission Summary (Full Text)

{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 <51> 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}------------------------------------------------ # K172851