Who is the manufacturer of Microcyn Antimicrobial Skin and Wound Cleanser?

Sonoma Pharmaceuticals filed the 510(k) submission for Microcyn Antimicrobial Skin and Wound Cleanser (K172622).

What is the FDA product code for Microcyn Antimicrobial Skin and Wound Cleanser?

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

What is the regulatory pathway for Microcyn Antimicrobial Skin and Wound Cleanser?

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

What are the predicate devices for Microcyn Antimicrobial Skin and Wound Cleanser?

Puracyn Skin and Wound Cleanser with Preservatives (K090206); Hydrocleanse Antimicrobial Skin and Wound Cleanser (K171727).

Who can help prepare an FDA 510(k) submission like Microcyn Antimicrobial Skin and Wound Cleanser?

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 Antimicrobial Skin and Wound Cleanser

K172622 · Sonoma Pharmaceuticals · FRO · Nov 21, 2017 · SU

Device Facts

Record ID	K172622
Device Name	Microcyn Antimicrobial Skin and Wound Cleanser
Applicant	Sonoma Pharmaceuticals
Product Code	FRO · SU
Decision Date	Nov 21, 2017
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended 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 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.

Device Story

Microcyn Antimicrobial Skin and Wound Cleanser is a clear, hypotonic aqueous solution; functions via mechanical removal of debris and foreign material through fluid irrigation across wound surfaces. Used in clinical settings under professional supervision (Rx) or by patients for home care (OTC). Output is the physical cleansing of the wound site; aids in management of various dermal lesions and wounds. Benefits include effective debridement and moistening of wound dressings, facilitating healing environment.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Bench performance testing included package integrity, visual inspection, osmolality, pH, and Free Available Chlorine (FAC). Preservative effectiveness testing (USP <51>) conducted against various organisms including P. aeruginosa, E. coli, S. aureus, C. albicans, A. niger, S. epidermidis, P. acnes, P. mirabilis, S. marcescens, MRSA, VRE, and A. baumannii.

Technological Characteristics

Hypotonic aqueous solution. Ingredients: water, sodium chloride, hypochlorous acid, sodium hypochlorite. Non-sterile. Mechanism: mechanical removal of debris via fluid irrigation. Shelf life: 24 months.

Indications for Use

Indicated for patients requiring wound cleansing, irrigation, moistening, and debridement of exudating wounds, acute/chronic dermal lesions (stage I-IV pressure ulcers, stasis/diabetic ulcers, post-surgical wounds, 1st/2nd degree burns, abrasions, minor skin irritations, diabetic foot ulcers, ingrown toe nails, grafted/donor sites, exit sites). Also for OTC management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Predicate Devices

Puracyn Skin and Wound Cleanser with Preservatives (K090206)
Hydrocleanse Antimicrobial Skin and Wound Cleanser (K171727)

Related Devices

K042729 — DERMACYN WOUND IRRIGATION · Oculus Innovative Sciences, Inc. · May 17, 2005
K171727 — Hydrocleanse Antimicrobial Skin and Wound Care Solution · Sonoma Pharmaceuticals · Jul 26, 2017
K233399 — Microdacyn Wound Care Solution · Sonoma Pharmaceuticals, Inc. · Sep 13, 2024
K161034 — Microcyn Plus Wound Care Solution · Oculus Innovative Sciences · Aug 19, 2016
K060113 — DERMACYN WOUND CARE · Oculus Innovative Sciences, Inc. · Feb 22, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional in appearance. 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------| | <div> ☑ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ ### 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 <51> 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.