Microdacyn Wound Care Solution

K233399 · Sonoma Pharmaceuticals, Inc. · FRO · Sep 13, 2024 · SU

Device Facts

• Record ID: K233399
• Device Name: Microdacyn Wound Care Solution
• Applicant: Sonoma Pharmaceuticals, Inc.
• Product Code: FRO · SU
• Decision Date: Sep 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Rx Indications for Use: Under the supervision of a healthcare professional, Microdacyn 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: Microdacyn Wound Care Solution is intended for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.

Device Story

Microdacyn Wound Care Solution is a clear aqueous solution used for mechanical removal of debris and foreign material from wounds and skin. It contains sodium hypochlorite and hypochlorous acid as preservatives to inhibit microbial growth within the solution. The device is applied to the site to facilitate cleansing and irrigation; it also serves to moisten and lubricate wound dressings. It is intended for both professional use (Rx) in clinical settings and patient self-use (OTC) for minor skin conditions. The solution acts via mechanical fluid movement across the wound or skin surface. It is provided in PET bottles with PP sprayers or spray guns. The device benefits patients by aiding in wound bed preparation and managing minor skin irritations.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Antimicrobial effectiveness testing performed per USP <51>.

Technological Characteristics

Aqueous solution containing water (99.97%), sodium chloride (0.023%), sodium hypochlorite (0.004%), and hypochlorous acid (0.003%). FAC specification: 140-150 ppm. Non-sterile. Shelf life: 24 months. Container: PET bottles with PP sprayer or PP spray gun. Mechanical action via fluid irrigation.

Indications for Use

Indicated for cleansing, irrigation, moistening, debridement, and removal of debris from exudating wounds, acute/chronic dermal lesions (stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, burns, abrasions, skin irritations, ingrown toenails, grafted/donor/exit sites) and for OTC management of minor skin abrasions, lacerations, irritations, and intact skin of face/eyelids/eyelashes.

Predicate Devices

• Microcyn Antimicrobial Skin and Wound Cleanser (K172622)
• Simple Science Antimicrobial Facial and Eyelid Cleanser (K181074)

Submission Summary (Full Text)

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September 13, 2024

Sonoma Pharmaceuticals, Inc. Everardo Garibay Ramirez General Manager 1129 North McDowell Blvd. Petaluma, California 94954

Re: K233399

Trade/Device Name: Microdacyn Wound Care Solution Regulatory Class: Unclassified Product Code: FRO Dated: August 13, 2024 Received: August 13, 2024

Dear Everardo Garibay Ramirez:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K233399

Device Name Microdacyn Wound Care Solution

#### Indications for Use (Describe)

Rx Indications for Use: Under the supervision of a healthcare professional, Microdacyn 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: Microdacyn Wound Care Solution is intended for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# 510(k) SUMMARY

The following is a summary of 510(k) safety and performation in accordance with 21 CFR 807.92.

#### SUBMITTER I.

#### Submitted by:

Sonoma Pharmaceuticals, Inc. 1129 North McDowell Blvd. Petaluma CA, 94954. Phone: [phone] Establishment Registration: 3004554409.

#### Manufacturer:

Oculus Technologies of Mexico, S.A. de C.V. Industria Vidriera No. 81, Fraccionamiento Industrial Zapopan Norte, Zapopan, Jalisco, MX 45130. Phone: [phone]. Establishment Registration Number: 3007244484.

#### Owner/Operator:

Sonoma Pharmaceuticals, Inc. 1129 North McDowell Blvd. Petaluma CA, 94954. Owner/Operator Number: 9063175.

Contact Person: Everardo Garibay Ramírez. General Manager Date Prepared: September 09th, 2024.

# II. DEVICE

Name of Device: Microdacyn Wound Care Solution Common or Usual Name: Wound Cleanser. Classification Name: Solution, Saline Wound Dressing. Class: Unclassified. Product Code: FRO 510(k) Review Panel: General & Plastic Surgery

# III. PREDICATE DEVICES

Primary Predicate Device: Microcyn Antimicrobial Skin and Wound Cleanser (K172622) manufactured for Sonoma Pharmaceuticals.

Secondary Predicate Device: Simple Science Antimicrobial Facial and Eyelid Cleanser (K181074) manufactured for Simple Science LLC.

# IV. DEVICE DESCRIPTION

Microdacyn Wound Care Solution is a clear solution that aids in the mechanical removal of debris and foreign material from the application site. The solution contains sodium hypochlorite and hypochlorous acid as preservatives to reduce/prevent the growth of microorganisms within the solution.

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# V. INDICATIONS FOR USE

#### Rx Indications for Use:

Under the supervision of a healthcare professional, Microdacyn 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:

Microdacyn Wound Care Solution is intended for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICES

| Characteristic | Proposed Device: Microdacyn<br>Wound Care Solution<br>(K233399) | Primary Predicate Device:<br>Microcyn Antimicrobial Skin<br>and Wound Cleanser<br>(K172622) | Secondary Predicate Device:<br>Simple Science<br>Antimicrobial Facial and<br>Eyelid Cleanser (K181074). |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Rx Indications for Use:<br>Under the supervision of a<br>healthcare professional,<br>Microdacyn Wound Care<br>Solution is intended for the<br>cleansing, irrigation,<br>moistening, debridement and<br>removal of foreign material and<br>debris from exudating wounds,<br>acute and chronic dermal lesions<br>including stage I-IV pressure<br>ulcers, stasis ulcers, diabetic<br>ulcers, post-surgical wounds,<br>first- and second-degree burns,<br>abrasions, minor irritations of<br>the skin, diabetic foot ulcers,<br>ingrown toe nails, grafted/donor<br>sites and exit sites. It is also<br>intended for use to moisten and<br>lubricate wound dressings and<br>for use with devices intended to<br>irrigate wounds.<br>OTC Indications for Use<br>Microdacyn Wound Care<br>Solution is intended for OTC<br>management of minor skin<br>abrasions, minor lacerations,<br>minor irritations and intact skin<br>of the face, eyelid and eyelashes. | Rx Indications for Use:<br>Under the supervision of a<br>healthcare professional,<br>Microcyn Antimicrobial Skin<br>and Wound Cleanser is<br>intended for the cleansing,<br>irrigation, moistening,<br>debridement and removal of<br>foreign material and debris<br>from exudating wounds, acute<br>and chronic dermal lesions<br>including stage I-IV pressure<br>ulcers, stasis ulcers, diabetic<br>ulcers, post-surgical wounds,<br>first- and second-degree burns,<br>abrasions, minor irritations of<br>the skin, diabetic foot ulcers,<br>ingrown toe nails,<br>grafted/donor sites and exit<br>sites. It is also intended for use<br>to moisten and lubricate wound<br>dressings and for use with<br>devices intended to irrigate<br>wounds.<br>OTC Indications for Use<br>Microcyn Antimicrobial Skin<br>and Wound Cleanser is<br>intended for OTC use in the<br>management of skin abrasions,<br>lacerations, minor irritations,<br>cuts, and intact skin. | For Over-the-Counter Use:<br>For management of minor skin<br>abrasions, minor lacerations,<br>minor irritations, and intact<br>skin of the face, eyelid, and<br>eyelashes. |
| Where Used | RX Only; OTC | Same | OTC |
| Delivery<br>System | Aqueous Solution | Same | Same |
| Mechanism of<br>Action | Dirt debris and foreign material<br>are mechanically removed by<br>the action of the fluid moving<br>across the skin or wound | Same | Same |

#### Table 12. Summary of comparison of technological characteristics.

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| Characteristic | Proposed Device: Microdacyn<br>Wound Care Solution<br>(K233399) | Primary Predicate Device:<br>Microcyn Antimicrobial Skin<br>and Wound Cleanser<br>(K172622) | Secondary Predicate Device:<br>Simple Science<br>Antimicrobial Facial and<br>Eyelid Cleanser (K181074). |
|--------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Composition | - Water (99.97%)<br>- Sodium Chloride (0.023%)<br>- Sodium Hypochlorite (0.004%)<br>- Hypochlorous acid (0.003%) | Same | - Ionized water (99.927%)<br>- Sodium Chloride (0.06%)<br>- Hypochlorous acid (0.011%)<br>- Hypochlorite ion (0.002%) |
| Sterilization | Non-sterile | Same | Same |
| Shelf Life | 24 months | Same | 12 months |
| Release<br>Specification | FAC: 140-150 ppm | FAC: 75-220 ppm | not available |
| Container<br>closure<br>system | PET bottles with a PP sprayer<br>or PP spray gun. | Glass bottles with lined caps | Glass bottle with spray inserts /<br>caps. |

# VII. NON-CLINICAL DATA

#### Biocompatibility Testing

- ISO-10993-1 Biological Evaluation of Medical Devices. .
#### Performance Testing

- . USP <51>Antimicrobial Effectiveness Test.
#### VIII. CONCLUSION

Microdacyn Wound Care Solution is substantially equivalent in intended use, technological characteristics, safety and performance to the primary predicate device Microcyn Antimicrobial Skin and Wound Cleanser (K172622) manufactured for Sonoma Pharmaceuticals, Inc. and to the secondary predicate device Simple Science Antimicrobial Facial and Eyelid Cleanser (K181074) manufactured for Simple Science LLC. Therefore, the Microdacyn Wound Care Solution is substantially equivalent to the predicate devices.