Microdacyn Wound Care Solution

• K Number: K233399
• Device Name: Microdacyn Wound Care Solution
• Manufacturer: Sonoma Pharmaceuticals, Inc.
• Date Cleared: 2024-09-13 ( 345 days)
• Product Code: FRO
• Regulation Number: N/A

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 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.

Predicate Devices

K172622, K181074

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a wound care solution with chemical components and mechanical action, with no mention of AI/ML terms, image processing, or data-driven performance metrics.

Therapeutic

No.
The device is a wound care solution intended for cleansing, irrigation, and removal of debris, containing preservatives. While it aids in wound management, it is not a therapeutic device that directly treats or cures a disease or condition. Its primary function is mechanical removal and maintenance of a clean application site.

Diagnostic

No.
The device is a wound care solution used for cleansing, irrigation, and debridement of wounds, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "clear solution" and contains chemical components (sodium hypochlorite and hypochlorous acid), indicating it is a liquid product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use of Microdacyn Wound Care Solution is for the cleansing, irrigation, moistening, debridement, and removal of foreign material and debris from wounds and skin. This is a topical application for treating the external body.
• Device Description: The description confirms it's a clear solution applied to the application site to aid in mechanical removal.
• Lack of In Vitro Diagnostic Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.

IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. Microdacyn Wound Care Solution is a topical treatment applied directly to the wound or skin.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

FRO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Skin, wounds, 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), face, eyelid, eyelashes.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Healthcare professional (for Rx Indications); Over-The-Counter (for OTC 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)

Non-Clinical Data:

• Biocompatibility Testing: ISO-10993-1 Biological Evaluation of Medical Devices.
• Performance Testing: USP Antimicrobial Effectiveness Test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172622, K181074

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/0 description: The image contains 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 ADMINISTRATION" in blue text.

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"

1

(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.

2

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

3

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)
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."

4

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.

5

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
Wound Care Solution
(K233399) | Primary Predicate Device:
Microcyn Antimicrobial Skin
and Wound Cleanser
(K172622) | Secondary Predicate Device:
Simple Science
Antimicrobial Facial and
Eyelid Cleanser (K181074). |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, 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
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. | 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 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 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. | For Over-the-Counter Use:
For management of minor skin
abrasions, minor lacerations,
minor irritations, and intact
skin of the face, eyelid, and
eyelashes. |
| Where Used | RX Only; OTC | Same | OTC |
| Delivery
System | Aqueous Solution | Same | Same |
| Mechanism of
Action | Dirt debris and foreign material
are mechanically removed by
the action of the fluid moving
across the skin or wound | Same | Same |

Table 12. Summary of comparison of technological characteristics.

6

| Characteristic | Proposed Device: Microdacyn
Wound Care Solution
(K233399) | Primary Predicate Device:
Microcyn Antimicrobial Skin
and Wound Cleanser
(K172622) | Secondary Predicate Device:
Simple Science
Antimicrobial Facial and
Eyelid Cleanser (K181074). |
|--------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Composition | - Water (99.97%)

• Sodium Chloride (0.023%)
• Sodium Hypochlorite (0.004%)
• Hypochlorous acid (0.003%) | Same | - Ionized water (99.927%)
• Sodium Chloride (0.06%)
• Hypochlorous acid (0.011%)
• Hypochlorite ion (0.002%) |
  | Sterilization | Non-sterile | Same | Same |
  | Shelf Life | 24 months | Same | 12 months |
  | Release
  Specification | FAC: 140-150 ppm | FAC: 75-220 ppm | not available |
  | Container
  closure
  system | PET bottles with a PP sprayer
  or PP spray gun. | Glass bottles with lined caps | Glass bottle with spray inserts /
  caps. |

VII. NON-CLINICAL DATA

Biocompatibility Testing

• ISO-10993-1 Biological Evaluation of Medical Devices. .

Performance Testing

• . USP 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.