(345 days)
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.
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.
This document is a 510(k) Pre-market Notification summary for a medical device called "Microdacyn Wound Care Solution." It categorizes the device as unclassified and uses predicate devices to establish substantial equivalence.
The document does not describe acceptance criteria or a study proving the device meets the acceptance criteria in the manner one would typically expect for an AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC for diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics, indications for use, safety, and performance.
Therefore, I cannot provide the information requested in the prompt (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) because the provided text does not contain this type of data or study design. The "performance testing" mentioned is an "Antimicrobial Effectiveness Test" (USP <51>), which is a microbiological test, not a clinical performance study measuring accuracy or efficacy in the context of disease diagnosis or treatment effectiveness in a human population.
Here's why the requested information isn't present in this type of submission:
- Device Type: Microdacyn Wound Care Solution is a physical chemical product (a wound cleanser), not an AI/ML diagnostic or prognostic device.
- Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a predicate device. For devices like this, the "acceptance criteria" are based on comparing characteristics like composition, mechanism of action, intended use, and safety, rather than statistical performance metrics from a clinical trial.
- "Study" Definition: The "studies" mentioned (Biocompatibility and Antimicrobial Effectiveness Tests) are laboratory tests to ensure safety and product integrity, not clinical trials to assess diagnostic accuracy or the impact of an AI algorithm on human reader performance.
If this were an AI/ML device submission, the requested information would be crucial. However, for this specific 510(k) for a wound care solution, the provided text contains the relevant information for its regulatory pathway.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (707) 9710128 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: (+52) 33 1605 6543/ (+52) 33 3833-6722. 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: MicrodacynWound Care Solution(K233399) | Primary Predicate Device:Microcyn Antimicrobial Skinand Wound Cleanser(K172622) | Secondary Predicate Device:Simple ScienceAntimicrobial Facial andEyelid Cleanser (K181074). |
|---|---|---|---|
| Indicationsfor Use | Rx Indications for Use:Under the supervision of ahealthcare professional,Microdacyn Wound CareSolution is intended for thecleansing, irrigation,moistening, debridement andremoval of foreign material anddebris from exudating wounds,acute and chronic dermal lesionsincluding stage I-IV pressureulcers, stasis ulcers, diabeticulcers, post-surgical wounds,first- and second-degree burns,abrasions, minor irritations ofthe skin, diabetic foot ulcers,ingrown toe nails, grafted/donorsites and exit sites. It is alsointended for use to moisten andlubricate wound dressings andfor use with devices intended toirrigate wounds.OTC Indications for UseMicrodacyn Wound CareSolution is intended for OTCmanagement of minor skinabrasions, minor lacerations,minor irritations and intact skinof the face, eyelid and eyelashes. | Rx Indications for Use:Under the supervision of ahealthcare professional,Microcyn Antimicrobial Skinand Wound Cleanser isintended for the cleansing,irrigation, moistening,debridement and removal offoreign material and debrisfrom exudating wounds, acuteand chronic dermal lesionsincluding stage I-IV pressureulcers, stasis ulcers, diabeticulcers, post-surgical wounds,first- and second-degree burns,abrasions, minor irritations ofthe skin, diabetic foot ulcers,ingrown toe nails,grafted/donor sites and exitsites. It is also intended for useto moisten and lubricate wounddressings and for use withdevices intended to irrigatewounds.OTC Indications for UseMicrocyn Antimicrobial Skinand Wound Cleanser isintended for OTC use in themanagement of skin abrasions,lacerations, minor irritations,cuts, and intact skin. | For Over-the-Counter Use:For management of minor skinabrasions, minor lacerations,minor irritations, and intactskin of the face, eyelid, andeyelashes. |
| Where Used | RX Only; OTC | Same | OTC |
| DeliverySystem | Aqueous Solution | Same | Same |
| Mechanism ofAction | Dirt debris and foreign materialare mechanically removed bythe action of the fluid movingacross the skin or wound | Same | Same |
Table 12. Summary of comparison of technological characteristics.
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| Characteristic | Proposed Device: MicrodacynWound Care Solution(K233399) | Primary Predicate Device:Microcyn Antimicrobial Skinand Wound Cleanser(K172622) | Secondary Predicate Device:Simple ScienceAntimicrobial Facial andEyelid 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 |
| ReleaseSpecification | FAC: 140-150 ppm | FAC: 75-220 ppm | not available |
| Containerclosuresystem | PET bottles with a PP sprayeror 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 <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.
N/A