(260 days)
Not Found
No
The document describes a hydrogel wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is described as "intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue," and for various types of burns and wounds, which are all conditions requiring therapeutic intervention.
No
Explanation: The device is a hydrogel intended for wound management and skin irritation, acting as a treatment or management tool, not for diagnosing conditions.
No
The device description clearly states it is an "aqueous hydrogel," which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue," and for use on burns, ulcers, and debrided wounds. This describes a topical treatment applied directly to the body surface.
- Device Description: The description states it's an "aqueous hydrogel" containing preservatives. This is consistent with a topical wound care product.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
Rx INDICATIONS: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
OTC INDICATIONS: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Microdacyn Hydrogel is a non-sterile, aqueous hydrogel that contains sodium hypochlorite and hypochlorous acid as preservatives to prevent the growth of microorganisms within the container during shelf-life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dermal tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional (for Rx 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)
Biocompatibility Testing:
- ISO-10993-1 Biological Evaluation of Medical Devices.
Performance Testing:
- USP Antimicrobial Effectiveness Testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Microcyn Skin and Wound HydroGel (K093585)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
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 and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2024
Sonoma Pharmaceuticals, Inc. Everardo Garibay Ramirez General Manager 1129 North McDowell Blvd. Petaluma, California 94954
Re: K240510
Trade/Device Name: Microdacyn Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: October 10, 2024 Received: October 11, 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" (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).
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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 Rule"). 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 mediation-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) K240510
Device Name Microdacyn Hydrogel
Indications for Use (Describe)
Rx INDICATIONS: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
OTC INDICATIONS: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.
| 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 performance information 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: October 16th, 2024.
II. DEVICE
Name of Device: Microdacyn Hydrogel. Common or Usual Name: Hydrogel Wound Dressing. Classification Name: Dressing, wound, drug. Class: Unclassified. Product Code: FRO. 510(k) Review Panel: General & Plastic Surgery.
III. PREDICATE DEVICE
Microcyn Skin and Wound HydroGel (K093585) manufactured for Sonoma Pharmaceuticals.
IV. DEVICE DESCRIPTION
Microdacyn Hydrogel is a non-sterile, aqueous hydrogel that contains sodium hypochlorite and hypochlorous acid as preservatives to prevent the growth of microorganisms within the container during shelf-life.
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INDICATIONS FOR USE v.
Rx Indications for Use: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
OTC Indications for Use: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
| Characteristic | Proposed Device: Microdacyn Hydrogel (K240510) | Predicate Device: Microcyn Skin and Wound HydroGel (K093585) |
|---|---|---|
| Indications for Use | Rx Indications for Use: | |
| Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds. | ||
| OTC Indications for Use: | ||
| Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn. | Rx Indications for Use: | |
| Under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microcyn Skin and Wound HydroGel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds. | ||
| OTC Indications for Use: | ||
| Microcyn Skin and Wound HydroGel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Microcyn is also indicated for the management of irritation and pain from minor sunburn. | ||
| Where Used | RX Only; OTC | Same |
| Delivery System | Hydrogel | Same |
| Mechanism of Action | The mode of action is achieved through the following: | |
| – Maintaining a moist wound environment. | Same | |
| Composition | – Water (96.524%) | |
| – Sodium Magnesium Fluorosilicate (3.000%) | ||
| – Sodium Phosphate (0.400%) | ||
| – Sodium Chloride (0.066%) | ||
| – Hypochlorous acid (0.008%) | ||
| – Sodium Hypochlorite (0.002%) | Same |
Table 1. Summary of comparison of technological characteristics.
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| Characteristic | Proposed Device: Microdacyn Hydrogel (K240510) | Predicate Device: Microcyn Skin and Wound HydroGel (K093585) |
|---|---|---|
| Sterilization | Non-sterile | Same |
| Shelf Life | 24 months | 18 months |
| Specification | Viscosity: 12,000-20,000 cP. | Same |
| Container | ||
| closure system | 50 mL, 100 mL and 200 mL | |
| polyethylene terephthalate (PET) bottles with a polypropylene (PP) Snap-top screw cap and lift 'n' peel liner. | 2oz polyethylene terephthalate (PET) bottles with a polypropylene (PP) Snap-top screw cap and lift 'n' peel liner. |
VII. PERFORMANCE DATA
Biocompatibility Testing
- ISO-10993-1 Biological Evaluation of Medical Devices. ●
Performance Testing
- . USP Antimicrobial Effectiveness Testing .
VIII. CONCLUSION
Microdacyn Hydrogel has the same intended use, technological characteristics and the performance and biocompatibility testing demonstrate that the device is as safe and effective as the Microcyn Skin and Wound HydroGel (K093585) manufactured for Sonoma Pharmaceuticals, Inc. Therefore, Microdacyn Hydrogel is substantially equivalent to the predicate device.