(101 days)
Rx: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
The Microcyn Antimicrobial Hydrogel is a clear hydrogel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of >1000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.
This document describes a 510(k) premarket notification for the Microcyn Antimicrobial Hydrogel. The core of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a disease state or clinical outcome. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of clinical performance metrics are not directly applicable here.
However, we can interpret the "acceptance criteria" as the required testing to demonstrate substantial equivalence and "reported device performance" as the results of those tests confirming equivalence to the predicates.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Required Testing for Substantial Equivalence) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility Testing: | |
| * Cytotoxicity | Evaluated based on FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Implied to meet acceptance for substantial equivalence, as the conclusion states the device is substantially equivalent.) |
| * Systemic toxicity | Evaluated based on FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Implied to meet acceptance for substantial equivalence.) |
| * Irritation | Evaluated based on FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Implied to meet acceptance for substantial equivalence.) |
| * Sensitization | Evaluated based on FDA Blue Book Memorandum #G95-1 and ISO 10993-1. (Implied to meet acceptance for substantial equivalence.) |
| * Toxicological risk assessment (for prolonged use) | Provided to support prolonged use. (Implied to be acceptable for substantial equivalence.) |
| Bench Testing: | |
| * Package integrity | Performed. (Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.) |
| * Visual inspection | Performed. (Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.) |
| * Viscosity | Performed. Reported target: >1000 cP. (Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.) |
| * pH | Performed. Reported range: 6.2-7.8. (Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.) |
| * Free Available Chlorine (FAC) | Performed. (Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.) |
| * Preservative Effectiveness Testing (in gel while on shelf) | Performed. Conforming to USP <51>. (Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.) |
| Comparison to Predicate Devices: | |
| * Indications for Use | Rx Indication: Proposed device's Rx indication is identical to the K153648 predicate. OTC Indication: Proposed device's OTC indication is identical to the K153648 predicate. (Differences noted with K171935 predicate, but found to be substantially equivalent overall, implying the differences are not significant enough to preclude equivalence.) |
| * Sterility Claim | "Non-sterile, Preserved/Conforming to USP <51>". Identical to K153648 and K171935 predicates. |
| * Mechanism of Action | "Wound moisturizer". Identical to K153648 and K171935 predicates. |
| * Delivery System | "Hydrogel". Identical to K153648 and K171935 predicates. |
| * Ingredients (Qualitative and Quantitative) | Proposed device and K153648 predicate have identical ingredients. K171935 predicate has additional ingredients (dimethicone, sodium bicarbonate, sodium sulfate) which are not found in the proposed device or K153648. Despite these differences, the conclusion states substantial equivalence, implying these differences do not raise new questions of safety or effectiveness. |
Since this is a 510(k) submission proving substantial equivalence for a medical device (a wound hydrogel), not a diagnostic algorithm, several of your requested points related to AI/algorithm performance studies, ground truth establishment, expert consensus, and reader studies are not applicable to this document. The document implicitly states that these tests demonstrate that the device is as safe and effective as the predicate devices, thereby meeting the "acceptance criteria" for 510(k) clearance.
Here's why the other points are not applicable or cannot be answered from the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This device is a hydrogel, not a diagnostic algorithm tested on a dataset of patient cases. The "test sets" here would be samples of the hydrogel subject to physical, chemical, and biological testing as per standards. The document does not specify the number of samples used for each test. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: There is no "ground truth" in the context of clinical disease states or image interpretation for a wound hydrogel being cleared via substantial equivalence. The "truth" is established by adherence to recognized standards for biocompatibility and bench performance, and by comparison to the established predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices, to establish a definitive diagnosis or reference standard. This is not relevant for the physical, chemical, and biological testing of a hydrogel.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable: This product is a hydrogel, not an AI-powered diagnostic device or an AI assistant for human readers. Therefore, MRMC studies and the concept of "human readers improving with AI" are entirely irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: As explained in point 3, there is no "ground truth" in the clinical diagnostic sense for this device. The "ground truth" for its performance is compliance with established physical, chemical, and biological specifications and equivalence to predicates already on the market.
8. The sample size for the training set
- Not Applicable: This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not Applicable: As explained in point 8.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 2, 2018
Sonoma Pharmaceuticals, Inc. Brian Martin VP Regulatory and Quality 1129 N. McDowell Blvd. Petaluma, California 94954
Re: K173896
Trade/Device Name: Microcyn Antimicrobial Hydrogel Regulatory Class: Unclassified Product Code: FRO Dated: March 6, 2018 Received: March 7, 2018
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173896
Device Name Microcyn Antimicrobial Hydrogel
Indications for Use (Describe)
Rx: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, abrasions and minor burns.
| 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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1 510(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, Vice President of RA, QC, QA Date Prepared: March 6, 2018
II. DEVICE
Name of Device: Microcyn Antimicrobial Hydrogel Common or Usual Name: Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO
III. PREDICATE DEVICE
Microcyn Plus Skin and Wound Gel manufactured by Oculus Innovative Sciences (K153648) and Alevicyn SG Antimicrobial Gel by Sonoma Pharmaceuticals, Inc., (K171935)
IV. DEVICE DESCRIPTION
The Microcyn Antimicrobial Hydrogel is a clear hydrogel, slightly chlorinated odor, viscous gel. The product has a pH range of 6.2-7.8 and a viscosity target of >1000 cP and will be supplied in polyethylene terephthalate (PET) tube-bottles with polypropylene (PP) screw-top closure.
V. INDICATIONS FOR USE
Rx Indication:
Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
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OTC Indication:
Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.
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| VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | |||
|---|---|---|---|
| -- | -- | --------------------------------------------------------------------------- | -- |
| Submitter/ Holder | Proposed Device:Microcyn Antimicrobial Hydrogel,Sonoma Pharmaceuticals | Previous 510k K153648- Microcyn PlusHydrogel- Oculus Innovative Sciences. | Predicate Device: K171935Alevicyn SG Antimicrobial Gel, SonomaPharmaceuticals, Inc. |
|---|---|---|---|
| Indications forUse | Rx Indication:Under the supervision of a health careprofessional Microcyn AntimicrobialHydrogel is intended for the management ofpost non ablative laser therapy procedures,post microdermabrasion therapy andfollowing superficial chemical peels.Microcyn Antimicrobial Hydrogel may alsobe used to relieve itch and pain from minorskin irritations, lacerations, abrasions andminor burns.OTC Indication:Microcyn Antimicrobial Hydrogel isintended for the management of minor skinirritations following post non ablative lasertherapy procedures, microdermabrasiontherapy or superficial chemical peels.Microcyn Antimicrobial Hydrogel may alsobe used to relieve itch and pain from minorskin irritations, lacerations, abrasions andminor burns. | Rx Indications for Use:Under the supervision of a health careprofessional Microcyn Plus Skin and WoundGel is intended for the management of post nonablative laser therapy procedures, postmicrodermabrasion therapy and followingsuperficial chemical peels. Microcyn PlusWound Gel may also be used to relieve itch andpain from minor skin irritations, lacerations,abrasions and minor burns.OTC Indications for Use:Microcyn Plus Skin and Wound Gel is intendedfor the management of minor skin irritationsfollowing post non ablative laser therapyprocedures, microdermabrasion therapy orsuperficial chemical peels. Microcyn Plus Skinand Wound Gel may also be used to relieve itchand pain from minor skin irritations, lacerations,abrasions and minor burns. | Rx Indications: Alevicyn SG Antimicrobial Gel isintended to moisten the wound bed and facilitate autolyticdebridement of acute and chronic dermal lesions.Alevicyn SG Antimicrobial Gel is indicated to manageand relieve the burning, itching, erythema, scaling, andpain experienced with various types of dermatoses,including atopic dermatitis, radiation dermatitis,seborrhea and seborrheic dermatitis, dermal irritation,sores, injuries, and ulcers of dermal tissue in addition tomoistening and lubricating absorbent wound dressings.The Alevicyn SG Antimicrobial Gel may also be used tomanage partial or full thickness wounds such as first andsecond degree burns, stage I - IV pressure ulcers,diabetic and stasis ulcers, abrasions and skin irritations,surgical wounds (donor and graft sites, incisions), andtrauma wounds. Alevicyn SG Antimicrobial Gel helps torelieve dry waxy skin by maintaining a moist wound &skin environment, which is beneficial to the healingprocess.OTC Indications for Use: Alevicyn SG Antimicrobial Gelis intended for OTC use to relieve itch and pain fromminor skin irritations, minor cuts, exit sites, minorlacerations, minor abrasions and minor burns, includingsunburns. Hydrogel is also intended to moisten andlubricate absorbent wound dressings and moisten thewound bed. A moist wound and skin environmentfacilitates autolytic debridement and is beneficial towound management and the healing process. |
| Sterility Claim | Non-sterilePreserved/Conforming to USP <51> | Same | Non-sterilePreserved/Conforming to USP < 51> |
| Mechanism ofAction | Wound moisturizer | Same | Same |
| Delivery System | Hydrogel | Same | Same |
| Ingredients | WaterSodium Lithium Magnesium FluorosilicateSodium PhosphateSodium ChlorideHypochlorous AcidSodium Hypochlorite | Same | Water, sodium lithium magnesium fluorosilicate,dimethicone, sodium phosphate, sodium bicarbonate,sodium chloride, sodium sulfate, hypochlorous acid andsodium hypochlorite |
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K173896
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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 Hydrogel 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. The gel is considered a breached/compromised surface device with limited contact. The biocompatibility evaluation for the Microcyn Antimicrobial Hydrogel was conducted in accordance with the FDA biocompatibility guidance issued on June 16, 2016 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. The Microcyn Antimicrobial Hydrogel was evaluated for cytotoxicity, systemic toxicity, irritation, and sensitization. In addition, a toxicological risk assessment was provided to support the prolonged use of the device.
Bench Testing
The following tests were performed to support the performance of Microcyn Antimicrobial Hydrogel: package integrity, visual inspection, viscosity, pH, Free Available Chlorine (FAC), Preservative Effectiveness Testing in the gel while on the shelf. Microcyn Antimicrobial Hydrogel meets specification and performance characteristics and is substantially equivalent to the predicate device.
VIII. CONCLUSION
Microcyn Antimicrobial Hydrogel is substantially equivalent in intended use, technological characteristics, safety and effectiveness to the Microcyn Plus Skin and Wound Hydrogel manufactured by Sonoma Pharmaceuticals, Inc. (K153648) and Alevicyn SG Antimicrobial Gel, K171935. Therefore, the Sonoma Pharmaceuticals, Inc. Microcyn Antimicrobial Hydrogel is substantially equivalent to the predicate devices.
N/A