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510(k) Data Aggregation
(101 days)
Microcyn Antimicrobial Hydrogel
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 . (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 ". 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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