(238 days)
For Over-the-Counter Use: Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel is intended for OTC use to relieve itch and pain from minor skin irritations, minor lacerations, minor abrasions and minor burns, including sunburns. Hydrogel is also intended to moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement and is beneficial to wound management and the healing process.
For Professional Use: Puracyn® Plus Antimicrobial Hydrogel Professional Formula is intended for use by healthcare professionals to moisten the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions, as indicated below. Puracyn® Plus Antimicrobial Hydrogel Professional Formula relieves itch and pain associated with dermal irritation, sores, injuries and ulcers of dermal tissue in addition to moistening absorbent wound dressings. Puracyn® Plus Antimicrobial Hydrogel Professional Formula is indicated for the management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula are opaque and pH balanced hydrogel dressings that are topically applied to skin and wound areas. The gel provides relief from itching and pain, and helps maintain a moist wound environment to assist with the wound healing process. The hydrogel dressings will be supplied in various packaging configurations. Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and the Puracyn® Plus Antimicrobial Hydrogel Professional Formula contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel.
This document is a 510(k) premarket notification summary for the medical device Puracyn® Plus Duo-Care™ Antimicrobial Wound & Skin Hydrogel and Puracyn® Plus Antimicrobial Hydrogel Professional Formula. It is a submission to the FDA seeking a determination of substantial equivalence to predicate devices, not primarily a report on a clinical study with detailed acceptance criteria and performance data in the context of an AI/human reader study.
As such, the document does not contain the specific information requested regarding acceptance criteria related to device performance in a clinical setting, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or detailed ground truth establishment as would be found in a clinical study report for a diagnostic or AI-assisted device.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use/Indications for Use
- Technological Characteristics (e.g., active ingredients, formulation, mechanism of action)
- Non-Clinical Testing (e.g., stability, biocompatibility, antimicrobial effectiveness for product preservation).
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study proving device meets those criteria because that detailed level of clinical performance data for a complex AI/diagnostic device is not present in this 510(k) summary for a wound hydrogel.
The "Non-Clinical Testing" section mentions "Antimicrobial/Preservative Effectiveness Testing per modified USP ". This refers to benchtop microbiological testing to ensure the product itself remains sterile or inhibits microbial growth within the product, not clinical effectiveness on a wound or a comparative study of a diagnostic/AI device.
For clarity, I will explain what is in the document regarding "acceptance criteria" in the context of a 510(k) for this type of device, which is primarily demonstrating similarity and safety/effectiveness through non-clinical means.
Understanding "Acceptance Criteria" in this Context:
In a 510(k) submission for a non-diagnostic, non-AI device like a wound hydrogel, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with:
- Technological Equivalence: The new device's technology, materials, and principle of operation are similar to legally marketed predicate devices.
- Performance Benchmarks (Non-Clinical): The device meets established standards for safety and basic function, such as:
- Stability: The product remains effective and safe over its shelf life (e.g., pH, viscosity, active ingredient concentration, sterility maintained).
- Biocompatibility: The materials used are not harmful to biological systems (e.g., ISO10993-1 testing results are within acceptable limits).
- Preservative Effectiveness: The preservative (hypochlorous acid) effectively inhibits microbial growth within the product for its intended shelf life (e.g., passing modified USP criteria for specified microorganisms).
- Intended Use Equivalence: The proposed indications for use are the same as or very similar to predicate devices, and the differences do not raise new questions of safety or effectiveness.
Study Proving Device Meets Acceptance Criteria (as described in this document):
The studies mentioned are non-clinical and focus on product characteristics, not clinical outcomes on patients with wounds in a comparative study against standard care.
Here's how the provided information relates to the closest interpretation of your request, adjusted for the nature of the document:
1. Table of "Acceptance Criteria" (interpreted as non-clinical performance and equivalence to predicates) and Reported Device Performance
| "Acceptance Criteria" (for 510(k) Submission) | Reported Device Performance (as stated in document) |
|---|---|
| Intended Use Equivalence | "There are no differences between the subject and predicate devices with respect to intended use." (Page 6) |
| Technological Equivalence | "The subject devices are similar in technology to the predicate devices in that the products are topical hydrogels which encourage autolytic debridement and protect the wound against contamination. The products contain viscosity enhancing agents which impart hydrogel characteristics, as well as hypochlorous acid and/or sodium hypochlorite as preservatives." (Page 6) |
| Biocompatibility (e.g., meeting ISO10993-1 standards) | "As supported by biocompatibility testing according to ISO10093-1, hydrogels are biologically safe." (Page 6) |
| Antimicrobial/Preservative Effectiveness (e.g., USP ) | "Expanded testing consistent with USP supports that the Free Available Chlorine (FAC) inhibits microbial contamination within the product." "Puracyn® Plus hydrogels contain hypochlorous acid, a known antimicrobial preservative, which is shown to inhibit the growth of microorganisms such as Candida albicans, Aspergillus brasiliensis, acinetobacter albumin, Vancomycinresistant Enterococcus (VRE), Escherichia coli, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Methicillin-resistant Staphylococcus aureus (MRSA) in the hydrogel." (Page 4, 6) |
| Stability (e.g., maintaining properties over shelf life) | "Stability Studies" were performed. (Page 6) Specific acceptance values not detailed in summary, but completion indicated passing. |
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical laboratory testing and a submission for substantial equivalence, not a clinical trial with patient "test sets." The "data provenance" mentioned would be laboratory data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic test is not established for this type of device in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic device.
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.): The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., ISO10993-1 for biocompatibility, USP for preservative effectiveness) which have defined criteria for "passing."
8. The sample size for the training set: Not applicable. This refers to laboratory and product characteristic data, not machine learning model training.
9. How the ground truth for the training set was established: Not applicable.
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