(323 days)
Puracyn® Plus Antimicrobial Irrigation Solution is applied with irrigation to cleanse and remove debris from wounds.
Puracyn® Plus Antimicrobial Irrigation Solution is a wound irrigation formula that contains hypochlorous acid as an antimicrobial preservative to inhibit the growth of micro-organisms within the solution.
Puracyn® Plus Antimicrobial Irrigation Solution is supplied sterile in 1000 mL and 3000 mL flexible LLDPE bag configurations. Each bag is packaged in a sealed foil pouch.
This document describes the FDA's decision regarding Innovacyn, Inc.'s Puracyn® Plus Antimicrobial Irrigation Solution (K232080).
Here's an analysis of the provided text with respect to your questions about acceptance criteria and study details:
The provided text is a 510(k) summary for a medical device that aims to demonstrate substantial equivalence to a predicate device. It does not describe a study involving a particular device meeting acceptance criteria in the sense of a clinical performance study with human subjects, AI systems, or diagnostic accuracy metrics. Instead, it focuses on the device's characteristics and various types of performance testing related to its manufacturing, safety, and physical properties to show that it is as safe and effective as a previously cleared device.
Therefore, many of your questions, particularly those related to AI assistance, human readers, diagnostic performance, and ground truth in a clinical context, are not applicable to the information presented.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in a tabular format with corresponding reported device performance for clinical efficacy or diagnostic accuracy. Instead, it lists various performance tests conducted to support safety and effectiveness, implicitly asserting that the device met the requirements of these tests.
No direct "acceptance criteria" and "reported device performance" table is present for clinical/diagnostic efficacy.
However, the "Comparison of Technological Characteristics" table can be interpreted as a comparison against the predicate device, implying that the subject device's characteristics meet or are equivalent to the predicate's.
| Characteristic | Subject Device (Puracyn® Plus Antimicrobial Irrigation Solution - K232080) | Primary Predicate (Puracyn Plus™ Skin and Wound Care - K133542) | Implied "Acceptance" / Equivalence |
|---|---|---|---|
| Composition | Purified water, Hypochlorous acid, phosphates | Purified water, Hypochlorous acid, phosphates | Equivalent chemical composition. |
| Description | Clear, colorless solution packaged in flexible plastic bags | Clear, colorless, non-sterile solution packaged in plastic PET bottles | Essentially equivalent in physical appearance and solution type, with differences in packaging material and sterility status noted and addressed by compliance with relevant standards. |
| Volume | 1000 mL, 3000 mL | 1000 ml to 55 ml | Volume differences are noted as not raising new questions of safety and effectiveness. |
| Indications For Use | Applied with irrigation to cleanse and remove debris from wounds. | Professional Use: Intended for use by healthcare professionals for cleansing, irrigating, moistening, and debriding to remove wound debris from acute and chronic dermal lesions that are partial or full thickness wounds such as 1st and 2nd-degree burns, stage I - IV pressure ulcers, diabetic ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings. | The subject device's indications are narrower ("cleanse and remove debris from wounds") but fall within the scope of the predicate's broader indications, and are deemed substantially equivalent in effect for the specified use. The wording difference is noted as not raising new questions of safety and effectiveness. |
| Mechanism(s) of Action | Mechanical action of fluid moving across the wound aids in removal of foreign objects. | Mechanical action of fluid moving across the wound aids in removal of foreign objects such as dirt and debris. | Equivalent mechanism of action. |
| Antimicrobial Preservative | Preservative: Hypochlorous acid | Preservative: Hypochlorous acid | Equivalent preservative. |
| Microbial Control and Sterility | Meets USP and USP | Meets USP | The subject device meets additional sterility requirements (USP ) compared to the predicate, which strengthens its safety profile, not posing new questions. |
| Biocompatibility | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements | Equivalent biocompatibility standards. |
| Use | Multiple use within a single patient | Multiple use for multiple patients | "Multiple use within a single patient" for the subject device is a more restrictive use case than "multiple use for multiple patients" for the predicate. This difference is noted as not raising new questions of safety and effectiveness, implying it is equally safe or safer. |
The performance testing section lists general tests to ensure safety and quality, not clinical efficacy:
- Stability Studies per ICH Q1A(R2)
- Biocompatibility studies in accordance with ISO10993-1
- Packaging Testing in accordance with ISO 11607-1 and ISO 11607-2
- Sterilization in accordance with ISO 11737-1 and 11737-2
- Endotoxin Testing per USP
- Preservative Antimicrobial Effectiveness Testing per USP
- Sterility Testing per USP
- Bioburden Testing per USP and USP
For these tests, the implied acceptance criterion is "meets the standard" (e.g., "Meets USP "). The document asserts that these studies were "performed to support the safety and effectiveness" and contribute to the conclusion of substantial equivalence.
2. Sample size used for the test set and the data provenance
Not applicable in the context of clinical performance or diagnostic accuracy. The performance tests listed are laboratory and materials tests. Sample sizes for these tests (e.g., number of units for stability, packaging, or sterility testing) are not detailed in this summary. Data provenance is not described as it relates to patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth for a test set (e.g., in imagery or diagnostic interpretation). The "ground truth" for the performance tests would be defined by the specifications of the standards themselves (e.g., a certain level of sterility, a certain shelf-life).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as this is not a study involving subjective interpretation of results.
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. The device is an antimicrobial irrigation solution, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the listed performance tests, the "ground truth" is defined by the industry and regulatory standards themselves (e.g., USP, ISO standards for sterility, biocompatibility, stability). For example, the "ground truth" for sterility is the absence of viable microorganisms as determined by USP . For biocompatibility, it's compliance with ISO 10993-1.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device, so there is no "training set" or establishment of ground truth for it.
N/A