(125 days)
OTC: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended for OTC use for the management of skin abrasions. lacerations, minor irritations. cuts, and intact skin.
Professional Use: Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is intended to be used by health care professionals in the management via debridement of wounds such as stage I-IV pressure ulcers, partial and full thickness wounds, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
Oculus Puracyn™ Skin and Wound Cleanser with Preservatives is a clear hypotonic solution that aids in the mechanical removal of the debris and foreign material from the application site. Dirt debris and foreign material are mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). The device also contains antimicrobial agents that inhibit the growth of microorganisms. Oculus Puracyn™ Skin and Wound Cleanser with Preservatives will be supplied in High Density Polyethylene (HDPE) bottles of various volumes with dosing inserts and caps as described in Section 11.3.
The provided text describes a 510(k) summary for the Oculus Puracyn™ Skin and Wound Cleanser with Preservatives. This is a medical device submission, and as such, the "acceptance criteria" and "device performance" are typically related to proving substantial equivalence to a predicate device and demonstrating safety and effectiveness through laboratory (in-vitro) and potentially animal (in-vivo) studies, rather than clinical studies with human readers or AI algorithms.
Therefore, many of the requested elements (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone algorithm performance, and sample size for training set) are not applicable in this context.
Here's the information derived from the provided text, adapted for the nature of this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Need) | Reported Device Performance (Means of Demonstration) |
|---|---|
| Safety: Device is biocompatible, non-cytotoxic, and non-sensitizing. | Established through biocompatibility testing, in-vitro cytotoxicity testing, and sensitization testing in animal species. Mucosal irritation testing in two animal species also performed. |
| Mechanical Removal of Debris: Aids in the mechanical removal of debris and foreign material. | Demonstrated by in-vitro studies showing the action of the fluid moving across the wound bed or application site. |
| Antimicrobial Effectiveness: Inhibits the growth of commonly found microorganisms, including antibiotic-resistant strains and fungi. | In-vitro time-kill testing utilizing USP Antimicrobial Effectiveness prescribed organisms and additional resistant bacterial strains (MRSA, VRE, Acinetobacter baumannii, etc.) and fungi (Candida albicans, Aspergillus niger). Results indicate inhibition and reduction of high concentrations of microorganisms to undetectable levels. |
| Stability: Product remains stable over its intended shelf life. | Stability study demonstrating the product is stable for at least 24 months when stored at room temperature. |
| Substantial Equivalence: Similar in function and intended use to a legally marketed predicate device, and does not raise new questions of safety and effectiveness. | Comparison to Anasept™ Antimicrobial Skin and Wound Cleanser (K073547), demonstrating similar intended use, and the provision of safety and effectiveness data as noted above. |
| Manufacturing Quality: Manufactured under good manufacturing practices. | Manufactured under cGMPs, with process validation completed and manufacturing controls implemented. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of this device. The "test set" refers to microorganisms and animal subjects used in laboratory and animal studies, not human clinical participants for evaluating an AI algorithm.
- For antimicrobial effectiveness, multiple strains of bacteria and fungi were tested as per USP and additional clinical relevance.
- For biocompatibility, animal species were used for sensitization and irritation testing.
- Data Provenance: The studies were conducted in-vitro (laboratory) and in-vivo (animal) as a part of the device's premarket submission. The specific location or institution where these studies were performed is not detailed, nor is the country of origin explicitly stated, but it's part of a US FDA submission. The studies are prospective in the sense they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. "Ground truth" in this context refers to established scientific methods and standards (e.g., USP for antimicrobial effectiveness, ISO standards for biocompatibility) and the experimental results against those standards, rather than expert consensus on medical images or diagnoses. The studies are performed by qualified laboratory personnel following established protocols.
4. Adjudication method for the test set
- Not applicable. Adjudication is typically for resolving discrepancies in expert interpretations of clinical data. For laboratory and animal studies, results are typically determined by direct measurement or observation against defined scientific criteria.
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
- No. This device is not an AI diagnostic tool and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a solution for wound cleansing, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device can be understood as:
- Established Scientific Standards: Performance against recognized standards like USP Antimicrobial Effectiveness for microbiology.
- Biocompatibility Standards: Results of biocompatibility, cytotoxicity, and sensitization tests in animal models, demonstrating non-harmful interaction with biological systems.
- Chemical/Physical Properties: In-vitro demonstrations of mechanical removal action and stability over time.
8. The sample size for the training set
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
N/A