(161 days)
OTC: Puracyn Plus™ Skin and Wound Care is intended for the management of minor skin wounds including minor lacerations, minor abrasions, minor cuts, minor bums and intact skin, in addition to moistening and lubricating absorbent wound dressings.
Professional Use: Puracyn Plus™ Skin and Wound Care is 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 1 - 1V pressure ulcers, stasis ulcers, abrasions and minor skin irritations, post-surgical wounds, grafted and donor sites, in addition to moistening and lubricating absorbent wound dressings.
Puracyn Plus™ Skin and Wound Care is a clear hypotonic solution topically applied to skin and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Puracyn Plus™ Skin and Wound Care will be supplied in food grade 4 oz. plastic PET bottles with spray inserts and caps.
The provided text describes the regulatory clearance for Puracyn Plus™ Skin and Wound Care, a wound cleanser. It focuses on demonstrating substantial equivalence to predicate devices rather than a direct clinical performance study with acceptance criteria in the sense of accuracy, sensitivity, or specificity commonly associated with AI/software devices. Therefore, the information requested in the prompt, especially concerning performance metrics, sample sizes, ground truth establishment, and expert involvement, is largely not applicable to this type of medical device submission.
However, I can extract the relevant information that is present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a wound cleanser, the "acceptance criteria" are not based on diagnostic performance metrics. Instead, they are related to safety and stability for its intended use.
| Acceptance Criteria / Performance Aspect | Reported Device Performance (as stated or implied) |
|---|---|
| Biocompatibility | Meets ISO 10993 standards; non-cytotoxic, non-sensitizing, non-irritating, and non-toxic. |
| Stability | Stable for at least 11 months when stored at 25°C/60%RH±2% Stability Conditions. |
| Intended Use | Cleansing, irrigating, moistening, and debriding dermal wounds and moistening absorbent wound dressings (OTC: minor skin wounds; Professional Use: acute and chronic dermal lesions like burns, pressure ulcers, diabetic ulcers, etc.). |
| Mechanism of Action | Mechanical action of fluid removing foreign objects (dirt, debris). |
| Chemical/Physical Characteristics | Clear hypotonic solution. |
| Antimicrobial Activity | Contains a preservative that may help inhibit growth of microorganisms within the solution (not presented as an acceptance criterion but as a characteristic). |
| Manufacturing | Manufactured under Good Manufacturing Practices (GMP) guidelines. |
| Substantial Equivalence | Deemed substantially equivalent to predicate devices (Vashe® Wound Therapy Solution, Nixall™ Wound and Skin Care) based on similarity of use indications, functionality, chemical and physical characteristics, antimicrobial activity, and biocompatibility. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable in the context of diagnostic accuracy. The biocompatibility and stability tests would have involved specific sample sizes as per ISO standards and internal protocols, but these numbers are not disclosed in this summary.
- Data provenance: Not explicitly stated for specific tests. Biocompatibility testing is a standard laboratory procedure. Stability testing would be conducted in a controlled lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., confirmed disease state) is not relevant for a wound cleanser's performance evaluation in this context. The "truth" for biocompatibility is absence of adverse biological reactions, and for stability, it's maintaining specified properties over time.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This concept is for resolving discrepancies in expert labeling or diagnoses, which is not part of a wound cleanser's evaluation for substantial equivalence.
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 device is not an AI or diagnostic imaging device that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical wound cleanser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility: General biological safety standards (ISO 10993 series), which involve objective laboratory tests rather than expert consensus on a diagnosis.
- Stability: Chemical and physical property measurements over time against predetermined specifications.
- Intended Use/Mechanism: Based on the known properties of hypotonic solutions and established medical practices for wound cleansing.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/machine learning model.
Summary of the Study:
The "study" described is a regulatory submission to demonstrate substantial equivalence for Puracyn Plus™ Skin and Wound Care to legally marketed predicate devices (Vashe® Wound Therapy Solution and Nixall™ Wound and Skin Care). This is a common pathway for many medical devices, particularly those that are not novel in their fundamental technology or intended use.
The key aspects of this demonstration were:
- Biocompatibility Testing (ISO 10993): To establish the safety of the product for topical application. The results confirmed it was non-cytotoxic, non-sensitizing, non-irritating, and non-toxic.
- Stability Testing: To show the product maintained its properties over a specified shelf-life (at least 11 months at 25°C/60%RH±2%).
- Comparison of Indications for Use: The intended uses for both OTC and professional settings were found to be similar to the predicate devices.
- Comparison of Device Technological Characteristics: The product's nature as a clear hypotonic solution, its mechanism of action (mechanical removal of debris), and the presence of a preservative were compared and found similar to predicates.
- Manufacturing Practices: Stated adherence to Good Manufacturing Practices (GMP).
The conclusion of the "study" (the 510(k) submission) was that Puracyn Plus™ Skin and Wound Care is substantially equivalent to the cited predicate devices based on similarities in use indications, functionality, chemical and physical characteristics, antimicrobial activity (referring to the preservative), and biocompatibility. The FDA concurred with this determination, allowing the device to be marketed.
N/A