(165 days)
The device is intended for moistening absorbent wound dressings and irrigating and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening, debriding and irrigating acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
NeutroPhase™ is a wound cleansing solution for irrigating and cleansing of dermal wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign objects such as dirt and debris.
The provided text is for a 510(k) premarket notification for a medical device called NeutroPhase™ Wound Cleanser. This type of submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria as typically seen for AI/ML-driven devices.
Therefore, many of the requested data points (such as acceptance criteria tables, sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable or not provided within this document. The device in question is a wound cleansing solution, not an AI-powered diagnostic or predictive tool.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable / Not Provided: The document states, "The NeutroPhase™ verification testing has confirmed the device's conformance with specifications. The functional specifications do not include any significant differences from those of the predicates." However, it does not specify what those "specifications" or "acceptance criteria" were, nor does it provide a table with quantitative performance metrics against such criteria. The focus is on substantial equivalence to existing devices rather than meeting new, pre-defined quantitative performance targets.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable / Not Provided: This device is a wound cleanser, not a data-driven diagnostic tool. Therefore, there is no "test set" in the context of AI/ML performance evaluation. The "verification testing" mentioned would likely refer to chemical, physical, and sterility testing of the solution, not performance on a dataset of patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable / Not Provided: See point 2.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not Applicable / Not Provided: The device is a wound cleanser, not an AI tool designed to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable / Not Provided: The device is a wound cleanser, not an algorithm.
7. The Type of Ground Truth Used
- Not Applicable / Not Provided: There is no "ground truth" in the context of AI model training or evaluation for this type of device. The "verification testing" likely relies on established laboratory methodologies for product quality and safety.
8. The Sample Size for the Training Set
- Not Applicable / Not Provided: This device is a wound cleanser, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided: See point 8.
Summary of the Study (Based on Provided Text):
The "study" described in the document is a 510(k) premarket notification to establish substantial equivalence of the NeutroPhase™ Wound Cleanser to two predicate devices: Dermacyn Wound Care (K060113) and Dermacyn Wound Irrigation (K042729).
- Objective: To demonstrate that NeutroPhase™ is as safe and effective as the predicate devices.
- Methodology: The submission highlights that the "intended use and technological specifications" of NeutroPhase™ are "substantially equivalent" to those of the predicate devices. It states that "NeutroPhase™ verification testing has confirmed the device's conformance with specifications." This implies internal testing was conducted, but the details of this testing (specific parameters, methods, and results) are not elaborated in the provided summary.
- Conclusion: The FDA reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market. The basis for this determination is the shared intended use and lack of significant differences in functional specifications from the predicates.
N/A