(42 days)
The device is intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding 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 device is offered in various bottle sizes.
The provided text describes a 510(k) summary for the NeutroPhase Wound Cleanser, a medical device. However, this document does not contain information about acceptance criteria, specific device performance metrics in a study, sample sizes for test/training sets, or details about ground truth establishment or expert involvement.
The document primarily focuses on establishing substantial equivalence to a predicate device (NeutroPhase K071056). It states that the "Modified NeutroPhase" represents a "minor change" to the predicate specification and that "The NeutroPhase verification testing under the company's Design Control Process has confirmed the device's conformance with specifications." However, it does not elaborate on what those specifications or acceptance criteria are, nor does it provide any quantitative performance data from such testing.
Therefore, I cannot fulfill your request for the specific types of information you've asked for. The text explicitly states:
- "The specifications do not include any significant differences from those of the predicate." This implies that the performance expectations are the same as the predicate, but it doesn't state what those are.
- "The NeutroPhase verification testing under the company's Design Control Process has confirmed the device's conformance with specifications." This confirms testing was done internally as per design controls, but the results and methodologies are not detailed in this public summary.
In summary, based only on the provided text, the requested information cannot be extracted. The document is a regulatory submission for substantial equivalence based on minor modification, not a detailed performance study report.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.