(90 days)
The HEMO-Valve is recommended for use in angiographic procedures involving blood or other potentially infectious materials, so that the procedure can be performed in such a manner as to minimize blood loss and patient/user exposure to these substances. The HEMO-Valve is intended for use in intra-arterial and intravenous administration of fluids, including radiographic contrast media.
The HEMO-Valve consists of an elastomeric valve located between male and female luer lock fittings. The valve may be opened by connecting a male luer lock (the luer fitting pushes the gland out of the way) or may be opened by introducing a guidewire in a forward or backloading manner.
This document describes a premarket notification for the "NAMIC HEMO-Valve." However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to AI or any advanced algorithmic analysis.
Instead, the document focuses on:
- Device Description: What the HEMO-Valve is and how it functions.
- Intended Use: The medical procedures it's designed for.
- Predicate Devices: Comparison to similar, already marketed devices.
- Performance Testing: A general statement about non-clinical performance testing for "functional claims," hemostasis, and pressure testing.
- Biocompatibility: Stating that predicate devices have undergone this testing and there are no material changes.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, AI study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
If you have a different document that details an AI device and its validation study, please provide that text, and I will do my best to extract the requested information.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.