(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.
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4695554
PREMARKET NOTIFICATION
| VII: 510(K) SUMMARY MAR - 4 1996 | |
|---|---|
| Manufacturer: | NAMIC U.S.A. Corporation |
| Glens Falls, New York 12801 | |
| Contact Person: | Mary Meagher Rubin |
| Regulatory Affairs Specialist | |
| Telephone Number (518) 798-0067 | |
| Facsimile Number (518) 798-5475 | |
| Date Prepared: | December 1, 1995 |
| Trade Name: | NAMIC HEMO-Valve |
| Common Name: | Adaptor |
| Classification Name: | Cardiopulmonary Bypass adaptor, stopcock, manifold, orfitting. |
| Predicate Devices: | NAMIC High Pressure Stopcock |
| NAMIC PTCA Y-Adaptor | |
| Braun Safsite [Valve] |
Product Description:
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.
Intended Use:
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 is identical to currently marketed NAMIC devices NAMIC High Pressure Stopcock, NAMIC PTCA Y-Adaptor, and the NAMIC Hemostatic Introducer Sheath with respect to materials of construction. The manufacturing process for the HEMO-Valve is common to other products manufactured by NAMIC. Packaging, sealing, and sterilization for the HEMO-Valve is identical to that of all NAMIC devices.
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PREMARKET NOTIFICATION
VII. 510(K) Summary (Continued).
The manner in which the normally closed valve is actuated (by insertion of a male luer lock) is the same as the predicate device.
The intended uses of the HEMO-Valve are consistent with those of the predicate devices.
As with all three predicate devices, the HEMO-Valve allows for syringe aspiration and Injection, its primary function, being an adaptor. Insertion and backloading of a guidewire in addition to hemostasis around a guidewire are functions the HEMO-Valve has in common with the NAMIC PTCA Y-Adaptor. Finally, as with the NAMIC High Pressure Stopcock, the HEMO-Valve is designed to withstand high pressure injections.
The HEMO-Valve has been subjected to non-clinical performance testing to provide data supporting the functional claims of the device. The test protocol included testing to confirm hemostasis during and after wire exchanges as well as with the valve in the vacant position. Hydrostatic and Dynamic pressure testing were performed to confirm the pressure rating of the device.
Biocompatibility testing has been performed on the NAMIC predicate devices. There are no changes regarding device material.
§ 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.