(90 days)
NAMIC High Pressure Stopcock, NAMIC PTCA Y-Adaptor, Braun Safsite [Valve]
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No
The description focuses on the mechanical function of a valve and does not mention any computational or data-driven capabilities.
No
The device is described for use in angiographic procedures to minimize blood loss and exposure to infectious materials, and for fluid administration, not for treating a specific disease or condition.
No
The device is described as a valve for angiographic procedures to minimize blood loss and manage fluid administration, not to diagnose a medical condition.
No
The device description clearly states it consists of physical components: an elastomeric valve and luer lock fittings.
Based on the provided information, the HEMO-Valve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in angiographic procedures, involving the administration of fluids and minimizing blood loss and exposure to infectious materials. This is a therapeutic or procedural use within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description of the valve and luer lock fittings aligns with devices used for connecting to catheters and administering fluids or introducing guidewires in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device's function is purely mechanical and procedural.
Therefore, the HEMO-Valve falls under the category of a medical device used in interventional procedures, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
NAMIC High Pressure Stopcock, NAMIC PTCA Y-Adaptor, Braun Safsite [Valve]
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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, or |
| fitting. | |
| 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.
1
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.