HEMO-VALVE

K955554 · North American Instrument Corp. · DTL · Mar 4, 1996 · Cardiovascular

Device Facts

• Record ID: K955554
• Device Name: HEMO-VALVE
• Applicant: North American Instrument Corp.
• Product Code: DTL · Cardiovascular
• Decision Date: Mar 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4290
• Device Class: Class 2

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.

Device Story

HEMO-Valve is an elastomeric valve adaptor with male and female luer lock fittings; used in angiographic procedures. Operation: valve opens via male luer connection or guidewire insertion (forward/backloading). Function: provides hemostasis during guidewire exchange; allows syringe aspiration/injection; withstands high-pressure injections. Used in clinical settings by physicians/technicians to manage fluid delivery and minimize blood loss/exposure to infectious materials.

Clinical Evidence

Bench testing only. Testing included hemostasis verification during and after wire exchanges, vacant valve hemostasis, and hydrostatic/dynamic pressure testing to confirm pressure ratings. Biocompatibility supported by existing data on predicate devices.

Technological Characteristics

Elastomeric valve with male/female luer lock fittings. Materials identical to predicate NAMIC devices. Designed for high-pressure injection. Sterilization identical to existing NAMIC product line.

Indications for Use

Indicated for patients undergoing angiographic procedures requiring intra-arterial or intravenous fluid administration, including radiographic contrast media, while minimizing blood loss and exposure to infectious materials.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NAMIC High Pressure Stopcock
• NAMIC PTCA Y-Adaptor
• Braun Safsite [Valve]

Reference Devices

• NAMIC Hemostatic Introducer Sheath

Submission Summary (Full Text)

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K95554

# 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 [phone]
Facsimile Number [phone] | |
| 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.

HEMO-Valve
NAMIC® USA CORPORATION
Page 42

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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.

HEMO-Valve
NAMIC® USA CORPORATION
Page 43