ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER

K960479 · Arrow Intl., Inc. · LDF · Oct 17, 1996 · Cardiovascular

Device Facts

• Record ID: K960479
• Device Name: ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
• Applicant: Arrow Intl., Inc.
• Product Code: LDF · Cardiovascular
• Decision Date: Oct 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2

Intended Use

The ARROW catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). The second pressure lumen allows infusion of a solution with simultaneous measurement of pressure. The catheter is intended for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording only.

Device Story

Radiopaque polymeric catheter; features two pressure lumens and balloon inflation lumen; two 2mm platinum electrodes for electrical conduction; 10cm increment markings. Used for right heart pressure measurement (CVP, RVP, PAP, PAWP), blood oxygen sampling, and temporary intracardiac stimulation/ECG recording. Operated by clinicians in clinical settings. Provides pressure data and electrical signals to external monitoring/recording equipment; facilitates solution infusion. Benefits include simultaneous pressure monitoring and pacing/recording capabilities.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included catheter flow rate, column strength, balloon inflation, torque, flexural modulus, lead pull, electrical continuity, signal-to-noise ratio, impedance, high pot, capacitance/inductance, and radiopacity.

Technological Characteristics

Radiopaque polymeric tubing; two 2mm platinum electrodes; two pressure lumens; balloon inflation lumen; female Luer fittings; 10cm increment markings. Electrical connectivity via proximal extension leads. Sterilization method not specified.

Indications for Use

Indicated for patients requiring right heart pressure monitoring, blood oxygen sampling, and temporary intracardiac stimulation or ECG recording during electrophysiology studies.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. Permanent pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

Predicate Devices

• Elecath® Ventricular Pacewedge® Pacing and Pressure Catheter (K832850, K844003)
• Arrow Balloon Temporary Bipolar Pacing Catheter (pre-enactment)
• Arrow Balloon Wedge Pressure Catheter (pre-enactment)

Submission Summary (Full Text)

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SECTION 2 - 510(k) SUMMARY
K960479
OCT 17 1996

The device is substantially equivalent to the following legally marketed devices:

1. The Elecath® Ventricular Pacewedge® Pacing and Pressure Catheter, open tip, catalog no. 34-6567, from the Electro-Catheter Corporation, Rahway, NJ, Premarket Notifications K832850 and K844003.
2. A combination of two Arrow pre-enactment catheters, the Balloon Temporary Bipolar Pacing Catheter and the Balloon Wedge Pressure catheter.

The ARROW Bipolar Pacing/Balloon Wedge Pressure Catheter is made of radiopaque polymeric tubing marked in 10 cm increments. The catheter body contains two separate pressure lumens, and a balloon inflation lumen, which lie parallel to each other and then form separate extensions at the proximal end of the catheter. The pressure lumens have female Luer fittings at extensions at the proximal end of the catheter. The "distal" pressure lumen terminates in an opening at the distal tip of the catheter. The "proximal" pressure lumen terminates in an opening 29.5 cm, proximal to the tip. The catheter electrically conducts through the use of two 2 mm platinum electrodes, located at 14 and 15.2 cm from the distal tip. This connection terminates proximal to the molded juncture with two extension leads marked "d" for distal and "p" for proximal.

The ARROW catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure, and pulmonary artery wedge pressure). The second pressure lumen allows infusion of a solution with simultaneous measurement of pressure. The catheter is intended for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording only.

The device has comparable technological characteristics to the predicate devices.

The nonclinical test results included in the submission comparable performance to the Elecath® device are as follows:

- Catheter flow rate testing
- Column strength test
- Balloon multiple inflation test
- Tube electrode torque test
- Catheter/electrode torque test
- Catheter body torque test
- Flexural modulus test
- Juncture lead pull test
- Electrical continuity test
- Signal to noise ratio test
- Impedance testing
- high pot test
- Catheter capacitance/inductance test
- Radiopacity testing

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