(258 days)
No
The device description and performance studies focus on the physical and electrical properties of a catheter, with no mention of AI or ML capabilities.
No
The device is indicated for diagnostic purposes (sampling blood for oxygen levels, measuring pressure, intracardiac stimulation/ECG recording) rather than treating a disease or condition.
Yes
The catheter is indicated for "sampling blood for oxygen levels and measuring pressure in the right heart," and for "intracardiac simulation and/or ECG recording," all of which are diagnostic functions.
No
The device description clearly details a physical catheter with lumens, electrodes, and a balloon, indicating it is a hardware device, not software-only. The performance studies also focus on physical characteristics and electrical properties of the hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for sampling blood, measuring pressure in the heart, and for temporary use in electrophysiology studies. These are all procedures performed directly on a patient.
- Device Description: The description details a catheter designed to be inserted into the body, with lumens for pressure measurement and balloon inflation, and electrodes for electrical stimulation and recording. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro), such as blood, tissue, or other bodily fluids, for diagnostic purposes.
IVDs are devices used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to interact directly with the patient's internal environment.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
The ARROW Bipolar Pacina/Balloon Wedge Pressure Catheter is made of radiopaque polymenc 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal 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.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is 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.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
SECTION 2 - 510(k) SUMMARY
K9600479
The device is substantially equivalent to the following legally marketed devices:
-
- A combination of two Arrow pre-enactment catheters, the Balloon Temporary Bipolar Pacing Catheter and the Balloon Wedge Pressure catheter.
The ARROW Bipolar Pacina/Balloon Wedge Pressure Catheter is made of radiopaque polymenc 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
OCT 17 1996
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