(159 days)
The Rithm ID™ Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Rithm ID™ Electrophysiology Catheters have been designed to facilitate electrophysiological mapping of cardiac structures in 115 models and 17 kind of curves.
The catheter has a high-torque shaft with an array of platinum electrodes at the distal tip that can be used for recording. The high-torque shaft allows the plane of the distal curve to be manually rotated to assist in positioning the catheter tip at the desired site.
The Rithm IDM Electrophysiology Catheters have to connect with the EP by interface cables, model CI8RS04S, C25S04S, C18RS10S and C25RS10S with different trunk length, leadwire and equipment connector for the different Electrophysiology Catheters.
The provided text does not contain information about specific acceptance criteria, reported device performance metrics, or the details of a study demonstrating the device meets such criteria. Instead, it details a 510(k) submission for the "Rithm ID™ Electrophysiology Catheter," which focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a test set.
- Information about an MRMC comparative effectiveness study or its effect size.
- Details of a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
What the document does provide is:
- Non-Clinical Test Conclusions: The submission states that non-clinical tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. These tests assessed compliance with various standards (IEC, ISO, ASTM) and included specific bench tests relating to the catheter's physical and electrical properties.
- Bench Test 1: Surface, Dimensions, and Shape Keeping of Tip Curve
- Bench Test 2: Buckling Force, Tip Fatigue, Shaft Fatigue, Torsional Strength, Tensile Strength, Connector Retention Force
- Bench Test 3: Electrode Isolation, Electrode Conductor Resistance, Insulation Resistance
- Bench Test 4: Corrosion Resistance and Radio-detectability
- Bench Test 5: Freedom from leakage
- Bench Test 6: Shape Keeping of Tip Curve, Electrode Conductor Resistance on Simulation Test
- Bench Test 7: Acquiring Clear Intracardiac Electrograms Test
- Bench Test 8: Stimulating Capability Test
- Clinical Test Conclusion: "No clinical study is included in this submission." This indicates that the device's clearance was based on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device, rather than through a clinical performance study.
The acceptance criteria here are implicitly linked to compliance with the listed standards and satisfactory performance in these bench tests, demonstrating similar characteristics and safety profiles to the predicate device. However, specific quantitative acceptance criteria or detailed performance metrics are not provided in this summary.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).