(88 days)
For recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The Inquiry AFocus™ catheters are for use in mapping atrial regions of the heart.
The Inquiry AFocusII™ Bi-Directional Steerable Electrophysiology Catheter is a flexible, radiopaque catheter with a variable number of electrodes with the first electrode located at the distal tip and the other band electrodes following at predetermined distances. A connecting cable is used to connect the catheter to electrogram devices. The catheter has a distal loop in a plane perpendicular to the catheter body. The circumferential shape or loop allows the electrophysiologist to record the potentials of cardiac structures without changing the position of the catheter. The catheter shaft and/or loop are steerable by manipulating the handle. The placement of the electrodes around the entire circumference of the distal loop also assists the electrophysiologist during fluoroscopy with visualization. The distal loop shape is easily straightened with the thumb and forefinger to facilitate insertion into sheaths and introducers. Once the catheter is extended beyond the sheath, the catheter resumes its pre-formed shape. The device is supplied sterile and is intended for single use only.
The provided documentation is a 510(k) summary for a medical device (Inquiry™ AFocusII™ Diagnostic Catheter). It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information typically found in a study or report that proves a device meets specific quantitative acceptance criteria.
The summary outlines the device's intended use, comparison to predicate devices, and mentions that nonclinical tests were conducted based on a preliminary guidance document. However, it does not provide any specific acceptance criteria for performance, nor does it detail the results of studies that would demonstrate the device meets such criteria.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document states "Test results indicate reliable performance when the device is used in accordance with the Instructions for Use," but it doesn't specify what "reliable performance" entails in terms of quantitative metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no human expert-based ground truth is reported for performance assessment.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not done or reported. This type of study is more common for diagnostic imaging AI systems, not typically for an electrophysiology catheter's performance documentation in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm/AI.
- The type of ground truth used: Not explicitly stated for performance testing beyond general "reliable performance."
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document's purpose is to establish substantial equivalence with a previously cleared device, not to present a detailed performance study with quantitative acceptance criteria in the way an AI/ML device or a novel diagnostic test might. The "nonclinical tests and results" section simply states that the tests were based on a guidance document and "indicate reliable performance," without further detail.
§ 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).