(29 days)
The Steerable Electrophysiology Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheter is indicated for mapping the atrial regions of the heart.
The Inquiry™ AFocus™, Inquiry™ AFocus IITM, or Inquiry™ Optima™ 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 loon 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 shaft and/or loop is 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.
I am sorry, but the provided text does not contain the detailed information needed to fill out the requested table and answer the specific questions about acceptance criteria and a study proving device performance.
The document is a 510(k) summary for a steerable electrophysiology catheter. It discusses:
- Device identification: Names, classification, and predicate devices.
- Device description and function: How it works and its components.
- Intended use: Electragram recording and cardiac stimulation during diagnostic electrophysiological studies, mapping atrial regions.
- Comparison to predicate devices: States that modifications do not affect intended use or scientific technology.
- Nonclinical tests: Mentions that a test plan was based on a guidance document and that results indicate reliable performance, but no specifics about the tests, acceptance criteria, or performance outcomes are provided.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: The document only vaguely mentions "test results indicate reliable performance" but provides no specific criteria or performance metrics.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
- 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 AI algorithm.
- The type of ground truth used: Not mentioned, and not directly applicable in the sense of AI ground truth as this isn't an AI/diagnostic imaging device.
- The sample size for the training set: Not applicable as this is a physical medical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory submission focused on substantial equivalence to predicate devices, not on a detailed clinical study demonstrating specific performance against quantitatively defined acceptance criteria.
§ 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).