(30 days)
Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording.
Same as the predicate Zynergy Zolution Electrophysiology catheter, the Zynergy Z.5000 Electrophysiology catheter is comprised of a radiopaque tubing reinforced with stainless steel braiding. The soft tip is fitted with electrodes in varying sizes and configurations. The back end of the catheter is comprised of an electrical connector.
The provided text is a 510(k) summary for a medical device (Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable) seeking substantial equivalence to a predicate device. It focuses on demonstrating that changes in material do not raise new safety or effectiveness concerns.
Therefore, the information required to answer the prompt is not present in the provided text. The document states that "Extensive functional and performance testing, and biocompatibility testing were conducted to assess the safety and effectiveness... All results are satisfactory," but it does not provide specific acceptance criteria or detailed study results.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This detailed information is not included in the summary.
- Sample sizes used for the test set and the data provenance: No sample sizes for testing are mentioned, nor is any information about the origin of data (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as the device is for physiological data acquisition, not image interpretation or diagnosis requiring expert ground truth. However, even for the device's operational performance, no expert involvement in defining 'ground truth' or evaluation is detailed.
- Adjudication method for the test set: Not applicable as per point 3.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic image interpretation by humans, often with AI assistance. This device is an electrophysiology catheter.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware component.
- The type of ground truth used: Not explicitly stated beyond "extensive functional and performance testing." For an electrophysiology catheter, ground truth would typically refer to physical measurements, electrical signal fidelity, and biocompatibility standards, not expert consensus or pathology in the diagnostic sense.
- The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML or statistical modeling.
- How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.
§ 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).