(27 days)
The St. Jude Medical (SJM) Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The SJM Livewire™ Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by remote means located at the proximal end of the catheter.
This device is a Livewire™ Electrophysiology Catheter. The submission indicates that there were "design modifications" to the predicate device, also a Livewire™ Electrophysiology Catheter (K022380 and K913940). The review focuses on these modifications.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product specification | Modified Livewire™ Electrophysiology Catheters design meets the product specification |
| Intended use | Modified Livewire™ Electrophysiology Catheters design meets the intended use |
| Safety | Design modifications do not adversely affect safety |
| Effectiveness | Design modifications do not adversely affect effectiveness |
2. Sample size used for the test set and the data provenance
The document explicitly states "Bench testing of the modified Livewire™ Electrophysiology Catheters was performed to verify the device modifications." It does not provide specific details on the sample size (e.g., number of catheters tested) or the provenance (e.g., country of origin, retrospective or prospective) of any data beyond the general mention of "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission describes physical bench testing of an electrophysiology catheter, not a study involving human data or expert review for ground truth establishment.
4. Adjudication method for the test set
Not applicable. The testing described is bench testing, not an assessment requiring adjudication by multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the substantial equivalence of device modifications through bench testing, not on comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrophysiology catheter, a physical medical device, not an algorithm or AI system. Therefore, a standalone performance study in the context of AI without human-in-the-loop performance is not relevant.
7. The type of ground truth used
For this device, the "ground truth" for the bench testing would be predefined engineering specifications, performance standards, and established safety/effectiveness parameters for electrophysiology catheters. The device's performance was compared against these established technical and regulatory standards.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm-based device that would require a training set. The "training" in this context would refer to internal design and development processes rather than data used to train a model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of an AI/algorithm. The "ground truth" for the device's design and manufacturing would be based on established engineering principles, material science, regulatory standards (e.g., ISO, ASTM), and historical performance data of similar devices.
§ 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).