(25 days)
St Jude Medical (SJM) Electrophysiology Catheters can be used in evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Response™ Electrophysiology Catheter with Lumen is a sterile, single use, electrophysiological diagnostic catheter with multiple electrodes and a fixed distal curve for intracardiac electrogram sensing (IECG). The body is a continuous tube with a central lumen for fluid infusion through a 3-way valve.
This document is a 510(k) summary for the St. Jude Medical Response™ Electrophysiology Catheter with Lumen. It is a submission for a modified device, establishing substantial equivalence to a predicate device (K914278) which was also a Response™ Electrophysiology Catheter with Lumen.
The submission is primarily focused on demonstrating substantial equivalence for a modified version of an existing device, rather than proving a new device meets specific performance criteria through a clinical study. Therefore, the information typically requested about acceptance criteria, detailed device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are common for AI/ML device submissions, is not present in this document.
This 510(k) focuses on showing that changes (specifically, a resin modification) to an already cleared device do not adversely affect its safety and effectiveness.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as numerical performance metrics in this document. The overarching "acceptance criterion" is proving substantial equivalence to the predicate device. For the bench testing, the acceptance criterion was that the modified design meets "specifications" and that "biocompatibility was confirmed in accordance with ISO 10993-1." Specific numerical targets for performance parameters are not detailed.
- Reported Device Performance: The document states that "Results of testing demonstrate that the modified design meets specifications as biocompatibility was confirmed in accordance with ISO 10993-1." However, no specific performance values are provided. The key claim is that the device "has the same intended use and fundamental scientific technology" as the predicate, and that the "resin modification does not adversely affect the safety and effectiveness."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Modified design meets specifications. | "Results of testing demonstrate that the modified design meets specifications." |
| Biocompatibility confirmed in accordance with ISO 10993-1. | "Biocompatibility was confirmed in accordance with ISO 10993-1." |
| Resin modification does not adversely affect safety and effectiveness. | "It was demonstrated that the resin modification does not adversely affect the safety and effectiveness." |
| Same intended use and fundamental scientific technology as predicate device. | "The modified Response™ Electrophysiology Catheter with Lumen has the same intended use and fundamental scientific technology as the predicate device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The submission mentions "bench testing" and "biocompatibility testing." These generally refer to laboratory (in vitro) and, potentially, animal (in vivo for biocompatibility) studies, not human clinical trials with "test sets" in the context of device performance in patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided as this type of expert review to establish ground truth is typical for diagnostic algorithms (e.g., AI/ML in imaging), not for a modified physical medical device like an electrophysiology catheter where performance is assessed via engineering and biocompatibility tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is not applicable to the type of testing described in this 510(k).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not provided and is not applicable. This is a physical medical device, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided and is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "bench testing," the "ground truth" would be the device's technical specifications and performance standards established by the manufacturer, often based on engineering principles and regulatory guidance.
- For "biocompatibility testing," the "ground truth" is compliance with the ISO 10993-1 standard.
8. The sample size for the training set
- This information is not provided and is not applicable. There is no concept of a "training set" for a physical medical device where manufacturing and materials are modified.
9. How the ground truth for the training set was established
- This information is not provided and is not applicable.
§ 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).