(30 days)
The Reflexion Spiral catheter can be used for recording intracardiac signals and for cardiac stimulation during electrophysiology studies. The Reflexion Spiral catheter is to be used to map the atrial regions of the heart.
The St. Jude Medical Reflexion Spiral™ Bi-directional Variable Radius Mapping Catheter (Reflexion Spiral™ Decapolar EP Catheter) is a flexible, bi-directional, variable radius loop electrophysiology catheter constructed of a polymer shaft that incorporates platinum electrodes.
The Reflexion Spiral™ Decapolar EP Catheter has a loop and a proximal handle (the ComfortGrip™ handle) that contains: 1) A shaft actuator mechanism for varying the distal portion of the shaft; 2) A loop actuator mechanism for varying the loop diameter from approximately 20mm to approximately 15mm; and 3) An electrical connector.
This 510(k) summary describes a medical device, the Reflexion Spiral™ Variable Radius Catheter, which is an electrode recording catheter used for cardiac mapping. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Reflexion Spiral™ Variable Radius Catheter K062251) through non-clinical bench testing.
Based on the provided text, there is no acceptance criteria or detailed study information presented in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device through bench testing rather than demonstrating performance against specific numerical acceptance criteria.
Therefore, many of the requested fields cannot be filled.
Here's an attempt to extract what is available and note what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Mechanical Properties) | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The general criteria are implied to be "meets product specifications and intended uses" and "does not adversely affect the safety and effectiveness" compared to the predicate. | "Results of the testing demonstrates that the Reflexion Spiral™ Variable Radius Catheter design meets product specifications and intended uses." |
| Functional equivalence to predicate device in terms of recording intracardiac signals and cardiac stimulation. | Claimed substantial equivalence; "same intended use and fundamental scientific technology." |
| Biocompatibility | Claimed substantial equivalence. |
| Sterilization | Claimed substantial equivalence. |
| Packaging | Claimed substantial equivalence. |
| Labeling | Claimed substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The study is described as "Bench testing," which implies testing of physical devices/components, but the number of units tested is not provided.
- Data Provenance: Not applicable in this context; it's bench testing, not human subject data.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was bench testing, not an expert-driven performance evaluation.
4. Adjudication method for the test set
- Not applicable. This was bench testing, not a study requiring adjudication of expert interpretations.
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
- No. This device is an electrode recording catheter, not an AI software. An MRMC study is not relevant to its stated purpose or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical catheter, not an algorithm.
7. The type of ground truth used
- For bench testing, the "ground truth" would be established by engineering specifications, validated test methods, and potentially comparisons against known performance characteristics of the predicate device. Details are not provided.
8. The sample size for the training set
- Not applicable. This device is not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI model that requires a training set.
Summary of Study:
The primary study mentioned is "Summary of Non-Clinical Testing: Bench testing."
- Objective: To support substantial equivalence to the predicate device (Reflexion Spiral™ Variable Radius Catheter K062251).
- Methodology: Bench testing was performed to evaluate the Reflexion Spiral™ Variable Radius Catheter.
- Findings: The testing demonstrated that "the Reflexion Spiral™ Variable Radius Catheter design meets product specifications and intended uses." It also showed that "differences [between proposed and predicate device] do not adversely affect the safety and effectiveness."
- Conclusion: The device is substantially equivalent to the predicate.
This document is a typical 510(k) submission for a Class II medical device, which often relies on demonstrating substantial equivalence to a predicate device through non-clinical (bench) testing, rather than extensive clinical trials with detailed performance metrics and human-in-the-loop studies.
§ 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).