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510(k) Data Aggregation
(28 days)
Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
The Radia™ Steerable Diagnostic Catheter is a steerable atrial mapping EP catheter with up to 20 electrodes. The device consists of a polymer shaft with platinum electrodes and internal steering wires mounted on a rotary-style handle for deflection of the catheter tip.
Acceptance Criteria and Device Performance Study for Radia™ Steerable Diagnostic Catheter (K091370)
The information provided describes a 510(k) submission for the Radia™ Steerable Diagnostic Catheter, indicating it is a Class II device (21 CFR 870.1220). The submission primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific quantitative acceptance criteria through a standalone clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, specific quantitative acceptance criteria or detailed performance metrics from a dedicated study are not explicitly stated. The submission relies on establishing substantial equivalence to predicate devices. The "performance" is generally described as meeting product specifications and intended uses, implied by the successful bench testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit Acceptance Criteria (quantitative values for sensitivity, specificity, accuracy, etc.) | Not explicitly stated in the provided document. The submission relies on substantial equivalence to predicate devices (Orbiter ST Diagnostic Electrode Catheter K992373, EP•XT Steerable Electrode Catheter K921872A). |
| Meeting product specifications and intended uses | Bench testing results demonstrate that the Radia™ Steerable Diagnostic Catheter design meets product specifications and intended uses. |
| Demonstration of substantial equivalence | The device has the same intended use and fundamental scientific technology as predicate devices. Technological characteristics (packaging, biocompatibility, sterilization, labeling) are substantially equivalent. Minor differences were addressed by performance testing showing no adverse effect on safety and effectiveness. |
2. Sample Size and Data Provenance for Test Set
- Sample Size Used for Test Set: Not explicitly stated. The document mentions "bench testing" but does not provide details on the number of units or conditions tested.
- Data Provenance: The study described appears to be a non-clinical bench testing study conducted by the manufacturer, Bard Electrophysiology Division of C. R. Bard, Inc. (Lowell, MA, USA). The data is not related to patient cases or clinical data in the traditional sense of a "test set" for performance metrics like sensitivity/specificity.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: This information is not applicable/not provided in the context of this 510(k) summary. The ground truth for this type of submission is typically based on engineering specifications and direct physical measurements during bench testing, not expert interpretation of diagnostic output.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not provided. As the described study is bench testing, there would be no expert adjudication of results in the traditional sense. Test outcomes would be compared against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The provided document does not mention an MRMC study. This device is a diagnostic catheter for intracardiac sensing, recording, stimulation, and temporary pacing, not a device that generates images or results requiring human reader interpretation in the way an AI algorithm might. Therefore, a comparative effectiveness study measuring human reader improvement with or without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study Done: No. This device is a physical medical instrument (catheter), not a software algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The "performance" is inherently linked to its physical characteristics and functionality.
7. Type of Ground Truth Used for Test Set
- Type of Ground Truth: The ground truth for the "bench testing" would likely be based on engineering specifications, direct physical measurements, and industry standards for catheter performance. This would include parameters like steering mechanisms, electrode integrity, electrical performance (sensing/recording/pacing capabilities), biocompatibility, and sterilization effectiveness.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not provided. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and manufacturing process are informed by established engineering principles and prior device experience, but not through a data-driven training set.
9. How Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable/not provided. As there is no training set, there is no ground truth established for one. The design and development of the device would follow medical device development processes, including design inputs, verification, and validation against specified requirements.
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