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510(k) Data Aggregation
(249 days)
Carto Octaray Mapping Catheter with Trueref Technology
The CARTO® OCTARAY™ Mapping Catheter with TRUErcf™ Technology is indicated for multiple electrode clectrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The catheter provides location information only when used with compatible versions of the CARTO® 3 EP Navigation System.
The Biosense Webster CARTO® OCTARA Y™ Mapping Catheter with TRUEref™ Technology is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 8 spines that radiate from the center. Each spine has 6 ring electrodes that are used for stimulation and recording within the heart. The catheter also includes an electrode located at the confluence of the spines that can be used as a close internal unipolar reference. The flower is available in a 30mm or a 40 mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.
The provided text describes the 510(k) summary for the CARTO® OCTARAY™ Mapping Catheter with TRUEref™ Technology. It outlines the device's indications for use, technical characteristics, and the performance data used to demonstrate substantial equivalence to a predicate device.
Key Findings from the Document Regarding Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence, relying on a combination of bench testing, animal studies, and a clinical study. The acceptance criteria for the clinical study are defined by primary objectives for effectiveness and safety.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance |
|---|---|
| Effectiveness: Completing pre-ablation mapping and clinically indicated mapping without the need for another device. | Pre-ablation mapping: 82.1% (23/28) in the Per-Protocol Population had pre-ablation mapping requirements successfully performed without the need of another catheter. (Note: Reasons for failure in the remaining cases were attributed to patient safety, operator's inability to maintain stable contact, or human error, not catheter deficiency). |
| Clinically indicated mapping: 100.0% (15/15) of cases where clinically indicated mapping was started and finished, it was done without the need for another device. | |
| Safety: No serious adverse events within 7 days of the study procedure resulting from the use of the study catheter. | No Serious Adverse Events were reported resulting from the use of the study catheter. All 17 observed adverse events in 12 subjects were classified as unrelated to the study device. |
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: The clinical study enrolled 31 subjects.
- One subject was withdrawn prior to the procedure.
- Two subjects had mapping performed but not for the study arrhythmia.
- This resulted in a Safety Population of 30 subjects and a Per-Protocol Population of 28 subjects.
- Data Provenance: The study was a prospective, single-arm, non-randomized, multi-center study. It was performed outside of the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical study. It describes the study as "single arm," implying that the assessment of mapping success and adverse events was likely done by the participating clinicians (physicians/operators) at the study sites. The "Sponsor" (Biosense Webster, Inc.) appears to have reviewed and attributed reasons for protocol deviations and adverse events.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe a formal adjudication method (like 2+1 or 3+1) for the clinical study's outcomes. The reporting of effectiveness and safety endpoints seems to be directly from the study results as interpreted by the sponsor, without explicit mention of independent adjudication of each case by a panel of experts.
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 document describes a clinical study for a medical device (mapping catheter) to demonstrate its safety and effectiveness, not an AI/human reader comparative effectiveness study. Therefore, there is no mention of MRMC studies or effect sizes related to human readers improving with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical mapping catheter, not an AI algorithm. Its performance is inherently linked to its use by a human operator in a clinical setting with the CARTO® 3 EP Navigation System. The study assessed the device in a human-in-the-loop context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for the clinical study was based on:
- Clinical assessment by interventional physicians during the procedures: For successful completion of mapping and initiation/completion of clinically indicated mapping without the need for another device.
- Observation and reporting of adverse events: Documented by study site personnel and reviewed by the sponsor.
- Protocol compliance: Reviewed against the study protocol by the sponsor to identify deviations.
This is a form of clinical outcome data and expert judgment from the performing physicians.
8. The sample size for the training set:
Not applicable. This device is a medical catheter, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm's development.
9. How the ground truth for the training set was established:
Not applicable, as explained in point 8.
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