(35 days)
For use in right and left atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multiple Electrode Recording and Pacing Catheter System may also be used for delivery of externally generated pacing stimuli.
The Boston Scientific Constellation® Multiple Electrode Recording and Pacing Catheter (Constellation Catheter) is a sterile, single use advanced heart mapping diagnostic device designed to detect electrical potentials from the endocardial surfaces of the heart and may also be used to deliver externally generated pacing stimuli. The distal expandable 'basket' assembly contains an array of 32 or 64 electrodes mounted along eight resilient support structures called 'splines.' Several configurations are available, including unipolar (electrodes evenly spaced), bipolar (electrodes evenly distributed into pairs), and lower density arrays. The product is available in 31, 38, 48, 60, and 75mm basket sizes.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Constellation® Multiple Electrode Recording and Pacing Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (510(k) Summary) does not explicitly list quantitative acceptance criteria in a dedicated section. Instead, the justification for substantial equivalence for the expanded indications for use (left atrial electrophysiology procedures) relies on the device being identical in design and materials to its predicate and the cumulative animal and human data supporting its safety and effectiveness.
Therefore, the "acceptance criteria" here are implicitly linked to demonstrating safety and effectiveness for the expanded indication, primarily by showing no new safety concerns and similar performance to existing, cleared devices.
| Acceptance Criteria (Implicit) | Reported Device Performance and Justification |
|---|---|
| Safety in Left Atrial Electrophysiology Procedures (e.g., no increased risk of stroke, TIAs, or other complications) | Demonstrated Safety: The CONFIRM study (Narayan et al., 2012) mapped the left atrium in 92 patients using the Constellation Catheter. The study reported "no strokes or TIAs (transient ischemic attack) reported nor any unanticipated complications related to cardiac catheterization and/or ablation." This, combined with existing animal data, prior IDE study data (G940612), and additional medical literature, supports continued safety. |
| Effectiveness in Left Atrial Electrophysiology Procedures (e.g., ability to diagnose complex arrhythmias) | Demonstrated Effectiveness: The device is indicated "to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone." The study relies on the fact that "The Constellation Catheter with expanded indications for use to include left atrial electrophysiology procedures is substantially equivalent to the predicate Constellation Catheter (K021232) and the Flower/PENTARAY High Density Mapping Catheter (K050217) based on comparison of the devices." The CONFIRM study also indicates its usage in left atrial mapping. |
| Similar Technological Characteristics to Predicate Devices | Identical/Equivalent Design: The Constellation Catheter for left atrial use is "the same device indicated for use in right atrial procedures. Design, principle of operation, and materials are identical to the Constellation Catheter cleared under K983171, K992777, K000277, K003782 and K021232 and equivalent to the Johnson & Johnson/Biosense-Webster Flower High-Density Mapping Catheter/ PENTARAY™ High-Density Mapping Catheter legally marketed under K050217." |
| Non-clinical Performance Data Remains Valid | Non-clinical equivalence: "Device design specifications are identical for both the predicate and subject Constellation Catheter. Therefore the non-clinical testing for the Constellation Catheter that was submitted in previous submissions (K983171, K992777, K000277, K003782, and K021232) remains relevant." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The primary human clinical data referenced is from the CONFIRM study (Narayan et al., 2012), which involved 92 patients.
- Data Provenance: The CONFIRM study is described as a published medical literature study. The location or country of origin for this study is not explicitly stated in the provided text. It is a prospective study, as it involved the active use and observation of the device in patients, evidenced by phrases like "the Constellation Catheter was advanced via an 8.5 F sheath to map the left atrium in 92 patients."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not detail how ground truth was explicitly established for the CONFIRM study in the context of validating a diagnostic device's performance through expert consensus. The study focused on safety outcomes (absence of strokes/TIAs) and the device's application in mapping. It doesn't appear to be a study designed to evaluate the diagnostic accuracy of the catheter against a 'ground truth' diagnosis for complex arrhythmias, but rather its safety and functional application in mapping.
Therefore, information on the number of experts, their qualifications, or their role in establishing ground truth for the test set is not available in the provided text.
4. Adjudication Method for the Test Set
As the study (CONFIRM) primarily focused on safety outcomes and the functional application of the mapping, there is no mention of an adjudication method (like 2+1, 3+1) for interpreting diagnostic results or reviewing discrepancies in a test set. This type of adjudication is typically relevant for studies evaluating the diagnostic accuracy of an AI algorithm or a new diagnostic tool where human readers assess the output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a physical medical device (catheter), not an AI algorithm intended to assist human readers. The clinical performance data focuses on the device's safety and effectiveness in a clinical procedure, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device (catheter) used by a clinician, not a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth or primary endpoints for the referenced CONFIRM study appear to be:
- Absence of adverse events: Specifically, "no strokes or TIAs reported nor any unanticipated complications related to cardiac catheterization and/or ablation." This is essentially patient outcomes data (safety).
- Successful application in mapping: The use of the catheter "to map the left atrium" implies its successful functional application for its intended purpose.
There isn't a "ground truth" in the sense of a definitive diagnosis (e.g., confirmed pathology) against which the catheter's diagnostic output was explicitly validated as being "correct" for specific arrhythmias in this summary. The primary clinical data focuses on safety during the use of the device for its indicated purpose.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The clinical data cited (CONFIRM study, IDE study, animal data) serves as evidence for the overall safety and effectiveness of the device, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no training set for this device.
§ 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).