(85 days)
The Cordis Webster Fixed Curve Catheter is indicated for electrophysiology mapping of cardiac structures in adults and children 4 years of age and older; i.e. stimulation and recording only.
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Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adequate pull strength | All samples passed the acceptance criteria. |
| Absence of adverse events in pediatric patients (implicitly, referring to smaller French size catheters) | Three letters from physicians discussing clinical experience with the absence of adverse events using smaller French size catheters in pediatric patients. |
| Number of complaints | Performance data was provided as the number of complaints versus the number of units sold. (Specific numbers are not provided in the document for direct comparison). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each performance measure.
- For "adequate pull strength," it states "All samples," but the number of samples is not specified.
- For "absence of adverse events in pediatric patients," it refers to "three letters from physicians," which implies a limited sample, but the specific number of pediatric patients observed by these physicians is not provided.
- Data Provenance: Not explicitly stated as retrospective or prospective studies. The physician letters suggest clinical experience, which could be retrospective observation. The complaints data would be real-world post-market data. The pull strength testing would be in a controlled lab environment.
- Country of Origin: Not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three (physicians).
- Qualifications: "Physicians" are mentioned. Their specific qualifications (e.g., pediatric cardiologists, electrophysiologists, years of experience) are not detailed.
4. Adjudication Method for the Test Set
- No formal adjudication method is described for the "absence of adverse events" data from the physicians. It appears to be based on individual clinical experience as reported in letters. For pull strength, it's a pass/fail mechanical test, so no expert adjudication is required. For complaint data, it is simply a record of complaints.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This device is a physical catheter, not an AI or imaging device where MRMC studies are typically conducted to assess reader performance with or without AI assistance.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Not applicable. This is a physical medical device (catheter), not a software algorithm.
7. Type of Ground Truth Used
- Pull Strength: Mechanical testing against predefined acceptance criteria for physical properties.
- Absence of Adverse Events: Clinical observation and experience as reported by physicians. This is a form of real-world evidence or expert opinion.
- Complaints: Real-world post-market surveillance data.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set. The "capability testing" for pull strength would be considered part of the verification and validation process, not "training."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of 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).