(242 days)
The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The Pathfinder is also indicated for pacing. It is contraindicated for ablation.
The Cardima Pathfinder 3mm catheter is intended for electrogram recording and pacing during diagnostic electrophysiology studies.
The Cardima Pathfinder® 3mm Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials in the heart. The catheter is available with 4 or 8, 3mm long electrodes spaced 2mm apart providing for a total electrode recording length of 4cm. The working outer diameter of the catheter is 3.3F and will be available with useable lengths of 100cm and 135cm. The Pathfinder is also indicated for pacing. It is contraindicated for ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.
The provided text describes a submission for a medical device (Cardima Pathfinder 3mm Mapping Microcatheter) for 510(k) clearance, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This is not a study proving the device meets acceptance criteria as typically found in an AI/ML context with performance metrics like sensitivity/specificity.
Instead, this document focuses on demonstrating substantial equivalence to an existing device and assessing safety and effectiveness through different types of testing common for physical medical devices. Therefore, many of the requested categories (e.g., AI performance metrics, readers, training sets, ground truth types) are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility | Acceptable per ISO 10993-1 categories using final sterilized product. | Confirms the material used is safe for contact with biological tissue. |
| Reliability (Mechanical & Electrical) | Acceptable for use based on "Electrode Recording Catheter Preliminary Guidance, March 1995" using sterilized product. | Ensures the device's physical and electrical properties are suitable for its intended function. |
| Maneuverability | Catheter could be positioned into coronary sinus, right atrium, and right ventricle without significant difficulty. | Assesses the ease of navigation within the heart. |
| Signal Quality | Signals were of good quality and adequate for clinical applications. | Confirms the ability to accurately record electrical potentials. |
| Pacing Capability | Pacing was easily achieved at clinically-relevant thresholds. | Verifies its secondary function of pacing is effective. |
| Safety (Animal Study) | No injury to animals, except for one instance of coronary sinus thrombosis in one animal, attributed to guiding catheter manipulation. Procedure found to be safe. | Assesses adverse events during use in a living organism. |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Studies: The text mentions "animal studies" and "one animal" where thrombosis occurred, implying a small number of animals were part of the study. The exact number of animals in the study is not specified.
- Data Provenance: The studies were conducted by the manufacturer, Cardima, Inc. They are prospective animal studies and laboratory bench testing. The country of origin is implicitly the USA (manufacturer is in Fremont, CA, and submission is to FDA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable (N/A) in the context of this device. The evaluations were primarily objective measurements (biocompatibility, electrical/mechanical tests) and direct observation by researchers/veterinarians during animal studies. There's no mention of expert consensus for interpreting complex data like images, which would require multiple human experts to establish "ground truth."
4. Adjudication Method for the Test Set
- N/A. As above, expert adjudication for a "test set" in the AI/ML sense is not relevant for this type of device submission. Direct measurements and observations were the basis of evaluation.
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 is not an AI/ML device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
7. The Type of Ground Truth Used
- For Biocompatibility: Laboratory test results against ISO 10993-1 standards (e.g., cytotoxicity tests, irritation tests).
- For Reliability: Laboratory measurements and physical inspections against specified performance criteria (e.g., electrical impedance, mechanical strength, flexibility).
- For Animal Study (Maneuverability, Signal Quality, Pacing, Safety): Direct observation of catheter performance, physiological signal analysis, and post-procedure examination of animal welfare/injury by the researchers/veterinarians conducting the study. This aligns more with outcomes data (direct observation of device function and biological response) rather than expert consensus on a subjective measure or pathology (though pathology might be part of post-mortem analysis, it's not explicitly detailed here as the primary ground truth).
8. The Sample Size for the Training Set
- N/A. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- N/A. As there is no training set for an AI/ML model, this question is not applicable.
§ 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).