(398 days)
The Cardima Pathfinder 1.5F Microcatheter is intended for electrogram recording from within the coronary venous system during diagnostic electrophysiology studies.
The Cardima Pathfinder® 1.5F Mapping Catheter is a diagnostic medical device designed to provide localized unipolar or bipolar sensing of electrical potentials as measured from within the venous system of the heart. The catheter is available with 4, 1mm long electrodes spaced either 2mm or 2-6-2mm apart providing for a total electrode recording length of 10-14 mm. The working outer diameter is 1.5F and will be available with working lengths of 135cm and 170cm. The Pathfinder is not indicated for pacing or ablation. The outer surface is treated with a hydrophilic coating to enhance lubriciousness.
Here's an analysis of the Cardima Pathfinder 1.5F Mapping Microcatheter's acceptance criteria and the study used to demonstrate its safety and effectiveness, based on the provided text:
Acceptance Criteria and Device Performance for Cardima Pathfinder 1.5F Mapping Microcatheter
The provided document describes the predicate device equivalence rather than a detailed list of acceptance criteria from a specific clinical trial with performance metrics. The safety and effectiveness evaluation for this device was primarily based on biocompatibility testing and animal studies, as it is a modified version (smaller outer diameter) of an already approved device. The "acceptance criteria" can therefore be inferred from the successful completion of these tests and the demonstration of substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for all categories. | Accepted for all categories per ISO 10993-1. |
| Reliability (Mechanical/Electrical) | Compliance with "Electrode Recording Catheter Preliminary Guidance, March 1995" for mechanical and electrical properties. | Mechanical and electrical properties found to be acceptable for use. |
| Maneuverability in vivo | Ability to be easily positioned into selected coronary veins. | Catheter was shown to be easily positioned into selected coronary veins (anterior interventricular, middle cardiac, posterolateral, lateral and anterolateral veins) without difficulty. |
| Signal Quality (Electrogram) | Production of good quality electrogram signals adequate for clinical applications. | Signals were of good quality and adequate for clinical applications. |
| Absence of Adverse Events (Major) | No evidence of dye effusion outside coronary venous system; no pericardial effusion. | Effusion of dye outside the coronary venous system was not evident, nor was there pericardial effusion found on gross examination of the heart. |
| Absence of Adverse Events (Minor) | Minor complications, if present, should not be clinically significant. | Some minor complications were noted (slight endothelial injury with thrombus in one case, small subepicardial hemorrhage in 2 dogs), but these were not considered to be clinically significant. |
Study Details:
Given the nature of the submission (510(k) for a modified device), the "study" demonstrating performance is primarily preclinical (animal study) and bench testing, rather than a full-scale human clinical trial with extensive statistical and expert-driven ground truth establishment.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "animal studies" and "2 dogs" for specific findings, but doesn't provide a precise total sample size for the animal study. It's safe to assume a small number of animals, typical for preclinical studies of this nature.
- Data Provenance: The study was (presumably) conducted by the manufacturer, Cardima, Inc., and is a preclinical, prospective animal study. The country of origin for the data is not specified, but would likely be the United States, given the manufacturer's location and FDA submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for evaluating the animal study results. This type of preclinical study would typically involve veterinary professionals, potentially electrophysiologists or cardiologists for interpreting signal quality, and pathologists for gross and microscopic examination of tissues.
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Adjudication method for the test set:
- The document does not mention any specific adjudication method (e.g., 2+1, 3+1). Decisions on clinical significance of findings and signal quality would have been made by the researchers conducting the animal study, likely through consensus or standard veterinary/medical practice.
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If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was NOT done. This type of study typically involves multiple human readers evaluating medical images or data, often with and without AI assistance, and comparing their performance. The provided document concerns a physical medical device (catheter) and preclinical testing, not an AI or imaging diagnostic tool. Therefore, effects of human readers improving with AI assistance are not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical mapping microcatheter, not an algorithm or AI system. Its performance is inherent in its physical and electrical characteristics and its ability to acquire signals in vivo.
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The type of ground truth used:
- Animal study observations, physiological measurements, and gross/histopathological findings.
- Maneuverability: Direct observation during the procedure.
- Signal Quality: Electrogram recordings and interpretation.
- Adverse Events: Direct observation of tissue, dye, and pericardial effusions during necropsy/examination.
- Biocompatibility: Laboratory analysis of biological response to materials.
- Animal study observations, physiological measurements, and gross/histopathological findings.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set" in the computational sense. The design and modifications were likely based on engineering principles and experience with the predicate device.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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).