(135 days)
The Reprocessed Cristacath Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed to facilitate electrograms in the atrial regions of the heart.
The Reprocessed CristaCath Diagnostic Electrophysiology (EP) Catheters have been designed for electrophysiological mapping of cardiac structures. The catheters have a high-torque shaft with a tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The Deflectable Tip CristaCath catheters facilitate simultaneous local electrograms due to the greater number of electrodes and their deflection capabilities.
The deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed CristaCath Diagnostic Electrophysiology (EP) Catheter. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of a novel AI-powered device. Therefore, a significant portion of the requested information, such as sample sizes for training/test sets, expert qualifications related to AI ground truth, MRMC studies, or standalone AI performance, is not applicable to this submission.
However, I can extract information related to the acceptance criteria and the type of studies conducted to support the safety and effectiveness of the reprocessed catheter.
Acceptance Criteria and Device Performance (Reprocessed CristaCath Diagnostic EP Catheter)
Since this is a reprocessed device submission aiming for substantial equivalence, the "acceptance criteria" are typically defined by demonstrating that the reprocessed device performs comparably to a new, legally marketed predicate device and maintains its safety and effectiveness after reprocessing. The studies conducted are focused on ensuring that the reprocessing does not compromise the original device's performance characteristics.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria (Implied from "as safe and effective as the predicate" and test types) | Reported Device Performance (Summary from text) |
|---|---|---|---|
| Biocompatibility | Compatibility with biological systems | Reaching acceptable biocompatibility levels post-reprocessing, comparable to original device. | "Biocompatibility" testing was conducted. (Implies satisfactory results to meet equivalence). |
| Cleaning Validation | Effectiveness of cleaning process to remove contaminants | Demonstrated effective removal of contaminants to prevent patient harm and ensure sterility. | "Cleaning Validation" was conducted. (Implies successful validation of the cleaning process). |
| Sterilization Validation | Effectiveness of sterilization process | Demonstrated sterility of the reprocessed device to prevent infection. | "Sterilization Validation" was conducted. (Implies successful validation of the sterilization process). |
| Functional Testing | Visual Inspection (integrity, damage, foreign matter) | No unacceptable visual defects, damage, or foreign matter post-reprocessing. | "Visual Inspection" was conducted. Each device is inspected. Innovative Health's reprocessing includes removal of visible soil and decontamination. (Implies devices meet visual standards). |
| Dimensional Verification (physical dimensions) | Dimensions remain within specified tolerances, comparable to the original device. | "Dimensional Verification" was conducted. (Implies dimensions are maintained). | |
| Electrical Continuity and Resistance (electrode function) | Electrical performance (continuity, resistance) remains within specifications for accurate electrophysiological mapping, comparable to the original device. | "Electrical Continuity and Resistance" testing was conducted. (Implies electrical function is preserved). | |
| Simulated Use (performance under intended conditions) | Performance during simulated use demonstrates effective electrophysiological mapping capabilities. | "Simulated Use" testing was conducted. (Implies the device functions as intended during simulated procedures). | |
| Mechanical Characteristics (flexibility, deflection, durability) | Mechanical properties (e.g., deflection, torque, shaft integrity) are maintained after reprocessing to allow for proper manipulation and positioning. | "Mechanical Characteristics" testing was conducted. The device description highlights deflection control and high-torque shaft for accurate positioning, implying these characteristics are maintained. (Implies mechanical integrity and functionality are preserved). | |
| Electrical Safety Testing | Dielectric and Current Leakage (electrical insulation) | Electrical insulation integrity and leakage current are within safe limits to prevent electrical hazards to patients and users. | "Dielectric and Current Leakage" testing was conducted as part of Electrical Safety Testing. (Implies electrical safety standards are met). |
| Packaging Validation | Integrity of sterile barrier and shelf-life | Packaging maintains sterility and device integrity until point of use, and shelf-life is established. | "Packaging Validation" was conducted. (Implies packaging is adequate to maintain sterility). |
| Reprocessing Limits | Number of reprocessing cycles | Device remains safe and effective for one reprocessing cycle. | The Reprocessed CristaCath Diagnostic Electrophysiology (EP) Catheters are reprocessed no more than one (1) time. Each device is marked and tracked. After the device has reached the maximum number of reprocessing cycles, the device is rejected from further reprocessing. Reprocessing is performed only by Innovative Health, excluding devices previously reprocessed by others. (Indicates controlled reprocessing limits and processes are in place). |
| Overall Equivalence | Safety and Effectiveness | The reprocessed device is as safe and effective as the predicate device, with similar purpose, design, materials, function, and intended use, and no changes to claims, clinical applications, or performance. | Innovative Health concludes that the Reprocessed CristaCath Diagnostic EP Catheters are as safe and effective as the predicate devices described herein. The purpose, design, materials, function, and intended use are identical to the predicate. There are no changes to claims, clinical applications, patient population, performance specifications, or method of operation. |
Study Details and Data Provenance
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Sample sizes used for the test set and the data provenance:
- The document does not specify the exact sample sizes used for each of the "bench and laboratory testing" categories (Biocompatibility, Cleaning Validation, Sterilization Validation, Functional Testing, Electrical Safety Testing, Packaging Validation).
- The data provenance is from bench and laboratory testing, which is typically performed internally by the manufacturer (Innovative Health, LLC.) in the USA (Scottsdale, Arizona, as per the address). This type of testing is generally prospective for the specific reprocessed units being evaluated, though the methodologies are often established based on existing standards and predicate device data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of submission. "Ground truth" in the context of AI/machine learning typically refers to expert-labeled data used to train and validate algorithms. This submission is for a reprocessed physical medical device, not an AI or diagnostic algorithm. The "truth" for the tests performed (e.g., sterility, electrical continuity) is established by validated assays and measurement techniques, not by expert interpretation of data for ground truth labeling.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable for the same reasons as above. Adjudication methods are used in cases where multiple experts interpret complex data (e.g., medical images) and their decisions need to be reconciled to establish a "ground truth" for algorithmic validation. The tests described here are objective physical, chemical, or electrical measurements.
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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:
- This is not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI, where the performance of human readers (e.g., radiologists) with and without AI assistance is evaluated across multiple cases. This submission is for a reprocessed diagnostic catheter, which is an invasive tool for electrophysiological mapping, not an imaging or interpretive diagnostic AI system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the submission is for a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- As noted, the concept of "ground truth" in the AI/machine learning sense is not applicable here. For the bench and laboratory tests, the "truth" is established by:
- Validated measurement standards/protocols: For dimensional verification, electrical properties, mechanical characteristics.
- Chemical/biological assays: For biocompatibility, cleaning validation (e.g., residual protein, endotoxin), sterility testing.
- Functional performance specifications: For simulated use testing.
- As noted, the concept of "ground truth" in the AI/machine learning sense is not applicable here. For the bench and laboratory tests, the "truth" is established by:
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The sample size for the training set:
- This is not applicable as there is no AI algorithm being developed or "trained."
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How the ground truth for the training set was established:
- This is not applicable as there is no AI algorithm or training set.
§ 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).