(141 days)
The Reprocessed Halo XP Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheters' preformed halo shape of the tip section is designed specifically for the tricuspid annulus.
The Reprocessed Deflectable Tip Halo XP Diagnostic Electrophysiology (EP) Catheters have been designed for electrophysiological mapping of the heart, in particular, the tricuspid annulus. The catheters have a high-torque shaft with a halo-shaped tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The tip section also contains a radiopaque mark in the center of the electrode array. The halo-shaped tip section has a preformed curve which can be positioned around the atrial aspect of the tricuspid annulus. The catheters facilitate simultaneous local electrograms spanning the tricuspid annulus, from the midseptal to anterior to lateral to posterolateral. Recordings of the entire annulus can be obtained without repositioning the catheter tip.
A piston in the handpiece is attached to an internal puller wire which changes the radius of curvature. When the piston is pushed forward, the radius of curvature of the preformed loop is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section returns to the preformed shape. The high torque shaft allows the plane of the curve to be maneuvered in order to facilitate accurate positioning.
The provided text describes a 510(k) premarket notification for Reprocessed Halo XP Diagnostic Electrophysiology Catheters. This is a medical device, and the information focuses on demonstrating its substantial equivalence to legally marketed predicate devices, rather than an AI-powered diagnostic tool. Therefore, many of the requested criteria related to AI performance, such as human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for training and test sets, are not applicable to this submission.
The "acceptance criteria" in this context refer to the demonstration of safety and effectiveness as a reprocessed device compared to its original and predicate devices.
Here's the information that can be extracted from the provided text, with an explanation of why other criteria are not applicable:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Testing conducted (performance not detailed, but implied successful) |
| Cleaning Validation | Testing conducted (performance not detailed, but implied successful) |
| Sterilization Validation | Testing conducted (performance not detailed, but implied successful) |
| Functional Testing | Conducted, including: |
| - Visual Inspection | Performed |
| - Dimensional Verification | Performed |
| - Electrical Continuity and | Performed |
| Resistance | |
| - Simulated Use | Performed |
| - Mechanical Characteristics | Performed |
| Electrical Safety Testing | Conducted, including: |
| - Dielectric and Current Leakage | Performed |
| Packaging Validation | Performed |
| Reprocessing Cycle Limit | Reprocessed no more than one (1) time |
| Reprocessing Restrictions | Only reprocessed by Innovative Health; excludes devices previously reprocessed by others |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The text mentions "Bench and laboratory testing," which would involve a sample of reprocessed devices, but the specific number is not provided.
- Data Provenance: The "tests" were conducted internally by Innovative Health, LLC, as part of their submission to the FDA. The data is thus internally generated by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not Applicable. This is a reprocessed medical device, not an AI diagnostic tool. "Ground truth" in this context would refer to established engineering and material science standards for device performance, integrity, and safety (e.g., electrical resistance within a spec, material strength meeting a threshold). These are typically verified by qualified engineers and technicians, not medical experts establishing a diagnostic ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As mentioned above, this is not an AI diagnostic study requiring adjudication of expert interpretations. The testing involves objective measurements and validations against predefined specifications.
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:
- Not Applicable. This device is not an AI algorithm assisting human readers. It is a reprocessed physical medical catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical instrument, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the reprocessed device, the "ground truth" or reference points for testing are established engineering specifications, safety standards, and performance characteristics for the original device and similar predicate devices. For example:
- Biocompatibility: Likely tested against ISO standards for medical devices concerning patient contact.
- Cleaning/Sterilization: Validation against established microbiological and sterility assurance level (SAL) standards.
- Functional/Electrical/Mechanical: Comparison to the original device's specifications and performance using objective measurements (e.g., resistance values, tensile strength, deflection range, etc.).
8. The sample size for the training set:
- Not Applicable. There is no AI model being trained for this device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no AI model being trained 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).