(233 days)
The Gyro Tip Lariat Deflectable Loop Mapping Catheter is indicated for multi-electrode electrophysiological mapping, recording, and or temporary stimulation of cardiac structure.
The Gyro-Tip Lariat Deflectable Loop Mapping Catheter of Cardiac Assist Devices, Inc. has been designed and developed as a diagnostic catheter for electrophysiological mapping of cardiac structures. The catheter has a braided outer tube that exhibits similar torsional stiffness, under a clockwise and counterclockwise-applied torque directions, to those of the named predicate devices. The distal portion of the subject catheter has up to 20 platinum electrodes that offer radiopacity under fluoroscopy for the required visibility during the cardiac electrophysiology mapping procedures. The accessory cables used to connect the subject device to a recorder/monitor comply with Section 12A of the Underwriters Laboratories UL 544 Standard for safety.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:
Disclaimer: This response is based solely on the provided text, which is a 510(k) summary, not a full submission. 510(k) summaries are intended to be concise and often reference more detailed information contained within the full submission (e.g., Appendices A, B, C, D, and E in this case). Therefore, some details you requested may not be explicitly present in this summary.
This 510(k) summary (K012520) for the Gyro-Tip Lariat Deflectable Loop Mapping Catheter describes a device intending to demonstrate substantial equivalence to predicate devices, rather than meeting specific performance criteria against a pre-defined standard in a de novo study. The acceptance criteria and "proof" primarily stem from demonstrating similarity in performance to legally marketed predicate devices through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Safety and Effectiveness comparable to predicate devices. | "The comparison of the results indicates that the subject device is as safe, and as effective, as the named predicate devices." |
"The results of the non-clinical tests... indicates that the subject device... performs as well as the named predicate devices, and any minute differences in the test results are not significant to influence the safety and effectiveness of the subject device." |
| Similar torsional stiffness (under clockwise and counterclockwise torque). | "The catheter has a braided outer tube that exhibits similar torsional stiffness, under a clockwise and counterclockwise-applied torque directions, to those of the named predicate devices." |
| Radiopacity under fluoroscopy for required visibility during cardiac electrophysiology mapping. | "The distal portion of the subject catheter has up to 20 platinum electrodes that offer radiopacity under fluoroscopy for the required visibility during the cardiac electrophysiology mapping procedures." (This is a feature description, implying it meets the need for visibility). |
| Steering mechanism and actuation resulting in a deflectable loop/halo-shaped configuration, safe and effective. | "The steering mechanism of the subject device is exactly similar to the steering mechanism of the primary predicate device... The halo-shaped configuration... and the process of assuming this final halo-shaped configuration... has shown to be safe and effective through a series of non-clinical testing." |
| Compliance with UL 544 Standard for Safety for accessory cables. | "The accessory cables used to connect the subject device to a recorder/monitor comply with Section 12A of the Underwriters Laboratories UL 544 Standard for safety." |
| Non-clinical performance, as determined by FDA's "Electrode Recording Catheter preliminary Guidance," should compare favorably. | "These tests were performed according to FDA's 'Electrode Recoding Catheter preliminary Guidance'." The summary states the device performs "as well as" predicate devices with no significant differences. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text states that a "series of non-clinical testing" was performed, and the results are included in "Appendices A, B, and C" of the 510(k) submission. However, the specific sample size for each non-clinical test (e.g., number of catheters tested for torsional stiffness, radiopacity, or deflection) is not mentioned in this 510(k) summary.
The data provenance is non-clinical testing, meaning it was performed in a laboratory or simulated environment, not on human subjects. This implies the data is retrospective in the sense that the tests were completed before submission. The country of origin of the data is not explicitly stated but would typically be where the manufacturer (Cardiac Assist Devices, Inc., Cleveland, Ohio) conducted their R&D and testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable / not provided in this context. The study is a non-clinical, benchtop, or simulated environment comparison to predicate devices, not a study involving human data requiring expert ground truth assessment (like image interpretation by radiologists). The "ground truth" here is the measured performance of both the subject device and the predicate devices against engineering and performance specifications.
4. Adjudication Method for the Test Set
This information is not applicable / not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation or subjective assessments, where multiple experts provide opinions that need to be resolved. For non-clinical tests, results are typically objective measurements compared against specifications or predicate device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers (e.g., clinicians) evaluating cases with and without AI assistance to measure performance improvement. The current submission is for a physical medical device (catheter) and focuses on its physical and functional performance, not on an AI algorithm's interpretative capabilities.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for a physical medical device, not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" used for this non-clinical testing comprises objective measurements and specifications related to the device's physical properties and functionality. This would include:
- Measurement of torsional stiffness.
- Evaluation of radiopacity.
- Assessment of deflection mechanism performance (loop formation, steerability, mechanical integrity).
- Compliance with electrical safety standards (UL 544 for cables).
The "ground truth" is established by the methods and standards used to measure these properties for both the subject device and the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable / not provided. The device in question is a physical medical catheter, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable / not provided. As explained in point 8, there is no training set for a physical device. Ground truth for non-clinical testing is established through standard measurement techniques and engineering specifications.
§ 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).