(106 days)
The Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision System to combine and display magnetic processed patient positioning and navigation mapping information.
The Reprocessed Advisor™ FL Circular Mapping Catheters, Sensor Enabled™ are steerable, flexible, insulated electrophysiology catheters constructed of thermoplastic elastomer material and noble metal electrodes. The shaft curvature is manipulated by the control mechanism located on the handle at the catheter's proximal end. To adjust the curve on the bi-directional catheter, use the actuator to deflect the catheter in either direction. The distal loop is oriented counter-clockwise as viewed from the handle.
This device is compatible with the EnSite Precision™ System which is a three dimensional (3-D) cardiac mapping system that combines impedance and magnetic field technology.
The provided text describes the 510(k) premarket notification for a reprocessed medical device, the "Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled." It primarily focuses on demonstrating substantial equivalence to a predicate device through functional and safety testing, rather than an AI/ML-based system. As such, many of the requested criteria regarding AI model performance, multi-reader studies, and ground truth establishment for AI training/test sets are not applicable to this submission.
However, I can extract information related to the device's performance against its own acceptance criteria, as well as the testing methodology.
Here's a breakdown based on the provided text, addressing the applicable points:
Acceptance Criteria and Device Performance (Based on the nature of this medical device submission)
The document primarily focuses on demonstrating that the reprocessed device performs "as safe and effective as the predicate and operate as originally intended." The acceptance criteria are implicitly met by successful completion of the listed tests, ensuring the reprocessed device maintains the functional and safety characteristics of the original.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported device performance. Instead, it lists the types of performance tests conducted to demonstrate the device's safety and effectiveness and its equivalence to the predicate device. The conclusion states these tests demonstrated that the reprocessed devices are "as safe and effective as the predicate and operate as originally intended."
Here's an interpretation of the performance tests as implicitly meeting acceptance:
| Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility | Tests conducted and successfully met. |
| Validation of Reprocessing | Tests conducted and successfully met. |
| Sterilization Validation | Tests conducted and successfully met. |
| EEPROM verification | Tests conducted and successfully met. |
| Location sensor testing | Tests conducted and successfully met. |
| Visual inspection | Tests conducted and successfully met. |
| Dimensional testing | Tests conducted and successfully met. |
| Electrode continuity/isolation | Tests conducted and successfully met. |
| Curve and in-plane deflection | Tests conducted and successfully met. |
| Rigidity testing | Tests conducted and successfully met. |
| Freedom from leakage | Tests conducted and successfully met. |
| Tensile testing | Tests conducted and successfully met. |
| Locking mechanism testing | Tests conducted and successfully met. |
| Electrical Safety Testing | Tests conducted and successfully met. |
Note: The document states "The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended," implying all listed tests were passed successfully to meet the acceptance of substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample size (number of reprocessed catheters) used for each of the bench and laboratory tests. It only states "Bench and laboratory testing was conducted."
- Data Provenance: Not explicitly stated (e.g., country of origin, specific labs). It indicates these were "bench and laboratory testing," suggesting they were controlled experimental environments. The nature of reprocessing validation typically involves prospective testing of reprocessed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission is for a reprocessed electrophysiology catheter, not an AI/ML diagnostic system. The "ground truth" for this device's performance is established through objective physical, electrical, and mechanical measurements and validations (e.g., successful sterilization, appropriate dimensions, electrical continuity, sensor function). It does not involve human expert interpretation of images or signals for establishing a "ground truth" for a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is not an AI/ML diagnostic system based on human interpretation, there is no need for expert adjudication of results for a test set. Device performance is determined by objective measurements compared to 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 is not an AI-assisted diagnostic system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device; it does not have an "algorithm-only" or "standalone" performance in the context of AI/ML. Its performance is inherent to its physical and electrical properties.
7. The type of ground truth used
- The "ground truth" for this reprocessed device is established through:
- Objective Engineering Specifications: The device must meet the original design specifications for dimensions, electrical properties (continuity, isolation), mechanical properties (curve, deflection, rigidity, tensile strength, locking mechanism), and sensor function (EEPROM and location sensor verification).
- Validation Standards: Compliance with validated reprocessing procedures (cleaning, sterilization) and biocompatibility standards is the "ground truth" for safety.
- Essentially, the ground truth is that the reprocessed device performs indentically to a new, original device according to its established specifications and regulatory standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML system that utilizes a "training set" in the machine learning sense. The "training" in the context of a reprocessed medical device would refer to the optimization/validation of the reprocessing procedure itself, but not in the data science meaning.
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
In summary, the provided document details the regulatory clearance of a reprocessed medical device through extensive bench and laboratory testing to demonstrate substantial equivalence to its predicate. The framework of questions provided is highly tailored to AI/ML software, which is not the subject of this 510(k) submission.
§ 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).