(97 days)
The Amigo Remote Catheter System (Amigo) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.
The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias, including atrial fibrillation, has not been established.
The safety and effectiveness of this device for cardiac mapping when used with ANY CATHETERS OTHER THAN the Boston Scientific Blazer® Dx-20 and Biosense Webster EZ STEER" diagnostic catheters has not been established.
The Amigo Remote Catheter System (Amigo) is designed to create a simple interface with commercially available catheters allowing the physician to insert, withdraw and rotate the catheter, and deflect the catheter tip via the remote controller. Catheter placement and positioning is performed under direct visualization using standard imaging equipment, while enabling the physician to remain seated and away from the xray radiation field. The Amigo system includes several disposable components which help to maintain the sterile field.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Amigo Remote Catheter System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantifiable acceptance criteria and device performance metrics are not detailed. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
The "performance" described is in terms of meeting design specifications and customer requirements through various verification and validation tests:
| Acceptance Criteria Category | Reported Device Performance (as inferred) |
|---|---|
| Safety | Meets design specifications and customer requirements. Demonstrated through electrical/mechanical safety, biocompatibility, and risk analysis conforme to ISO 14971. Conforms to IEC 60601-1 and 60601-1-2 for electrical/mechanical safety and EMC. |
| Functionality | Meets design specifications and customer requirements. Demonstrated through functional performance tests. |
| Material/Sterility | Meets design specifications and customer requirements. Demonstrated through cleaning, sterilization, and biocompatibility studies conforming to ISO 10993-1. |
| Usability/Durability | Meets design specifications and customer requirements. Demonstrated through shelf life and transit studies. |
| Intended Use | Facilitates manipulation, positioning, and control of percutaneous diagnostic catheters for stimulating cardiac tissue and recording electrophysiological data in the right atrium and right ventricle. (No specific performance metrics like precision or speed are given). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set (human patient data) was used. The testing was non-clinical (benchtop, in-vitro, etc.).
- Data Provenance: Not applicable. The data comes from internal non-clinical laboratory testing (e.g., electrical, mechanical, biocompatibility labs).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. Since no clinical test set was used, no experts were needed to establish ground truth for patient data. Expert judgment would have been involved in defining design specifications and interpreting non-clinical test results, but this is not a "ground truth" establishment in the typical sense for a clinical study.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document explicitly states: "No additional clinical evaluations of the Amigo for the intended use were performed." This means no human reader studies, with or without AI assistance, were conducted.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Was standalone performance done? Yes, in a non-clinical context. The "standalone performance" refers to the device itself (the Amigo system) performing its intended functions without human intervention acting as a variable in the performance metric. The non-clinical tests (electrical/mechanical safety, functional performance, cleaning, biocompatibility, sterilization, shelf life, transit studies) assess the device's inherent performance against specifications. However, this is not an "algorithm" in the typical sense of AI/ML.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" was established by engineering design specifications, industry standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, ISO 10993-1), and customer requirements. The device's performance was compared against these pre-defined benchmarks.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a mechanical/electrical catheter control system, not an AI/ML algorithm that requires a training set. The "design verification and validation testing" serves as the assessment of the final product, not a "training set" in the machine learning context.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. No training set was used.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).