(303 days)
The Amigo™ Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of compatible percutaneous electrophysiological ablation catheters that deliver RF energy in the right atrium. Use of Amigo RCS should also be in accordance with the indications for use of compatible ablation catheters. The Amigo RCS should only be used with the Boston Scientific catheters (with the Blazer" " handle) and/or the Biosense Webster catheters (with the EZ Steer® handle) in the right atrium.
The Amigo™ Remote Catheter System (Amigo RCS) is designed to facilitate the manipulation, positioning and control of compatible cardiac electrophysiological catheters. It is designed to remotely control Boston Scientific catheters (with the Blazer™ handle) and Biosense Webster catheters (with the EZ STEER® handle).
The Amigo RCS consists of four (4) main reusable, non-sterile components including the remote catheter system (sled, track, and turret), a hard-wired remote control, 100 ft extension cable, and a bridge support with rail and frame. In addition, the Amigo RCS includes three (3) sterile, single-use disposable kits including the docking station and spreader) to interface with the compatible ablation catheter, and a sterile cover kit (sled cover, turret cover, nose sleeve and side covers) and track kit (track and nosecone) used to maintain a sterile field during device use. The Amigo RCS is intended to attach to the rails of an IEC 60601-1 compliant EP bed system.
The Amigo RCS only interfaces with the catheter's handle such that the Amigo RCS connects to and operates the manual handle of the compatible steerable cardiac ablation catheter to remotely control its advancement, retraction, rotation, and deflection.
Here's a breakdown of the acceptance criteria and the study details for the AMIGO REMOTE CATHETER SYSTEM based on the provided text:
Acceptance Criteria and Reported Device Performance
For non-clinical mechanical performance testing:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (1) Ability to attach catheter handle and maintain mechanical attachment to docking station. | Not explicitly quantified, but included in "Mechanical testing included evaluation of the following acceptance criteria" and implied by successful animal study. |
| (2) Deflection of the catheter with Amigo RCS is equivalent to manual deflection (less than or equal to 1° difference in catheter handle throw) over the range of functional clinical application. | Not explicitly quantified, but included in "Mechanical testing included evaluation of the following acceptance criteria." |
| (3) Catheter and spreader remains in the track and the catheter extends, retracts, and rotates in both directions through the spreader and articulates correctly. | Not explicitly quantified, but included in "Mechanical testing included evaluation of the following acceptance criteria" and implied by successful animal study. |
| (4) Improper configuration of Amigo RCS/docking station does not result in overstressing the catheter. | Not explicitly quantified, but included in "Mechanical testing included evaluation of the following acceptance criteria." |
| Amigo RCS does not impact catheter function and performance (all ranges of motion of catheter, tip deflection, and mapping). | Achieved (demonstrated in animal study and mechanical performance testing). |
| Accuracy and function of all device mechanical controls for proper tip placement within the chambers of the heart. | Achieved (evaluated in animal study). |
For non-clinical electrical performance testing:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Amigo RCS does not impact catheter function and performance (all ranges of motion of catheter, tip defection, and mapping). | Achieved (demonstrated in animal study and mechanical performance testing). |
| Accuracy and function of all device electrical controls for proper tip placement within the chambers of the heart. | Achieved (evaluated in animal study). |
For clinical performance (three prospective cohort studies):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device-related, serious AEs comparable to manual ablation. | No device-related, serious AEs reported. |
| Safety: Major procedural complications comparable to literature/manual ablation. | Procedure-related major vascular access complication: 1/85 (1.2%). |
| Efficacy: Acute procedural success. | 84/85 (98.8%) subjects achieved acute procedural success. |
| Efficacy: Chronic success. | 62/63 (98.4%) of subjects achieved chronic success (at 6 or 12 months, depending on the study). |
| Operator fluoroscopy time reduction. | Decreased by 71% for typical AFL ablation and by 81% for AVNRT ablation by using Amigo RCS compared with manual ablation. |
| Procedural parameters (procedural time, total fluoroscopy time for patient) comparable to manual ablation. | Comparable in one study with a matched control group. |
Study Details
1. Sample Size and Data Provenance
- Clinical Studies:
- Sample Size: 85 patients in total across three clinical studies.
- Data Provenance: Not explicitly stated, but likely from the US where FDA approval is sought. The studies were described as "3-center study" and "single-center studies," implying medical centers where the procedures were performed. The studies were prospective.
- Non-Clinical (Animal) Study:
- Sample Size: Not specified.
- Data Provenance: Not specified, but generally conducted by the manufacturer or a contract research organization.
2. Number of Experts Used to Establish Ground Truth and Qualifications
- Clinical Studies:
- The document implies that acute procedural success and chronic success were assessed by the treating physicians and follow-up clinical assessments. There's no mention of a separate panel of experts establishing "ground truth" for the outcomes in the same way one might for diagnostic imaging interpretation. The outcomes (absence of arrhythmia recurrence, procedural success) are clinical endpoints based on established diagnostic criteria.
- Non-Clinical Studies:
- Not applicable in the same way as clinical or diagnostic studies. Performance was measured against engineering specifications and observed by testing personnel/engineers.
3. Adjudication Method
- Clinical Studies:
- No specific adjudication method (e.g., 2+1, 3+1) is mentioned for the clinical outcomes (acute/chronic success, adverse events). The text notes "limited rigor in adverse event detection, documentation and adjudication," suggesting that a highly structured adjudication process by independent experts may not have been a primary component of these studies.
- Non-Clinical Studies:
- Not applicable.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC study was not explicitly conducted for the Amigo RCS. The clinical studies compared Amigo RCS-controlled ablation to manual ablation, but largely focused on patient outcomes and operator fluoroscopy time. There is no mention of a "multi-reader multi-case" design typical for evaluating diagnostic performance where multiple readers interpret cases for a ground truth.
- Effect Size of Human Readers Improvement with AI vs Without AI Assistance: Not applicable, as this device is a robotic catheter control system, not an AI-assisted diagnostic tool for human readers. Its benefit to the human operator is reduced radiation exposure, not improved diagnostic accuracy.
5. Standalone Performance
- Yes, a standalone (algorithm only without human-in-the-loop performance) was done for the mechanical and electrical tests. The device's mechanical and electrical functionalities were tested independently and in conjunction with compatible catheters to ensure it met performance specifications. The "Amigo RCS does not impact catheter function and performance" and "Accuracy and function of all device electrical controls" were assessed in non-clinical settings.
6. Type of Ground Truth Used for Test Set
- Clinical Studies:
- Acute/Chronic success: Clinical endpoints (e.g., absence of arrhythmia recurrence based on follow-up evaluations using standard clinical diagnostic methods for arrhythmias).
- Adverse events: Clinical diagnosis and documentation of events by medical staff and follow-up.
- Non-Clinical Studies:
- Mechanical/Electrical Performance: Engineering specifications, measured physical parameters (e.g., 1° difference in catheter throw).
- Animal Studies: Observed functionality, performance, and tip placement in an in vivo model.
7. Sample Size for Training Set
- The document does not specify a separate "training set" sample size in the context of device development or machine learning. This is a robotic control system, not a machine learning model that is "trained" on data in the same way. The development and refinement of the system would have involved iterative design, bench testing, and animal studies, which are analogous to a development/validation process but not a "training set" in the common AI sense.
8. How Ground Truth for Training Set Was Established
- As above, the concept of a "training set" in the context of a machine learning model isn't directly applicable here. The "ground truth" during the development phase would have been established by engineering specifications, performance targets, and preclinical testing results informing the design and functionality of the robotic system.
§ 870.5700 Steerable cardiac ablation catheter remote control system.
(a)
Identification. A steerable cardiac ablation catheter remote control system is a prescription device that is external to the body and interacts with the manual handle of a steerable cardiac ablation catheter to remotely control the advancement, retraction, rotation, and deflection of a compatible, steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical mechanical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance testing must be performed:
(i) Mechanical performance of the system (without catheter connected);
(ii) Mechanical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following:
(A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and
(B) Evaluation of the accuracy and function of all device control safety features; and
(iii) Simulated-use testing in a bench anatomic model or animal model.
(2) Non-clinical electrical testing must include validation of electromagnetic compatibility (EMC), electrical safety, thermal safety, and electrical system performance. The following performance testing must be performed:
(i) Electrical performance of the system with compatible catheters connected to verify that the system does not impact catheter function or performance. Assessments must include the following:
(A) Side-by-side remote control and manual comparisons of catheter manipulation (including all ranges of motion of catheter deflection and tip curl) for all compatible catheters; must include testing for worst-case conditions, and
(B) Evaluation of the accuracy and function of all device control safety features; and
(ii) Electrical safety between the device and ablation catheter system and with other electrical equipment expected in the catheter lab or operating room.
(3) In vivo testing must demonstrate that the device performs as intended under anticipated conditions of use, including an assessment of the system impact on the functionality and performance of compatible catheters, and documentation of the adverse event profile associated with clinical use. Evidence must be submitted to address the following:
(i) Manipulation and Positioning: Ability to manipulate compatible catheters to pre-specified cardiac locations and confirm proper anatomic placement and tissue contact, in accordance with the system indications for use and the compatible catheter indications for use;
(ii) Safety: Assess device-related complication rate and major procedural complication rate (regardless of device relatedness) in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use;
(iii) Efficacy: Assess ablation success in comparison to literature and/or a manual comparison group for compatible ablation catheters to support the indications for use; and
(iv) User assessment of device remote controls and safety features.
(4) Post-market surveillance (PMS) must be conducted and completed in accordance with FDA agreed upon PMS protocol.
(5) A training program must be included with sufficient educational elements that, upon completion of the training program, the clinician and supporting staff can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use for the indication of compatible catheters.
(6) Performance data must demonstrate the sterility of the sterile disposable components of the system.
(7) Performance data must support shelf life by demonstrating continued sterility of the device (of the sterile disposable components), package integrity, and device functionality over the requested shelf life.
(8) Labeling must include the following:
(i) Appropriate instructions, warnings, cautions, limitations, and information related to the intended patient population, compatible ablation catheters, and the device safeguards for the safe use of the device;
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations, including installation and removal of compatible catheters;
(B) Instructions and explanation of all controls, inputs, and outputs;
(C) Instructions on all available modes or states of the device;
(D) Instructions on all safety features of the device; and
(E) Validated methods and instructions for reprocessing/disinfecting any reusable components;
(iii) A detailed summary of the mechanical compatibility testing including:
(A) A table with a complete list of compatible catheters tested (manufacturer trade name and model number), and
(B) A table with detailed test results, including type of test, acceptance criteria, and test results (
i.e., pass for meeting acceptance criteria);(iv) A detailed summary of the in vivo testing including:
(A) A table with a complete list of compatible catheters used during testing (manufacturer trade name and model number);
(B) Adverse events encountered pertinent to use of the device under use conditions;
(C) A detailed summary of the device- and procedure-related complications; and
(D) A summary of study outcomes and endpoints. Information pertinent to the fluoroscopy times/exposure for the procedure, patient, and operator fluoroscopic exposure;
(v) Other labeling items:
(A) A detailed summary of pertinent non-clinical testing information: EMC, mechanical, electrical, and sterilization of device and components;
(B) A detailed summary of the device technical parameters; and
(C) An expiration date/shelf life and storage conditions for the sterile accessories; and
(vi) When available, and according to the timeframe included in the PMS protocol agreed upon with FDA, provide a detailed summary of the PMS data including:
(A) Updates to the labeling to accurately reflect outcomes or necessary modifications based upon data collected during the PMS experience, and
(B) Inclusion of results and adverse events associated with utilization of the device during the PMS.