Search Results

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:

For non-clinical electrical performance testing:

For clinical performance (three prospective cohort studies):

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.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

The Amigo Remote Catheter System (RCS) 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 catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.

The Amigo RCS 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 x-ray radiation field. The Amigo RCS system includes several disposable components which help to maintain the sterile field.

The provided text describes the Amigo Remote Catheter System (RCS) and its 510(k) clearance (K113628) but does not contain a table of acceptance criteria or a detailed study description with specific performance metrics against those criteria.

Instead, it states that:

• Design verification and validation testing was performed to ensure the device met design specifications and customer requirements.
• Testing activities included: electrical/mechanical safety tests, functional performance tests, cleaning, biocompatibility, sterilization, shelf life, and transit studies.
• Risk analysis activities were completed based on ISO 14971.
• Electrical/mechanical device safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1 and 60601-1-2, respectively.
• Biocompatibility studies were performed in accordance with ISO 10993-1.
• A clinical evaluation was performed and "confirmed that Amigo RCS is safe and effective and operates as designed for its intended use and as described in its proposed labeling."

Without access to the actual verification and validation reports or the clinical study report, it's impossible to extract the specific acceptance criteria and detailed reported device performance in a tabular format as requested. The document only provides general statements about testing and compliance with standards.

Therefore, I cannot fulfill your request for item 1, 2, 3, 4, 5, 6, 7, 8, and 9 as the detailed information on the study, including specific performance metrics, sample sizes, ground truth establishment, and expert involvement, is not present in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices and general compliance with regulatory standards.

Ask a specific question about this device