(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.