(a) Identification. A pacing system analyzer (PSA) is a prescription device that combines the functionality of a pacemaker electrode function tester (§870.3720) and an external pacemaker pulse generator (EPPG) (§870.3600). It is connected to a pacemaker lead and uses a power supply and electronic circuits to supply an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential. A PSA may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.

(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (i.e., battery power, AC mains connections, or both).

(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:

(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;

(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;

(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and

(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.

(4) Appropriate software verification, validation, and hazard analysis must be performed.

(5) Labeling must include the following:

(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;

(ii) Connector terminals should be clearly, unambiguously marked on the outside of the PSA. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals. Triple chamber devices should clearly identify atrial, right ventricular, and left ventricular terminals;

(iii) The labeling must list all pacing modes available in the device;

(iv) Labeling must include a detailed description of any special capabilities (e.g., overdrive pacing or automatic mode switching);

(v) Labeling must limit the use of external pacing to the implant procedure; and

(vi) Appropriate electromagnetic compatibility information must be included.

[81 FR 22350, Apr. 18, 2016]