§ 870.3605. Pacing system analyzer.
406 words·~2 min read·
/us/cfr/t21/s§ 870.3605·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]