(28 days)
The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic or diagnostic purposes. The temporary pacemaker must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient.
Specific indications for temporary cardiac pacing include, but are not limited to, the following:
- · Complete heart block
- · Sinus bradycardia
- Sick sinus syndrome
- · Bradycardia with congestive heart failure
- · Atrial and/or ventricular arrhythmias
- · Cardiac arrest
- · Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
- · Support during permanent pacemaker replacement
- · Cardiac complications during invasive or surgical procedures
- · Support following cardiac surgery
- · Acute myocardial infarction complicated by heart block
- · Atrial tachyarrhythmias that require high-rate burst pacing for treatment
The Model 5392 EPG is a batterv-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.
This document is a 510(k) Premarket Notification from the FDA regarding a Medtronic External Pulse Generator (EPG). It primarily focuses on demonstrating substantial equivalence to a predicate device due to a minor firmware modification. Crucially, this document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving a device meets these criteria.
The 510(k) summary (page 4-5) explicitly states, "The data from the newly verified firmware show that the devices could be manufactured with a new firmware version to mitigate rebooting of the device caused by interrupts in the firmware system." It also mentions "firmware design verification and system verification" and that "The results of the above testing met the specified acceptance criteria and did not raise new safety or performance issues."
However, the document does not disclose:
- The specific acceptance criteria for this firmware change.
- The details of the "firmware design verification and system verification" study. This would typically include performance metrics, sample sizes, ground truth establishment, or any human reader studies.
Therefore, based solely on the provided text, I cannot answer the questions as the required information about specific acceptance criteria and the study proving the device meets them (in the context of detailed performance metrics, test sets, expert involvement, etc.) is not present. The document focuses on the regulatory clearance process rather than the technical details of the verification study itself.
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(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 EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and 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); and(v) Appropriate electromagnetic compatibility information must be included.