(16 days)
The Medtronic Temporary External Pacemaker 53401 is intended to be used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. It can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes.
Specific indications for temporary cardiac pacing include, but are not limited to, the following indications:
- Complete heart block
- Sinus bradycardia
- Sick Sinus Syndrome
- Bradycardia with congestive heart failure
- Atrial and/or ventricular arrhythmias
- Cardiac arrest
- Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation
- Support during permanent pacemaker replacement
- Cardiac complications during invasive or surgical procedures
- Temporary support of a patient following cardiac surgery
- Acute myocardial infarction complicated by heart block
- High-rate burst pacing for the treatment of supraventricular tachyarrhythmias
The Medtronic Temporary External Pacemaker Model 53401 (hereafter simply referred to as the 53401; or the 53401 SC EPG where SC EPG stands for Single Chamber External Pulse Generator) is a battery-powered, single chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The Model 53408 is an optional disposable protective cover to reduce accidental activation of the controls of the 53401 SC EPG.
The Medtronic Model 53401 External Pulse Generator (EPG) (K180873) is found to be substantially equivalent to its predicate device (K162054) based on verification testing that met specified acceptance criteria.
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Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Firmware Verification: Ensure the updated firmware (Version 1.03) operates as intended. Data from the newly verified firmware (Version 1.03) showed that the devices could be manufactured with this new version to mitigate rebooting of the device caused by interrupts in the firmware system. System Verification: Confirm overall system functionality and safety with the updated firmware. The results of system verification testing met the specified acceptance criteria and did not raise new safety or performance issues. Maintain Substantial Equivalence in intended use/indications, operating principle, design, functionality, biological safety, packaging, and shelf life compared to the predicate device. The modified device has the same intended use/indications for use, operating principle, design features, device functionality, biological safety, packaging materials, and shelf life as the predicate. -
Sample size used for the test set and the data provenance: Not applicable. The submission focuses on firmware and system verification rather than performance with patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved engineering verification of firmware and system, not expert-based ground truth establishment for clinical outcomes.
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Adjudication method for the test set: Not applicable.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This was not an MRMC study for AI assistance; it was a verification study for a hardware/firmware update to an existing medical device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The study focused on the standalone performance of the updated firmware and the overall system according to engineering specifications. While not explicitly framed as "algorithm only," it evaluates the device's functional performance in isolation of a human operator, outside of standard operating parameters.
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The type of ground truth used: The ground truth for this verification study was based on engineering specifications and expected functional behavior of the device and its firmware. The objective was to confirm that the updated firmware addressed a known issue (rebooting due to interrupts) and that the system continued to function according to its established design requirements.
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The sample size for the training set: Not applicable. This was a verification study of a firmware update for an existing device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable.
§ 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.