(16 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, prophylactic 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 battery-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 FDA 510(k) premarket notification is for a Medtronic Model 5392 External Pulse Generator (EPG). This document establishes substantial equivalence to a previously cleared device, rather than proving performance against specific acceptance criteria in a clinical study for a new device. Therefore, many of the requested categories for a new device's performance study are not directly applicable or are not detailed in this document.
The core of this submission is to demonstrate that the modified Medtronic Model 5392 EPG is substantially equivalent to its predicate device (Medtronic Model 5392 EPG K132924), despite a minor design modification.
Here's the information presented, framed within your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use/Indications for Use | Same as predicate device | Same as predicate device |
| Operating Principle | Same as predicate device | Same as predicate device |
| Design Features | Largely same as predicate device | Largely same as predicate device (with one stated modification) |
| Device Functionality | Same as predicate device | Same as predicate device |
| Biological Safety | Same as predicate device | Same as predicate device |
| Packaging Materials | Same as predicate device | Same as predicate device |
| Shelf Life | Same as predicate device | Same as predicate device |
| Safety and Effectiveness | No new safety or performance issues introduced by modification, meeting product-level performance requirements. | "The results of the above [bench] verification tests met the specified acceptance criteria and did not raise new safety or performance issues." |
Explanation: The "acceptance criteria" here are primarily based on demonstrating that the modified device performs equivalently to the predicate device, especially considering the minor "modified negative battery contact design." Performance is implicitly accepted if it aligns with the predicate and passes standard engineering verification.
2. Sample Size Used for the Test Set and the Data Provenance
This document describes bench testing for verification, not clinical studies with human participants. Therefore:
- Sample Size: Not explicitly stated in terms of patient numbers or clinical test cases. The testing was "regression bench testing to product level performance requirements." This implies engineering test units.
- Data Provenance: Not applicable. This refers to engineering bench test data, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth for clinical outcomes or diagnoses is not established in this type of submission focused on substantial equivalence through bench testing. The "truth" is whether the device meets its engineered specifications and performs consistently with the predicate.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies to resolve discrepancies among human readers/experts. This submission focuses on engineering verification.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device for providing temporary cardiac pacing, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an external pulse generator, not an algorithm. Its operation inherently involves "trained personnel" in a "clinical environment where the patient is monitored continuously."
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is based on engineering specifications and performance characteristics of the predicate device, as confirmed through bench testing. It's about demonstrating that the modified device's performance aligns with established engineering standards and the known performance of the predicate, not clinical outcomes derived from expert consensus, pathology, or long-term patient follow-up.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set for an algorithm, as this is a hardware device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm described in this document.
§ 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.