(214 days)
The MPC Model 7000 External Temporary Pacemaker System is indicated for temporary (1-10 days typical) ventricular cardiac pacing in a controlled clinical environment.
The MPC Model 7000 External Temporary Pacemaker System is a battery powered, single chamber external pacemaker. It consists of two major components: the MPC Model 3000 Programmer and the MPC Model 1000 Pulse Generator. The System also includes an MPC Model 5003 Patient Arm/Leg Strap used to secure the Pulse Generator to either the patient's arm or leg. An MPC Model 5002 Programmer Holder to store the Programmer on a wall is also available.
The MPC Model 3000 Programmer transmits the pulse programming data selected by the physician for patient therapy to the MPC Model 1000 Pulse Generator by infrared telemetry.
The MPC Model 1000 Pulse Generator and the MPC Model 3000 Programmer are re-usable. The MPC Model 1000 Pulse Generator and the MPC Model 3000 Programmer are designed so that they may be disinfected between patient use. The MPC Model 5003 Patient Arm/Leg Strap is disposable and labeled for single-use only.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": [
"No new issues of safety when compared to the predicate device (Pace EV 4542 External Pacemaker)",
"Operate safely and to specification in an environment with potential electromagnetic challenges",
"Pass radiated emissions test",
"Pass Drop Test",
"Pass Ship Test",
"Software validated and tested",
"Cleaning and disinfection validated for MPC Model 1000 Pulse Generator and MPC Model 3000 Programmer",
"MPC Model 5003 Patient Arm/Leg Strap determined to be biocompatible and non-cytotoxic"
],
"Reported Device Performance": [
"Tests show that differences due to the ergonomic design features do not introduce different safety issues. Extensive qualification and validation conducted. MPC 7000 significantly enhances patient safety considerations.",
"Extensive Electromagnetic Compatibility (EMC), Electromagnetic Interference (EMI), and Safety testing was conducted. The MPC Model 7000 External Temporary Pacemaker passed these EMC/EMI/Safety and Defibrillation Tests.",
"The MPC Model 7000 External Temporary Pacemaker System was tested for radiated emissions and passed this test.",
"The MPC Model 7000 External Temporary Pacemaker System was Drop Tested and passed this test.",
"The MPC Model 7000 External Temporary Pacemaker System was Ship Tested and passed this test.",
"The MPC Model 7000 External Temporary Pacemaker System's software has been validated and tested.",
"Cleaning and disinfection described in the Instructions for Use have been validated for the MPC Model 1000 Pulse Generator and MPC Model 3000 Programmer.",
"The MPC Model 5003 Patient Arm/Leg Strap has been tested and determined to be biocompatible and non-cytotoxic."
]
},
"2. Sample sized used for the test set and the data provenance": "Not specified in the provided text. The testing appears to be primarily laboratory-based and engineering validation, not clinical trials with human subjects for the 'test set' in the traditional sense of a diagnostic device. The 'test set' here refers to the device and its components undergoing various engineering validations.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts": "Not applicable. The study involves engineering and safety testing against established standards and predicate device performance, not expert-derived ground truth for diagnostic accuracy.",
"4. Adjudication method for the test set": "Not applicable, as the evaluation is based on engineering and safety test results rather than expert adjudication of clinical outcomes or interpretations.",
"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 device is an external temporary pacemaker, not an AI-assisted diagnostic tool. No human reader studies with or without AI assistance are mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device (pacemaker), not an algorithm or AI system for standalone performance evaluation.",
"7. The type of ground truth used": "Engineering specifications, safety standards, and performance characteristics of the predicate device (Pace Medical, Inc. Model EV 4542 External Pulse Generator). For biocompatibility, standard biological testing methods were used.",
"8. The sample size for the training set": "Not applicable. This device is an external temporary pacemaker, not an AI system that requires a 'training set'. The 'extensive qualification and validation' likely refers to engineering testing of multiple device units, but this is not a 'training set' in the AI sense.",
"9. How the ground truth for the training set was established": "Not applicable, as there is no 'training set' for this medical device."
}
§ 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.