(87 days)
The PACE 203 / PACE 203H / MODEL 3085 external pulse generator / temporary pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or A-V sequential pacing. The PACE 203 / PACE 203H / MODEL 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
Specific indications include, but are not limited to, the following:
- Sick Sinus Syndrome;
- Bradycardia with congestive heart failure;
- Complete heart block;
- Acute myocardial infarction complicated by heart block;
- Sinus bradycardia;
- Cardiac arrest with ventricular asystole;
- Atrial and/or ventricular ectopic arrhythmia;
- Postoperatively after cardiac surgery;
- Temporary application during implantation or exchange of permanent pacemaker.
Indication for atrial overdrive stimulation (rapid atrial pacing):
- Supra-ventricular tachycardia.
The PACE 203 / PACE 203H / MODEL 3085 can be used to measure atrial or ventricular voltage stimulation thresholds and determine the approximate P wave potentials sensed via the atrial pacing lead electrodes and the approximate R wave potentials sensed via the ventricular pacing lead electrodes.
The XI.TME and XI.RAC Extension Cables are used with external pulse generators / temporary cardiac pacemakers and pacing system analyzers.
The PACE 203 / PACE 203H / MODEL 3085 is a dual-chamber external cardiac pacemaker with atrial controlled timing for routine temporary heart stimulation. Synchronous and asynchronous modes of atrial, ventricular and A-V sequential stimulation are available for treatment of acute brady-arrhythmia and for pre-, intra-, and post-operative stimulation of the heart. The stimulation parameters are easily adjustable by rotating dials through a wide range of values.
The PACE 203 / PACE 203H / MODEL 3085 offers the possibility for atrial overdrive stimulation, or rapid atrial pacing, for terminating supra-ventricular tachycardia. The rate of the overdrive stimulation is adjustable within a wide range and is independent of the selected stimulation rate. The overdrive rate can be determined before and changed during overdrive therapy. If required, overdrive stimulation can be initiated with the touch of a button. The overdrive stimulation is indicated optically and acoustically.
The battery operated device can be affixed to the patient's arm by the arm strap included. The housing is protected against accidental liquid spills.
The functional design of the PACE 203 / PACE 203H / MODEL 3085 allows safe and easy operation with regards to all requirements of DDD stimulation.
The PACE 203 / PACE 203H / MODEL 3085 further offers the following features:
• During battery changes, stimulation will be maintained for at least 30 s.
• A non-volatile memory keeps any desired stand-by program ready for use, even if the device is shut off.
• A standard program, which can be individualized, is available for each primary pacing mode.
• An emergency program can be "called up" by pressing an emergency key.
• A burst- and a ramp function are available for atrial overdrive-stimulation.
• An Unlock/Lock button protects against accidental change of the set parameters.
• The set parameters and (error) messages are shown on a liquid crystal display.
• The detection of the intrinsic heart activity as well as the emission of stimulation impulses are shown separately by blinking LEDs for both atrium and ventricle. Additionally, a beep-tone can be switched on whenever desired.
• System malfunctions that occur are indicated optically and acoustically.
• A lead surveillance system indicates interruptions and short circuits.
• When a battery change is required, optical and acoustic alerts are provided.
• During dual chamber pacing, an automatic mode for adapting A-V delay, maximum tracking rate (MTR), and PVARP is available.
• An automatic mode for adjusting the sensitivity in both the atrium and ventricle may be chosen.
• A Pause function is available for easy determination and measurement of the patient's intrinsic heart activity.
The Series XI Extension Cables support proper connection of the PACE 203 / PACE 203H / Model 3085 to various types of pacing lead systems (accessories).
The Series AS Arm Straps ensure proper attachment of the PACE 203 / PACE 203H / Model 3085 to the patient's arm (optional accessory).
Here's a summary of the acceptance criteria and study information for the Osypka Medical PACE 203 / PACE 203H / MODEL 3085 external cardiac pacemaker, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functionality and Safety (General) | "The results of the bench testing and the clinical evaluation verified the correct function of the PACE 203 / PACE 203H / MODEL 3085, and validated that the PACE 203 / PACE 203H / MODEL 3085 is as safe, as effective, and performs as well as the predicate device." |
| Performance against specifications (Bench Testing) | Bench testing compared the performance of both devices (PACE 203 / PACE 203H / MODEL 3085 and MEDTRONIC MODEL 5330) against their specifications and determined substantial equivalence. |
| Safety and effectiveness of insulated connector terminals | Bench testing validated safety and effectiveness of the insulated connector terminals matching the protected pins of the Series XI Extension Cables. |
| Absence of serious adverse events (Clinical Evaluation) | "No serious adverse event related to the PACE 203 / PACE 203H / MODEL 3085 occurred during the course of the investigation." |
| Reliable tracking of P & R wave peak amplitudes and sensitivity adjustment (AUTO SENSE function) | "The optional AUTO SENSE function reliably tracks P wave and R wave peak amplitudes and adjusts the sensitivities in the atrial and, respectively, ventricular channel accordingly." |
| Correct sensing, pacing, and A-V sequential demand pacing (DDD) performance (Clinical Evaluation) | "Based on the recordings obtained, the PACE 203 / PACE 203H / MODEL 3085 provided corrects sensing, pacing and A-V sequential demand pacing (DDD) performance without failure." |
| Maintenance of stimulation during battery changes (for at least 30s) | "During battery changes, stimulation will be maintained for at least 30 s." and "After at least 30 minutes of operation, continuous pacing therapy is maintained during a battery change for at least 30 seconds." |
| Meets 21 CFR Part 898 performance standard (for insulated connector terminals) | "Insulated connector terminals matching the protected pins of the Series XI Extension Cables (meet 21 CFR Part 898 performance standard)." |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state a specific sample size for a "test set" in the context of a prospective clinical trial with individual patient data.
- Bench Testing: The "sample" would be the devices themselves (PACE 203 / PACE 203H / MODEL 3085 and MEDTRONIC MODEL 5330) and possibly various components during testing with a simulator. No specific number is given for how many devices or test runs. Data provenance is not specified beyond "bench testing using a simulator."
- Clinical Evaluation: The document mentions "the course of the investigation" and "recordings obtained," implying a clinical study with patients. However, no sample size (number of patients) or data provenance (e.g., country of origin, retrospective/prospective) and type of data (e.g. number of electrodes, number of leads etc.) is explicitly detailed in the provided text. It is described as a "clinical evaluation," which typically implies a prospective study.
3. Number of Experts and Qualifications for Ground Truth for Test Set:
Not applicable in the provided summary. The clinical evaluation implicitly relies on observation of device performance in patients, likely by medical professionals, but it does not describe a process of expert consensus for establishing ground truth for evaluating reader performance or diagnostic accuracy of the device. The device is a pacemaker, not a diagnostic imaging AI.
4. Adjudication Method for the Test Set:
Not applicable in the provided summary. There is no mention of an adjudication process as would be used for multi-reviewer assessments of diagnostic output.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The device is an external pacemaker, and the evaluation focuses on its functional performance and safety, not on the diagnostic effectiveness of human readers with or without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Yes, a standalone evaluation of the device's performance was performed through:
- Bench Testing: The device (and its predicate) were "subject to bench testing using a simulator" to compare performance against specifications. This is an algorithm/device-only evaluation.
- Clinical Evaluation: The "clinical evaluation validated safety and effectiveness" and observed that the device "provided correct sensing, pacing and A-V sequential demand pacing (DDD) performance without failure." While used with humans, the focus is on the device's autonomous function.
7. The Type of Ground Truth Used:
- Bench Testing: The ground truth was based on the specifications of the devices being tested and the expected outputs from the simulator.
- Clinical Evaluation: The ground truth would be the physiological response of the patients and the observed functional performance of the pacemaker as determined by clinical assessment and recordings, confirming correct sensing, pacing, and A-V sequential demand pacing without failure.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its functionality is based on established engineering principles for cardiac pacing.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of 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.