(111 days)
This device is indicated for use in stimulation lead system analysis prior or during implantation of an electrical stimulator (pacemaker, pulse generator), for emergency stimulation and for high-rate (burst) stimulation limited to temporary diagnostic and therapeutic application.
PSA™ Series devices are portable pacing system analyzers, which are intended to be used for the evaluation of the integrity and most beneficial placement of stimulation leads. The integrity of a stimulation lead system is characterized by its electrical impedance, the measurement results of which shall meet the specifications of the manufacturer of the lead system. The most beneficial placement of a stimulation lead system is determined by the ability of the PSA Series device to capture the heart rhythm (successful stimulation) and to measure reasonable high amplitudes of P and/or R waves and corresponding slew rates. The PSA™ Series encompasses a single-channel device (PSA 100) and dual-channel device (PSA 200) with each channel employing a differential stimulation output and a differential sensing input. Stimulation leads or extension cables are connected to patented receptacles accommodating pins of 0.9 ... 2 mm or Hypertronics ™ style sockets. In addition to the aforementioned intra-cardiac channels, a PSA Series device offers an additional channel and corresponding terminal for a 5-lead surface ECG. The user interface is divided into a touch screen and an array of four keys dedicated to the functions: On / Off, Emergency, High-Rate, Home. The user monitors device measurements, heart activity and device status through the touch screen and LED indicators. Functions provided by PSA™ series pacing system analyzers are organized into so called applications such as (availability depending on PSA Series model): 1/A (Single-chamber stimulation (Channel 1/A)), 2/RV (Single-chamber stimulation (Channel 2/RV)), DDD (Atrioventricular (dual-chamber) stimulation), UHS (Burst stimulation (Universal Heart Stimulator)). By choosing one application, the (touch) screen displays all functions and information relevant to the specific application. The screen displays with minimal delay a marker signal and up to four signal waveforms all of which a user can select from the group of up to three IEGM signal waveforms (1/A, 2/RV; availability depending on PSA model) and seven surface ECG standard vectors (I, II, III, aVR, aVL, aVF, V). The device provides or facilitates the following measurements: Sensing of intrinsic events of the heart: P/R wave amplitudes and slew rate, Rates (PP, RR interval), Intrinsic AV delay (antegrade conduction time), Retrograde conduction time, Wenckebach point (2:1 conduction). Stimulation of the heart: Capture threshold in up to 2 chambers, Lead impedances, Burst stimulation. During an implantation procedure a PSA™ Series device can temporarily take over the functions of a cardiac pacemaker. Measurement results can be stored to a virtual print-out page, which upon completion of all measurements is transmitted wirelessly to a separate printer or computer. User-configurable settings for general use of the device and individual applications are stored in non-volatile memory. The HIGH-RATE function (dedicated key below the touch screen) provides bust stimulation at rates variable from 70 to 1,000 ppm for terminating atrial and ventricular tachycardia. The (optional) UHS application is special form of the high rate function. Within the UHS application, the user can program a train of burst prior to clinical application, which is also referred to as programmable electrical stimulation (PES). Pressing the EMERGENCY key (dedicated key below the touch screen) immediately initiates an emergency stimulation (VVI, 60 ppm, 7.5 V, 1.0 ms). Pressing the HOME key allows the user to return to the home screen (main menu). The device can operate from line power or the integrated rechargeable battery which provides up to 4 hours of continuous operation. A medical-grade AC power supply is part of the delivery unit. An integrated backup battery maintains stimulation in the unlikely event of a failure of the integrated rechargeable battery or AC power. The robust device enclosure is protected against accidental fluid spill.
1. Acceptance Criteria and Reported Device Performance
The provided document describes both bench testing and a clinical investigation for the Osypka Medical PSA™ Series Pacing System Analyzer (PSA 100™ and PSA 200™).
Bench Testing Acceptance Criteria (Implicitly, the device 'performs as intended' or 'verified for' the specified ranges):
| Parameter | Acceptance Criteria (Bench) | Reported Device Performance (Bench) |
|---|---|---|
| Stimulation Modes | AAI, VVI, DDD, VDD, DDI, VDI modes, high-rate pacing, emergency pacing | Performed as intended |
| Stimulation Parameters | ||
| Pulse Amplitude | 0.1 - 10 V | Verification for pulse amplitude of 0.1...10 V for each stimulation channel 1/A, 2/RV |
| Pulse Width | 0.1 - 2.5 ms | Verification for pulse widths of 0.1...2.5 ms for each stimulation channel 1/A, 2/RV |
| Pulse Rate | 30 - 220 ppm | Verification for pulse rates of 30...220 ppm for each stimulation channel 1/A, 2/RV |
| Sensing Parameters | ||
| Sensitivity | 0.2 - 20 mV | Verification for sensitivity threshold of 0.2...20 mV for each sensing channel 1/A, 2/RV |
| Timing Parameters | ||
| AV Delay | 10 - 400 ms | Verification for AV Delay settings of 10...400 ms measured between channel 1/A and 2/RV |
| Refractory Periods | 250 - 500 ms | Verification for refractory period settings of 250...500 ms for each channel 1/A, 2/RV |
| Fault Conditions | Device reacts as intended to specified faults | Device reacted as intended to: Start-up self-test failed, electrode impedance too low/high (short/open circuit), EGM signal noise, battery low/empty, attempt to switch device off during stimulation, High Rate pacing timeout atrium. |
| Comparison to Predicate | Substantial equivalence to predicate device (Biotronik ERA 300) | Demonstrated substantial equivalence with respect to Heart Rate/RR Interval, P/R Wave Amplitude, Lead Impedance, Retrograde Conduction Time, Wenckebach Point. Test results showed substantial equivalence. |
Clinical Investigation Acceptance Criteria and Reported Performance:
| Parameter | Acceptance Criteria (Clinical) | Reported Device Performance (Clinical) |
|---|---|---|
| Intrinsic Measurement Comparisons | PSA measurements (heart rate, amplitude, slew rate, impedance, anterograde/retrograde conduction time) are equivalent to predicate device (Biotronik ERA 300). Specific equivalence criteria for each parameter were established. | The PSA fulfilled the acceptance criteria for each parameter and thus can be considered equivalent to the ERA (Biotronik ERA 300). |
| Stimulation & Sensing Evaluation | - No adverse events occur when PSA is applied. |
- Effective sensing: Inhibition of atrial/ventricle pacemaker stimulus in the presence of P/R waves, respectively.
- Effective pacing: Effective atrial/ventricle stimulation with their respective time domains.
- Specific quantitative thresholds for effective sensing and pacing were likely part of the methodology, though not explicitly stated as "% of cycles". | - No adverse events occurred while PSA was applied to the patient.
- PSA correctly recognized atrial and ventricular heart activity and inhibited in 364/364 (100%) cardiac cycles recorded.
- PSA correctly caused atrial and/or ventricle capture in 1,621/1,621 (100%) of cardiac cycles recorded.
- Conclusion: PSA is considered safe and effective. |
2. Sample Size and Data Provenance (for test set/clinical study)
- Sample Size: 17 patients were used for the clinical investigation comparing intrinsic measurements.
- Data Provenance: Prospective. The clinical investigations were conducted during routine pacemaker implantation procedures in the operating room at two clinical sites in Hamburg, Germany.
3. Number of Experts and Qualifications (for ground truth in clinical study)
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it mentions:
- "ECG tracings and physician notes will be used to determine whether an adverse event occurred while the PSA was applied to the patient." This implies that qualified physicians (likely cardiologists or electrophysiologists) were involved in reviewing patient data and making clinical judgments.
4. Adjudication Method (for test set)
The document does not explicitly describe an adjudication method like 2+1 or 3+1 for consensus building. The clinical data appears to have been collected and analyzed by "physicians" at the clinical sites. For intrinsic measurements, the comparison was directly between the PSA, the predicate device (ERA 300), and a reference device (M2290); it's a comparison of device readings rather than expert consensus on a singular diagnosis. For stimulation and sensing, effective sensing/pacing and adverse events were determined using "ECG tracings and physician notes," suggesting a medical professional's direct observation and judgment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the device's performance against a predicate device and direct physiological measurements, not on the improvement of human reader performance with or without AI assistance.
6. Standalone Performance (Algorithm Only)
Yes, standalone performance was assessed through the "Bench Testing" and "Intrinsic measurement comparisons" portions of the clinical investigation.
- Bench Testing: The device was tested against an "Interstim II heart simulator" and a custom-built computer-assisted test system (Osypka SMS 1000) to verify various stimulation, sensing, and timing parameters. This represents the device's technical performance in a controlled environment.
- Clinical Intrinsic Measurement Comparisons: The PSA's intrinsic measurements were directly compared to those from two other pacing system analyzers (Biotronik ERA 300 and Medtronic Carelink 2290 Analyzer) on the same patients. This evaluates the device's direct measurement capabilities in a real-world setting without human interpretation as an intermediate step.
- Stimulation and Sensing Evaluation: The effectiveness of the PSA's pacing and sensing capabilities was directly observed based on ECG tracings and physician notes, indicating the device's direct performance.
7. Type of Ground Truth Used
The ground truth used was a combination of:
- Bench Test Standards/Known Values: For bench testing, the ground truth was the known or precisely controlled input signals from the test equipment (Interstim II heart simulator, Osypka SMS 1000).
- Predicate Device/Reference Device Measurements: For the intrinsic measurement comparisons in the clinical study, the measurements from the legally marketed predicate device (Biotronik ERA 300) and a reference device (Medtronic Carelink 2290 Analyzer) served as the reference or "ground truth" against which the PSA's measurements were compared for equivalence.
- Clinical Observation/Physician Notes: For determining effective stimulation and sensing, and the occurrence of adverse events, the ground truth was established through direct clinical observation, review of ECG tracings, and physician notes during the procedures. This represents a form of expert clinical judgment based on objective physiological data (ECG).
8. Sample Size for the Training Set
This document describes a premarket notification (510(k)) for a medical device that performs measurements and provides stimulation. It is not an AI/ML-based device that typically requires a "training set" in the machine learning sense. Therefore, there is no mention of a training set or its size. The device's functionality is based on established engineering principles for sensing and delivering electrical signals in cardiac pacing.
9. How Ground Truth for Training Set Was Established
As noted in point 8, this device does not appear to be an AI/ML-based system that uses a discrete "training set" with established ground truth in the context of machine learning. Its validation relies on engineering specifications, comparisons to established devices, and clinical observation.
§ 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.