(227 days)
The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
The Micropace EPS320 Cardiac Stimulator (Clinical Stimulator) is an external programmable computerised diagnostic cardiac stimulator. It is used in specialised hospital electrophysiological diagnostic laboratories by specialist cardiologists to electrically stimulate the heart to initiate and terminate tachyarrhythmias and allow measurement of refractory and conduction properties of the heart by third party equipment. The EPS320 system consists of a Stimulus Generator Unit (SGU) comprising of a manufactured metal instrument case and a standard IBM clone type Personal Computer (PC), the two interconnected by a serial data connection. The device has two independent fully programmable and isolated constant current pulse generator channels intended for temporary programmacro and locativa third party transvenous intracardiac electrodes. The pacing stimulus is output via a Stimulus Connection Box and may typically be routed to the intravenous pacing electrodes via third party electronic switching equipment. During normal operation of the EPS320, custom software on the PC provides keyboard input device and a graphical user interface which the operator uses to control the stimulation process in real time. The custom PC software interprets the user instructions and sends specific real-time commands to the I he ousehi I O software and and to control its function and generate appropriate pacing stimulus pulses. The two isolated outputs can deliver stimulus pulse widths from 0.5ms to 10ms, adjustable in 0.5 to 1ms steps with current amplitudes adjustable from 0.1mA to 25mA in steps of 0.1mA. Current delivery is limited within the specified range by a maximum available output voltage of 26V. The EPS320 is not a life support device and may be used only in the presence of a backup cardiac THE LE SES IS .In case of failure of mains power supply, malfunction of the PC or its software, or loss of the data link, the SGU can operate independently of the PC in the Manual Backup mode, powered by an internal backup battery. This operational mode can provides regular pacing stimuli at intervals and pulse current amplitudes programmable from and displayed on the SGU's front panel. It may be used to briefly support a bradycardic patient until temporary external pacing is established using an approved temporary pacemaker. A secondary electrically self-contained Emergency Fixed Pace approved willing the front of the SGU may be used for the same purpose in case of loss of normal SGU function.
The provided text describes the Micropace Model EPS320 Clinical Stimulator and seeks 510(k) clearance based on its substantial equivalence to the predicate device, the DCI Model EP-2 Clinical Stimulator. The document primarily focuses on technical specifications and functional comparisons rather than a study demonstrating performance against specific acceptance criteria in a clinical setting.
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Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical thresholds. Instead, it aims to demonstrate that the EPS320 is substantially equivalent to the predicate device (DCI Model EP-2) and is as safe and effective. The "acceptance criteria" are implicitly met if the FDA agrees that the EPS320's specifications and functionality are comparable or improved, and its differences do not raise new questions of safety or effectiveness.
The "reported device performance" is presented through a direct comparison with the predicate device's specifications in Tables 5-1 and 5-2.
Table of Acceptance Criteria (Implicit) and Reported Device Performance
| Feature/Parameter | Implicit Acceptance Criteria (Comparable to Predicate Device) | Micropace Model EPS320 Performance (Reported Values) | Predicate Device (DCI Model EP-2) Performance (Reported Values) | Rationale for Equivalence (as per submission) |
|---|---|---|---|---|
| 1. Isolated Stimulus Channels | Same number of channels. | 2 | 2 | Same number of Channels as the EP-2. |
| 2. Pulse Amplitude | Range sufficient for therapeutic purposes; comparable to EP-2. | 0.1 to 25mA into 800Ω load | ||
| Increment: 0.1 mA up to 1mA Amplitude | ||||
| Accuracy: ± 2% or ± 0.2 mA (whichever is greater) | 0.1-20 mA (2500Ω load) | |||
| Accuracy: 5% or 0.2 mA (whichever is larger) | EPS320 output current is sufficient for therapeutic purposes and substantially the same as the EP-2. | |||
| 3. Pulse Duration | Within accepted clinical requirements; comparable to EP-2. | 0.5 to 10 msec | ||
| Increment: 0.5 – 10msec, increments of 1 – 10 msec | ||||
| Accuracy: ± 0.15ms | 0.5-10 msec (maximum 10% of ISI) | |||
| Increment: 0.1 msec | ||||
| Accuracy: 0.05 msec (Pulse amplitude > 2 mA) | Pulse Duration is within the profession's accepted requirements as attested by 4 years of post-market surveillance of the EPS320. | |||
| 4. Interstimulus Interval (ISI) | Substantially the same as EP-2. | 180 msec to 9990 msec ± 1msec or 0.1% (whichever is greater) (Range) | ||
| 30 - 9900 msec ± 1msec or 0.1% (whichever is greater) (Burst) | ||||
| Increment: 1 msec | 100-10000 ± 1 msec (Range) | |||
| 10-1000 ± 1 msec (Burst) | ||||
| Increment: 1 msec | Substantially the same as the EP-2. | |||
| 5. Sequential (AV) Delay | Substantially the same as EP-2, with enhanced safety. | Min: 25 - 980msec (maximum ISI – 120 msec) | ||
| Increment: 1 msec | 10-1000 ± 1 msec (maximum ISI - 50 msec) | |||
| Increment: 1 msec | A-V delay is substantially the same as the EP-2. EPS320 is limited to ISI less 120 msec which is considered an enhanced safety feature whilst retaining equivalent operational effectiveness. | |||
| 6. Reprogrammed Protocols | Equivalent functionality to EP-2, covering common clinical needs. | Equivalent protocol to all but 1 protocol in the EP-2 (Refractory Threshold omitted as no longer in common clinical use). Contains additional protocols like Multi-Sx, Nodal ERP / RSync_S2, Overdrive Burst / Load ATP. | Threshold, Refractory study, Wenckebach block, SA Node recovery, Pace, Burst, Overdrive, Underdrive, Arrhythmia Induction, Refractory Threshold. | EPS320 contains an equivalent protocol to all but 1 protocol in the EP-2, providing substantially equivalent functionality. One protocol, the Refractory Threshold protocol present in the EP-2 is no longer in common clinical use in the experience of the expert designer and was not included in the EPS320. |
| 9. Sensing (ECG synchronization) | External ECG input range appropriate; enhanced safety features. | External: 50 - 2000mV | ||
| Internal: Pacing catheter tip | ||||
| Trigger lockout (refractory time): 50 - 5000msec | ||||
| ECG delay: 50-5000msec | Automatic or manual trigger setting - Sensitivity: 1-500 mV | |||
| Automatic or manual trigger setting - Trigger lockout (refractory time): 10-1000 msec (100 Hz max) | ||||
| Automatic or manual trigger setting - ECG delay: 100-5000 msec | External ECG input range (mV) for the EPS320 is appropriate for common external ECG sources. Presence of pacing catheter tip sensing in EPS320 is considered an enhanced safety feature. Longer minimum lockout (50 vs. 10msec) is an enhanced safety feature reducing susceptibility to noise, without significant loss of functionality. Lockout period and ECG delay are substantially equivalent to the EP-2. | |||
| Hardware Platform | Similar architecture; safe and effective. | Standard "PC" Personal Computer / custom "Stimulus Generator Unit " | "Control Terminal" custom computer / custom "Stimulus Module" | Both devices have similar architectures. The EPS320's 'open PC architecture' uses verification of software environment and resource integrity and is based on extensive risk analysis. The absolute safety and efficacy of the EPS320 hardware platform has been demonstrated in clinical practice and is thus at least equivalent to that of the predicate EP-2 device. |
| Backup Pacing Circuits | As safe or more safe than EP-2. | Yes (2) – Manual Backup operation mode and Emergency Fixed Pace circuit. | No | These functions are safety enhancements over the predicate device EP-2. |
| Device Feedback to User | As safe or more safe than EP-2. | Open Pacing Circuit Warning: Yes | ||
| Stimulation impedance display: Yes | ||||
| Graphical display of ECG Trigger: Yes | No | These features are safety enhancements over the predicate device EP-2. | ||
| Power Source | Comparable reliability and safety. | Mains operated with 2 backup battery systems (12V lead acid, 9V Lithium). | Internal rechargeable 6V battery. | Mains source of power was considered safer than a battery as it removes the possibility of lack of device availability due to depleted batteries. Batteries in EPS320 are for fault conditions. |
Breakdown of Study Information:
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Sample Size Used for the Test Set and Data Provenance:
- The submission does not describe a specific "test set" or a formal clinical study with a defined sample size to prove the device meets acceptance criteria in a quantitative manner.
- The provided information states that the EPS320 is an "expert-designed product, based upon the electrophysiological expertise of the cardiologist Managing Director and on extensive post market experience with an earlier EPS220 model in service in eight (8) Australian hospitals since 1995." It also mentions that "The current and earlier EPS320 models have been in clinical use in more than 40 clinical centres predominantly in Australia, Europe and India, as well as in Turkey, Vietnam and China for up to 4 years without significant adverse effects." This "post-market experience" serves as informal evidence of performance and safety rather than a structured clinical test set.
- Data Provenance: Australia, Europe, India, Turkey, Vietnam, and China.
- Retrospective/Prospective: The "post-market experience" suggests a retrospective review of observational data from clinical use, not a prospective study designed to evaluate the EPS320 against specific endpoints.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Since there's no formal "test set" or ground truth establishment process described for a specific study, this information is not directly applicable.
- However, the device design itself is based on "electrophysiological expertise of the cardiologist Managing Director." This individual serves as a key "expert" influencing the device's design and functionality. The submission does not detail specific qualifications of this Managing Director beyond "cardiologist."
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Adjudication Method for the Test Set:
- Not applicable, as no formal test set and ground truth establishment with adjudication is described.
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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 a cardiac stimulator, not an AI-driven diagnostic imaging device that uses multi-reader studies.
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If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The EPS320 is a medical device that requires human operation by specialist cardiologists to apply electrical stimulation. It is not an autonomous algorithm.
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The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- No formal ground truth for a test set is described. The closest equivalent to "ground truth" for the device's design and effectiveness claims comes from:
- Expert experience: "electrophysiological expertise of the cardiologist Managing Director."
- Clinical outcomes/safety data: "4 years of post-market surveillance of the EPS320" and "clinical use in more than 40 clinical centres... for up to 4 years without significant adverse effects." This implicitly refers to positive clinical outcomes and lack of adverse events as evidence of safety and effectiveness in real-world scenarios.
- Comparison to predicate: The EP-2's established safety and effectiveness serve as the baseline "ground truth" for the EPS320's substantial equivalence claim.
- No formal ground truth for a test set is described. The closest equivalent to "ground truth" for the device's design and effectiveness claims comes from:
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The Sample Size for the Training Set:
- Not applicable. This submission does not describe an AI or machine learning algorithm that requires a "training set." The extensive clinical use of "current and earlier EPS320 models" in "more than 40 clinical centres" acts more as an extended real-world validation of the device's design and safety.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set described for an AI/ML algorithm.
§ 870.1750 External programmable pacemaker pulse generator.
(a)
Identification. An external programmable pacemaker pulse generators is a device that can be programmed to produce one or more pulses at preselected intervals; this device is used in electrophysiological studies.(b)
Classification. Class II (performance standards).