(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.
Here's an analysis based on the provided input:
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:
-
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.
-
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."
-
Adjudication Method for the Test Set:
- Not applicable, as no formal test set and ground truth establishment with adjudication is described.
-
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.
-
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.
-
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:
-
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.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set described for an AI/ML algorithm.
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5. 510(k) Summary
5.1 21 CFR 807.92(a)(1) - Submitter details
Submitter's name: Address:
Phone number: Fax number:
Contact person:
Date the summary was prepared:
JAN 2 4 2002
Dr. Michael Cejnar 571 Canterbury Road, Campsie, NSW. 2194 Australia. 61+ 2 9787 6166
61+ 2 9787 6144
Dr. Michael Cejnar
25th May 2001
5.2 21 CFR 807.92(a)(2) - Device name
Trade name: Common name: Classification name:
Micropace model EPS320 Clinical Stimulator Programmable Cardiac Electrophysiological Stimulator External programmable pacemaker pulse generator (Per 21 CFR section 870.1750)
5.3 21 CFR 807.92 (a)(3) - Identification of Substantially Equivalent device
Predicate Company name
Predicate Device name
Digital Cardiovascular Instruments Inc. Berkeley CA
DCI Model EP-2 Clinical Stimulator
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5.4 21 CFR 807.92 (a)(4) - Description of the Micropace model EPS320
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 12.25"(W) x 13.25"(D) x 3.5"(H) 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 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. 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.
5.5 21 CFR 807.92 (a)(5) - Statement of the Intended Use
INTENDED USE:
The EP320 stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of I it is 220 alimitation of tachyarrhythmias, refractory measurements and measurements of electrical conduction.
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5.6 21 CFR 807.92 (a)(6) - Summary of Technological differences
This section compares the specifications and other relevant performance characteristics of the EPS320 and the predicate device, EP-2. It tabulates the compared items side by side and then specifies the rationale for claims of substantial equivalence.
5.6.1 Definition of terms used in the following tables
| TERM | DEFINITION | TERM | DEFINITION |
|---|---|---|---|
| ISIERP | Interstimulus IntervalEffective RefractoryPeriod | SNRTATP | Sinus Node Recovery TimeAnti Tachycardia Pacing |
| PCECGIECG | Personal ComputerElectrocardiographIntracardiac ECG | SGUIECAICD | Stimulus Generator UnitInternational Electrotechnical CommissionAutomatic Implantable CardioverterDefibrillator |
5.6.2 Technological differences between devices.
A comparison of published performance specifications in the "Specifications" sections of the EPS320 and in the equivalent section of the predicate device, EP-2 documentation is shown in Table 5-1 below.
| Comparativeelement | DCI Model EP - 2(Predicate Device) | Micropace model EPS320 |
|---|---|---|
| A. Manufacturer | Digital CardiovascularInstruments, Inc. Berkeley, CA | Micropace Pty Ltd. Campsie, N.S.WAustralia |
| B. FDA Concurrence | Yes (K854196/B) | Pending |
| 1. Isolated StimulusChannels | 2 | 2 |
| 2. Pulse Amplitude –Range | 0.1-20 mA ( $2500 \Omega$ load) | 0.1 to 25mA into $800 \Omega$ load |
| Increment | 0.1 mA up to 1mA Amplitude | |
| Accuracy | 5% or 0.2 mA (whichever islarger) | $\pm$ 2% or $\pm$ 0.2 mA, (whichever is greater) |
| 3. Pulse durationRange | 0.5-10 msec (maximum 10% ofISI) | 0.5 to 10 msec |
| Increment | 0.1 msec | 0.5 – 10msec, increments of 1 – 10 msec |
| Accuracy | 0.05 msec (Pulse amplitude > 2mA) | $\pm$ 0.15ms |
| 4. InterstimulusInterval (ISI)Range | 100-10000 $\pm$ 1 msec | 180 msec to 9990 msec $\pm$ 1msec or 0.1%(whichever is greater) |
| Comparativeelement | DCI Model EP - 2(Predicate Device) | Micropace model EPS320 |
| Range (Burst) | 10-1000 ± 1 msec | 30 - 9900 msec ± 1msec or 0.1% (whicheveris greater) |
| Increment | 1 msec | 1 msec |
| 5. Sequential (AV)Delay | ||
| Range | 10-1000 ± 1 msec (maximum ISI- 50 msec) | Min: 25 - 980msec (maximum ISI – 120msec) |
| Increment | 1 msec | 1 msec |
| 6. Reprogrammed | Threshold | Threshold, |
| Protocols | Refractory study | Nodal ERP / RSync_S2 |
| Wenckebach block | Wenckebach | |
| SA Node recovery | SNRT | |
| Pace | Pace | |
| Burst | Burst Pace | |
| Overdrive | Overdrive Burst / Load ATP | |
| Underdrive | - | |
| Arrhythmia Induction | Multi-Sx | |
| Refractory Threshold | - | |
| 7. Programmable | 5 | 5 programmable stimulator complete set-ups |
| Protocol keys | ||
| 8. Number of | 6 (s2-s7) | Max: 6 (s2-s7) |
| Extrastimuli | ||
| 9. Sensing (ECG | ||
| synchronisation) | ||
| Automatic or manual | 1-500 mV | External: 50 - 2000mV |
| trigger setting - | Internal: Pacing catheter tip | |
| Sensitivity | ||
| Automatic or manual | 10-1000 msec (100 Hz max) | 50 - 5000msec |
| trigger setting - | ||
| Trigger lockout | ||
| (refractory time) | ||
| Automatic or manual | 100-5000 msec | 50-5000msec |
| trigger setting - | ||
| ECG delay | ||
| 10. Additional | Stimulus Channel A Marker | Sync 3 Input Marker |
| Outputs: | Stimulus Channel B Marker | Sync 3 Input Marker |
| Programmable Auxiliary/Paperadvance | Sync 1 Input Marker | |
| ECG trigger marker | Sync 2 Input MarkerN/A | |
| 11. Power Source | Internal rechargeable 6V battery | Main power source: 2201-240VAC or 110-120VAC to 14.5 VDC, 750mA Low VoltagePower Supply Transformer |
| Backup power: 1. 12V 2.1Ah lead acidbattery | ||
| Backup power: 2. 9V PP3 Lithium battery | ||
| Battery operating time: | 17 hours (typical) | Indefinite (Mains operated) |
| 12. Stimulation | ||
| Module | ||
| Physical Dimensions | 3.0 x 12.0 x 14.0 | 3.3 x 12.25 x 13.25 |
| (inches) | ||
| Comparativeelement | DCI Model EP - 2(Predicate Device) | Micropace model EPS320 |
| Weight (lbs) | 11.2 | 18. 7 |
| 13. Control Terminal | ||
| Listings | UL | UL & CE |
| Type | 14 in diagonal green phosphorCRT | PC with LCD display |
| Display dimensions(inches) | 13.5 x 14 x 15 | 12 wide x 9 high x 3 deep (flat Screen) |
| Footprint dimensions(inches) | 12.25 x 10.25 | 10.6wide x 7.5deep x 15high (includingLCD panel) |
| Keyboard dimensions(inches) | 2.25 x 17.25 x 7.6Modified QWERTY keyboard | 1.6 high x 19.0 wide x 8.4 deepModified QWERTY keyboard |
| Weight (lbs) | 31.5 | Approx. 12.0 lb. |
| 14. IsolationTransformer | ||
| Leakage current | Less than 100 μA | Less than 100 μA |
| Power rating | 500 VA | 400VA |
| Physical dimensions(inches) | 8.12 x 9.00 x 6.75 | 7.75 x 5 x 4 |
| Weight (lbs) | 22 | 15.4 |
| 15. Charger | ||
| Listings | UL544 3-prong wall plug-in,automatic cut-off | Internal SGU 'on-board' circuitry |
| Charge/Discharge timeration | Less than 1 | Less than 1 |
| Charge time from lowbattery indication tofull charge | < 16 hours | <16 hours |
| Dimensions (inches) | 2.55 x 2.89 x 1.88 | N/A |
| 16. Environment | ||
| Operating Temperature | +10 to +40 degrees Celsius | +10 to +40 degrees Celsius |
| Storage Temperature | -20 to +60 degrees Celsius | -20 to +60 degrees Celsius |
| Relative Humidity | 25% to 90% non-condensing | 25% to 90% non-condensing |
| Operating Altitude | 0 to 4572 m | 0 to 4572 m |
| Storage Altitude | 0 to 7620 m | 0 to 7620 m |
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510(k) Pre-market Submission Micropace Pty Ltd.
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1 Input electrical mains voltage will be dependant on geographical location/available mains voltage
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510(k) Pre-market Submission Micropace Pty Ltd.
Version 5.5
Table 5-1 Substantial Equivalence Comparison -1
Table 5-2 below lists technological differences in performance characteristics between the EPS320 and the predicate EP-2 device not included in the "Specifications" section of either device.
| Comparative item | DCI Model EP - 2(Predicate Device) | Micropace model EPS320 |
|---|---|---|
| 1. Hardwarecomputer platform | "Control Terminal" customcomputer /custom "Stimulus Module" | Standard "PC" Personal Computer /custom "Stimulus Generator Unit " |
| 2. User interface | ||
| Output | Text Windowed Display | Graphical Windowed Display |
| 3. ECG Sensing | ||
| Catheter-Tip IECGsensing | No | Yes |
| Balanced ChargePacing | No | Yes |
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| 4. Device feedback touser | ||
|---|---|---|
| Open Pacing CircuitWarning | No | Yes |
| Stimulation impedancedisplay | No | Yes |
| Graphical display ofECG Trigger | No | Yes |
| 5. Backup PacingCircuits | No | Yes (2) |
| 6. StimulationProtocolImplementation | ||
| A-V Joined PacingStimulation | Limited | Yes |
| Load_ATP - AICD-Style Overdrive Pacing | No | Yes |
| ECG trigger time out | No | Yes |
| On the flyprogramming of allparameters | Limited | Yes |
| Shortcut Keys | Yes | Yes (different) |
Table 5-2 Substantial Equivalence Comparison -2
5.6.3 Rationale for claims of equivalence of devices
The EPS320 and the predicate device are equivalent in their published specifications (see Table 5-1) for the following reasons:
| Table 5.1Section | Reducedsafety oreffectiveness issues? | Is the EPS320 as safe and effective as the EP-2?(Rationale) |
|---|---|---|
| 1 IsolatedStimulusChannels | No | Same number of Channels as the EP-2. |
| 2 PulseAmplitude | No | EPS320 output current is sufficient for therapeutic purposes and substantiallythe same as the EP-2. |
| 3 Pulseduration | No | Pulse Duration is within the profession's accepted requirements as attested by4 years of post-market surveillance of the EPS320. |
| 4InterstimulusInterval (ISI) | No | Substantially the same as the EP-2. |
| 5 Sequential(AV) Delay | No | A-V delay is substantially the same as the EP-2. EPS320 is limited to ISI less120 msec which is considered an enhanced safety feature whilst retainingequivalent operational effectiveness. |
| 6Reprogrammed Protocols | No | EPS320 contains an equivalent protocol to all but 1 protocol in the EP-2,providing substantially equivalent functionality. One protocol, the RefractoryThreshold protocol present in the EP-2 is no longer in common clinical use inthe experience of the expert designer and was not included in the EPS320. |
| Table 5.1Section | Reducedsafety oreffectiveness issues? | Is the EPS320 as safe and effective as the EP-2?(Rationale) |
| 7Programmable Protocolkeys | No | EPS320 implements programmability by storing and recalling completestimulator set ups rather than individual dual protocols. The two approachesare basically functionally similar. |
| 8 Number ofExtrastimuli | No | The number of selectable extra stimuli is the same as the EP-2, dependant onthe protocol selected. |
| 9 Sensing(ECGsynchronisation | No | External ECG input range (mV) for the EPS320 is appropriate for commonexternal ECG sources found in contemporary laboratories. |
| Presence of pacing catheter tip sensing in EPS320 is considered an enhancedsafety feature in providing an additional source of ECG trigger. | ||
| Longer minimum lockout in EPS320 (50 vs. 10msec) is an enhanced safetyfeature reducing susceptibility to noise, without significant loss offunctionality. Lockout period and ECG delay are substantially equivalent tothe EP-2 | ||
| 10 AdditionalOutputs: | No | Sync 3 output on the EPS320 provides essentially the same function asStimulus Ch 'A' and Stimulus Ch 'B' outputs of the EPS320 |
| There is no requirement for an auxiliary (printer) output on the EPS320 as it isconnected to recording external systems. | ||
| 11 PowerSource | No | All components of the EPS320 system are powered from electrical mainspower via an isolation transformer. The SGU is powered from this isolatedmains by a 14.5V DC Power Supply Unit containing a transformer. TheEPS320 system, including these accessories (isolation transformer and DCPower Supply Unit, have been subjected to appropriate electrical and safetytests (See appendix A1 and A2). |
| Mains source of power was considered safer than a battery as it removes thepossibility of lack of device availability due to depleted batteries. | ||
| Batteries contained in the EPS320 are used solely under fault conditions. | ||
| 12StimulationModule | No | Physical attributes of the EPS320 are substantially the same as the EP-2, whilstmaintaining operational functionality in similar environment |
| 13 ControlTerminal | Yes | The Computer used with the EPS320 can have software files added by theoperator creating potential for corruption of operating environment. To controlthis possibility, the EPS320 software checks for integrity of operatingenvironment during startup. Other parameters are essentially equivalent as theEP-2 terminal. |
| 14 IsolationTransformer | No | The Isolation transformer is essentially equivalent to that described in the EP-2documentation. |
| 15 Charger | No | The EPS320 does not require a separate battery charger. Batteries are notrequired for normal operation. |
| 16Environment | No | Environmental conditions are essentially equivalent as the EP-2. |
| Table 5.2Section | Reducedsafety oreffectiveness issues? | Is the EPS320 as safe and effective as the EP-2?(Rationale) |
| 1. Hardwareplatform | Yes | Both devices have similar architectures, in that a microprocessor is used tocontrol output pulse generation circuitry, and a physically separate computingdevice is used to provide user interface via a video display unit and akeyboard.The two devices differ predominantly in using different implementations toachieve similar functional requirements.The EP-2 used propriety microprocessor software whereas the EPS320 uses an'open PC architecture' - a standard PC loaded with custom software. Therewill also be differences in software architectures and interface designs andimplementations.The EPS320 system removes the danger of corruption of software environmentfrom unauthorised addition of third party software or incorrect operatingsystems by verification of software environment and resource integrity prior tostartup. The custom software is implemented on a stable DOS platform and itsdesign is based on extensive risk analysis and subject to appropriate designcontrol, verification and validation.The absolute safety and efficacy of the EPS320 hardware platform has beendemonstrated in clinical practice and is thus at least equivalent to that of thepredicate EP-2 device. |
| 2. Userinterface | No | The user interface displays and input keyboards of the two devices aresubstantially functionally equivalent technologies.Software performance of the EPS320 is designed for user flexibility andergonomy and while these performance features probably represent the mainfunctional difference between the EPS320 and the predicate device they havelimited impact on device safety. |
| 3. ECGSensing | No | Catheter-Tip IECG sensing: The predicate EP-2 can trigger only on anexternal ECG source, which is usually derived from third party equipmentwhich amplifies the patient's intracardiac ECG (IECG) or surface ECG.The EPS320 contains an ECG amplifier connected to the pacing channel andcan thus trigger on this IECG source or on an external ECG source.Balanced Charge Pacing: This feature refers to a configuration of IECGamplifier sensing between stimulation pulses to minimise electrical chargebuild up on the pacing electrodes. It has no impact on the stimulation pulseshape, amplitude or efficacy and thus has no performance or safety impact. |
| 4. Devicefeedback touser | No | Open Pacing Circuit Warning: This feature indicates to the user whenprogrammed stimulation current fails to be delivered to the patient.Stimulation impedance display: This feature displays to the user approximatestimulus-to-stimulus impedance of the stimulation circuit.Graphical display of ECG Trigger: This feature conveys to the user thequality of the ECG source used for Triggering.These features are safety enhancements over the predicate device EP-2. |
| 5. BackupPacingCircuits | No | The EPS320 has a Manual Backup operation mode which operates in theabsence of a correctly functioning computer and allows user to perform simplestimulation tasks.The EPS320 also contains a separate, self-powered Emergency Fixed Pacecircuit, capable of delivering pacing stimuli in the case of loss of function ofthe Stimulus Generator Unit.These functions are safety enhancements over the predicate device EP-2. |
| 6. StimulationProtocolOptions | No | Both devices provide predominantly equivalent stimulation protocols withdifferences confined to issues hotkey and menu layout, ergonomy and userconvenience. Below are representative examples.A-V Joined Pacing Stimulation: This stimulation allows simultaneousstimulation of both output channels for only some pacing stimuli in a pacingprotocol and not others.Load_ATP - AICD-Style Overdrive Pacing: This additional protocol in theEPS320 is an automated combination of the Burst and Overdrive protocols inthe predicate device.ECG trigger time out: In case of failure of arrival of a Trigger event, pacingwill commence in any case after this period of time.On the fly programming of all parameters: All pacing parameters can bealtered by hotkeys without stopping stimulation.Shortcut Keys: Various shortcut keys, different to the predicate device, areimplemented to enhance efficiency of use. |
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Table 5-3 Rationale of the data in Table 5-1
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The EPS320 and the predicate device are equivalent in performance characteristics other than specifications (see Table 5-2) for the following reasons:
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Table 5-4 Rationale of the data in Table 5-2
5.6.4 Conclusion
The discussion above demonstrates that the EPS320 and the predicate device EP-2 posses similar architectural and functional characteristics, although differences exist in the specific technological implementation of some of the functional requirements. The EPS320, has demonstrably greater number of safety characteristics than the EP-2.
5.7 21 CFR 807.92 (b)(2) - Clinical comparison to the predicate device
Not Applicable
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5.8 21 CFR 807.92 (b)(3) - Clinical & non-clinical test conclusions
Having analysed the characteristics that differ and those which are similar between the Model EP-2 and Model EPS320, we have concluded that, in our opinion:
- The intended use of the EPS320 and EP-2 are the same. .
- Safety of the EPS320 is as effective if not more effective than the predicate device. .
- Differences between the systems are limited to the technological implementation of . equivalent functions, layout design and ergonomy of the user interface
- The EPS320 is substantially equivalent to the EP-2 . .
5.9 21 CFR 807.92 (c) - 510(k) Summary
Presentation of the 510[k] summary is considered compliant with the requirements of this section.
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Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles, with three wavy lines forming the central design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2002
Mr. Michael Cejnar Micropace Pty. Ltd. 571 Canterbury Road Campsie, NSW 2194 Australia
Re: K011826 EPS320 Cardiac Stimulator Regulation Number: 870.1750 Regulation Name: External Programmable Pacemaker Pulse Generator Regulatory Class: Class II (two) Product Code: JOQ Dated: October 23, 2001 Received: October 26, 2001
Dear Mr. Cejnar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. In addition, if you wish to change or expand the current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Michael Cejnar
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dela Teh
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Statement of Indications for Use
Indications for Use Statement
Ver/ 3 - 4/24/96
Applicant: Micropace Pty Ltd.
510(k) Number (if known):
Device Name: EPS320
Indications For Use:
The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
1-2-96)
Division of Cardiovascular & Respiratory Devices
Division of Cardiovascular & Respiratory Devices
510(k) Number K611826
§ 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).