(227 days)
K854196/B
None
No
The description focuses on programmable electrical stimulation and control via standard PC software, with no mention of AI or ML algorithms for analysis, decision-making, or adaptive stimulation.
No
The device is described as an "electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing." Its primary purpose is to diagnose cardiac conditions by initiating and terminating tachyarrhythmias and measuring heart properties, rather than treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is an "electrical stimulus generator for diagnostic cardiac stimulation." Additionally, the "Device Description" characterizes it as a "diagnostic cardiac stimulator" used in "electrophysiological diagnostic laboratories."
No
The device description explicitly states it consists of a Stimulus Generator Unit (SGU) comprising a manufactured metal instrument case and a standard PC, interconnected by a serial data connection. It also describes hardware components like pulse generator channels, a Stimulus Connection Box, and an internal backup battery, indicating it is not solely software.
Based on the provided information, the EPS320 Stimulator System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "diagnostic cardiac stimulation during electrophysiological testing of the human heart." This involves directly interacting with the patient's heart to gather diagnostic information.
- Device Description: The device is an "external programmable computerised diagnostic cardiac stimulator." It delivers electrical stimuli to the heart via electrodes. This is an in-vivo procedure, meaning it takes place within the living organism.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. The EPS320 does not analyze specimens; it directly interacts with the patient's organ.
The EPS320 is a device used for in-vivo diagnostic procedures related to the heart's electrical activity.
N/A
Intended Use / Indications for 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.
The EPS320 Stimulator System is an electrical stimulus generator for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
Product codes
JOQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Specialist cardiologists in specialised hospital electrophysiological diagnostic laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K854196/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Version 5.5
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
1
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.
2
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 |
|---|---|---|---|
| ISI | |||
| ERP | Interstimulus Interval | ||
| Effective Refractory | |||
| Period | SNRT | ||
| ATP | Sinus Node Recovery Time | ||
| Anti Tachycardia Pacing | |||
| PC | |||
| ECG | |||
| IECG | Personal Computer | ||
| Electrocardiograph | |||
| Intracardiac ECG | SGU | ||
| IEC | |||
| AICD | Stimulus Generator Unit | ||
| International Electrotechnical Commission | |||
| Automatic Implantable Cardioverter | |||
| Defibrillator |
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.
| Comparative
element | DCI Model EP - 2
(Predicate Device) | Micropace model EPS320 |
|--------------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| A. Manufacturer | Digital Cardiovascular
Instruments, Inc. Berkeley, CA | Micropace Pty Ltd. Campsie, N.S.W
Australia |
| B. FDA Concurrence | Yes (K854196/B) | Pending |
| 1. Isolated Stimulus
Channels | 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 is
larger) | $\pm$ 2% or $\pm$ 0.2 mA, (whichever is greater) |
| 3. Pulse duration
Range | 0.5-10 msec (maximum 10% of
ISI) | 0.5 to 10 msec |
| Increment | 0.1 msec | 0.5 – 10msec, increments of 1 – 10 msec |
| Accuracy | 0.05 msec (Pulse amplitude > 2
mA) | $\pm$ 0.15ms |
| 4. Interstimulus
Interval (ISI)
Range | 100-10000 $\pm$ 1 msec | 180 msec to 9990 msec $\pm$ 1msec or 0.1%
(whichever is greater) |
| Comparative
element | DCI Model EP - 2
(Predicate Device) | Micropace model EPS320 |
| Range (Burst) | 10-1000 ± 1 msec | 30 - 9900 msec ± 1msec or 0.1% (whichever
is greater) |
| Increment | 1 msec | 1 msec |
| 5. Sequential (AV)
Delay | | |
| Range | 10-1000 ± 1 msec (maximum ISI
- 50 msec) | Min: 25 - 980msec (maximum ISI – 120
msec) |
| 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/Paper
advance | Sync 1 Input Marker |
| | ECG trigger marker | Sync 2 Input Marker
N/A |
| 11. Power Source | Internal rechargeable 6V battery | Main power source: 2201-240VAC or 110-
120VAC to 14.5 VDC, 750mA Low Voltage
Power Supply Transformer |
| | | Backup power: 1. 12V 2.1Ah lead acid
battery |
| | | 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) | | |
| Comparative
element | 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 phosphor
CRT | 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 (including
LCD panel) |
| Keyboard dimensions
(inches) | 2.25 x 17.25 x 7.6
Modified QWERTY keyboard | 1.6 high x 19.0 wide x 8.4 deep
Modified QWERTY keyboard |
| Weight (lbs) | 31.5 | Approx. 12.0 lb. |
| 14. Isolation
Transformer | | |
| 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 time
ration | Less than 1 | Less than 1 |
| Charge time from low
battery indication to
full charge | 1 Input electrical mains voltage will be dependant on geographical location/available mains voltage
:
:
j
,
4
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. Hardware
computer platform | "Control Terminal" custom
computer /
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 IECG
sensing | No | Yes |
| Balanced Charge
Pacing | No | Yes |
.
5
Version 5.5
| 4. Device feedback to
| user | ||
|---|---|---|
| Open Pacing Circuit | ||
| Warning | No | Yes |
| Stimulation impedance | ||
| display | No | Yes |
| Graphical display of | ||
| ECG Trigger | No | Yes |
| 5. Backup Pacing | ||
| Circuits | No | Yes (2) |
| 6. Stimulation | ||
| Protocol | ||
| Implementation | ||
| A-V Joined Pacing | ||
| Stimulation | Limited | Yes |
| Load_ATP - AICD- | ||
| Style Overdrive Pacing | No | Yes |
| ECG trigger time out | No | Yes |
| On the fly | ||
| programming of all | ||
| parameters | 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 5.1
Section | Reduced
safety or
effectivene
ss issues? | Is the EPS320 as safe and effective as the EP-2?
(Rationale) |
|------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 Isolated
Stimulus
Channels | No | Same number of Channels as the EP-2. |
| 2 Pulse
Amplitude | No | EPS320 output current is sufficient for therapeutic purposes and substantially
the same as the EP-2. |
| 3 Pulse
duration | No | 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) | 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 less
120 msec which is considered an enhanced safety feature whilst retaining
equivalent operational effectiveness. |
| 6
Reprogramm
ed Protocols | No | 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. |
| Table 5.1
Section | Reduced
safety or
effectivene
ss issues? | Is the EPS320 as safe and effective as the EP-2?
(Rationale) |
| 7
Programmab
le Protocol
keys | No | EPS320 implements programmability by storing and recalling complete
stimulator set ups rather than individual dual protocols. The two approaches
are basically functionally similar. |
| 8 Number of
Extrastimuli | No | The number of selectable extra stimuli is the same as the EP-2, dependant on
the protocol selected. |
| 9 Sensing
(ECG
synchronisati
on | No | External ECG input range (mV) for the EPS320 is appropriate for common
external ECG sources found in contemporary laboratories. |
| | | Presence of pacing catheter tip sensing in EPS320 is considered an enhanced
safety feature in providing an additional source of ECG trigger. |
| | | Longer minimum lockout in EPS320 (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 |
| 10 Additional
Outputs: | No | Sync 3 output on the EPS320 provides essentially the same function as
Stimulus Ch 'A' and Stimulus Ch 'B' outputs of the EPS320 |
| | | There is no requirement for an auxiliary (printer) output on the EPS320 as it is
connected to recording external systems. |
| 11 Power
Source | No | All components of the EPS320 system are powered from electrical mains
power via an isolation transformer. The SGU is powered from this isolated
mains by a 14.5V DC Power Supply Unit containing a transformer. The
EPS320 system, including these accessories (isolation transformer and DC
Power Supply Unit, have been subjected to appropriate electrical and safety
tests (See appendix A1 and A2). |
| | | 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 contained in the EPS320 are used solely under fault conditions. |
| 12
Stimulation
Module | No | Physical attributes of the EPS320 are substantially the same as the EP-2, whilst
maintaining operational functionality in similar environment |
| 13 Control
Terminal | Yes | The Computer used with the EPS320 can have software files added by the
operator creating potential for corruption of operating environment. To control
this possibility, the EPS320 software checks for integrity of operating
environment during startup. Other parameters are essentially equivalent as the
EP-2 terminal. |
| 14 Isolation
Transformer | No | The Isolation transformer is essentially equivalent to that described in the EP-2
documentation. |
| 15 Charger | No | The EPS320 does not require a separate battery charger. Batteries are not
required for normal operation. |
| 16
Environment | No | Environmental conditions are essentially equivalent as the EP-2. |
| Table 5.2
Section | Reduced
safety or
effectiveness issues? | Is the EPS320 as safe and effective as the EP-2?
(Rationale) |
| 1. Hardware
platform | Yes | Both devices have similar architectures, in that a microprocessor is used to
control output pulse generation circuitry, and a physically separate computing
device is used to provide user interface via a video display unit and a
keyboard.
The two devices differ predominantly in using different implementations to
achieve 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. There
will also be differences in software architectures and interface designs and
implementations.
The EPS320 system removes the danger of corruption of software environment
from unauthorised addition of third party software or incorrect operating
systems by verification of software environment and resource integrity prior to
startup. The custom software is implemented on a stable DOS platform and its
design is based on extensive risk analysis and subject to appropriate design
control, verification and validation.
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. |
| 2. User
interface | No | The user interface displays and input keyboards of the two devices are
substantially functionally equivalent technologies.
Software performance of the EPS320 is designed for user flexibility and
ergonomy and while these performance features probably represent the main
functional difference between the EPS320 and the predicate device they have
limited impact on device safety. |
| 3. ECG
Sensing | No | Catheter-Tip IECG sensing: The predicate EP-2 can trigger only on an
external ECG source, which is usually derived from third party equipment
which amplifies the patient's intracardiac ECG (IECG) or surface ECG.
The EPS320 contains an ECG amplifier connected to the pacing channel and
can thus trigger on this IECG source or on an external ECG source.
Balanced Charge Pacing: This feature refers to a configuration of IECG
amplifier sensing between stimulation pulses to minimise electrical charge
build up on the pacing electrodes. It has no impact on the stimulation pulse
shape, amplitude or efficacy and thus has no performance or safety impact. |
| 4. Device
feedback to
user | No | Open Pacing Circuit Warning: This feature indicates to the user when
programmed stimulation current fails to be delivered to the patient.
Stimulation impedance display: This feature displays to the user approximate
stimulus-to-stimulus impedance of the stimulation circuit.
Graphical display of ECG Trigger: This feature conveys to the user the
quality of the ECG source used for Triggering.
These features are safety enhancements over the predicate device EP-2. |
| 5. Backup
Pacing
Circuits | No | The EPS320 has a Manual Backup operation mode which operates in the
absence of a correctly functioning computer and allows user to perform simple
stimulation tasks.
The EPS320 also contains a separate, self-powered Emergency Fixed Pace
circuit, capable of delivering pacing stimuli in the case of loss of function of
the Stimulus Generator Unit.
These functions are safety enhancements over the predicate device EP-2. |
| 6. Stimulation
Protocol
Options | No | Both devices provide predominantly equivalent stimulation protocols with
differences confined to issues hotkey and menu layout, ergonomy and user
convenience. Below are representative examples.
A-V Joined Pacing Stimulation: This stimulation allows simultaneous
stimulation of both output channels for only some pacing stimuli in a pacing
protocol and not others.
Load_ATP - AICD-Style Overdrive Pacing: This additional protocol in the
EPS320 is an automated combination of the Burst and Overdrive protocols in
the predicate device.
ECG trigger time out: In case of failure of arrival of a Trigger event, pacing
will commence in any case after this period of time.
On the fly programming of all parameters: All pacing parameters can be
altered by hotkeys without stopping stimulation.
Shortcut Keys: Various shortcut keys, different to the predicate device, are
implemented to enhance efficiency of use. |
6
Table 5-3 Rationale of the data in Table 5-1
7
The EPS320 and the predicate device are equivalent in performance characteristics other than specifications (see Table 5-2) for the following reasons:
8
Version 5.5
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
9
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.
10
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.
11
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
12
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