EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

• K Number: K071348
• Device Name: EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM
• Manufacturer: MENNEN MEDICAL LTD.
• Date Cleared: 2007-09-07 ( 116 days)
• Product Code: DQK
• Regulation Number: 870.1425
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K993414 , K011826
• Predicate For: K134044

Intended Use

EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded.

The system allows the user to monitor, display and record the signal data.

The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

Device Description

The EMS-XL Cardiac Electrophysiology System consists of a software driven, multichannel amplifier and stimulator that are connected to a computer.

Input signals include 12 lead surfaces ECG, two Blood pressure channels and 18 or 50 channel intra-cardiac ECG.

The signals are digitized and sent to the computer for analysis, display and storage.

Signals are displayed with sweep speeds of 25 to 300mm/sec in either predefined or customized configurations.

The system consists of a computer, Front end amplifiers with integrated stimulator.

Two display screens, one used for Real Time signal display and the other for Non real Time display for analysis and review and playback of stored signals.

A Laser printer is used to print surface and intra-cardiac ECG and a CD or DVD is used for archive of signals.

The two display screens are used to show the signals. The real time display, RT, shows the real time signal waveforms. Each waveform channel is color-coded for easy identification. The non real time display, NRT, serves as a Review monitor allowing the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

The stimulator is computer controlled and provides basic stimulation rate plus up to 4 stimulations delayed after the basic stimuli. Stimulation can be either synchronized to the cardiac electrical activity or non synchronized. Pacing protocols with automatic increment and decrement functions provides refractory period measurements.

A variety of stimulation sequences can be created and stored for future use.

The EMS-XL can be used for all types of electrophysiological procedures, including His bundle recording, Sinus Node Recovery Time - SNRT, Overdrive, Wenckebach, and tachy-arrhythmias. An interface to ablation generators provide Ablation Start and End information with data on the ablation parameters.

Each waveform is color-coded for easy identification.

The review monitor allows the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

Special display options support the signal analysis

This includes Trigger mode and template comparison. Event marking. Holter mode: quick. minute-by-minute scrolls and jumps to event, On screen calipers: both real-time and review screen with auto measurement , Auto Tachycardia detection. Free text labeling, and Customized reports in Word™.

The input to the amplifiers is via a patient connection box, to which the intra-cardiac catheter electrodes (not manufactured and not supplied by Mennen Medical) are connected.

AI/ML Overview

This 510(k) summary for the Mennen Medical EMS-XL Cardiac Electrophysiology System focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials. The provided document is a predicate device comparison, which is a common approach for 510(k) submissions.

Therefore, the acceptance criteria and study detailed below are interpreted from the provided predicate comparison tables and the accompanying "Rational for claims of equivalence".

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1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the specifications of the predicate devices. The reported device performance (EMS-XL) is presented in direct comparison to these predicate specifications. The table below synthesizes information from the various comparison tables provided in the document (Amplifier Spec comparison, Stimulator Spec Comparison, Comparison of Systems).

Feature	Acceptance Criteria (Predicate)	Reported Device Performance (EMS-XL)	Deviations & Rationale (Effect on Safety/Intended Use/Performance)
Amplifier Specifications	Cardiolab EP System (GE Prucka)	EMS-XL Amplifier
Physical (HxWxD, 32/64 ch)	9.5x 14.0x 14.0 in (64/32 ch)	4.5x 11.5x 8 in (32 ch); 9.0x 11.5x 8 in (64 ch)	No (Smaller physical size, no effect)
Temperature Operating	0°C to +35°C	Same	Same
Temperature Transport/Storage	-15°C to +50°C	-30°C to +65°C	No (Wider range, no effect on safety/intended use)
Humidity Operating	<95% RH at 35°C non-condensing	30% - 75% non-condensing	No (Within predicate range, no effect)
Humidity Transport/Storage	<95% RH at 35°C non-condensing	5% - 95% non-condensing	No (Wider range, no effect)
Power Requirements	100-240 V AC; 50-60 Hz	Same	Same
Sampling Rate	1K, 2K and 4K	1KHz	No (Meets clinical requirements, Note 2)
CMMR	100 dB min	Same	Same
Input Impedance	>1 Billion Ohms	Typical 20 MΩ (Above 2.5 MOhm req by ANSI/AAMI EC11 par 3.2.9)	No (Meets standard, no effect)
Leakage Current (Patient Source)	<10 uA	Same - Per ISO 60601-1	Same
Leakage Current (Patient Sink)	<10 uA	Same - Per ISO 60601-1	Same
Leakage Current (Chassis)	<100 uA	Same - Per ISO 60601-1	Same
ECG Outputs	12 lead ECG produced	Same	Same
ECG High Pass Filter	0.05 Hz, 0.5 Hz, 5 Hz	0.05, 0.2, 40, 80 Hz	No (Provides necessary filtration, Note 3)
ECG Low Pass Filter	100 Hz	Same	Same
Gain	50-10,000 in 8 settings	Between 0 and 255 mm/mVolt – Continuous	No (Equivalent gain, different terms/control, Note 4)
Saturation Recovery	Less than 1 sec	Same	Same
Notch Filter	Power line (50/60 Hz)	Same	Same
Intracardiac Inputs (32ch)	32 intracardiac, 4 pressure, 10 ECG	36 intracardiac (18 ch), 2 pressure, 10 ECG (12 ch)	No (Covers wide range of clinical applications, Note 5)
Channel Switching	Any input can be switched to any output within a Block	Each channel can be Bipolar or Unipolar with Manual switching	No (Difference overcome by manual switching, Note 6)
IECG High Pass Filter	DC, 0.05 Hz, 0.5 Hz, 5.0 Hz, 30 Hz, 100 Hz	0.05, 0.2, 40, 80 Hz	No (Provides necessary filtration, Note 7)
IECG Low Pass Filter	500 Hz, 2,000 Hz	500 Hz	No (500Hz same, 2000Hz not relevant for 1KHz sampling, Note 8)
Pressure Inputs	Compatible with all standard external pressure transducers. 5uV/V/mmHg	Same	Same
Excitation Voltage	5V DC	10 V DC (+5 to -5V)	No (Sensitivity is important parameter, which is same, Note 9)
Pressure Channels Outputs	Up to 4 pressure channels	2 pressure channels	No (Covers wide range of clinical applications, Note 5)
Stimulator Specifications	Micropace model EPS 320	EMS-XL (integrated)
Isolated Stimulus channels	2	2	Same
Pulse Amplitude Range	0.1 to 25 mA into 800 Ω load	0.1 to 25 mA into 1500 Ω load	No (Same current range, higher load impedance source, Note 10)
Pulse Amplitude Increment	0.1 mA up to 1 mA Amplitude	0.1 mA within whole range	No
Pulse Amplitude Accuracy	+/- 2% or +/- 0.2 mA (whichever is larger)	Same	Same
Pulse Duration Range	0.5 to 10 msec	0.1 to 9.9 msec	No
Pulse Duration Increment	0.5 - 10 msec, increment of 1-10 msec	0.1 msec	No (Smaller increments, no effect on performance)
ISI Range (Pace)	180 msec to 9990 msec	Same	Same
ISI Range (Burst)	30 - 9900 msec	Same	Same
ISI Increment	1 msec	10 msec	No (Easier control, Note 11)
Sequential Delay (AV) Range	10-1000+/- 1 msec (maximum ISI - 50 msec)	11 - 250 msec	No (No clinical significance for longer intervals, Note 12)
Number of Extra-stimuli	6 (S2-S7)	4 (S2-S5)	No (4 extra sufficient for most clinical apps, Note 13)
Sensing (ECG sync)	External: 50 – 2000 mV; Internal: Pacing catheter tip	Internal from any surface or intra-cardiac channel	No
Sync Output	Multiple sync outputs for external devices	No	No (Integrated system doesn't need external sync, Note 14)
Power Source (Stimulator)	Mains 220/110 to 14.5 VDC, 750 mA low voltage power supply. Backup battery	Integrated with Amplifier power (+5V, -+12V, -12V)	Yes (Integrated, but safety covered by other precautions, Note 15)
Programmed Protocols (Auto TP/Ectopic/Stop Tachycardia)	Yes	No	Yes (Physician decision used instead due to safety burden, Note 16)
Backup Stimulator	Integrated	No backup stimulator (Requires external backup)	Yes (User manual requires external backup, Note 17)
System Specifications	Carto® XP System (GE Prucka)	EMS-XL
Processor	Intel® 2.66GHz Pentium IV Xeon or greater	Intel® 2.4GHz Pentium IV or greater	No
RAM	512 MB	Same	Same
Hard drives	2 x 40 GB	80 GB	No
Monitors	1 or 2	2	No
Holter Mode	Yes	Integrated Holter mode with full disclosure	No
Ablation Connectivity	Connectivity to RF Ablation generator(s)	Same	Same
Statistics and Inventory	Xi2 Data Management System	No	No (Administrative package, no direct use on EP procedure, Note 18)
Mapping	Isochronal and Isopotential Maps	No	No (External devices can be used for mapping, Note 19)
Vital Signs	Integrated Vitals Monitoring with Audible Indicators	Not integrated (Integrated tachycardia message; recommends external monitor, Note 20)	No

2. Sample Size Used for the Test Set and Data Provenance

This document describes a predicate comparison for a 510(k) submission, not a direct clinical study with a specified "test set" as one might find for an AI/ML device.

• Sample Size: Not applicable in the context of a prospective or retrospective clinical study of user data. The "sample" here refers implicitly to the specifications and functionalities of the two predicate devices being compared.
• Data Provenance: The data provenance is the technical specifications and reported features of the two predicate devices:
  • K993414 Cardiolab EP system (Prucka Engineering, Inc)
  • K011826 Micropace model EPS 320 (Micropace Pty Ltd.)
    The submission itself is from Mennen Medical Ltd., Israel. The clinical experience mentioned for EMS-XL notes use by clinics "out of the USA" since December 2003, implying international (likely European) usage.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in this type of submission. The "ground truth" for this submission is the established and legally marketed performance and specifications of the predicate devices. The review and interpretation of these specifications for equivalence determination would be performed by the manufacturer's regulatory affairs team and then by FDA reviewers.

4. Adjudication Method for the Test Set

Not applicable. This is a technical specification comparison, not a clinical trial requiring adjudication of patient outcomes or expert reads. The "adjudication" is essentially the manufacturer's justification (Rational for claims of equivalence) and the FDA's acceptance of those justifications for "substantial equivalence."

5. 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

No, an MRMC study was not done. This device is a cardiac electrophysiology system, which includes signal acquisition, display, recording, and stimulation capabilities. It is not an AI/ML diagnostic interpretation tool that would typically undergo an MRMC study to assess reader performance with and without AI assistance. The submission confirms that the EMS-XL system is a software-driven, multichannel amplifier and stimulator connected to a computer, focused on acquiring and analyzing physiological signals.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, implicitly. The comparison tables are a standalone comparison of the technical specifications and functions of the EMS-XL device against the technical specifications and functions of its predicate devices. The "performance" being evaluated is the device's inherent functional capabilities as designed and manufactured, not an AI algorithm's interpretive ability.

7. The Type of Ground Truth Used

The "ground truth" used is the published and legally established technical specifications and performance characteristics of the predicate devices (Cardiolab EP system and Micropace model EPS 320) as detailed in their 510(k) clearances and product documentation. This is a regulatory "truth" rather than a clinical "truth" (like pathology or outcomes data).

8. The Sample Size for the Training Set

Not applicable. This document does not describe the development of an AI/ML algorithm that would require a "training set." The EMS-XL is a hardware and software system for electrophysiological studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for an AI/ML algorithm is described.

Summary

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K07/348

Image /page/0/Picture/2 description: The image shows the logo for "mennen medical". The logo consists of a black circle with a white "m" inside it on the left. To the right of the circle, the word "mennen" is written in black, and below it, the word "medical" is written in gray.

SEP - 7 2007

Date: July 30, 2007

Topic: 510K Summery EMS-XL Cardiac Electrophysiology system

Establishment Name, Registration Number and Address:

Name:	Mennen Medical Ltd.
Registration Number:	9611022
Operator Number:	9069173
Address:	4 Hayarden Street, Yavne, 81228, Israel
Postal Address:	PO Box 102,Rehovot, 76100, Israel
Tel:	[phone]
Fax:	[phone]
Contact person:	Micha Oestereich, Regulatory Affairs

The following information is being submitted in conformance with [807.92(a)(2)].

1. Device Name:	EMS-XL - Cardiac Electrophysiology System
2. Classification Name:	Programmable Diagnostic Computer
3. Trade/Proprietary Name:	EMS-XL Cardiac Electrophysiology System
4. Common/Usual Name	Cardiac Electrophysiology system
5. Classification Number:	870.1425 computer, diagnostic, programmable
	870.1750 External programmable pacemaker pulse generator
6. FDA Classification	Class II
7. Product Code	DQK

8. Predicated Devices:

Substantial Equivalence is claimed to the following devices:

• K993414 (4 July 2000) Cardiolab EP system. Prucka Engineering, Inc -
• K011826 (24 Jan 2002) -- Micropace model EPS 320. Micropace Pty Ltd. -

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Device description

The EMS-XL Cardiac Electrophysiology System consists of a software driven, multichannel amplifier and stimulator that are connected to a computer.

Input signals include 12 lead surfaces ECG, two Blood pressure channels and 18 or 50 channel intra-cardiac ECG.

The signals are digitized and sent to the computer for analysis, display and storage.

Signals are displayed with sweep speeds of 25 to 300mm/sec in either predefined or customized configurations.

The system consists of a computer, Front end amplifiers with integrated stimulator.

Two display screens, one used for Real Time signal display and the other for Non real Time display for analysis and review and playback of stored signals.

A Laser printer is used to print surface and intra-cardiac ECG and a CD or DVD is used for archive of signals.

The two display screens are used to show the signals. The real time display, RT, shows the real time signal waveforms. Each waveform channel is color-coded for easy identification. The non real time display, NRT, serves as a Review monitor allowing the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

The stimulator is computer controlled and provides basic stimulation rate plus up to 4 stimulations delayed after the basic stimuli. Stimulation can be either synchronized to the cardiac electrical activity or non synchronized. Pacing protocols with automatic increment and decrement functions provides refractory period measurements.

A variety of stimulation sequences can be created and stored for future use.

The EMS-XL can be used for all types of electrophysiological procedures, including His bundle recording, Sinus Node Recovery Time - SNRT, Overdrive, Wenckebach, and tachy-arrhythmias. An interface to ablation generators provide Ablation Start and End information with data on the ablation parameters.

Each waveform is color-coded for easy identification.

The review monitor allows the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.

Special display options support the signal analysis

This includes Trigger mode and template comparison. Event marking. Holter mode: quick. minute-by-minute scrolls and jumps to event, On screen calipers: both real-time and review screen with auto measurement , Auto Tachycardia detection. Free text labeling, and Customized reports in Word™.

The input to the amplifiers is via a patient connection box, to which the intra-cardiac catheter electrodes (not manufactured and not supplied by Mennen Medical) are connected.

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Indication for use:

EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded.

The system allows the user to monitor, display and record the signal data.

The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

The intended use

The EMS-XL is a computerized Electrophysiological Measurement System, designed for conducting regular or experimental electrophysiology (EP) studies.

The EMS-XL System is intended to be used for performing computerized Electrophysiological and Ablation procedures.

The EMS-XL is intended for sale as a system for performing EP clinical studies Prescription Use under the supervision of a physician

Control and Integration

The EMS-XL integrated stimulator allows complete control of all stimulator functions at all times, featuring programmable pacing protocols with automatic increment and decrement functions, comprising all basic modes. Furthermore, the system includes online Holter and Event windows that allow for simple and immediate tracking of ectopic events. Fully editable final reports are generated in a Microsoft Word™ format, easily integrating measured intervals and procedure notes, to improve efficiency and productivity while saving valuable staff time.

Additional Features

• · Trigger mode and template comparison
• · Customized reports in MS WordTM
• · Auto Tachycardia detection: Jump to event
• · SNRT Protocol
• · Automatic snapshot after pacing
• · Event marking
• · Holter mode: Quick, minute-by-minute scrolls and jumps to event
• · On screen calipers: Both real-time and review screens with auto measurement

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• · Export snapshots as image file for a PowerPoint presentation
• · Multiple interfaces to Ablation RF generators for display of ablation parameters and ablation stop/start events
• · Total case full disclosure archiving on hard drive
• · Easily upgradeable software

Product Highlights

• · Built-in integrated stimulator:
• · Total full disclosure: Guaranties data integrity and long term archiving
• · Off-line review station: Review, analysis and printing of entire case from remote location (optional)

Product Comparison to predicated devices

The EMX-XL system combined signal amplification, display and recording features with stimulation capabilities.

We thus have two predicated devices:

• Cardiolab EP system. Prucka Engineering, Inc K993414 (4 July 2000) | for the signal amplification, display and recording
• Micropace model EPS 320. Micropace Pty Ltd. K011826 (24 Jan 2002) --for the stimulation specification and features.

The following are the comparison tables:

• Amplifier Spec comparison .
• Comparison of Systems .
• Stimulator Spec Comparison .

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Manufacturer	Predicated - GE Pruka	Mennen Medical	Effectonsafety	Effect onIntended use
System	CardioLab II PlusAmplifier	EMS-XL amplifier
Item	Description	Description
Physical Specifications
64/32 channel HxWxD	9.5x 14.0x 14.0 in	32 = 4.5x 11.5x 8 in x64 = 9.0x 11.5x 8 in x	No	No
128/96 channel HxWxD	14.0 x 14.0 x 14.0 in	Not used	N/A	N/ANote 1
Environmental Specifications
Temperature Operating	0°C to +35°C	Same
Transport/Storage:	-15°C to + 50°C	-30°C to + 65°C	No	No
Humidity Operating:	< 95% relative at 35°C non-condensing	30% - 75% noncondensing	No	No
HumidityTransport/Storage:	< 95% relative at 35°C non-condensing	5% - 95% noncondensing	No	No
rower Specifications:
Power Requirements	100-240 V AC; 50-60 Hz	Same		Same
Power Input (64/32channel)	0.0-0.5 Amps Class I, TypeCF Continuous operation	+ 5 V , 0.0 - 0.2 A+ 12 V, 0.0 - 0.3 A- 12 V , 0.0 - 0.3 A	No	No
Power Input (128/96channel)	0.5-0.75 Amps Class I,Type CF Continuousoperation	Not used	N/A	N/ANote 1
Design
Sampling and Hold	Each channel sampled priorto acquisition.	Same		Same
Sampling Rate	1K, 2K and 4K	1KHz	No	NoNote 2
CMMR	100 dB min	Same		Same
		Typical 20 MΩ	No	No
Input Impedance	> 1 Billion Ohms	Above the 2.5 MOhmrequired by theANSI/AAMI EC11 par3.2.9		Per standard
akage Current
Patient Source:	< 10 uA	Same - Per ISO 60601-		Same
...anufacturer	Predicated – GE Pruka	Mennen Medical	Effect on safety	Effect on Intended use
System	CardioLab II PlusAmplifier	EMS-XL amplifier
Item	Description	Description
		1
Patient Sink:	< 10 uA	Same – Per ISO 60601-1		Same
Patient Sink (measured atpatient leads under singlefault conditions):	< 50 uA	Same – Per ISO 60601-1		Same
Chassis Leakage:	< 100 uA	Same – Per ISO 60601-1		Same
ECG Input
Outputs	12 lead ECG produced	Same		Same
High Pass Filter	0.05 Hz, 0.5 Hz, 5 Hz	0.05, 0.2, 40, 80 Hz	No	NoNote 3
Low Pass Filter	100 Hz	Same		Same
RF Filtering	All inputs	Same		Same
ain	50-10,000 in 8 settings	Between 0 and 255 mm/mVolt – Continuous	No	Note 4
Saturation Recovery	Less than 1 sec.	Same		Same
Notch Filter	Power line (50/60 Hz)	Same		Same
	No data	+/- 5 mVoltAAMI EC11 par 3.2.3		Per standard
Dynamic range
	No data	+/- 300 mVoltAAMI EC11 par 3.2.3		Per standard
Baseline correction
Input / Output
Inputs 32 channels	32 intracardiac inputs, 4pressure inputs, 10 ECGinputs	36 intracardiac inputs(18 channels), 2pressure inputs, 10 ECGinputs (12 channels)	No	NoNote 5
Inputs 64 channels	96 intracardiac inputs, 4pressure inputs, 10 ECGinputs	100 intracardiac inputs,(50 channels), 2pressure inputs, 10 ECGinputs (12 channels)	No	NoNote 5
Inputs 96 channels	160 intracardiac inputs, 4pressure inputs 10 ECGinputs	Not used	No	NoNote 1
Inputs 128 channels	224 intracardiac inputs, 4	Not used	No	No
...anufacturer	Predicated - GE Pruka	Mennen Medical	Effectonsafety	Effect onIntended use
System	CardioLab II PlusAmplifier	EMS-XL amplifier
Item	Descriptionpressure inputs, 10 ECGinputs	Description		Note 1
Outputs	16 channels/Block. Up to112 channels. 32 channel:Block A 64 channel: BlocksA-C 96 channel: Blocks A-E128 channel: Blocks A-G	No outputs	No	NoNote 1
Switching	Any input can be switchedto any output within a Block.	Each channel can beeither Bipolar or Unipolarwith Manual switching	No	NoNote 6
High Pass Filter	DC, 0.05 Hz, 0.5 Hz, 5.0 Hz,30 Hz, 100 Hz	0.05, 0.2, 40, 80 Hz	No	NoNote 7
Low Pass Filter	500 Hz, 2,000 Hz	500 Hz	No	NoNote 8
RF Filtering	All inputs	Same		Same
Gain	50-10,000 in 8 settings	Between 0 and 255mm/mVolt - Continuous	No	NoNote 4
Saturation Recovery	Less than 1 sec.	Same		Same
Notch Filter	Power line (50/60 Hz)	Same		Same
Dynamic range	No data	+/- 5 mVoltAAMI EC11 par 3.2.3		Per standard
Baseline correction	No data	+/- 300 m VoltAAMI EC11 par 3.2.3		Per standard
Pressure Inputs
Inputs	Compatible with all standardexternal pressuretransducers. 5uV/V/mmHg	Same		Same
Input Impedance	> 1 Billion Ohms	Typical 20 MΩAbove the 2.5 MOhmrequired by the ANSI/AAMIEC11 par 3.2.9	No	NoPer standard
Outputs	Up to 4 pressure channels	2 pressure channels	No	NoNote 4
Low Pass Filter	6 Hz, 25 Hz, 100 Hz, 400Hz	DC to 12 Hz(DC to 40 Hz optional).IEC 60601-2-34 Standardpar. 51.103 requests atleast DC to 10 Hz.	No	NoPer standard
Excitation Voltage	5V DC	10 V DC (+5 to -5V).	No	Note 9
...anufacturer	Predicated – GE Pruka	Mennen Medical	Effectonsafety	Effect onIntended use
System	CardioLab II PlusAmplifier	EMS-XL amplifier
Item	Description	Description
Output Impedance	< 0.050 Ohms	Same		Same
Range	-400mm Hg to +400 mmHg	Same		Same

Amplifier Technical Specifications comparison

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Stimulator Specification comparison

Manufacturer	Micropace Pty. Ltd.Austria	Mennen Medical Ltd.Israel	Effectonsafety	Effect onPerformance
	Predicated device
Subject/Parameter	EPS320	(integrated in) EMS-XL
JA Concurrence	Yes K011826	Pending
Isolated Stimuluschannels	2	2
Pulse Amplitude
Range	0.1 to 25 mA into 800 Ωload	0.1 to 25 mA into 1500Ω load	No	Note 10
Increment	0.1 mA up to 1 mAAmplitude	0.1 mA within wholerange	No	No
Accuracy	+/- 2% or +/- 0.2 mA(whichever is larger)	Same		Same
Pulse duration
Range	0.5 to 10 msec	0.1 to 9.9 msec	No	No
Increment	0.5 - 10 msec, incrementof 1-10 msec	0.1 msec	No	No, smallerincrements
Accuracy	+/- 0.15 msec	Same		same
Inter-stimulus Interval (ISI)
Range	180 msec to 9990 msec +/-1msec or 0.1% (whicheveris greater)	Same		Same
Manufacturer	Micropace Pty. Ltd.AustriaPredicated device	Mennen Medical Ltd.Israel	Effectonsafety	Effect onPerformance
Subject/Parameter	EPS320	(integrated in) EMS-XL
Range (Burst)	30 - 9900 msec +/- 1msecor 0.1% (whichever isgreater)	Same		Same
Increment	1 msec	10 msec	No	Note 11
Sequential Delay (AV)
Range	10-1000+/- 1 msec(maximum ISI - 50 msec)	11 - 250 msec	No	Note 12
Increment	1 msec	same
ProgrammedProtocols	Threshold	Threshold panel key	No	No
	SNRT	SNRT panel key
	Burst	Vent. Burst key
	Overdrive	Atrial Burst key
		Vent. Overdrive key
		Atrial Overdrive key
	Multi- Sx	Same
ProgrammedProtocols	Pace	Same	No	No
	Wenkebach	User defined protocol
	Nodal ERP / RSync_S2	User defined protocol
ProgrammableProtocol Key	5	Same
Number of Extra-stimuli	6(S2-S7)	4(S2-S5)	No	Note 13
Sensing (ECG synchronization)
Automatic or Manualtrigger setting -sensitivity	External: 50 – 2000 mVInternal: Pacing cathetertip	Internal from anysurface or intra-cardiacchannel	No	No
Automatic or Manualtrigger setting -Trigger lockup(refractory time)	5 - 5000 msec	Same		Same
Automatic or Manualgger setting - ECGdelay	5 - 5000 msec	Same		Same
Manufacturer	Micropace Pty. Ltd.AustriaPredicated device	Mennen Medical Ltd.Israel	Effectonsafety	Effect onPerformance
Subject/Parameter	EPS320	(integrated in) EMS-XL
Additional Outputs	Stimulus channel A:Sync 3Input markerStimulus channel A:Sync 3Input markerProgrammable Auxiliary /Paper advance: Sync 1Input markerECG trigger marker: Sync1, Sync 2 .	No	No	Note 14
Power Source	Mains 220/110 to 14.5VDC, 750 mA low voltagepower supply.Backup Power: battery	Integrated withAmplifier+ 5 V , 0.0-0.2 A+ 12 V, 0.0-0.3 A- 12 V , 0.0 - 0.3 A	Yes	Note 15
Simulation module		N/A
Dimension	3.0x12.9x14.0 inch	N/A
Weight	18.7 lbs.	N/A
Control terminal
IsolationTransformer		Yes		Note 15
Environment		Stimulator integratedwith amplifier
OperatingTemperature	+10 to +40 Celsius	0°C to +35°C	No	No, Note 15
Storage Temperature	-20 to +60 Celsius	-30°C to + 65°C	No	No, Note 15
Operating Relativehumidity	20% to 90% non-condensing	30% - 75% noncondensing	No	No, Note 15
Storage Relativehumidity	20% to 90% non-condensing	5% - 95% non condensing	No	No, Note 15
Operating altitude	0 to 4572 meter	- 400 to 3050 meter	No	No
Storage Altitude	0 to 7620 meter	- 400 to 5000 meter	No	No
Controller	Embedded micro-controller	Integrated into theAmplifier and computer	No	No, Note 15
*Manufacturer	Micropace Pty. Ltd.AustriaPredicated device	Mennen Medical Ltd.Israel	Effectonsafety	Effect onPerformance
Subject/Parameter	EPS320	(integrated in) EMS-XLcontrol
User Interface	PC windows-stylegraphical display	Same on the EMS-XLdisplay	No	Note 15
Power supply	Class II	See EMS-XL computer	No	Note 15
Isolation transformer	Toroidal 1 : 1 medicalgrade, 110-240 VAC, 100VA max	See EMS-XL computer	No	Note 15
0/S Software:	Custom RTOS / DatalightROM-DOS	See EMS-XL computer	No	Note 15
Backup power	12V 2.1 Ah sealed leadacid	See Note A.	No	Note A
Emergency power:	9V LiMn02i PP3, 10y life	See Note A.	No	Note A
Operating time	Two (2) hours on backupbattery	See Note A.	No	Note A
Pacing Channels
Isolated Channels(3)	(i) Atrial and(ii) Ventricular via greenRedel 4 pin socket(iii) Emergency FixedPace Output to Ventricle,via red Redel 4 pin socket	Same function withdifferent connectors	No	Same
Power Source:	Internal DC-DC converters	See Note A.	No	No, Note A
Circuit Isolation:	Compliant with IEC601-1,Class CF, 5kV, common &differential mode	Compliant withIEC60601-1, Class CF,5kV, common &differential mode	No	No
Computer Controlled Stimulus Pulses
Current:	0.1 to 25 mA into 800 Ωload	0.1 - 25.5 mA, into1500 Ω load 40V	No	Note 10
Current Steps:	0.1 mA	0.1 mA		Same
"Manufacturer	Micropace Pty. Ltd.AustriaPredicated device	Mennen Medical Ltd.Israel(integrated in) EMS-XL	Effect onsafety	Effect onPerformance
Subject/Parameter	EPS320
Accuracy:	+/- 2% or +/- 0.2 mA, which ever is greater	+/- 0.1 mA
Pulse Duration:	0.5 ms, 1-10 ms in steps of 0.1ms	Pulse width 0.1 – 9.9 mSec steps of 0.1 mS	No	No
Accuracy:	+/- 0.15 ms	+/- 0.1 mA		Same
Load Impedance:	200-1000 Ω, $<$ 700 Ω for max current	1500 Ω	No	Note 10
Max Output Voltage	27V	40 V	No	Note 10
Inter-stimulus Intervals
S1 Range:	180 - 9990 ms (Pace)30 - 9990 ms (Burst Pace)	Same		Same
ability:	Quartz computer clock,+/- 30 parts per million @ 25° C	Same
Extra-Stimuli:	6 max, S2-S7, independent	4 max, S2-S5, independent	No	Note 13
Coupling interval:	30 - 9990 ms	Same		Same
Accuracy	+/- 1 ms or 0.1 % whichever is greater	+/- 10 ms	No	Note 11
Protocol Automation
Auto decrement / increment:	Yes	Same		Same
	SNRT S1 intervals and RT calculation	Same		Same
	Auto pace and sense -	Same		Same
	His-coincident extra-stimulus timing calculation	Caliper with labels	No	Same function
	ATP S1 calculation from % of TCL	No	Yes	Note 16
	Trigger output on sensed ectopic beats	No	Yes	Note 16
Manufacturer	Micropace Pty. Ltd.AustriaPredicated device	Mennen Medical Ltd.Israel	Effect onsafety	Effect onPerformance
Subject/Parameter	EPS320	(integrated in) EMS-XL
	Stop On Tachycardia	No	Yes	Note 16
	All automation subject toinstant operatoradjustment	Same	No	Same
Backup ManuallyControlledStimulation		No backup stimulatorUse external backupstimulator	Yes	Note 17
Emergency BackupPacing		No backup stimulator.Use external backupstimulator	Yes	Note 17

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:

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Comparison of Systems

.

Manufacturer	GE - PruckaPredicateddevice	Mennen MedicalLtd.	Effectonsafety	Effect onperformance
Subject/Parameter	Carto® XPSystem Bi-directionalInterface	EMS-XL
Processor/Data Storage
Processor	Intel® 2.66GHzPentium IV Xeon orgreater	• Intel® 2.4GHzPentium IV or greater	No	No
RAM	512 MB	Same		Same
Hard drives	2 x 40 GB	80 GB	No	No
Diskette Drive	No	1.44 MB	No	No
DVD-RAM/CD-RV drive	• 9.4 GB DVD-RAM/CD-RV drive	DVD-RW / CD R	No	No
Magnetic Optical Drive	• 2.6 GB MagneticOptical Drive	Optional	No	No
Mouse	• Optical ScrollMouse	same		Same
Operating System	• OS: Windows XP	Same		Same
Manufacturer	GE - PruckaPredicateddevice	Mennen MedicalLtd.	Effectonsafety	Effect onperformance
Subject/Parameter	Carto® XPSystem Bi-directionalInterfaceProfessional	EMS-XL
Office	• Microsoft Office XP Professional	Same		Same
Modem	Modem
	• 56K B. 90 BaudData	Same		Same
Networking
Ethernet	• 100 Base-TEthernet, TCP/IP	Same		Same
Flat panel display	• 20" flat panel ultrahigh-resolutioncolor	Same		Same
Monitors
solution	• 1600 x 1200	Same		Same
No of monitors	1 or 2	2	No	No
Printer Options
Black/White	• HP Black/WhiteLaserJet 2300	HP LaserJet 4100 orgreater	No	No
• Color LaserJet	Yes	No	No	No
Compliance with Standards
standards	• UL 2601-1, IEC60601-1-2,European UnionMedical	Same		Same
Device Directive (CEMarked)	Device Directive(CE Marked)	Same		Same
Environmental/Electrical Specifications
• Operating Temperature:	+10°C to +30°C	0°C to 35°C	No	No
• Storage Temperature: -	-10°C to +45°C	-20°C to 65°C
• Humidity: operating	30%-75% (non-condensing)	Same		Same
Humidity: storage	10%-95%, (non-condensing)	5%-95%, (non-condensing)	No	No
Manufacturer	GE - PruckaPredicated device	Mennen MedicalLtd.	Effect onsafety	Effect onperformance
Subject/Parameter	Carto® XPSystem Bi-directionalInterface	EMS-XL
• Maximum Current Draw:	15A/115V,7A/230V	Same		Same
• Chassis Leakage Current:	<100μA	Same		Same
Advance Features
IT Interface	Yes	Yes		Same
Holter	Yes	Integrated Holtermode with fulldisclosure,.	No	No
Ablation	Connectivity to RFAblationgenerator(s)	Same		Same
Statistics and Inventory	Xi2 DataManagementSystem.	No	No	Note 18
Documentation	Configurableelectronicdocumentation	Configurable Worddocumentation	No	No - Same
Networking	Remote waveformreview and Nurses'Workstation, forsimultaneous dataentry withwaveform archive	Remote Reviewstation	No	No - Same
Security	Standard securityfeatures	Same
Access to raw data	Easy access to rawwaveform data(data extraction),binary &ASCII formats	Yes , in FullDisclosure	No	No, Same
Manufacturer	GE - PruckaPredicateddevice	Mennen MedicalLtd.	Effectonsafety	Effect onperformance
Subject/Parameter	Carto® XPSystem Bi-directionalInterface	EMS-XL
Mapping	Isochronal andIsopotential Maps	No	No	Note 19
Vital Signs	Integrated VitalsMonitoring withAudible Indicators	Not integrated	No	Note 20

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:

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Certification
MDD Device Class:	Class IIb	Class IIb
IEC60601-1	certified	certified
EMC compliance	certified	certified
CE Marking	certified	Certified CE 0473
US Regulations	510(k) Accepted	Applied

Note 1: The stimulator is integrated with the amplifier and controlled by the EMS-XL software – Thus it does not have a separated power supply and battery backup.

Dimensions
System Dimension	Widthcm/inch	Depthcm/inch	Heightcm/inch	Widthcm/ inch	Depthcm/inch	Heightcm/inch
	Workstation (65")			Cart with display
	165/65	76/30	172/77	61/24	61/24	162/64
	Workstation (45")			Consol with display
	114/47	76/30	75/30	90/35	85/33	125/50
	Workstation (Box)
	61/24	71/28	75/30
Amplifier Dimension	32/64 Channel			32 Channel
	36/14	36/14	24/10	29/11	22/9	11/5
	64 channel
				29/11	22/9	22/9

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	Predicated - GE Pruka	Mennen Medical -EMS-XL
Certification
MDD Device Class:	Class IIb	Class IIb
IEC60601-1	certified	certified
EMC compliance	certified	certified
CE Marking	certified	Certified CE 0473
US Regulations	510(k) Accepted	Applied

Note A : The stimulator is integrated with the amplifier and controlled by the EMS-XL software - Thus it does not have a separated power supply and battery backup.

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Rational for claims of equivalence of Mennen Medical EMS-XL amplifier and GE Prucka Plus Amplifier

Subject	Reducedsafety	Is EMS-XL as safe and effective as the Plus Amplifier(Rational)
Note 1-No. ofchannels	No	Assumed equivalence to the 32/64 channel Plus Amplifier and not to the128 channel amplifier
Note 2-Samplingrate	No	Assumed equivalence to the 1 KHz sampling rate. This sampling ratemeets the requirements for clinical practice and sufficiently showsconduction pathway potentials clearly.
Note 3 -ECG HighPass filter	No	Both systems provide 0.05 Hz diagnostic filter that show high fidelityECG. 0.5 Hz (Plus Amplifier) and 0.2 Hz (EMS-XL) provides a fasterresponse to electrode movement, with same QRS detection capability.The EMS-XL 40 and 80 Hz filters yields the best deflection of HRA, HISbundle and ventricle electrocardiogram-
Note 4 -ECG gain	No	The gain of the two systems is equivalent and only uses different terms.The term mm/mVolt used by EMS-XL shows the relation between thesignal amplitude in mVolt and the display amplitude in mm.EMS-XL has continuous gain control that covers the whole gain rangeinstead of the 8 steps of the Plus Amplifier
Note 5 -Number ofchannels	No	Assumed equivalence to the 32/64 channel Plus Amplifier and to 2 of the 4pressure channels. 32/64 channel system is clamed to cover a wide range ofclinical application.
Note 6 -Channelswitching	No	The difference in this switching capability is practically overcome bymanual switching of electrodes between inputs that using the Bipolar input
Note 7 -IECG highpass filter	No	The set of filters provided by EMS-XL provide the necessary filtration fordetection of fast changing intra-cardiac signals and cover the same range offilters of the Plus Amplifier and the changes between 30 and 40, andbetween 80 and 100 are not significant.
Note 8IECG lowpass filter	No	EMS-XL has same 500 Hz filter as the Plus Amplifier.As stated in Note 2, Mennen claims equivalence to the 1 KHz samplingrate. This sampling rate meets the requirements for clinical practice andshows intra-cardiac potential clearly. The low pass filter of 2000Hz is notrelevant for sampling rate of 1 KHz
Note 9Excitationvoltage	No	The important parameter for transducers is the sensitivity, that is5μV/V/mmHg (industry standard), and this is same for both amplifiers
Subject	Reducedsafety	Is EMS-XL as safe and effective as the EPS320(Rational)
Note 10Stimulation current	No	The EMS-XL stimulator and the predicated EPS320 stimulator are both constant current stimulators and cover the same current range with the EMS-XL source is up to 1500 Ω, and EPS320 only 800 ΩThis effects the maximal stimulation voltage.
Note 11-Stimulationincrement	No	The EMS-XL stimulator has increments of 10 mSec that provide easier control than 1 mSec increment of the EPS320.
Note 12-AV delay	No	EPS320 =10-1000+/- 1 msec (maximum ISI - 50 msec)EMS-XL =11 - 250 msec - No clinical significance in usin longer intervals
Note 13No. ofstimuli	No	EMS-XL has S1 and 4 extra stimuli, EPS320 has 6 extra.In almost all clinical applications 4 extra are sufficient to achieve the intended use and diagnostic requirement (none of the EPS320 protocols in Par 10.5 use more than 4)
Note 14SyncOutput	No	The EPS320 uses external sync, to synchronize between the amplifier and the stimulator.The EMS-XL has amplifier and stimulator integrated within the same system and thus external sync is not necessary.
Note 15Stimulatorpower	No	The EMS-XL has integrated amplifiers, stimulator and control software, thus the requirement for separate power supply is irrelevant.The stimulator safety issues are covered by the following precautions:• The system includes an Isolation transformer (see User manual page IX)• Warning in User manual page X requires a defibrillator and external pacer in the EP procedure room• The EMS-XL amplifier and stimulator unit provides fixed rate stimulation in case of a fault of the cable connection of the unit to the computer. (page 2-1 of the user manual)
Note 16	No	Mennen Medical finds that the EPS320 use of the automation for ATP -- Anti-tachycardia protocol, Trigger on ectopic beat and Stop on tachycardia may create a safety burden and thus decided to use the physician decision for these function as provided also on the EPS320
Note 17	No	Warning in EMS-XL User Manual page X requires a backup stimulator to be available in the EP procedure room
Note 18	No	The EMS-XL does not claim to contain an integrated Statistic and Inventory software package as does the GE.Prucka system. Such
		administrative package has no direct use on the EP procedure.
Note 19		The EMS-XL does not claim to have mapping capabilities. DuringEP procedures external devices can be used for mapping.
Note 20		The Prucka provides Vital signs audible indicator. The EMS-XLprovides integrated tachycardia message.For other vital signs the User manual recommends to have anexternal patient monitor.

. .

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Rational for claims of equivalence of Mennen Medical EMS-XL stimulator and Micropace Pty EPS320

·

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Clinical experience

· ।

The EMS-XL system has CE mark since December 2003 and is used by clinics out of the USA

Conclusion:

On the basis of the specification comparison we reach the conclusion that the EMS-XL is as safe, as effective, and performs as well as the predicate device

{21}------------------------------------------------

Image /page/21/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus-like design, with three abstract human profiles facing right, overlaid with three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2007

Mennen Medical Ltd. c/o Mr. Micha Oestereich QA & RA Manager 4 Ha-Yarden St. POB 102 Rehovot Yavne 76100 ISRAEL

Re: K071348

Trade Name: EMS-XL Cardiac Electrophysiology System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: August 29, 2007 Received: September 5, 2007

Dear Mr. Oestereich:

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.

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.

{22}------------------------------------------------

Page 2 - Mr. Micha Oestereich

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Bhimmarfor

Bram B. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K071348

Device Name:_EMS-XL Cardiac Electrophysiology System

Indications For Use:

EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded.

The system allows the user to monitor, display and record the signal data.

The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B.Bumman

16n Sian-Off. scular Devices

Page 1 of 1

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).