K Number

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

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K993414, K011826

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on signal acquisition, display, storage, basic measurements (calipers), and controlled stimulation. There is no mention of algorithms that learn from data or perform complex pattern recognition beyond basic auto-detection of tachycardia, which is a common rule-based function in these systems.

Therapeutic

No.
The device is primarily for acquiring, monitoring, displaying, and recording electrical signals and derived physiological parameters for diagnostic purposes during electrophysiological studies. While it includes a stimulator for diagnostic cardiac stimulation, its main function is data acquisition and analysis, not therapy.

Diagnostic

Yes

The device's intended use explicitly states: "The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart." Additionally, it performs various analyses to derive physiological parameters and supports procedures like His bundle recording and SNRT, which are diagnostic in nature for cardiac electrophysiology.

SaMD (Software as a Medical Device)

The device description explicitly states that the system consists of hardware components including a multichannel amplifier, stimulator, computer, display screens, and a printer, in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, the EMS-XL device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The intended use and device description clearly state that the EMS-XL acquires electrical signals from the patient's heart (ECG, direct cardiac signals, pressure recordings) and uses a stimulator for diagnostic cardiac stimulation. This is a direct interaction with the patient's body, not the analysis of a sample taken from the body.
The device is used in an electrophysiological laboratory for procedures conducted on the patient. The description details procedures like His bundle recording, SNRT, Overdrive, etc., which are performed directly on the patient.
The device's function is to acquire, process, and display physiological signals and provide stimulation. This is characteristic of a medical device used for monitoring, diagnosis, and treatment planning based on real-time physiological data, not the analysis of a biological sample.

Therefore, the EMS-XL falls under the category of a medical device used for in-vivo (within the living body) procedures, not an in-vitro (in glass, i.e., outside the living body) diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DQK

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.

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

Prescription Use under the supervision of a physician

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparison of Specifications: The submission provides comparative tables for Amplifier Specifications, Stimulator Specifications, and System Features between the EMS-XL and its predicate devices (Cardiolab EP system and Micropace model EPS 320). The rationale for claiming equivalence despite differences is provided in notes.
Key Results: The comparison indicates that the EMS-XL is as safe, as effective, and performs as well as the predicate devices, with some differences in features (e.g., specific filter settings, number of extra stimuli, level of automation) that are justified as not impacting safety or effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K993414, K011826

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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:	+972-8-9323333
Fax:	+972-8-9328510
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. -

Device description