CARDIOSOFT/CARDIOSYS

K951130 · Marquette Electronics, Inc. · LOS · Apr 4, 1996 · CV

Device Facts

• Record ID: K951130
• Device Name: CARDIOSOFT/CARDIOSYS
• Applicant: Marquette Electronics, Inc.
• Product Code: LOS · CV
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Attributes: Software as a Medical Device

Intended Use

CardioSoft / CardioSys are intended to be used in resting ECG, emergency- and stress-test departments to record, archive and disseminate ECG information. They are intended to be used by trained operators under the direct supervision of a physician when ECG records are required in the judgement of a physician. The arrhythmia detection portion of the CardioSoft / CardioSys stress test system is provided to the user for the convenience of automatic documentation. The CardioSoft / CardioSys offers no diagnostic opinion to the user. Instead, it provides a high fidelity instrument recording ECG waveforms during exercise, for the purpose of providing the operator with a tool to expedite the documentation of a test for which he/she renders his/her own medical opinion. They are not designed for intracardial use. They are not designed to provide alarms for arrhythmia and ST-segment measurement. The devices are not intended for home use.

Device Story

ECG data acquisition and recording system; records resting ECGs and stress test examinations; measures and interprets ECGs. Operates in clinical settings (resting ECG, emergency, stress-test departments) by trained operators under physician supervision. Inputs: ECG waveforms. Outputs: ECG recordings and documentation. Arrhythmia detection feature provides automatic documentation for operator convenience; no diagnostic opinion provided. System facilitates clinical decision-making by providing high-fidelity waveforms for physician review. Benefits: expedites test documentation.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1, IEC 601-1-1, IEC 601-1-2, and IEC 601-2-25. Quality assurance included requirements specification, design reviews, code inspections, software/hardware testing, safety/environmental testing, final validation by independent group, and field tests.

Technological Characteristics

ECG acquisition system. Standards: ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-2-25. Uses commercially available hardware and system software. Software functionality reused from predicate device.

Indications for Use

Indicated for patients requiring resting ECG or stress test examinations in clinical settings. Not for intracardial use or home use.

Predicate Devices

• HELLIGE CARDIOGNOST EK 512

Submission Summary (Full Text)

{0}

6 | K951130
HELLIGE
K95130 APR - 4 1995

HELLIGE GMBH · Postfach 728 · D-79007 Freiburg i. Br.

HELLIGE GMBH
Munzinger Str. 3
D-79111 Freiburg im Breisgau
Germany
Phone [phone]
Telex 7 72 705

## Section 2 - Summary & Certification

Date 03-09-1995

### 2.1 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

**Submitter**
HELLIGE GmbH
Munzinger Str. 3
79111 Freiburg, Germany
Telephone [phone]
Fax [phone]
Contact person: Mr. Klaus Rudolf

**Device**
Trade name: CardioSoft / CardioSys
Classification name: Electrocardiograph; Detector and Alarm, Arrhythmia

**Predicate Device**
HELLIGE CARDIOGNOST EK 512

**Device Description**
CardioSoft / CardioSys is an ECG data acquisition and recording system designed and manufactured by HELLIGE GmbH.

CardioSoft / CardioSys allows to
- record resting ECGs,
- run stress test examinations,
- measure and interprete the ECGs.

**Intended Use**
CardioSoft / CardioSys are intended to be used in resting ECG, emergency- and stress-test departments to record, archive and disseminate ECG information.

- They are intended to be used by trained operators under the direct supervision of a physician when ECG records are required in the judgement of a physician.

Commerzbank AG Freiburg BLZ 680 400 07 Kto.-Nr. 1400050/00
Dresdner Bank AG Freiburg BLZ 680 800 30 Kto.-Nr. 4012483/00
Sparkasse Freiburg BLZ 680 501 01 Kto.-Nr. 2006796
Volksbank Freiburg BLZ 680 900 00 Kto.-Nr. 12191200
Postbank Karlsruhe BLZ 660 100 75 Kto.-Nr. 52061-754
Landeszentralbank Freiburg BLZ 680 000 00 Kto.-Nr. 68007254
Chairman of the board of directors:
Peter P. Tong
Managing director: Karl F. Braun
HRB 3093 Freiburg im Breisgau

{1}

7
# HELLIGE

- The arrhythmia detection portion of the CardioSoft / CardioSys stress test system is provided to the user for the convenience of automatic documentation. The CardioSoft / CardioSys offers no diagnostic opinion to the user. Instead, it provides a high fidelity instrument recording ECG waveforms during exercise, for the purpose of providing the operator with a tool to expedite the documentation of a test for which he/she renders his/her own medical opinion.
- They are not designed for intracardial use.
- They are not designed to provide alarms for arrhythmia and ST-segment measurement.
- The devices are not intended for home use.

The intended use of CardioSoft / CardioSys does not differ from the intended use of the predicate device.

## Technology

CardioSoft / CardioSys basically employ the same technology as the predicate device.

All parts of the software which determine the medical functionality of the device have been re-used from the predicate device.

The main difference between CardioSoft / CardioSys and the predicate device is that commercially available hardware and system software are used instead of proprietary hardware and software.

## Performance

CardioSoft / CardioSys comply with the voluntary standard ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1, IEC 601-1-1, IEC 601-1-2 and IEC 601-2-25.

CardioSoft and CardioSys passed the EC type-examination and thus bear the CE mark.

The following quality assurance measures were applied to the development of CardioSoft / CardioSys:

Requirements specification and design reviews, code inspections, software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group, field tests.

The results of these measures demonstrated that CardioSoft / CardioSys are as safe, as effective, and perform as well as the predicate device CARDIOGNOST EK 512.

Signature: *Wano M. Doly*
Date: *March 9, 1995*
Name: Klaus Rudolf, Manager Regulatory Affairs

510(k) Notification "CardioSoft / CardioSys" - March 09 1995