CARDIOSMART

K950989 · Hellige GmbH · DPS · May 13, 1996 · Cardiovascular

Device Facts

• Record ID: K950989
• Device Name: CARDIOSMART
• Applicant: Hellige GmbH
• Product Code: DPS · Cardiovascular
• Decision Date: May 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

CardioSmart is intended to be used for resting ECG and for recording ECG in realtime with and without arrhythmia detection. CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician. The arrhythmia detection portion of CardioSmart is provided to the user for the convenience of automatic documentation.

Device Story

CardioSmart is a portable ECG data acquisition and recording system. It records resting ECGs and real-time ECGs; performs arrhythmia detection for automatic documentation. Operated by trained personnel in clinical settings; not for home use or vital signs monitoring. Device provides interpretive statements; physician renders final medical opinion. Output used for clinical decision-making regarding cardiac status. Device lacks stress test functionality compared to predicate; includes graphics display with 3 traces, B4 paper format, and ECG storage.

Clinical Evidence

No clinical trial data provided. Evidence based on bench testing, design reviews, code inspections, software/hardware testing, safety/environmental testing, and final validation by an independent test group. Compliance with ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1, IEC 601-1-2, and IEC 601-2-25 standards confirmed.

Technological Characteristics

Portable ECG acquisition system. Features 3-trace graphics display, B4 paper printer, and ECG storage. Complies with ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1, IEC 601-1-2, and IEC 601-2-25. Software functionality reused from predicate device.

Indications for Use

Indicated for patients requiring resting ECG or real-time ECG recording. Intended for use by trained operators in clinical settings. Not for home use, not for vital signs monitoring, and not for intracardial use.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• HELLIGE CARDIOGNOST EK 56

Submission Summary (Full Text)

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HELLIGE

k950989

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

MAY 13 1995

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

## Section 2 - Summary & Certification

Date 02-24-1995

## 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 |
| --- | --- |

Date February 24, 1995

| Device | Trade name: | CardioSmart |
| --- | --- | --- |
| | Classification name: | Electrocardiograph;
Detector and Alarm, Arrhythmia |

Predicate Device HELLIGE CARDIOGNOST EK 56

Device Description CardioSmart is a portable ECG data acquisition and recording system designed and manufactured by HELLIGE GmbH.

CardioSmart allows to
- record resting ECGs,
- measure and interpret the ECGs.

Intended Use CardioSmart is intended to be used for resting ECG and for recording ECG in realtime with and without arrhythmia detection.

- CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician.
- The arrhythmia detection portion of CardioSmart is provided to the user for the convenience of automatic documentation.

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. 6800735

Chairman of the board of directors:
Peter P. Tong
Managing director: Karl F. Braun
HRB 3093 Freiburg im Breisgau

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# HELLIGE

CardioSmart does not provide alarms for arrhythmia detection.
- CardioSmart is not intended for use as a vital signs physiological monitor.
- CardioSmart offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion.
- CardioSmart is not designed for intracardial use.
- CardioSmart is not intended for home use.

The intended use of CardioSmart is a subset of the intended use of the predicate device. CardioSmart is a low cost alternative for all users who are not required to perform stress test ECGs.

## Technology

CardioSmart basically employs the same technology as the predicate device.
All parts of the software which determine the medical functionality of the device were re-used from the predicate device.
The main differences between CardioSmart and the predicate device are
- lack of stress test,
- availability of a graphics displays with 3 traces,
- paper format B4,
- ECG storage function.

## Performance / Standards

CardioSmart complies with the voluntary standards ANSI/AAMI EC11-1991, ANSI/AAMI ECAR-1987, IEC 601-1, IEC 601-1-2 and IEC 601-2-25.
CardioSmart passed the EC type-examination and thus bears the CE mark.

The following quality assurance measures were applied to the development of CardioSmart:
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 CardioSmart is as safe, as effective, and performs as well as the predicate device CARDIOGNOST EK 56.

Signature: Klaus Rudolf
Date: 24. Feb. 1995

Name: Klaus Rudolf, Manager Regulatory Affairs

510(k) Notification "CardioSmart" - Febr 24 1995