(388 days)
HELLIGE CARDIOGNOST EK 512
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its functions do not indicate the use of AI/ML. The arrhythmia detection is described as "automatic documentation" and not a diagnostic opinion.
No
The device is used to record, archive, and disseminate ECG information for diagnostic purposes, not to treat a medical condition.
No
The device description states that the system can "measure and interpret the ECGs," and the intended use section explicitly says, "The CardioSoft / CardioSys offers no diagnostic opinion to the user." While it provides data for interpretation, it does not provide a diagnosis.
No
The device description explicitly states "CardioSoft / CardioSys is an ECG data acquisition and recording system designed and manufactured by HELLIGE GmbH." and mentions "software and hardware testing". This indicates the device includes hardware components for ECG data acquisition, making it a hardware-software system, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The CardioSoft / CardioSys system records and analyzes electrical signals from the heart on the body (ECG).
- The intended use clearly describes recording and analyzing ECG waveforms. This is a physiological measurement, not an analysis of a biological sample.
- There is no mention of analyzing biological samples. The description focuses on ECG data acquisition, recording, measurement, and interpretation.
Therefore, the CardioSoft / CardioSys is a medical device, specifically an ECG system, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operators under the direct supervision of a physician / resting ECG, emergency- and stress-test departments
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)
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 spefication 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
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.
HELLIGE CARDIOGNOST EK 512
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
Not Found
N/A
0
HELLIGE
K951130 APR - 4 1996
HELLIGE GMBH · Postfach 728 · D-79007 Freiburg i. Br.
6
HELLIGE GMBH Munzinger Str. 3 D-79111 Freiburg im Breisgau Germany Phone (0761) 4543-0 Telex 7 72 705
Section 2 - Summary & Certification
Date 03-09-1995
510(k) Summary of Safety and Effectiveness 2.1
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
Fax
Contact person: | +49-761-4543-0
+49-761-4543-223
Mr. Klaus Rudolf |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Device | Trade name:
Classification name: | CardioSoft / CardioSys
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. 60007254 |
1
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 spefication 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:
Maro Prdory
Date: March 9, 1935
Name:
Klaus Rudolf, Manager Regulatory Affairs
510(k) Notification 'CardioSoft / CardioSys'' - March 09 1995