(437 days)
HELLIGE CARDIOGNOST EK 56
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ECG recording and interpretation, not advanced AI/ML features.
No
Explanation: The device is intended for recording and interpreting ECGs, not for providing therapy. It explicitly states it provides no diagnostic opinion and does not provide alarms for arrhythmia detection, nor is it intended for use as a vital signs physiological monitor.
No
The device description explicitly states, "CardioSmart offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion." This indicates that while it provides data and interpretive statements, it does not provide a definitive diagnosis.
No
The device description explicitly states "CardioSmart is a portable ECG data acquisition and recording system designed and manufactured by HELLIGE GmbH." This indicates it includes hardware for data acquisition, not just software.
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 description of CardioSmart clearly states it's an ECG data acquisition and recording system that records resting ECGs and measures and interprets them. This involves directly measuring electrical activity of the body, not analyzing samples taken from the body.
- The intended use is for recording and interpreting ECGs, which is a physiological measurement. This falls under the category of medical devices that measure physiological signals, not IVDs.
The description focuses on the device's function in acquiring and processing electrical signals from the heart, which is characteristic of an ECG device, not an IVD.
N/A
Intended Use / Indications for 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.
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.
Product codes
ECG, DRG
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 interprete the ECGs.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
CardioSmart is intended to be used by trained operators when ECG records are required in the judgement of a physician.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 CardioSmart is as safe, as effective, and performs as well as the predicate device CARDIOGNOST EK 26.
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 56
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2340 Electrocardiograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
HELLIGE
HELLIGE GMBH · Postfach 728 · D-79007 Freiburg i. Br.
6
Sparkasse Freiburg
Volksbank Freiburg
Postbank Karlsruhe
Landeszentralbank Freiburg
01 168 UBS Z 18
00 006 000 00
BLZ 660 100 75
000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
MAY 1 3 1996
HELLIGE GMBH Munzinger Str. 3 D-79111 Freiburg im Breisgau Germany Phone (0761) 4543-0 Telex 7 72 705
Section 2 - Summary & Certification
Date 02-24-1995
510(k) Summary of Safety and Effectiveness 2.1
This summary of 510(k) safety and effectiveness nformation is being submitted in accordance with the requirements of SMDA 1990 and 21 CFF 807.92.
| Submitter | HELLIGE GmbH
Munzinger Str. 3
79111 Freiburg, Germany
Telephone +49-761-4534-0
Fax +49-761-4543-223
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 interprete 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 |
Kto.-Nr. 2006796
Kto.-Nr. 12191200
Kto.-Nr. 52061-754
Kto.-Nr. 6800735
ard of directors: Managing director: Karl F. Braun HRB 3093 Freiburg im Breisgau
1
HELLIG
CardioSmart does not provide alarms for arrhythmia detection.
- -CardioSmart is not intended for use as a vital signs physiological monitor.
- ı 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 cetermine 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 disp ays with 3 traces, i
- 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 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 CardioSmart is as safe, as effective, and performs as well as the predicate device CARDIOGNOST EK 26.
Signature:
Whaas Puddy
Date: 24. Febr. 1855
Name:
Klaus Rudolf. Manager Regulatory Affairs
510(k) Notification 'CardioSmart'' - Febr 24 1995