(437 days)
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.
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.
This looks like a 510(k) summary for a medical device called "CardioSmart" from HELLIGE GmbH. This document describes the device, its intended use, and its equivalence to a predicate device.
However, the provided text does not contain the specific acceptance criteria or the study details that prove the device meets those criteria, as requested in the prompt.
The document states that:
- "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 results of these measures demonstrated that CardioSmart is as safe, as effective, and performs as well as the predicate device CARDIOGNOST EK 26."
These statements indicate that performance studies were conducted and the device met certain standards or demonstrated equivalence, but they do not provide the detailed acceptance criteria or the study methodology (like sample size, ground truth, expert qualifications, etc.).
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document is a summary and points to compliance with standards and equivalence, rather than detailing the actual performance study results and acceptance criteria.
{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 GmbHMunzinger Str. 379111 Freiburg, GermanyTelephone +49-761-4534-0Fax +49-761-4543-223Contact person: Mr. Klaus Rudolf |
|---|---|
| Date | February 24, 1995 |
| Device | Trade name: CardioSmartClassification 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
§ 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).