← Product Code [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS) · K950989 # CARDIOSMART (K950989) _Hellige GmbH · DPS · May 13, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K950989 ## Device Facts - **Applicant:** Hellige GmbH - **Product Code:** [DPS](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS.md) - **Decision Date:** May 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2340 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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. ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 6 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 (0761) 4543-0 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 +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 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 {1} 7 # 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K950989](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DPS/K950989) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com