(184 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes standard ECG measurement and interpretation, not AI/ML-driven analysis.
No.
The device is used for acquiring and recording ECG data, measuring and interpreting ECGs, and performing stress tests; it does not provide any therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states "CardioSmart ST 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 the device itself does not provide a diagnosis.
No
The device description explicitly states that CardioSmart ST is a "portable ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH," indicating it includes hardware components for data acquisition.
Based on the provided information, the CardioSmart ST is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- The CardioSmart ST is an ECG system. ECGs measure the electrical activity of the heart directly from the body's surface using electrodes. It's a physiological measurement, not an analysis of a biological sample.
The description clearly states its purpose is for recording and interpreting ECGs for resting and stress tests, which are in-vivo procedures.
N/A
Intended Use / Indications for Use
CardioSmart ST is intended to be used for resting and stress test ECG and for recording ECG in real-time without arrhythmia detection. CardioSmart ST is intended to be used by trained operators when ECG records are required in the judgement of a physician. CardioSmart ST is not intended for use as a vital signs physiological monitor. CardioSmart ST offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion. CardioSmart ST is not designed for intracardial use. CardioSmart ST is not intended for home use.
Product codes
74 LOS
Device Description
CardioSmart ST is a portable ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH. CardioSmart ST allows the user to record resting ECGs, measure and interpret the ECGs, and perform ECG stress tests.
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 / Not Found
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)
Performance & Conclusion CardioSmart ST complies with the following standards: ANSI/AAMI EC11-1991, ANSI/AAMI ES1-1993, IEC 601-1, IEC 601-1-2 and IEC 601-2-25. CardioSmart ST passed the EC type-examination and thus bears the CE mark. The following quality assurance measures were applied to the development of CardioSmart ST: Requirements specification and design reviews, code inspections, software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group. The results of these measures demonstrated that CardioSmart ST is as safe, as effective, and performs as well as the predicate devices CardioSmart, CardioSys, and Responder 1500.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary of Safety and Effectiveness
Date
September 2, 1997
MAR 1 2 1998
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.
Marquette Medical Systems Submitter 8200 West Tower Avenue Milwaukee, WI 53223 USA
Contact Person Dianne Schmitz Corporate Regulatory Affairs Marquette Medical Systems
Phone: (414)362-3230
Common / Usual Device NameElectrocardiograph
Trade / Proprietary Device Name CardioSmart ST
Classification Name(s)
The classification names, classification panels, and regulation citations include the following:
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Legally Marketed Predicate Devices
The CardioSmart ST, is substantially equivalent to devices already in legal commercial distribution. These predicate devices include:
| Marquette Hellige CardioSmart | K950989 |
|---|---|
| Marquette Hellige CardioSys | K951130 |
| Marquette Responder 1500 | K903644 |
Device Description CardioSmart ST is a portable ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH.
CardioSmart ST allows the user to
- record resting ECGs,
- i measure and interpret the ECGs,
- perform ECG stress tests. ,
Intended Use
CardioSmart ST is intended to be used for resting and stress test
00005
1
ECG and for recording ECG in real-time without arrhythmia detection.
- CardioSmart ST is intended to be used by trained operators । when ECG records are required in the iudgment of a physician.
- CardioSmart ST is not intended for use as a vital signs । physiological monitor.
- CardioSmart ST offers no diagnostic opinion to the user. Instead, . it provides interpretive statements for which the physician renders his/her own medical opinion.
- CardioSmart ST is not designed for intracardial use. ..
- CardioSmart ST is not intended for home use. ﮯ
The intended use of CardioSmart ST is a subset of the intended use of the predicate devices.
The CardioSmart ST hardware architecture is identical to the Technology predicate device CardioSmart.
All parts of the software which determine the medical functionality of the CardioSmart ST were re-used from the predicate devices.
Performance & Conclusion CardioSmart ST complies with the following standards:
ANSI/AAMI EC11-1991, ANSI/AAMI ES1-1993, IEC 601-1, IEC 601-1-2 and IEC 601-2-25.
CardioSmart ST passed the EC type-examination and thus bears the CE mark.
The following quality assurance measures were applied to the development of CardioSmart ST:
Requirements specification and design reviews, code inspections, software and hardware testing, safety testing, environmental testing, final validation testing by an independent test group.
The results of these measures demonstrated that CardioSmart ST is as safe, as effective, and performs as well as the predicate devices CardioSmart, CardioSys, and Responder 1500.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1998
Ms. Dianne Schmitz Marquette Medical Systems 8200 West Tower Avenue Milwaukee, WI 53223
Re: K973403 CardioSmart ST Requlatory Class: III (three) Product Code: 74 LOS Dated: December 19, 1997 Received: December 22, 1997
Dear Ms. Schmitz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Dianne Schmitz
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your dev`ice to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K973403: 510(k) filed September 5, 1997 510(k) Number:
Device Name: CardioSmart ST
Indications For Use:
CardioSmart ST is an ECG data acquisition and recording system designed and manufactured by Marquette Hellige GmbH.
CardioSmart ST is intended to be used for resting ECG and stress test ECG and for recording ECG in real-time without arrhythmia detection. It is intended to be used by trained operators when ECG records are required in the judgement of a physician.
ECG may be interpreted by optionally available analysis program. CardioSmart ST offers no diagnostic opinion to the user. Instead, it provides interpretive statements for which the physician renders his/her own medical opinion.
CardioSmart ST is not intended for use as a vital signs physiological monitor.
CardioSmart ST is not designed for intracardial use.
CardioSmart ST is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
M. Rugh
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K973403 -510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)