(121 days)
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No
The summary mentions digital and analog hardware, firmware, and software, but there is no mention of AI, ML, or related concepts like image processing, deep neural networks (DNNs), or training/test sets which are typically associated with AI/ML device descriptions in 510(k) summaries.
No
The device description indicates it is for "Stress and ECG systems," which are typically diagnostic tools used to measure heart activity and stress responses, not to treat a condition. While physicians use the device, its function as described is for measurement and analysis.
No
Explanation: The device description mentions "Stress and ECG systems," which typically record physiological signals. However, there is no explicit mention that the device interprets these signals to provide a diagnosis of a disease or condition. The "Intended Use / Indications for Use" section is "Not Found," so we cannot confirm any diagnostic purpose. While a physician is mentioned as the "Intended User," this alone does not confirm a diagnostic function for the device itself.
No
The device description explicitly states it contains "digital and analog hardware, associated firmware and software," indicating it is not software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on hardware, firmware, and software for stress and ECG systems. There is no indication of analyzing samples (like blood, urine, or tissue) outside of the body, which is the core characteristic of an IVD.
- Focus on physiological measurement: Stress and ECG systems are used to measure the electrical activity of the heart and its response to stress, which are in vivo (within the living body) measurements.
- Intended Use/Indications for Use is "Not Found": While this is missing, the device description strongly suggests a diagnostic purpose related to cardiac function, not laboratory testing of samples.
- No mention of typical IVD components or processes: There's no mention of reagents, assays, sample preparation, or laboratory settings, which are common in IVD descriptions.
In summary, the description points towards a device used for physiological monitoring and diagnosis performed directly on a patient, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Section 2 - Safety and Effectiveness Information
2.1 Summary of Safety and Effectiveness Information
Safety
Stress and ECG systems can be sources for macroshock and microshock hazards for the patient and the user. Details and protection requirements are explained in 'Medical Instrumentation: Theory and Application:, J.G. Webster, Ch. 13, 1978. These protection requirements are compiled into National and International Safety Standards. The most comprehensive ones are ANSI/AAMI/ES-1 and IEC 601-1 and 2.
For safe use of Stress and ECG systems, labeling and documentation must be complete. Standards for these are also covered in the above mentioned standards and also in ANSI/AAMI EC11-1982.
Effectiveness
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ﻣﺴﺎﺳ
Stress and ECG systems contain digital and analog hardware, associated firmware and software, which must perform effectively, accurately, and reliably. Standards and test methods for the performance of these systems are compiled in detail in ANSVAAMI EC11-1982 and IEC 601-2 and 3.
In addition to these, because of lack of proper user training, problems may arise regarding the following:
(a) Lead placement (Correct positions for electrodes are explained in ECG textbooks such as "Harrison's Principles of Internal Medicine", Eds. R.G. Fetersdorf, R.D. Adams, E. Braunwald, K.J. Isselbacher, J.B. Martin and J.D. Wilson, 100 edition, pp: 1320-21. McGraw Hill, 1983).
(b) Line Interference (A comprehensive reference list for causes and reduction methods for line interference is given in "A new technique for line interference monitoring and reduction in biopotential amplifiers", Y.Z. Ider and H. Koymen, IEEE Trans. Biomedical Engineering, Vol. 37, pp. 624-31, 1990.) 50/60 Hz Notch filters can reduce partially or substantially an problems with line interference.
(c) EMG (myopotential) interference (A low pass filter may be provided as an option as too much muscle interference may be encountered during an ECG or stress recording. Users should be notified continuously when this filter is in use, since low pass filters may affect the diagnostic value of the ECG recording information. The PC ECG 1200 ECG and Stress Electrocardiography System provides such notification on screen.)
(d) Baseline wander (High pass correction filters may be provided as an option as baseline wander may occur during ECG or stress recording. Users should be notified continuously when this filter is used, since baseline wander filters may affect the diagnostic value of the recording. The PC ECG 1200 ECG and Stress Electrocardiography System provides such notification on screen.)
(e) Averaging (In Stress and ECG systems, ST level changes must be accurately measured for each lead and at each exercise step. Due to myopotential, baseline wander and other noise interference, such measurements cannot be reliably made using a single beat. Therefore,
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beats are averaged and measurements are made from average beats to minimize errors. These average beats must be recorded for every exercise step level during stress testing.)
(f) Diagnostic Accuracy (In Stress and ECG systems that measure heart rate, ST values and other ECG parameters, the algorithms used to make such measurements and report trends to the physician influence the quality of information provided to the physician. Testing of the diagnostic accuracy of the ST measurements, QRS detector and VE detector are necessary to evaluate the value of the measurements and trends supplied to the physician for review.)
2.2 Certification:
I certify that we have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the PC ECG 1200 ECG and Stress Electrocarc ു raphy System. I further certify that I am aware of the types of problems to which the PC ECG 1200 ECG and Stress Electrocardiography System is susceptible and that the above summary of the types and causes of safety and/or effectiveness problems about the PC ECG 1200 ECG and Stress Electrocardiography System is complete and accurate
Steve Springrose
Steve Springróse President Biosensor Corporation January 23, 1996