(94 days)
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients:
l ) suspected of cardiac abnormalities, or
2) in populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics are desired.
3) OT Analysis is useful in the assessment of long QT syndrome (LQTS). In some instances, LQTS can be corrected by pharmacologic therary. QT analysis is also used to measure QT dispersion, the difference between maximal and minimal QT values. QT dispersion is a measure of the inhomogeneity of ventricular repolarization. 4) The PC ECG 1200W System has been tested to measure Heart Rate Variability within 1 millisecond tolcrance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
5) The PC ECG 1200W System has been tested to measure Latc Potential within 1 millisecond tolerance in the time domain, and I microvolt tolerance in voltage. The clinical significance of Heart Rate Variability measures should be determined by a physician.
Stress testing intended use:
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemia, indicative of a reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of ischemic heart disease if characteristic changes are present. Stress testing is the most widely used method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary artery disease. In stress testing, the contractile capability of the heart muscle is monitored via ECG during patient exercise. Patients are exercised by bicycle, treadmill, or other means while continuously monitoring the ECG. Exercise loads are determined by predefined protocols. The ECG signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The changes in ECG waveforms are compared to the resting ECG records. Although not necessary, most of the commercial stress test systems control the bicycle or treadmill automatically according to the requirements of the chosen protocol.
ST segment monitoring is intended as an aid in the evaluation of myocardial ischemia in patients with known or suspected coronary artery disease. The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing. The significance of the ST segment changes must be determined by a physician.
The PC ECG 1200W System is designed to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. The System comprises:
- · PCECG 1200W data acquisition unit
- · PCECG 1200WR RF transceiver
- · USB communications cable
- · Software application
- · Software security lock (dongle) for access to stress testing functions (optional)
The NORAV PC ECG 1200W System is substantially equivalent to the predicate device, Norav's PC ECG 1200 K000404, with the primary difference being the addition of wireless data communication capabilities. The submission primarily focuses on the device's technical specifications and intended use, asserting its safety and reliability based on similarity to the predicate and adherence to recognized standards.
Here's an analysis of the provided information regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the device's intended functionality and accuracy in certain measurements, but it does not explicitly state specific pass/fail acceptance criteria in a quantitative manner for most functions. Instead, it makes claims of the device's capabilities and how it has been tested.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| ECG intended to disclose normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value. | "ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value..." (Indication of intended capability rather than a performance metric against a specific threshold) |
| Heart Rate Variability analysis accuracy | "The PC ECG 1200W System has been tested to measure Heart Rate Variability within 1 millisecond tolerance." |
| Late Potential analysis accuracy (time domain) | "The PC ECG 1200W System has been tested to measure Late Potential within 1 millisecond tolerance in the time domain..." |
| Late Potential analysis accuracy (voltage) | "...and 1 microvolt tolerance in voltage." |
| ST segment algorithm accuracy for myocardial ischemia evaluation | "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing." (No specific numerical accuracy or tolerance is given, only that it has been tested for accuracy.) |
| Safety and reliability | "PC ECG 1200W System constitutes a safe and reliable medical device. Similarly to the predicate devices, the System operation presents no adverse health effect or safety risks to patients when used as intended." (Qualitative statement based on adherence to standards and similarity to predicate, rather than specific performance metrics from a study.) |
| Compliance with wireless communication standards (Wireless capability is the primary difference from predicate) | The device uses wireless data communication. The document references several EMC and Radio spectrum standards (e.g., EN301 489-1, EN301 489-3, EN300 440) which would imply compliance with these as acceptance criteria for its wireless functionality, but no specific performance results related to wireless communication (e.g., range, data integrity, latency) are provided, only that the capability exists and the standards are relevant. |
| Functional equivalence to predicate device (K000404) | "PC ECG 1200W System is identical to the predicate device in all features, functions and specifications except its capability of wireless data communication." and "The clearance for the PC ECG 1200W System is sought on the grounds of its claimed substantial equivalence (SE) to Norav's PC ECG 1200 K000404 for complete physical and functional identity except the capability of wireless data communication." (This is a foundational claim for the 510(k) process, implying verification through comparison and testing, though specific comparative test results or criteria are not detailed in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions that for the ST segment algorithm, "a database has been used as a tool for performance testing." However, no specific sample size for this database or any other test set is provided.
- Data Provenance: Not specified. It does not mention the country of origin, nor whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The document states that "The significance of the ST segment changes must be determined by a physician," but it does not detail how ground truth was established for the performance testing database.
4. Adjudication Method for the Test Set:
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC comparative effectiveness study was not mentioned or implied in the provided summary. The submission focuses on device equivalence and performance claims rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
- The claims regarding Heart Rate Variability ("within 1 millisecond tolerance") and Late Potential analysis ("within 1 millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage") appear to relate to the standalone performance of the device's algorithms or measurement capabilities.
- Similarly, the statement that "The ST segment algorithm has been tested for accuracy of the ST segment data, and a database has been used as a tool for performance testing" indicates a standalone algorithmic test.
- However, specific metrics or a detailed study of standalone performance results (e.g., sensitivity, specificity, AUC) are not explicitly provided beyond the tolerance statements for HRV and Late Potential.
7. Type of Ground Truth Used:
- For Heart Rate Variability and Late Potential analysis, the "tolerance" statements imply the device's measurements were compared against a reference standard for accuracy, which would constitute the ground truth. However, the nature of this reference standard (e.g., a gold standard measurement, expert-derived ground truth) is not specified.
- For the ST segment algorithm, it states a "database has been used as a tool for performance testing." The ground truth for this database to assess "accuracy" of ST segment data is not explicitly stated (e.g., expert consensus, pathology, follow-up outcomes). The "significance of the ST segment changes must be determined by a physician" suggests clinical interpretation is ultimately required.
8. Sample Size for the Training Set:
- This information is not provided in the document. The document refers to "testing" with a database but does not distinguish between training and test sets.
9. How the Ground Truth for the Training Set Was Established:
- As no information about a training set is provided, the method for establishing its ground truth is also not mentioned.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).