(29 days)
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.
Ambulatory (Holter) ECG intended use:
The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.
-
Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
-
Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
-
Evaluation of patients for ST segment changes.
-
Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
-
Clinical and epidemiological research studies.
-
- Evaluation of patients with pacemakers
-
- Reporting of time and frequency domain heart rate variability
- Reporting of QT Interval
The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).
| Attribute | DigiTrakPlus | Model #1005 |
|---|---|---|
| Storage capacity | Up to 48 hours | 24 hours |
| Memory type | Flash (non-volatile) | Flash (non-volatile) |
| Memory portability | Non-removable | Non-removable |
| On-board ECG analysis | No | Yes |
| Liquid Crystal Display (LCD) | Yes | No |
| Data transfer method | USB port | Bi-directional parallel I/O |
| Pacemaker detection & reporting | Yes | Yes |
| Belt clip | Yes | No |
| Battery | One AA | Four AA |
| Size | 8.5 x 6.5 x 2 cm | 15 x 6 x 2 cm |
| Weight | 100 g | 140 g |
The provided text does not contain detailed information regarding acceptance criteria for device performance, nor a study proving the device meets said criteria in the format requested. The document is a 510(k) summary for a medical device (DigiTrakPlus Holter Recorder) indicating its substantial equivalence to a predicate device.
The summary focuses on:
- Modification Background: Changes to the device (smaller hardware, reduced power, removal of on-board ECG analysis) and validation of pacemaker detection logic.
- Comparison to Predicate Device (Model #1005): A table outlining differences in physical attributes and features.
- Regulatory Information: FDA’s determination of substantial equivalence and related regulatory details.
- Indications for Use: The intended applications for the Holter recorder.
Therefore, I cannot populate the table and answer the study-related questions as the information is not present in the provided text.
Specifically, the text is missing:
- A table of acceptance criteria and reported device performance: While a comparison table to the predicate is given, it lists product attributes, not performance metrics against acceptance criteria.
- Sample size used for the test set and data provenance: No information about a test set is provided.
- Number of experts used to establish ground truth and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned, and the device doesn't perform AI-assisted analysis.
- Standalone performance (algorithm only): The device's on-board ECG analysis was removed. While "pacemaker detection logic has been modified slightly, and its performance validated," no specific performance metrics or standalone study details are given.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
The document states that the "methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein." However, the "reporting herein" refers to an attached document that is not provided.
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).