(99 days)
The CardioPAL A1 with Diogenes SV (CardioPal SV) Model PM410, is a pager-sized, hand-held or patient worn device designed specifically to record and transmit ambulatory ECG signals. The device can be worn for days or weeks, as it is intended for use by patients who are experiencing symptoms that are transient and infrequent in nature.
The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, is a small, auto triggered, hand-held device, prescribed by physicians for patients who are experiencing symptoms that may be attributable to cardiac arrhythmia. Shortness of breath and palpitations are examples of these symptoms. This device may be worn for a period of days or weeks – whatever time is necessary to capture and record the ECG.
The device consists of the CardioPAL SV event monitor and patient cable. The device can be used with accessories, including a belt clip, lanyard, and PC interface cable.
This 510(k) summary does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Instead, it is a submission for a new device, the CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410, seeking clearance based on substantial equivalence to a predicate device (CardioPAL Model PM20).
Here's why the requested information is absent:
- Acceptance Criteria and Device Performance: The document does not define specific performance metrics or acceptance criteria for the new device's functionality (e.g., arrhythmia detection accuracy, sensitivity, specificity). It focuses on comparing features with the predicate and stating that non-clinical tests (IEC standards, environmental, software validation) were performed.
- Study Proving Acceptance Criteria: Since no acceptance criteria are explicitly stated, there is no study described that "proves the device meets the acceptance criteria."
- Clinical Tests: Section 8 explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This means no clinical study was conducted to evaluate the device's diagnostic performance, including elements like sample size, data provenance, expert ground truth, adjudication, MRMC studies, or standalone performance.
- Ground Truth (for test or training sets): There is no mention of ground truth establishment for any test or training set because no clinical or performance study involving diagnostic accuracy is discussed.
- Training Set Sample Size/Ground Truth: As there's no mention of a clinical or performance study, there's no information about a training set or how its ground truth might have been established.
What the document does provide:
- Device Description and Intended Use: The CardioPAL AI with Diogenes SV (CardioPAL SV) Model PM410 is a small, auto-triggered, hand-held device for recording and transmitting ambulatory ECG signals in patients with transient, infrequent symptoms of cardiac arrhythmia.
- Comparison to Predicate: It highlights differences from the predicate device (CardioPAL PM20), notably the addition of "On Board Analysis" in the subject device, different ECG input options, an LCD user interface, and USB PC interface.
- Non-Clinical Tests: Stated that testing included IEC 60601-1, IEC 60601-1-2, and environmental and software validation testing, derived from a risk assessment. This type of testing focuses on electrical safety, EMC, and software reliability, not diagnostic performance.
- Conclusion: The submission concludes that the new device is substantially equivalent to the predicate because its indications for use are the same, and bench testing demonstrated no differences in technological characteristics that would raise new safety or effectiveness issues. The "On Board Analysis" feature is a significant difference highlighted in the comparison chart, but its performance is not detailed or validated in this submission.
In summary, this 510(k) summary is for a device based on substantial equivalence, and it explicitly states that clinical tests were "Not Applicable." Therefore, it does not include the details about acceptance criteria, clinical study results, ground truth, or expert involvement that your prompt requested.
§ 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).