(11 days)
The M3810A Philips TeleMonitoring System with M3812B TeleStation is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
The M3810A Philips TeleMonitoring System with M3812B TeleStation is intended to be used upon prescription by a licensed physcian or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines, between a patient, typically at home, and a healthcare professional at the authorized provider. Apart from the convenience features added for enhanced interaction, and blood glucose meter data transmission, that is the same intended use as previously cleared for the M3810A Interactive Health System
The M3810A Philips TeleMonitoring System with M3812B TeleStation underwent verification and validation testing to establish its performance and reliability characteristics. The acceptance criteria for these tests were based on the specifications cleared for the predicate device (K993169, cleared September 22, 1999).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the testing conducted in general terms, stating that "Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, it does not provide a specific table detailing the acceptance criteria for each measured parameter (e.g., accuracy for blood pressure, ECG, weight) nor the quantitative reported device performance against those criteria.
The modifications primarily involve adding functionality for glucose meter downloads and subjective questions (automated interactions). Therefore, it can be inferred that the performance of the core physiological measurements (weight, blood pressure, non-diagnostic ECG) was expected to be equivalent to the predicate device.
| Measurement/Functionality | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|---|
| Core Physiological Measurements: | ||
| Weight | Equivalent to predicate device K993169 specifications | Substantially equivalent to predicate device |
| Blood Pressure | Equivalent to predicate device K993169 specifications | Substantially equivalent to predicate device |
| Non-diagnostic ECG | Equivalent to predicate device K993169 specifications | Substantially equivalent to predicate device |
| New Functionality: | ||
| Glucose Meter Downloads | Successful and accurate data transmission | Demonstrated to function as intended |
| Subjective Questions (Automated Interactions) | Correct operation and recording of responses | Demonstrated to function as intended |
| General Device Performance: | ||
| Biocompatibility | Met established safety standards | Passed laboratory studies |
| Electrical Safety | Met established safety standards | Passed laboratory studies |
| EMC (Electromagnetic Compatibility) | Met established safety standards | Passed laboratory studies |
| Radio Telemetry | Reliable and effective wireless communication | Passed laboratory studies |
| Consumer Accuracy (User Evaluation) | Met intended accuracy for home use | Passed user evaluations |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "laboratory studies" and "user evaluations for consumer accuracy" without specifying the sample sizes for these tests. It also does not explicitly state the data provenance (e.g., country of origin or whether data was retrospective or prospective). Given the nature of a Special 510(k) for a device modification, it's likely that a mix of prospective performance testing for new features and re-validation of existing features was conducted. The lack of detail suggests these were internal validation studies rather than a large-scale clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth. For a device like this, ground truth would typically involve:
- For blood pressure: Comparison against a reference standard (e.g., mercury sphygmomanometer) as read by trained clinicians.
- For weight: Comparison against a calibrated reference scale.
- For ECG: Comparison against simultaneously acquired, higher-fidelity ECGs interpreted by cardiologists or electrophysiologists (though the ECG here is "non-diagnostic").
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method. Considering the description of "laboratory studies" and "user evaluations," it's more probable that direct comparisons to reference instrumentation or expert assessments were made, rather than a multi-reader adjudication process typically associated with diagnostic image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done or reported. The modifications are related to data transmission and interaction, not advanced diagnostic interpretation requiring human-in-the-loop performance evaluation for improved diagnostic accuracy. The device is for "collect[ing] and transmit[ting] medical information," and the ECG is explicitly "non-diagnostic."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance assessment was effectively done for the device itself. The "verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device." This would include evaluating the accuracy of the measurements (weight, blood pressure) and the functionality of data transmission and automated interactions, independent of a specific human interpreter's real-time interaction influencing the primary data acquisition.
7. The Type of Ground Truth Used:
The document does not explicitly state the type of ground truth. However, for a physiological monitoring system measuring weight, blood pressure, and non-diagnostic ECG, the ground truth would typically be:
- Reference standard measurements: Comparison of device readings against highly accurate and calibrated reference instruments (e.g., certified scales for weight, calibrated blood pressure devices for blood pressure, and potentially simultaneous recordings from clinical-grade ECG machines for basic rhythm assessment for the "non-diagnostic ECG").
- Functional verification: For the new glucose meter downloads and subjective questions, ground truth would be established by verifying that the data is accurately transmitted and recorded as intended by checking the source data against the received data.
8. The Sample Size for the Training Set:
The document does not mention a training set or its sample size. This is expected as the device is a physiological transmitter and receiver, not an AI/Machine Learning algorithm that requires a distinct training phase.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no mention of a training set, indicating this is not an AI/ML device in the context of this submission.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).