(28 days)
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No
The summary describes a system for collecting and transmitting basic physiological data (weight, blood pressure, ECG, SpO2) and explicitly states that clinical judgment is required for interpretation. There is no mention of AI, ML, or any form of automated analysis or interpretation of the data.
No
Explanation: The device is intended for collecting and transmitting medical information for monitoring purposes, not for treating or mitigating a disease or condition.
No
The "Intended Use / Indications for Use" explicitly states that the device collects and transmits "non-diagnostic ECG" and "The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered." This indicates that the device itself is for information collection and transmission, not for diagnosing conditions.
No
The device description explicitly mentions the "M3814A SpO2 unit" and describes testing involving "biocompatibility, electrical safety testing, EMC testing and radio telemetry testing," which are indicative of hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for collecting and transmitting medical information such as weight, blood pressure, and non-diagnostic ECG. It is used by patients at home to send this data to a healthcare professional.
- Device Description: The description focuses on the system's function of transmitting physiological data, including pulse oximetry.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide diagnostic information. IVDs are specifically designed for this purpose.
- Focus on Data Transmission: The core function described is the collection and transmission of physiological measurements taken directly from the patient.
Therefore, the M3810A Philips TeleMonitoring System with M3814A SpO2 unit falls under the category of a telemonitoring or remote patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit 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 which is the same intended use as previously cleared for the M3810A Interactive Health System
The M3810A Philips TeleMonitoring System with M3814A SpO2 unit 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 does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.
Product codes
DRG, DXN, DPS, FRW, DQA, CGA
Device Description
The M3810A Philips TeleMonitoring System with M3814A SpO2 Physiological Transmitter and Receiver
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
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Intended User / Care Setting
licensed physcian or authorized healthcare provider; patients, typically at home.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the modified device. Testing involved safety testing from the risk analysis, including laboratory studies for biocompatibility, electrical safety testing, EMC testing and radio telemetry testing. Acceptance criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0