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The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-3B is a device intended to measure the systolic and diastolic blood pressure, pulse rate of an adult individual with arm circumference sizes ranging from 22-42 cm by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the single upper arm.

The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.

The device can be used in connection with a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

The blood pressure monitor is an automatic digital blood pressure measuring device for use by adults on the upper arm at home or in your doctor's/nurse's office.

Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-3B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual with arm circumference sizes ranging from 22 -42 cm by using a non- invasive technique in which one inflatable cuff is wrapped around the single upper arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but use two resistive pressure sensors rather than a stethoscope and mercury manometer. The sensors convert tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement, and the symbol " ** " = "is displayed after the measurement. In addition, the device can be used in connection with smart mobile devices running the APP. The memory data can be transferred to the smart mobile devices via Bluetooth.

The blood pressure monitor is an automatic digital blood pressure measuring device for use by adults on the upper arm at home or in your doctor's/nurse's office.

This document is a 510(k) premarket notification for a blood pressure monitor, not a study evaluating a new AI/ML-driven device. Therefore, it does not contain the information requested in points 1-9, which are typically associated with the rigorous testing and validation of AI/ML systems, particularly in medical imaging or diagnostic contexts.

Specifically:

• No AI/ML Component: The device described, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MS1-3B, is a traditional oscillometric blood pressure monitor. It uses established techniques for blood pressure measurement and irregular heartbeat detection. There is no indication of an AI or machine learning algorithm being used for diagnosis, image analysis, or complex pattern recognition as would be relevant for the requested criteria.

• Clinical Testing for BP Monitors: The "Discussion of Clinical Tests Performed" (Section 8) explicitly states that repeated clinical testing for the subject device (BP3MS1-3B) was not necessary because its technical and algorithmic aspects are identical to a previously cleared predicate device (BP3MS1-4A). The clinical performance of this type of device is typically validated against a standard like ANSI/AAMI IEC81060-2, which focuses on accuracy compared to a reference method, not against complex diagnostic criteria or human reader performance.

• Scope of 510(k) Submission: A 510(k) submission primarily aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove novel clinical efficacy or superiority through comparative studies like MRMC.

Therefore, I cannot provide the requested information based on the provided text. The document describes a traditional medical device and its regulatory clearance process, not the validation of an AI/ML-driven diagnostic or assistive system.

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