(133 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor,Model WatchBP Office (BP3SK1-3B) is a noninvasive digital blood pressure device using oscillometric technique and an upper-arm blood pressure cuff to measure systolic and diastolic blood pressures, pulse rate, mean arterial pressure (MAP) for use in adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm.
The device can accurately measure in pregnant patients including those with known or suspected preeclampsia.
The device provides aortic blood pressure parameters. includes central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic blood pressure (cDBP), non-invasively through the use of a brachial cuff.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal together with the measured blood pressure value if atrial fibrillation is detected.
The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer software by connecting the monitor via USB cable or Bluetooth.
The device is for hospital use only.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B) is designed to measure systolic and diastolic blood pressure, pulse rate, and mean arterial pressure (MAP) of the adults and pediatrics (but not neonates) populations with arm circumference sizes ranging from 14 -52 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 a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor 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, mean arterial pressure (MAP), central systolic blood pressure (cSBP), central pulse pressure (cPP) and central diastolic pressure (cDBP) which is a well - known technique in the market called the "oscillometric method".
The device has two measurement modes that can be used :> mode and > mode. It has number of measurements setting function, resting time setting function, measurement intervals setting function, atrial fibrillation detection function, Central Blood Pressure (CBP) measurement function etc. In addition, the device can be used in connection with your personal computer (PC) running the WatchBP Analyzer software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable or Bluetooth.
The measurement program in > mode of the device can be set, includes Number of Measurements, Resting Time (Countdown time), Interval Time, AFIB detector, CBP measurement, HIDE and Average calculation (Discard 1st measurement). Select > mode, press the Ubutton to perform automatic measurements based on the settings of > mode. The device shows all the settings and then starts counting down the Resting Time before the first measurement. The average measurement reading is displayed and saved after the measurements are complete.
The measurement program in > mode can be set to preferences. The program includes setting the Highest Cuff Pressure and Hide Cuff Pressure during deflation. Select the >mode if auscultatory blood pressure measurement is preferred above oscillometric blood pressure measurement. In > mode, the device serves as a pressure gauge. No oscillometric measurements will be taken. Systolic and diastolic Korotkoff sounds are determined by the physician using a stethoscope placed over the brachial artery.
The device can accurately measure blood pressure in pregnant patients including those with known or suspected pre-eclampsia.
The device detects the appearance of atrial fibrillation during measurement and the atrial fibrillation symbol "is displayed on the LCD screen if any atrial fibrillation signal has been detected.
The device is for hospital use only.
This document is a 510(k) summary for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B).
The information provided does not contain specific acceptance criteria or detailed study results for the device itself. Instead, it focuses on demonstrating substantial equivalence to two predicate devices (ProBP 2400 and WatchBP Office Central (TWIN200 CBP)) by explaining that the new device shares the same fundamental scientific technology and algorithms for blood pressure measurement, AFIB detection, and central blood pressure measurement.
The document claims that no repeated clinical testing was required for the subject device because it leverages the clinical validation of the predicate devices. Therefore, it does not provide original acceptance criteria or study data for the Model WatchBP Office (BP3SK1-3B).
However, it does mention that the predicate device ProBP 2400 was proven in K152770 and the predicate device WatchBP Office Central (TWIN200 CBP) was proven in K171937, implying that these earlier submissions would contain the clinical study data and acceptance criteria for those devices, which the current device is deemed equivalent to.
Based on the provided text, I cannot complete the requested tables and information directly for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Office (BP3SK1-3B) as it does not present its own clinical study results or acceptance criteria.
The document explicitly states:
- "Repeat clinical testing in accordance with the standard AAMI / ANSI/ISO81060-2 for the subject device WatchBP Office (BP3SK1-3B) regarding brachial blood pressure measurement in pregnant patients including those with known or suspected preeclampsia, adults and pediatrics (but not neonates) with arm cuff circumference sizes ranging from 14 -52 cm is therefore not necessary."
- "There was no repeated clinical testing required for brachial blood pressure, AFIB detection and CBP&CPP measurement to support WatchBP Office as the subject device WatchBP Office (BP3SK1-3B) can leverage the clinical validation of WatchBP Office Central (TWIN200 CBP) that was proven in K171937.Repeat clinical testinq in accordance with the standard AAMI / ANSI/IEC81060-2 for the subject device WatchBP Office (BP3SK1-3B) regarding brachial blood pressure measurement, AFIB detection and CBP&CPP measurement for use in adults is therefore not necessary."
To answer your request thoroughly, one would need access to the 510(k) submissions K152770 and K171937 for the predicate devices, which would contain the original clinical study data and acceptance criteria.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).