(122 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual with arm cuff circumference sizes ranging from 22 -42 cm by using a non-invasive oscillometric technique in one inflatable cuff being wrapped around the upper arm.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected.
The memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The device is intended for use by patient at home or by health care givers in primary care settings.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) is designed to measure systolic and diastolic blood pressure and pulse rate of an adult 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 a resistive pressure sensor rather than a stethoscope and mercury manometer. The sensor converts 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 has > and > measurement modes. The > mode is selected for a regular single measurement. The > mode is selected for diagnosis or follow-up.
The device detects the appearance of atrial fibrillation during measurement and gives a warning signal with the reading once the atrial fibrillation is detected. If atrial fibrillation is detected during all readings of the triple measurements in usual mode or all four readings of one day in diagnostic mode, the Afib icon is displayed.
In addition, the memory data can be transferred to the PC (personal computer) running the WatchBP Analyzer Home software by connecting the monitor via cable. The device can also be used in connection with smart mobile devices running the APP and via Bluetooth.
The device is intended for use by patient at home or by health care givers in primary care settings.
The provided text is a 510(k) Summary for a medical device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C). This summary focuses on establishing substantial equivalence to a predicate device, the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home N (BP3MX1-4) (K100763).
The document does not contain a new study that proves the device meets specific acceptance criteria based on independent clinical data for the subject device (BP3MX1-3C). Instead, it leverages the clinical validation of the predicate device (BP3MX1-4) to argue for substantial equivalence.
Therefore, for the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for the subject device (BP3MX1-3C), the answer is that a new clinical study was not performed to independently prove the subject device's performance against specific acceptance criteria.
The document explicitly states:
"From a clinical validation standpoint, the subject device is identical to the 510(k) cleared predicate device, WatchBP Home N (BP3MX1-4), K100763, in blood pressure measurement and atrial fibrillation detection."
"Therefore the performance of the WatchBP Home A BT (BP3MX1-3C) in terms of blood pressure measurement and atrial fibrillation detection would be essential equivalent with performance of the predicate device WatchBP Home N (BP3MX1-4). There was no repeated clinical testing required for blood pressure measurement and atrial fibrillation detection to support WatchBP Home A BT (BP3MX1-3C) as the subject device can leverage the clinical validation of WatchBP Home N (BP3MX1-4) that was proven in K100763."
Given this, it is not possible to provide the requested details for the subject device's independent clinical study as it was asserted that such a study was not warranted due to substantial equivalence to the predicate.
Information that CANNOT be Extracted from the Provided Text:
- A table of acceptance criteria and the reported device performance for the subject device's own clinical study: No such study was reported for the subject device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) for the subject device's own clinical study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) for the subject device's own clinical study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set for the subject device's own clinical study.
- If a multi reader multi case (MRMC) comparative effectiveness study was done for the subject device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for the subject device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the subject device's own clinical study.
- The sample size for the training set for the subject device’s algorithm (if applicable).
- How the ground truth for the training set was established for the subject device’s algorithm (if applicable).
Information that MAY be Inferred or Found in the Referenced Predicate Device (K100763):
The document states that the predicate device (WatchBP Home N, K100763) had its clinical validation for blood pressure measurement and atrial fibrillation detection proven. Therefore, the requested information (acceptance criteria, study details, ground truth, etc.) would likely be found in the 510(k) submission for K100763. The current document only refers to that previous clearance.
The only "acceptance criteria" presented are the non-clinical tests performed to demonstrate safety and effectiveness, based on recognized international standards. These are not clinical acceptance criteria for performance in measuring blood pressure or detecting AFib.
Non-Clinical Testing Standards (from section 7):
The device underwent non-clinical testing according to the following standards, demonstrating it met the requirements of these standards:
- IEC 60601-1 / AAMI / ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R) 2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-2:2014 (Electromagnetic Disturbances - Requirements And Tests)
- ISO 14971: 2007 (Medical devices Application of risk management)
- AAMI/ANSI/ISO 10993-1:2009/(R)2013, -5:2009/(R)2014, -10:2010/(R)2014 (Biological evaluation of medical devices)
- AAMI/ANSI/IEC 80601-2-30: 2013 (Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers)
- IEC 60601-1-11:2015 (Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment)
- AAMI/ANSI /ISO 81060-2: 2013 (Non-Invasive Sphygmomanometers Part 2: Clinical Validation of Automated Measurement Type) - This standard is the relevant one for clinical performance, but the document states that the subject device leveraged the predicate's validation for this, rather than performing a new one.
In summary, the provided text does not contain a report of a new clinical study for the Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model WatchBP Home A BT (BP3MX1-3C) to prove its performance against acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (K100763) which had already undergone such clinical validation.
§ 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).