(55 days)
The Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF 1-2B is a device intended to measure the systolic and diastolic blood pressure, pulserate of an adult individual 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 your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3NF1-2B is designed to measure systolic and diastolic blood pressure, pulse rate of an individual 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 with the reading. The device can be used in connection with your personal computer (PC) running the software. The memory data can be transferred to the PC by connecting the monitor with the PC via cable. The device can also be used in connection with smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria in the format requested.
The document is a 510(k) premarket notification for a blood pressure monitor, focusing on demonstrating substantial equivalence to a predicate device. It briefly mentions non-clinical and clinical tests but does not provide the specific data points requested in the prompt.
Here's a breakdown of what is mentioned, and what is missing:
What is mentioned:
- Non-Clinical Tests: The document states that testing was conducted in accordance with FDA guidance and various national and international standards (e.g., IEC 60601-1, AAMI/ANSI SP10, EN 1060-1, ISO 14971, AAMI/ANSI/IEC 80601-2-30). These standards typically define performance requirements and test methods for electrical safety, EMC, and blood pressure measurement accuracy.
- Clinical Tests: It explicitly states that repeat clinical testing in accordance with ANSI/AAMI IEC81060-2 for the subject device BP3NF1-2B was not necessary. The justification is that the subject device is technically identical to the predicate device (BP3MC1-PC) in terms of its blood pressure measurement algorithm and program codes, meaning their performance should be identical.
- Predicate Device: The clinical performance of the device is inferred from the performance of its predicate devices, specifically "Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MC1-PC, K061471". While the standards listed (like AAMI/ANSI SP10 and AAMI/ANSI/IEC 80601-2-30) define accuracy requirements, the document does not report the specific performance metrics of the predicate device or the subject device against these requirements.
- Sample Size (Clinical): Not applicable for the subject device, as no new clinical study was performed.
- Ground Truth (Clinical): Not directly applicable for a new clinical study. The implied ground truth would be from the clinical studies conducted for the predicate device, likely using auscultation by trained observers.
What is missing from the provided text to fulfill your request:
- A table of acceptance criteria and the reported device performance: This is the most crucial missing piece. While standards like AAMI/ANSI SP10 and IEC 81060-2-30 are mentioned, which contain accuracy criteria (e.g., mean difference and standard deviation between device and reference measurements), the document does not report the actual performance of the device against these criteria. It only states that the device "met all relevant requirements."
- Sample sized used for the test set and the data provenance: Not provided, as no new clinical study was documented for this submission. This information would be found in the original clinical validation for the predicate device(s).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This information would be part of the predicate device's clinical validation report.
- Adjudication method: Not provided. This information would be part of the predicate device's clinical validation report.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself is a standalone algorithm for blood pressure measurement. However, the specific performance metrics are not reported here.
- The type of ground truth used: Implied to be auscultatory reference measurements by trained observers for the predicate device's clinical validation, as per standard blood pressure validation protocols (e.g., AAMI/ANSI/ISO 81060-2).
- The sample size for the training set: Not applicable. This document pertains to the evaluation of a medical device, not the development of a machine learning model with a distinct training set. The "algorithm" here refers to the oscillometric measurement method.
- How the ground truth for the training set was established: Not applicable.
In summary, the document leverages the concept of substantial equivalence by arguing that no new clinical data is needed because crucial components, especially the measurement algorithm, are identical to a previously cleared predicate device. Therefore, the detailed acceptance criteria and performance data for the subject device are not presented, but are implicitly covered by the predicate device's prior approval against relevant standards.
§ 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).