(198 days)
FB-100U Series Digital Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure, and pulse rate (heart rate) by using an inflating cuff which is wrapped around the upper arm. The device is indicated for use by people over 15 years old in home use.
FB-100U Series DIGITAL Blood Pressure Monitor is designed to measure the systolic and diastolic blood pressure, and pulse rate(heart of an individual). All values can be read out in one LCD DISPLAY. Measurement position is on adult arm only.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Device Performance (FB-100U Series) |
|---|---|
| Conformance to ANSI/AAMI SP-10 | Meets requirements |
| Conformance to IEC 60601-1 | Meets requirements |
| Conformance to IEC 60601-1-2 | Meets requirements |
| Intended Use: Measure systolic and diastolic blood pressure, and pulse rate, in adults over 15 years old for home use | Same as predicate device |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It mentions "bench testing" to demonstrate conformance to standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the given document. The study relies on conformance to established standards (ANSI/AAMI SP-10, IEC 60601-1, IEC 60601-1-2) rather than expert-established ground truth for specific measurements.
4. Adjudication Method for the Test Set:
This information is not applicable or not provided. Since the primary method of demonstrating performance is conformance to standards through "bench testing," a formal adjudication method like 2+1 or 3+1 typically used for subjective clinical assessments is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a digital blood pressure monitor that directly provides readings.
6. If a Standalone Study Was Done:
Yes, a standalone performance evaluation was done through "bench testing" to demonstrate the device's conformance to the specified standards (ANSI/AAMI SP-10, IEC 60601-1, and IEC 60601-1-2). This refers to the algorithm/device operating independently to perform its intended function.
7. The Type of Ground Truth Used:
The ground truth used for this device's evaluation is primarily the requirements and specifications outlined in the referenced performance standards: ANSI/AAMI SP-10 (Manual, electronic, or automated sphygmomanometers), IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance), and IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests).
8. The Sample Size for the Training Set:
This information is not applicable or not provided. For a blood pressure monitor, the device's algorithms are typically designed based on established physiological principles and engineering standards, not through training on a large dataset in the way a machine learning algorithm would be.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or not provided. As mentioned above, the device's functionality is based on established engineering and physiological principles rather than a "training set" with ground truth in the context of machine learning.
§ 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).