(284 days)
U60 Series Wrist Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.
The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.
All the models included in this submission follow the same measurement principle and same specifications. The main differences are data storage and time display. These two differences will not affect the safety and effectiveness of the device.
The provided document is a 510(k) summary for a blood pressure monitor, which primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and international standards. It does not contain information about a clinical study involving human patients to directly "prove the device meets acceptance criteria" in terms of clinical accuracy or performance, as one would typically expect for a software-as-a-medical-device (SaMD) or AI-based device.
The "acceptance criteria" for this device are defined by its adherence to recognized industry standards for non-invasive sphygmomanometers, rather than specific clinical performance metrics derived from a dedicated study reported within this document.
However, I can extract the relevant information based on the context of this 510(k) and general FDA requirements for such devices:
1. Table of Acceptance Criteria and Reported Device Performance
For non-invasive blood pressure monitors, the acceptance criteria are generally defined by the accuracy requirements in standards like ANSI/AAMI/IEC 80601-2-30. The document states the device complies with this standard.
| Acceptance Criteria (Based on ANSI/AAMI/IEC 80601-2-30) | Reported Device Performance (U60 Series) |
|---|---|
| Blood Pressure Accuracy: ± 3 mmHg | ± 3 mmHg |
Note: The document lists the pulse rate range as 40-199 bpm for the proposed device, while the predicate is 30-180 bpm. It clarifies this difference is not considered to affect substantial equivalence as the differing ranges (30-40 bpm and 180-199 bpm) are "very rare and abnormal". However, a specific accuracy for pulse rate is not explicitly stated in the table for either the criteria or performance, but it would also be covered by the ANSI/AAMI/IEC 80601-2-30 standard.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the context of patient data to assess diagnostic or predictive accuracy. Instead, it refers to "bench tests" to verify design specifications and compliance with standards. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as there is no described clinical study involving human patients and expert review to establish ground truth for a diagnostic performance assessment. The "ground truth" for the device's accuracy is its measurement against a calibrated standard (presumably, an invasive BP measurement or a validated reference device) as part of the standards compliance testing.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring expert adjudication is described in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The device is an automated blood pressure monitor and does not involve human readers interpreting output that would necessitate an MRMC study.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
The device itself is a "standalone" system in the sense that it automatically measures blood pressure and pulse rate. The document states:
"The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique."
The "standalone performance" is demonstrated through compliance with the ANSI/AAMI/IEC 80601-2-30:2009 standard, which dictates performance requirements for automated noninvasive sphygmomanometers. However, the details of the results of such testing (e.g., number of subjects, average difference, standard deviation) are not provided in this 510(k) summary; only that the device "complies."
7. Type of Ground Truth Used
For the accuracy claim of ± 3 mmHg, the ground truth would be established through comparison of the device's measurements against a standardized reference method for blood pressure measurement (e.g., auscultation with a mercury column sphygmomanometer performed by trained professionals, or more advanced invasive methods in controlled settings). This is an inherent part of the testing required by standards like ANSI/AAMI/IEC 80601-2-30. The document does not explicitly state the methodology for establishing this ground truth, but merely that the device complies with the standard.
8. Sample Size for the Training Set
This information is not applicable. The U60 Series Blood Pressure Monitor is an oscillometric device, which uses established algorithms for blood pressure determination. It is not an AI/ML device that requires a "training set" in the conventional sense of machine learning. The algorithms are typically developed and validated using physiological data but not in a way that is described as a "training set" for an AI model.
9. How Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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).