(261 days)
The 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 upper arm. It can be used at medical facilities or at home. The intended arm circumference includes 22 cm32 cm and 32 cm42 cm.
The proposed device, Electronic Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa.
The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. It has a bar indicating function, which can indicate the World Health Organization (WHO) Blood Pressure Classification of the measured blood pressure by referencing Diastolic Blood Pressure issued at Journal of Hypertension 1999. Vol 17, No.2.
The proposed electronic blood pressure monitor has six models, including PG-800B18, PG-800B19, PG-800B19L. PG-800B28. PG-800B29. PG-800B51. All models follow the same software, measurement principle and NIBP algorithm.
The proposed device is intended to be used in medical facilities or at home.
The product is provided non-sterile, and not to be sterilized by the user prior to use.
The provided document describes the FDA 510(k) premarket notification for an Electronic Blood Pressure Monitor (K200716).
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a separate section, but it does list specifications the device claims to meet, which serve as acceptance criteria. The device's reported performance is directly stated as meeting these specifications or being identical to the predicate device.
| Acceptance Criteria (from Proposed Device Specifications) | Reported Device Performance |
|---|---|
| Blood Pressure Range | 30~280mmHg |
| Blood Pressure Accuracy | ±3mmHg |
| Pulse Rate Range | 40~199 bpm |
| Measurement Method | Oscillometric |
| Measured Items | Systolic Pressure, Diastolic Pressure, Pulse Rate |
| Measurement Site | Upper arm |
| Patient Population | Adult |
| Arm Circumference | 22cm |
| Electrical Safety | Comply with IEC 60601-1 |
| EMC (Electromagnetic Compatibility) | Comply with IEC 60601-1-2 |
| Particular Performance (Sphygmomanometers) | Comply with IEC 80601-2-30:2009 |
| Home Healthcare Environment | Comply with IEC 60601-1-11:2010 (implied, as the standard is listed) |
| Power Supply Safety (Rechargeable Battery) | Meets the requirements of IEC 62133 (for PG-800B51 model) |
| Software Level Concern | Moderate |
| General Safety and Essential Performance | Met all design specifications (as verified by non-clinical tests) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No Clinical study is included in this submission" for the proposed device (K200716). Therefore, there is no sample size for a test set, nor data provenance information for a clinical study of this specific device.
The basis for proving substantial equivalence to the predicate device (K170151) is that the blood pressure measurement function, including the measurement principle and NIBP algorithm, and cuff size are identical. The predicate device did conduct a clinical study according to ISO 81060-2 (as noted in the comparison table), but the details of that study (sample size, provenance) are not provided in this document.
3. 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)
Since no clinical study was conducted for the proposed device (K200716), there were no experts used to establish ground truth for a test set for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study was conducted for the proposed device.
5. 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. The device is an automated blood pressure monitor and does not involve AI assistance for human readers/operators in its primary function of blood pressure measurement.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
For the proposed device (K200716), a standalone performance evaluation in a clinical setting was not done. Its performance is asserted as identical to the predicate device (K170151) due to shared measurement principles and algorithms.
Non-clinical tests were conducted to verify design specifications and compliance with standards (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, IEC 60601-1-11, IEC 62133), which can be considered "standalone" technical evaluations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the proposed device (K200716) submission, no new clinical ground truth was established. The submission relies on the ground truth established by the predicate device's clinical study (which was "conducted according to ISO 81060-2"). ISO 81060-2 defines the clinical investigation of non-invasive sphygmomanometers, which typically involves comparing the device's readings against a reference measurement (e.g., auscultatory method performed by trained observers).
8. The sample size for the training set
Not applicable. There is no mention of a training set for a machine learning model, as this is an automated blood pressure monitor based on an established oscillometric algorithm, not an AI/ML-based diagnostic device in the context of typical training sets. The comparison focuses on the measurement algorithm being identical to the predicate.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for this device.
§ 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).