(266 days)
The BPro® BT Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of a BPro BT wrist-mounted tonometric monitor, a BPCalibrator MC3100+ oscillometric blood pressure monitor for calibration, and BProSOft BT software, a PC-based computer program.
Before each measurement session, the wrist device is calibrated using the oscillometric monitor. Once calibrated, the BPro wrist device is capable of recording and displaying up to 96 measurements of systolic and diastolic blood pressure and pulse rate over a period of 24 hours.
BProSOft BT PC software is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 24-hour period.
The BPro BT system is intended for use on patients who are eighteen (18) years and older and who have a palpable radial pulse.
The BPro BT system is intended only for measurement, recording, and display. It makes no diagnosis.
HealthSTATS BPro® BT Ambulatory Blood Pressure Monitoring System with BProSOft PC software is a noninvasive ambulatory blood pressure monitoring system based on arterial tonometry at the radial artery of the wrist. The system consists of three main elements:
- BPro BT wrist-mounted tonometric monitor.
- BProSoft BT report management software, a PC-based computer program.
- BPCalibrator MC3100+ oscillometric blood pressure monitor [listed device, K131788] for calibration of BPro BT monitor.
Once the BPro BT is calibrated using the BPcalibrator oscillometric device, it is capable of measuring and recording systolic pressure, diastolic pressure and pulse rate over a period of 24 hours. Blood pressure measurements obtained over the 24 hour period are transferred wirelessly by the BProSoft BT PC software for storage, display, and reports.
This FDA 510(k) summary provides information for the HealthSTATS BPro® BT Ambulatory Blood Pressure Monitoring System with BProSOft BT PC Software. However, it explicitly states "No clinical tests have been submitted - the blood pressure measurement is unaffected by the device modification, which is limited to the device display change to color, wireless data transmission of blood pressure records, and the addition of an internal rechargeable battery."
Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as no new clinical study was conducted for this specific 510(k) submission (K173028). The device's equivalency is based on modifications to an existing predicate device (K060315), and the assumption that the core blood pressure measurement functionality remains unchanged.
However, I can extract the information provided about the non-clinical tests and the product's general characteristics:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical study was submitted for K173028, there are no specific numerical acceptance criteria for blood pressure accuracy or reported performance metrics from a new clinical study. The device's performance is assumed to be equivalent to its predicate.
| Acceptance Criteria Category | Reported Device Performance (from Non-Clinical Tests) |
|---|---|
| Medical Device Electrical Safety | Device met applicable standards. |
| Electromagnetic Compatibility | Device met applicable standards. |
| Shock and Vibration | Device met applicable standards. |
| Environmental (Temperature & Humidity) | Device met applicable standards. |
| Biocompatibility (skin contact surfaces) | Materials met requirements. |
| Software Verification | Software was verified to requirements. |
| Software Validation | Software was validated to meet intended use. |
| Risk, Hazard, Failure Mode Analysis | Performed, residual risks determined acceptable. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable, as no new clinical test data was submitted.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new clinical test data was submitted.
4. Adjudication method for the test set
Not applicable, as no new clinical test data was submitted.
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. This device is a blood pressure monitor, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable for a new study. The device's core blood pressure measurement algorithm is inherited from the predicate device, and its performance is assumed to be equivalent.
7. The type of ground truth used
Not applicable for a new study. For the predicate device, standard reference methods for blood pressure measurement would have been used as ground truth.
8. The sample size for the training set
Not applicable, as no new clinical study was conducted for this submission. The device modifications did not involve changes to the blood pressure hardware sensor or software algorithms (implying the measurement algorithm was not retrained).
9. How the ground truth for the training set was established
Not applicable, as no new clinical study was conducted for this submission. For the predicate device, the ground truth for any initial algorithm development would have been established through comparison with established reference blood pressure measurement methods.
§ 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).