(207 days)
BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.
The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.
It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.
The cuff circumference is limited to 13.5cm - 21.5cm.
BP210 Wrist Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method is a well - known technique in the market called the "oscillometric method".
The device stores automatically 180 (2*90) sets of measurement values with the measuring date and time. You can read the stored data conveniently by pressing the memory button. If any irregular heartbeat is detected, the symbol IHB will be displayed on the LCD. Moreover, it has the function of averaging the last three measurement values. The memory data can be transferred to the PC by connecting the device with the PC via USB cable.
The provided text describes the non-clinical and "clinical" testing for the BP210 Wrist Blood Pressure Monitor. However, it explicitly states that no new clinical study was performed for the BP210 device. Instead, the manufacturer argues that the BP210 is substantially equivalent to the predicate device (BP201) and that the previous clinical testing for the BP201 is sufficient.
Therefore, for the BP210 device specifically, there is no direct study described that proves its own acceptance criteria were met through a new clinical trial. The justification for its performance relies on the substantial equivalence to the predicate device.
Based on the provided text for the BP210, here's a breakdown of the requested information, focusing on what is available and noting what is not for this specific device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria or reported device performance in the format of a clinical validation study for the BP210. Instead, it refers to compliance with standards.
For blood pressure monitors, the primary performance standard referenced is ANSI/AAMI SP10: 2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers."
While the text states "The BP210 met all relevant requirements of this standard," it doesn't provide specific numerical performance metrics from a new clinical study for the BP210.
It should be noted that for a blood pressure monitor to meet ANSI/AAMI SP10, its accuracy requirements typically relate to the mean difference and standard deviation between the device readings and a reference measurement (e.g., auscultation by trained observers).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No new test set for clinical validation was used for the BP210.
- Data Provenance: Not applicable, as no new clinical data was collected. The device's performance relies on the equivalence to the predicate device (BP201). The provenance of the predicate device's data is not detailed in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. No new test set for clinical validation was used for the BP210.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No new test set for clinical validation was used for the BP210.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, with or without AI assistance, for the BP210. This type of study is more common for diagnostic imaging AI devices, rather than a standalone blood pressure monitor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The BP210 is a standalone device that provides blood pressure and heart rate measurements using an oscillometric method. Its "performance" refers to its accuracy against a gold standard. The manufacturer asserts this performance remains identical to the predicate device (BP201). The text states, "the measurement algorithm and its program codes of the BP210 remain unchanged." This implies the algorithm's standalone performance is assumed to be the same as the predicate.
7. The Type of Ground Truth Used
- Ground Truth Type: Not applicable for a new clinical study of the BP210. For the predicate device (BP201) or any device validated under ANSI/AAMI SP10, the ground truth for blood pressure measurements is typically established through simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device), following a specific protocol.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The document does not describe the development of a new algorithm that would require a separate training set. The existing "oscillometric method" algorithm is stated to be unchanged from the predicate device.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as no new training set or algorithm development is described for the BP210.
Summary of the Study that Proves the Device Meets Acceptance Criteria (for BP210):
The manufacturer's argument for the BP210 meeting acceptance criteria relies entirely on substantial equivalence to the predicate device, BP201 (K083043).
- Rationale: The document states, "The BP210 is, from a technical point of view, identical to the predicate device, Model BP201. Moreover, the measurement algorithm and its program codes of the BP210 remain unchanged. The fundamental scientific technology of the modified BP210 device is the same as the predicate BP201 device."
- Conclusion: "Therefore the performance of the BP210 in terms of blood pressure measurement would be identical with performance of the predicate BP201 device. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject BP210 device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device."
In essence, the "study" proving the BP210 meets acceptance criteria is the original clinical validation study performed on the BP201 (predicate device), which satisfied the requirements of ANSI/AAMI SP10: 2002. The details of that study are not included in this 510(k) summary for the BP210. The changes in the BP210 (PC link, classification, memory) were deemed not to affect the core measurement performance by the manufacturer.
§ 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).