(155 days)
Measure blood pressure (systolic and diastolic) and pulse rate.
UA-651 uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START" button, the cuff is inflated automatically by an internal pump of UA-651. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300mmHg. UA-651 will not inflate the cuff higher than 300mmHg. UA-651 will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.
The provided document is a 510(k) premarket notification for a medical device, the A&D Medical UA-651 Digital Blood Pressure Monitor. It aims to demonstrate substantial equivalence to previously cleared predicate devices.
Acceptance Criteria and Device Performance Study Information:
For a non-invasive blood pressure measurement system like the UA-651, the crucial acceptance criteria revolve around its accuracy in measuring blood pressure and pulse rate. The document indicates that the device's accuracy specifications are unchanged from its predicate devices, which suggests these specifications were previously found acceptable.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Predicate Devices) | Reported Device Performance (UA-651) |
|---|---|---|
| Accuracy (BP) | +/- 3 mmHg or +/- 2% of measured value, whichever is greater | No change – the same (i.e., +/- 3 mmHg or +/- 2% of measured value, whichever is greater) |
| Accuracy (Pulse) | +/- 5 % (pulse) | No change – the same (i.e., +/- 5 % (pulse)) |
| Measurement Range (BP) | 20 to 280 mmHg | No change – the same (i.e., 20 to 280 mmHg) |
| Measurement Range (Pulse) | 30 to 200 pulse/min | No change – the same (i.e., 30 to 200 pulse/min) |
| IHB Detection | More than +/-25% to the mean interval of all pulse intervals | No change – the same (i.e., more than +/-25% to the mean interval of all pulse intervals) |
Important Note: The document consistently states "No change – the same" for the UA-651's performance characteristics compared to the predicate devices. This implies that the previous clearance of the predicate devices established these as acceptable performance criteria, and the current device meets them due to technological equivalence. The document does not provide new, specific test results for the UA-651 to explicitly prove it meets these criteria in this submission. Instead, it relies on the argument of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide details on a specific clinical test set for the UA-651 itself. Since the submission relies on demonstrating substantial equivalence to predicate devices, it asserts that the modifications (primarily cosmetic changes and removal of certain features) do not affect safety or effectiveness. Therefore, a new, comprehensive clinical study with a dedicated test set and sample size specifically for the UA-651's accuracy is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document as there is no description of a new clinical study to establish ground truth for the UA-651.
4. Adjudication Method for the Test Set:
This information is not provided in the document as there is no description of a new clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not mentioned or implied in this document. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. Blood pressure monitors are automated devices, and their performance is typically assessed through direct comparison to a reference standard, not through human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The blood pressure monitor is an inherently standalone device in terms of its measurement algorithm. It measures blood pressure without direct human real-time intervention in the measurement process itself (though a human initiates the measurement). The accuracy specifications (e.g., +/- 3 mmHg) inherently represent the standalone performance of its oscillometric algorithm. However, the document does not describe a new standalone study conducted for the UA-651. It relies on the standalone performance of its predicate devices.
7. Type of Ground Truth Used:
For blood pressure monitors, the gold standard (ground truth) is typically a sphygmomanometer (manual blood pressure measurement using a stethoscope and cuff), often performed by trained clinicians, or an invasive arterial line measurement. While the document doesn't explicitly state the type of ground truth a reference standard to which the predicate devices were compared, it's implicitly understood that such a reference standard was used in the original validation of the predicate devices to establish their accuracy claims. No new ground truth establishment is described for the UA-651.
8. Sample Size for the Training Set:
The concept of a "training set" is usually associated with machine learning algorithms where data is used to train a model. While the oscillometric method involves algorithms, they are typically based on established physiological principles and signal processing, rather than iterative machine learning training on a large dataset in the modern sense. Therefore, the document does not mention a specific training set size.
9. How the Ground Truth for the Training Set Was Established:
As above, the concept of a "training set" in the context of modern machine learning is not directly applicable or discussed. The underlying algorithms for oscillometric blood pressure measurement would have been developed and validated against established physiological principles and clinical data during the development of the predicate devices, likely using reference methods for ground truth (as described in point 7). The document does not detail this process for the UA-651 or its predicate devices' initial development.
In summary: The submission for the A&D Medical UA-651 hinges on the argument of "substantial equivalence" to its predicate devices. This means that instead of presenting new studies for the UA-651, it asserts that because the core technological and operational characteristics related to blood pressure measurement are unchanged, and the modifications are primarily aesthetic or involve the removal of non-critical features, the UA-651 is presumed to have the same performance as the already-cleared predicate devices. The details about sample sizes, experts, adjudication, and specific ground truth establishment are not provided for the UA-651 itself in this document, as those would have been part of the original predicate device clearances.
§ 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).