(56 days)
The A&D Medical UA-851THW digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
Measure blood pressure (systolic and diastolic) and pulse rate.
The A&D Medical UA-851THW digital blood pressure monitor is intended for used by adults with 12 years older to measure the systolic and diastolic blood pressure and pulse rate.
UA-851THW uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal electronic-controlled exhaust valve. There is a quick exhaust mechanism so that the pressure of the cuff can be completely released. There is a maximum pressure safety setting at 300mmHg. The culT will inflate higher than 300mmHg. The arm distribution range is from 5.1" to 17.7" (13 cm to 45 cm). At the end of the measurement, the result can be uploaded to a PC with ActiLink USB transceiver and viewed by the Wellness Connected software.
Here's an analysis of the provided 510(k) summary regarding the A&D Medical UA-851THW Digital Blood Pressure Monitor, focusing on its acceptance criteria and the study that proves its performance:
Based on the provided document, the UA-851THW Digital Blood Pressure Monitor is generally compared to its predicate devices for substantial equivalence, rather than a detailed study proving its meeting of specific acceptance criteria. The document highlights that the technological and operational characteristics are largely the same as the predicate devices, implying that the established accuracy of those predicates serves as the basis for the current device's performance.
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (UA-851THW) |
|---|---|
| Blood Pressure Accuracy | +/- 3mmHg or +/- 2% of measured value, whichever is greater |
| Pulse Rate Accuracy | +/- 5% (pulse) |
| Measurement Range (BP) | 20 to 280 mmHg |
| Measurement Range (Pulse) | 30 to 200 pulse/min |
Study Information:
The 510(k) summary does not contain a description of a specific new study performed for the UA-851THW to "prove" it meets these acceptance criteria directly. Instead, the core argument for substantial equivalence relies on the fact that these performance specifications are "No change – the same" as the predicate devices (UA-789 & UA-767PBT).
Therefore, the following information is not available or directly applicable from the provided text for the UA-851THW itself:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document implies reliance on previous testing of predicate devices.
- 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): Not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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 is a blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a standalone device (automated blood pressure monitor). However, specific performance studies of the algorithm itself are not detailed. Its performance is stated as "No change - the same" as the predicate devices.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, but for blood pressure monitors, ground truth is typically established using a reference standard (e.g., auscultatory method with a trained observer, or validated invasive measurements). The reliance on predicate devices suggests this was performed during their respective clearances.
- The sample size for the training set: Not applicable based on the information provided. The device uses an oscillometric method, and its core algorithm is essentially the same as previous, cleared devices. Specific "training set" for a new machine learning algorithm is not mentioned.
- How the ground truth for the training set was established: Not applicable based on the information provided.
Summary of the "Study" and Basis for Acceptance:
The "study" in this context is the comparison to predicate devices to demonstrate substantial equivalence, rather than a de novo clinical trial for the UA-851THW itself to establish its accuracy.
- The manufacturer states that the Measurement Method, Measurement Range, and Accuracy are "No change – the same" as the predicate devices (A&D LifeSource model UA-767PBT with FDA 510(k) K043217 and A&D LifeSource model UA-789 with FDA 510(k) K062027).
- The argument is that the major changes (radio replacement and plastic mold changes) "do not affect the devices' intended use or alter the device's fundamental scientific technology." Therefore, because the core technology and performance specifications are unchanged from devices already cleared by the FDA, the UA-851THW is deemed to meet the same acceptance criteria.
In essence, the acceptance criteria are met implicitly by proving substantial equivalence to previously cleared devices which themselves had demonstrated meeting such criteria. The document explicitly avoids describing new, independent testing data for the UA-851THW's accuracy against these criteria.
§ 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).