(19 days)
Manual inflate type blood pressure monitor for measurement of human's systolic, diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
The intended use of this over-the counter device is for adult patients whose arm circumference is between 24-44cm (approx. 9.4" to 17.5").
Manual inflate type blood pressure monitor for measurement of human's systolic, diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD panel.
This looks like a 510(k) clearance letter for a non-invasive blood pressure monitor. Such letters generally do not contain detailed information about acceptance criteria or specific study results as they primarily confirm substantial equivalence to a predicate device.
Therefore, the requested information cannot be extracted from the provided text.
Here is a summary of why the information is unavailable:
- Acceptance Criteria and Device Performance: The document is a clearance letter, which determines substantial equivalence. It does not contain performance data, clinical trial results, or specific acceptance criteria. These would typically be found in the 510(k) submission itself, not the clearance letter.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set, etc.: All these categories relate to a detailed study design and results, which are not part of the FDA's clearance decision letter. The letter confirms the device is substantially equivalent to a predicate, based on information provided in the original 510(k) submission, but does not reiterate or summarize the study specifics.
To obtain this information, one would need to access the full 510(k) submission for K043186, which is usually a much more extensive document.
§ 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).