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K Number
K230176
Device Name
Upper Arm Blood Pressure Monitor
Manufacturer
Shenzhen Yolanda Technology Co., Ltd.
Date Cleared
2023-06-29

(157 days)

Product Code
DXN
Regulation Number
870.1130
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Upper Arm Blood pressure Monitor a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm42 cm or 22cm48cm. It is intended to be used in hospital environment or at home.

Device Description

Upper Arm Blood pressure Monitor (Model:SP10A).

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for an Upper Arm Blood Pressure Monitor, Model SP10A. It primarily addresses the regulatory approval process and includes the device's indications for use.

Crucially, this document does NOT contain information about acceptance criteria, specific study designs (like sample sizes, data provenance, expert qualifications, or multi-reader studies), or the detailed performance metrics of the device against such criteria. It only states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance.

Therefore, I cannot fulfill your request for:

  • A table of acceptance criteria and reported device performance: This information is not present in the document.
  • Sample sizes used for the test set and data provenance: Not detailed.
  • Number of experts used to establish ground truth and qualifications: Not detailed.
  • Adjudication method: Not detailed.
  • MRMC comparative effectiveness study details: Not mentioned. This type of study is more common for AI/imaging devices, not a blood pressure monitor.
  • Standalone (algorithm only) performance: Not applicable for this device.
  • Type of ground truth used: Not detailed.
  • Sample size for the training set: Not detailed.
  • How ground truth for the training set was established: Not detailed.

For these details, one would typically need to refer to the full 510(k) submission or supporting clinical validation reports, which are not included in this FDA clearance letter. The letter confirms clearance based on substantial equivalence, but not the detailed study results that led to that determination.

§ 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).