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K Number
K021252
Device Name
BLOOD-PRESSURE METER
Manufacturer
IDT TECHNOLOGY LIMITED
Date Cleared
2002-06-17

(59 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

By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel.

Device Description

Blood-pressure meter, Model BPW128

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a blood pressure monitor (Model BPW128) and largely focuses on regulatory approval rather than a detailed study report with acceptance criteria. As such, most of the requested information cannot be extracted from the provided text.

Here is what can be determined from the document:

  • Device: Blood-pressure Meter, Model BPW128
  • Intended Use: "By using oscillometric method, measures automatically human's Systolic, Diastolic, mean blood pressure, and heart rate. All values will be read out in LCD panel. The intended for use of this device is for age 15 and above."

The document does not contain the following information:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for the test set or data provenance.
  • Number of experts used to establish ground truth or their qualifications.
  • Adjudication method for the test set.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
  • Whether a standalone performance study was done.
  • The type of ground truth used.
  • Sample size for the training set.
  • How the ground truth for the training set was established.

In summary, this document is an FDA clearance letter confirming substantial equivalence to a predicate device, which implies the device meets certain safety and effectiveness standards, but it does not provide the specific details of performance data and study methodologies that would typically be included in a technical report or scientific publication.

§ 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).