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K Number
K042853
Device Name
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA
Manufacturer
HEALTH & LIFE CO., LTD.
Date Cleared
2004-11-10

(26 days)

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

Measure automatically 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").

Device Description

H&L Full Automatic (NIBP) Blood Pressure Monitor, Model HL888EA, HL888CF, HL888GF, HL888QA

AI/ML Overview

This document is a 510(k) clearance letter for a non-invasive blood pressure measurement system, specifically a blood pressure monitor. It does not contain the acceptance criteria or a study that proves the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices. It states the indications for use of the device: "Measure automatically 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")."

To answer your request, I would need a different document, such as a summary of safety and effectiveness (SSE) or a clinical study report submitted with the 510(k) application, which would detail the performance data and acceptance criteria used to demonstrate substantial equivalence.

Without such a document, I cannot provide the requested information, including:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth and their qualifications
  4. Adjudication method
  5. If an MRMC study was done and the effect size
  6. If standalone performance was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 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).