LogoFDA 510(k) Search
K Number
K032913
Device Name
HL888 AF
Manufacturer
HEALTH & LIFE CO., LTD.
Date Cleared
2003-10-02

(30 days)

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

Measures 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 for use of this over-the-counter device is for adult patients whose arm circumference between 24-32cm (approx. 9.4" to 12.6" ) .

Device Description

H&L Full Automatic (NIBP) Blood Pressure Monitor

AI/ML Overview

This document is a 510(k) clearance letter for a non-invasive blood pressure measurement system, the HL888AF. It does not contain the detailed study results, acceptance criteria, or performance data that would allow for a comprehensive answer to your request.

Here's what can be inferred and what is missing:

Based on the nature of a 510(k) submission for a non-invasive blood pressure monitor, the acceptance criteria and study would typically revolve around accuracy and precision compared to a reference method.

Information that CANNOT be extracted from the provided text:

  1. A table of acceptance criteria and the reported device performance: This detailed information is not present in the clearance letter. For a blood pressure monitor, acceptance criteria would typically involve mean difference and standard deviation of differences when compared to a reference measurement (e.g., intra-arterial measurement or a validated oscillometric device), often following standards like ISO 81060-2.
  2. Sample sized used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a blood pressure monitor, as physical measurements are the ground truth, not expert interpretation.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a diagnostic device that outputs a numerical reading, not an image interpreted by multiple readers.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is standalone in terms of generating the blood pressure reading. The "human-in-the-loop" here is the user applying the cuff and reading the display. The performance study would evaluate the device's accuracy in producing these readings.
  7. The type of ground truth used: While not explicitly stated, for a NIBP device, the ground truth would typically be established by a reference measurement method, often intra-arterial blood pressure monitoring or simultaneous measurement with another independently validated oscillometric device, as per relevant standards (e.g., ISO 81060-2).
  8. The sample size for the training set: Not applicable based on the information provided. For blood pressure monitors, while there might be internal algorithm development, the "training set" concept isn't typically discussed in the same way as for AI/machine learning models in image analysis. The validation is against a reference method.
  9. How the ground truth for the training set was established: Not applicable.

What can be inferred:

  • The device being cleared is a "Non-invasive blood pressure measurement system" (HL888AF).
  • It measures "Systolic, Diastolic blood pressure and heart rate using the oscillometric method."
  • It is an "over-the-counter device" intended for "adult patients whose arm circumference between 24-32cm (approx. 9.4" to 12.6")."
  • The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This implies that the performance data submitted (though not included here) met the generally accepted standards for NIBP monitors and demonstrated comparable safety and effectiveness to the predicate.

To get the specific details of the acceptance criteria and the study, you would need to access the full 510(k) submission (K032913), which is usually available through the FDA's public records, though often requires a Freedom of Information Act (FOIA) request for the complete documentation.

§ 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).