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K Number
K050711
Device Name
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
Manufacturer
HEALTH & LIFE CO., LTD.
Date Cleared
2005-04-07

(20 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

Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be ressure and heart rate measurements will be announced in English (suit measurements will be announced in English (optional).

The intended use of this over-the counter device is for age 16 and above.

Device Description

H&L Full Automatic (NIBP) Blood Pressure Monitor

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor. It does not contain any information about the acceptance criteria or how the device met those criteria through a study.

Specifically, the document lacks all the requested information:

  • A table of acceptance criteria and the reported device performance: Not present.
  • Sample sized used for the test set and the data provenance: Not present.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  • Adjudication method for the test set: Not present.
  • If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant for this type of device, and not present.
  • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for this type of device, and not present.
  • The type of ground truth used: Not present.
  • The sample size for the training set: Not present.
  • How the ground truth for the training set was established: Not present.

The letter merely states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would include performance data, but that specific data and the associated acceptance criteria are not detailed within this FDA clearance letter.

§ 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).