HL888 AF by HEALTH & LIFE CO., LTD.

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:

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.
Sample sized used for the test set and the data provenance: Not mentioned.
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.
Adjudication method: Not applicable.
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.
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.
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).
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.
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.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

OCT - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Health & Life Co, Ltd. c/o Mr. Paul Hung General Manager 9F No. 186, Jian Yi Road Chung Ho City, Taipai CHINA TAIWAN 235

Re: K032913

Trade Name: HL888AF Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: August 28, 2003 Received: September 2, 2003

Dear Mr. Hung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of r devices; good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Paul Hung

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Vollertn
Bram D. Zuckerman, M.D.

Zuckerman, M.D. ( ) ma Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) :

Device Name : H&L Full Automatic (NIBP) Blood Pressure Monitor

Trade Name : HL888AF

Indications For 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" ) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription USE ()
(Per 21 CFR 801.109)

Reletrn

510(k) Number K032913

Over-The-Counter Use( V ) ( Optional Format 1-2)

Regulation Number and Section

§ 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).