KD-575 Memory Automatic Electronic Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic, systolic blood pressure and pulse rate on anyone each time, except infants and unconscious people, with the air cuff around the left upper arm according to the instruction in the user's guide manual.

The YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Model AK-3000T, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 18, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3" - 8.5".

Device Description

KD-575 Fully Automatic Electronic Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, this devise is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Swathing the air cuff around the left upper arm 1-2cm above elbow joint automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results. It can storage and show 120 times measuring result with the month, day, time of measuring.

AI/ML Overview

This document (K042581) is a 510(k) summary for two different blood pressure monitors, only one of which is addressed in the study. The information below pertains to the KD-575 Memory Automatic Electronic Blood Pressure Monitor from Kodon (Tianjin) Electronic & Electrical Apparatus Co., LTD. The second device from Ya Horng Electronic Co., Ltd. (AK-3000T) has its own separate information in the document beyond the scope of a unified description.

Acceptance Criteria and Study for KD-575 Memory Automatic Electronic Blood Pressure Monitor

The acceptance criteria for the KD-575 device are based on the accuracy requirements of the ANSI/AAMI SP10-1992 standard. The study performed directly assesses the device's adherence to these requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (ANSI/AAMI SP10-1992)	Reported Device Performance
Accuracy requirements of ANSI/AAMI SP10-1992	"The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992."

Note: The 510(k) summary does not provide specific numerical values for accuracy (e.g., mean difference and standard deviation) from the study. It only states a qualitative conformance to the standard.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the sample size used for the clinical tests.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states "Clinical tests were performed."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. For blood pressure monitors, ground truth is typically established by trained clinical personnel (e.g., physicians, nurses, or technicians) using auscultatory methods with a mercury sphygmomanometer or validated oscillometric devices as a reference, following a standardized protocol like the ANSI/AAMI SP10.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of blood pressure measurement studies where reference measurements are taken by clinical personnel, formal adjudication for ground truth (as might be seen in imaging studies) is less common, but specific protocols for obtaining and reconciling reference readings would be part of the study design.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated.
The study focuses on the standalone accuracy of the device against a standard, not on comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone study was presented. The "Clinical Tests" section directly reports on the device's performance, stating it "complied with the accuracy requirements of ANSI/AAMI SP10-1992" and that "The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-1992." This indicates an assessment of the algorithm's performance without a human in the loop for measurement interpretation, only for operation.

7. Type of Ground Truth Used

The ground truth used for blood pressure monitor accuracy studies, such as those conforming to ANSI/AAMI SP10, is typically established through simultaneous or near-simultaneous measurements by trained observers using a validated reference method (e.g., auscultatory method with a mercury sphygmomanometer). While not explicitly stated as "expert consensus," the standard implicitly relies on trained human observers as the gold standard for comparison.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. This device is a traditional electronic blood pressure monitor based on oscillometric principles, not an AI/machine learning device that would typically have a separate "training set" in the computational sense. Its design and calibration are based on established physiological principles and engineering.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a training set for an AI/ML algorithm.

Summary

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K042581
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510(k) Summary

OCT 1 3 2004

Identification of the submitter:

Kodon (Tianjin) Electronic & Electrical Apparatus Submitter: Co., LTD No 31, Changjiang Road, Nankai District, Tianjin, P.R. China, 300193 86-22-60526082 Telephone number: Fax number: 86-22-60526162 Liu Yi Contact: 08/25/04 Date of Application:

Identification of the product:

Device proprietary Name:	KD-575 Memory Automatic Electronic BloodPressure Monitor
Common name:	Noninvasive blood pressure measurementsystems
Classification name:	Noninvasive blood pressure measurement systemClass II per 21 CFR 870.1130

Marketed Devices to which equivalence is claimed:

Device	manufacture	510(k) number
KD-559	Kodon (Tianjin) Electronic and ElectricalApparatus Co., Ltd.	K030358

Device description:

Intended use:

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Comparison of technological characteristics of new device to predicate devices:

KD-575 Memory Automatic Electronic Blood Pressure Monitor can storage and show 120 times measuring results with the month, day, time of measuring. It can help patients to memorize the measuring data of their measuring results. Therefore the patients can analyze the measuring data and inspect their physical conditions. The time and the date are the advantages of KD-575 compare with the predicate device.

Clinical Tests:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMISP10-1992. The results meet or exceed the accuracy requirements of ANSI/AAMISP10-1992.

Non-clinical Tests:

standards, including tests coincide the following non-clinical All Electromagnetic Compatibility test.

IEC601-1 (1988)

Medical electrical equipment-----Part 1:General requirements for safety IEC601-1 (1988)

Amendment 2

IEC 60602-2-30: 1995

Medical electrical equipment-part2: Particular requirements for the safety of automatic cycling indirect blood pressure monitoring equipment. GB9706.1-1995 ISO 1833-1977

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

OCT 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ya Horng Electronic Co., Ltd. c/o Dr Ke-Min Jen Cro Dr No Ninese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, TAIWAN 300 CHINA

Re: K042581

K042581
Trade Name: YA HORNG Automatic Digital Wrist Blood Pressure Monitor, AK-3000T
Trade Name: YA HORNG Automatic Case Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 18, 2004 Received: September 22, 2004

Dear Dr. Jen:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainter in the the may are created in interests a referenced above and nave decemblied the arrised predicate devices marketed in interstate for use stated in the encrosule for legally manatos people of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Trug commerce prior to May 28, 1976, the enastinone with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval applications of the Act. The and Cosment Act (Act) that do not require app to the general controls provisions of the Act. The You may, merelore, market the devree, seejeer of use annual registration, listing of general controls provisions of the free herstand company.
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 If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controls. Extrangemage of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of I sacra. Its gas ...
publish further announcements concerning your device in the Federal Register.

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Page 2 -- Dr Ke-Min Jen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition with other requirements of the Act
that FDA has made a determination that your device of a forelocares . You must that FDA has made a decertification that your as res by other Federal agencies. You must a or any Federal statules and regulations daministed or registration and listing (21 little (21 l comply with all the Act S requirements, moradial was and one and security of the sent of CFR Part 807); labeling (21 CFR Part 001); good manager (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat (2); 1000 1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000product radiation control provisions (becalons of to vice as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your I his letter will anow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale there permi premarket nother in TDA miding of basemation 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 If you desire specific advice for your ac not one one one one one the regulation entitled, and Colliact the Office of Complanes at (301) 317 - 17 - 17 - 10 may obtain Misoranuiling of Icrerchee to premaintentibilities under the Act from the Division of Small other general Information on your respended 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,

Blinxlma for

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Ya Horng CO. LTD. The logo is in black and white, with the words "YA HORNG" in large, bold letters. Below that, in smaller letters, are the words "Ya Horng CO. LTD.". The logo is simple and easy to read.

No. 35. Zsha Lur Antin Shiang, Tainan, T Fax: 886-6-5935870 Tel: 886-6-5932201 E-mail: lab@yahorng.com http:// www.yahorng.com

Applicant: _ YA HORNG CO., LTD. 510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________

YA HORNG Automatic Digital Wrist Blood Pressure Monitor, Device Name: AK-3000T

Indications for use: .

. Note:

Data Transmission: Connection to PC using RS232 cable.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off)
vision of Cardiovascular Devices
10(k) Number K042581

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).