The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 are noninvasive blood pressure measurement systems 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" for Wrist type and 9.0" ~ 13.0" for Arm type.

Device Description

YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J. BP-110J; and Digital Wrist Blood Pressure Monitor BP-500. BP-510 use the Oscillometric method to measure the blood pressure. The Oscillometric method is adopted clinically to measure the blood pressure recently. It is not needed to use the stethoscope, as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. The Oscillometric method senses the vibrating signal via the closed air pipe system and utilizes the microcomputer to automatically sense the characteristics of the pulse signal. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systolic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.

AI/ML Overview

The provided 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J and Digital Wrist Blood Pressure Monitor BP-500, BP-510 primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety and EMC standards. It makes a general claim about clinical performance but lacks detailed reporting to fully answer all the questions.

Here's a breakdown of what can be gleaned and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device meets AAMI / ANSI SP10 standards for performance and clinical testing. While it doesn't provide a table of precise acceptance criteria values and reported performance metrics for accuracy (e.g., mean difference and standard deviation in mmHg for systolic and diastolic pressure, as typically required by AAMI/ISO 81060-2), it implies that these standards have been met.

Acceptance Criteria (Implied by AAMI / ANSI SP10 Adherence)	Reported Device Performance
Blood Pressure Measurement Accuracy:
Mean difference and standard deviation for systolic BP	Met AAMI / ANSI SP10
Mean difference and standard deviation for diastolic BP	Met AAMI / ANSI SP10
(Specific thresholds for mean difference and standard deviation are not provided in this document, but are defined by AAMI/ANSI SP10.)

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 test (PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10). AAMI SP10 typically requires a minimum of 85 subjects for validation.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It just mentions "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10".

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. For AAMI SP10, ground truth is typically established by trained observers (e.g., physicians or nurses) using a reference sphygmomanometer following a specified auscultatory method. The number and qualifications of these observers are usually detailed in a full clinical study report, which is not available here.

4. Adjudication Method for the Test Set

This information is not provided. For AAMI SP10 validation, typically two or more trained observers measure blood pressure concurrently, and their readings are compared to ensure agreement, establishing a "ground truth" reference measurement. The adjudication method would describe how discrepancies between observers are handled, but this level of detail is absent.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned. This type of study (comparing human readers with and without AI assistance) is not typically performed for a standalone blood pressure monitor like this, which operates without human interpretation of complex medical images or data. The device provides a direct measurement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this device is a standalone blood pressure monitor. The clinical performance refers to the device's ability to accurately measure blood pressure independently, without human interaction beyond operating the device. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" would assess this standalone performance against a clinical reference standard.

7. The Type of Ground Truth Used

Based on the reference to AAMI / ANSI SP10, the ground truth would have been established by expert auscultatory measurements (using a mercury or validated aneroid sphygmomanometer) typically by trained clinical personnel. This is the standard reference method for validating automated blood pressure devices.

8. The Sample Size for the Training Set

This information is not provided. Oscillometric blood pressure monitors rely on algorithms derived from physiological principles and extensive empirical data. There isn't typically a "training set" in the sense of machine learning models for image analysis. Instead, the algorithms are developed and refined using a large dataset of pressure waveforms and corresponding auscultatory reference measurements. The size of this underlying dataset used during the design and development of the oscillometric algorithm is not disclosed here.

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

As with the test set, the ground truth for any data used in the development or "training" of the oscillometric algorithm would have been established through expert auscultatory measurements synchronized with cuff pressure oscillations.

Summary

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K072860

Image /page/0/Picture/1 description: The image shows the word "YAHORNG" in large, bold, black letters. Below the main word, there is a smaller text that reads "Ya Horng CO., LTD". The text is also in black, but the font size is significantly smaller than the main word.

No. 35, Zsha Lun, Jon Zsha village. Antin Shiang, Tainan, Taiwan, ROC Tel: 886-6-5932201 Fax: 886-6-5935870 E-mail: lab@yahorng.com http:// www.yahorng.com

FEB 25 2008

"510(k) Summary"

Submitter's Name: YA HORNG Electronic Co., Ltd.

Address: No. 35, Zaha Lun, Jon Zsha Village, Antin Shiang, Tainan, 74555, Taiwan, ROC

Telephone: 886-6-5932201

FAX: 886-6-5935870

Contact Person: Dr. Jen, Ke-Min

Date Summary October 1, 2007 Prepared:

Proprietary Name: Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J : Digital Wrist Blood Pressure Monitor BP-500, Bb-210

Common Name: BLOOD PRESSURE MONITOR

Classification Name: NON-INVASIVE BLOOD-PRESSURE MEASUREMENT SYSTEM

( per 21CFR section 870.1130)

Device Class: Class II (performance standards)

Specialty: CARDIOVASCULAR

Product code: DXN

YA HORNG PC Compatible Blood Pressure Legally Marketed Monitor AK-4000TU, BP-410U, BP-410R; and ( Predicate ) Automatic Digital Wrist Blood Pressure Monitor Device : BP-420U, BP-420R

510(k) No: K051862

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Image /page/1/Picture/0 description: The image shows the logo and contact information for Ya Horng CO., LTD. The address is No. 35, Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC. The telephone number is 886-6-5932201, and the fax number is 886-6-5935870. The email address is lab@yahorng.com, and the website is http://www.yahorng.com.

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Description of the new device:

Technological Characteristics of our new device compared to the predicate device:

The technological characteristics of YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J; and Digital Wrist Blood Pressure Monitor BP-500, BP-510 are substantially equivalent to YA HORNG PC Compatible Blood Pressure Monitor AK-4000TU, BP-410U. BP-410R; and Automatic Digital Wrist Blood Pressure Monitor BP-420U, BP-420R. There is the same Owner, AMLUNK Inc., which FDA owner number is 9040892. Especially, there are the same design specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices.

The mainly different are:

1. The new devices are only different vision appearance for the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo and contact information for Ya Horng CO., LTD. The address is No. 35, Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC. The telephone number is 886-6-5932201, and the fax number is 886-6-5935870. The email address is lab@yahorng.com, and the website is http://www.yahorng.com.

1. The predicate devices can connect to the PC and the new devices are just for the general upper arm or wrist uses.
  Thus there are substantially equivalent.

Test Summary:

ELECTRIC SAFETY and EMC test reports, 1.

General safety	EN 60601-1:1990+A1+A2+A11+A12+A13	PASS
	EN 1060-1:1995, EN 1060-3:1997	PASS
EMC conformity	EN 60601-1-2: 1993	PASS

WOVEN COTTON SHEETING 2.

Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).

3. PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10

YA HORNG Co. Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.

Kristen

Dr. Jen, Ke-Min official correspondent YA HORNG Electronic Co., Ltd.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

FEB 25 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ya Horng Electronic Co. Ltd. c/o Dr. Jen Ke-Min ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun St. Hsin-Chu City, 30067 Taiwan, ROC

K072860 Re:

Trade/Device Name: Digital Upper Arm Blood Pressure Monitor Models BP-100J, BP-110J; Digital Wrist Blood Pressure Monitor Models BP-500, Bb-210 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: January 17, 2008 Received: January 23, 2008

Dear Dr. Jen:

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 may, 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 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 - Dr. Jen Ke-Min

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 (QS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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/5/Picture/0 description: The image shows the text "YAHORNG Vo Horng CO., LTD". The text is in a bold, sans-serif font and is black. The letters are slightly distressed, giving the text a textured appearance. The words "Vo Horng CO., LTD" are smaller than the word "YAHORNG" and are located directly below it.

No. 35. Zsha Lun, Jon Z Antin Shiang, Tainan, Taiwan, ROC Tel: 886-6-5932201 Fax: 886-6-5935870 E-mail: lab@yahorng.com http:// www.yahorng.com

Indications for Use

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: YA HORNG ELECTRONIC CO., LTD.

Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J :

Digital Wrist Blood Pressure Monitor BP-500, BP-510

. Indications for use:

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)
(Divisio
Division of C...
510(k) Number	K072860
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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).