The YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB 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 upper arm. The cuff circumference is limited to be 9.0" ~ 13.0" for Arm type.

Device Description

YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB 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 document describes the 510(k) summary for the YA HORNG Digital Upper Arm Blood Pressure Monitor (models BP-700 series). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data for the device itself.

Based on the available information, here's an attempt to answer your questions, highlighting what is present and what is not:

Acceptance Criteria and Study for YA HORNG Digital Upper Arm Blood Pressure Monitor (BP-700 series)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., mean difference, standard deviation thresholds for blood pressure accuracy) or quantitative performance data from a clinical accuracy study for the BP-700 series.

Instead, it refers to overall compliance with standards:

General Safety: EN 60601-1:1990+A1+A2+A11+A12+A13 – Reported as "PASS".
EMC Conformity: EN 60601-1-2: 1993 – Reported as "PASS".
FCC Conformity: ANSI C63.4: 2003 – Reported as "PASS".
Blood Pressure Measurement Standard: EN 1060-1:1995, EN 1060-3:1997 – Reported as "PASS".
Performance & Clinical Test Standard: AAMI / ANSI SP10 – The document states that the company "believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent." This implies that the device was tested against AAMI/ANSI SP10, and it passed, thereby meeting the clinical accuracy requirements outlined in that standard, but no specific numerical results are provided.

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

The document does not specify the sample size used for the clinical test set (i.e., the number of subjects). It also does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that the company is based in Taiwan, it is plausible that the testing occurred there, but this is not confirmed.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth. For blood pressure monitors tested against AAMI/ANSI SP10, ground truth (reference blood pressure measurements) is typically established by trained and certified observers using auscultation with a mercury sphygmomanometer or validated reference device.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method. In clinical studies for blood pressure monitors, if multiple observers are used for reference measurements, their readings are usually averaged or handled according to the specific protocol of the AAMI/ANSI SP10 standard.

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

Not applicable. This device is an automated blood pressure monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation improvements.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was implicitly done. The "PERFORMANCE & CLINICAL TEST AAMI / ANSI SP10" indicates that the device's accuracy in measuring blood pressure was evaluated independently against reference measurements, without human intervention in the device's measurement process. The device operates as an "algorithm only" in generating the blood pressure readings.

7. Type of Ground Truth Used

The ground truth used for blood pressure monitors compliant with AAMI/ANSI SP10 would be reference blood pressure measurements obtained through a validated method, typically auscultation by trained observers using a mercury sphygmomanometer or an equivalent validated reference device.

8. Sample Size for the Training Set

Not applicable. This is an automated measurement device and the document does not suggest the use of a machine learning model that requires a separate "training set" in the conventional sense (e.g., for image classification). The device uses the Oscillometric method, which relies on a pre-programmed algorithm based on physical principles, not on a machine learning model trained on a large dataset.

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

Not applicable, as there is no "training set" in the machine learning context for this device. The oscillometric algorithm is developed based on physiological principles and validated against known reference measurements.

Summary

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Image /page/0/Picture/1 description: The image displays the text "YAHORNG" in large, bold, black letters. Below this, in a smaller font, is the text "Ya Horng CO., LTD.". The text is simple and clear, with a focus on the company name.

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.yahomg.com

APR 2 2 2009

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"510(k) Summary"

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

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

Telephone: 886-6-5932201

886-6-5935870 FAX:

Contact Person: Dr. Jen, Ke-Min

March 1, 2008 Date Summary Prepared:

Proprietary Name: Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB

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 Digital Upper Arm Blood Pressure Legally Marketed ( Predicate ) Device : Monitor BP-100J, BP-110J; and Digital Wrist Blood Pressure Monitor BP-500, BP-510

510(k) No: K072860

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K090058

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Image /page/1/Picture/1 description: The image shows the company name "YAHORNG" in large, bold letters, followed by "Ya Horng CO., LTD." in a smaller font. Below that is the address "No. 35, Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC". The text is clear and easy to read, with a simple, professional layout.

Tel: 886-6-5932201 Fax: 886-6. E-mail: lab@yahorng.com http:// www.yahorng.com

Description of the new device: (Same as the predicate devices)

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

The technological characteristics of YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB are substantially equivalent to YA HORNG Digital Upper Arm Blood Pressure Monitor BP-100J, BP-110J; and Digital Wrist Blood Pressure Monitor BP-500, BP-510 (K072860). There is the same Owner. YA HORNG Electronic Co., Ltd., which FDA owner number is Especially, there are the same design specifications, the same form and 9040892. 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 different vision appearance and memory capacity for the predicate devices.

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Image /page/2/Picture/1 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.

E-mail: lab@yahorng.com http:// www.vahomg.com

1. The new devices just for the general upper arm use and the predicate devices are either for the general upper arm or wrist use.
1. The subject devices BP-700 series are the identical device with the optional functions including connects to the PC, backlight, and the voice function for the general upper arm use.

Thus there are substantially equivalent.

Test Summary:

ELECTRIC SAFETY, EMC and FCC 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
FCC conformity	ANSI C63.4: 2003	PASS

1. WOVEN COTTON SHEETING: (Same as the predicate devices)
  Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).
1. 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.

Keizila

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

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Public Health Service

APR 2 2 2009

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

Re: K090058

Trade/Device Name: Ya Horng Digital Upper Arm Blood Pressure Monitor, Models BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB and BP-700TUB. Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: April 10, 2009 Received: April 16, 2009

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Dr. Jen, Ke-Min

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 Pours,

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 "YAHONG Ya Hong CO., LTD." in a bold, sans-serif font. The text is black and appears to be slightly distressed or textured. The words "Ya Hong CO., LTD." are smaller and located directly below the word "YAHONG".

No. 35, Zsha Lun, Jon 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

K080671 K090058 510(k) Number:

Device Name: YA HORNG ELECTRONIC CO., LTD.

Digital Upper Arm Blood Pressure Monitor BP-700. BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB

. Indications for use:

※ Optional model: BP-700U, BP-700UB, and BP-700TUB, software in the PC for record archiving and printing purposes only.

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)
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(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	KU90058
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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).