The YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W are noninvasive blood pressurement 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" for Arm type.

Device Description

YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W 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

Here's the breakdown of the acceptance criteria and study information for the YA HORNG Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Standard	Reported Device Performance
IEC/EN 60601-1:2007 (General Safety)	PASS
EN 1060-1:2009, EN 1060-3:2009	PASS
IEC/EN 60601-1-2: 2010 (EMC Conformity)	PASS
ANSI C63.4: 2003 (FCC Conformity)	PASS
FCC 47 part 15 subject B class B	PASS
EN 30148-1:2008, EN 30148-17:2009 (ERM Conformity)	PASS
EN 300328:2006 (RF Conformity)	PASS
ANSI / AAMI SP 10: 2002 (Performance & Clinical Test)	Not explicitly stated as "PASS" but implied through the statement "YA HORNG Electronic Co. Ltd. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent..."
ANSI / AAMI ISO 81060-2:2009 (Performance & Clinical Test)	Not explicitly stated as "PASS" but implied (see above).
EN 1060-4:2004 (Performance & Clinical Test)	Not explicitly stated as "PASS" but implied (see above).

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. It mentions the application of standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009, which typically outline sample size requirements for blood pressure monitor validation. However, the exact number of subjects tested is not provided.

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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 document. For blood pressure monitor validation, ground truth is typically established by trained observers (healthcare professionals) using a reference method, but the details are absent.

4. Adjudication Method for the Test Set

The adjudication method is not described in the provided text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This type of study is more common for diagnostic imaging AI systems to evaluate the impact of AI assistance on human reader performance. This document concerns a standalone blood pressure monitor.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was conducted. The device (BP-700NW and BP-700W) is designed to operate as a standalone device, taking measurements and displaying them. The performance tests against standards like ANSI / AAMI SP 10: 2002 and ANSI / AAMI ISO 81060-2:2009 are evaluations of its automated measurement capabilities. No human-in-the-loop component is described for its fundamental operation or accuracy evaluation.

7. Type of Ground Truth Used

The ground truth used for the performance and clinical tests (i.e. those conforming to ANSI / AAMI SP 10: 2002, ANSI / AAMI ISO 81060-2:2009, EN 1060-4:2004) would typically be invasive blood pressure measurements or auscultatory measurements by trained observers using a validated reference method. However, the document does not explicitly state the type of ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, as this device uses the oscillometric method with microcomputer processing, not explicitly a deep learning or AI model that requires a separate training set. So, this information is not applicable in the traditional sense.

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

Since there is no "training set" described for a machine learning model, this information is not applicable. The oscillometric method relies on established physiological principles and algorithms, not necessarily on a training set in the AI sense.

Summary

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YA HORNG ELECTRONIC CO., LTD.

No.35, Shalun, Anding Dist., Tainan City 745, Taiwan (R.O.C.)

TEL: 886-6-5932201-8 FAX: 886-6-5930030 web:www.yahorng.com e-mail: rdsafety@yahomg.com

SUMMARY OF SAFETY AND EFFECTIVENESS

( According to 21 CFR 807.92)

AUG 17 2012

" 510(k) Summary for K121025 "

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

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

886-6-5932201 Telephone:

886-6-5930030 FAX:

Contact Person: Dr. Jen, Ke-Min

Date Summary Prepared: March 23, 2012

Upper Arm Blood Pressure Monitor, model Proprietary Name: BP-700NW and Bluetooth Transmission BP-700W

BLOOD PRESSURE MONITOR Common Name:

Classification Name:

NON-INVASIVE BLOOD-PRESSURE MEASUREMENT SYSTEM

( per 21CFR section 870.1130)

Class II (performance standards) Device Class:

Specialty: CARDIOVASCULAR

Product code: DXN

O Legally Marketed ( Predicate ) Device :

YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, and BP-700TUB (K090058)

A & D Medical UA-767BT Digital Blood Pressure Monitor (K040371)
EI

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YA HORNG ELECTRONIC CO., LTD.

No.35, Shalun, Anding Dist., Tainan City 745,Taiwan (R.O.C.) TEL: 886-6-5932201-8 FAX: 886-6-5930030 web:www.yahorng.com e-mail: rdsafety@yahomg.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 Upper Arm Blood Pressure Monitor, model BP-700NW and Bluetooth Transmission BP-700W are substantially equivalent to YA HORNG Digital Upper Arm Blood Pressure Monitor BP-700, BP-700T, BP-700U, BP-700B, BP-700TB, BP-700UB, BP-700TUB (K090058). There is the same Owner, YA HORNG Electronic Co., Ltd., 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.

Besides, the subject device BP-700W and the other predicate device A & D Medical UA-767BT Digital Blood Pressure Monitor (K040371) are also with the wireless communication function connect to the PC for record archiving and printing purposes.

The major differences from the predicate devices and the subject devices as below:

The predicate devices: BP-700U, BP-700UB, and BP-700TUB (K090058), software . in the PC for record archiving and printing purposes.
E2

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YA HORNG ELECTRONIC CO.,

No.35, Shatun, Anding Dist., Tainan City 745, Taiwan (R.O. TEL: 886-6-5932201~8 FAX: 886-6-5930030 web:www.yahorng.com e-mail: rdsafety@yahomg.com

The subject device BP-700W: replace the USB cable to transfer data of the BP-700W ● with Bluetooth module for the wireless communication function connect to PC for record archiving and printing purposes.
The predicate device: A & D Medical UA-767BT Digital Blood Pressure Monitor (K040371) and subject device BP-700W are also with the wireless communication function, and only has the different dimensions and the conditions of the operation and storage. Besides, they use the different size of cuffs.
The subject device BP-700NW is identical for the BP-700W; and only does not with the wireless communication function.

Thus there are substantially equivalent.

Test Summary:

ELECTRIC SAFETY, EMC and FCC test reports, 1.

General safety	IEC/EN 60601-1:2007	PASS
	EN 1060-1:2009, EN 1060-3:2009	PASS
EMC conformity	IEC/EN 60601-1-2: 2010	PASS
FCC conformity	ANSI C63.4: 2003	PASS
	FCC 47 part 15 subject B class B	PASS
ERM conformity	EN 30148-1:2008, EN 30148-17:2009	PASS
RF conformity	EN 300328:2006	PASS

WOVEN COTTON SHEETING: (Same as the predicate devices K090058) 2. Uses the 510K Blood-Pressure Cuff: YA HORNG Blood-Pressure Cuff (K051539).

PERFORMANCE & CLINICAL TEST 3.

ANSI / AAMI SP 10: 2002 ANSI / AAMI ISO 81060-2:2009 EN 1060-4:2004

YA HORNG Electronic 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.

Ke Zister

Dr. Jen, Ke-Min official correspondent

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-W066-G609 Silver Spring MD 20993-0002

AUG 17 2012

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

Re: K121025

Trade/Device Names: 1) Ya Horng Upper Arm Blood Pressure Monitor BP-700NW; and 2) Ya Horng Upper Arm Blood Pressure Monitor, Bluetooth

Transmission BP-700W

Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: July 16, 2012 Received: July 24, 2012

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Page 2 - Dr. Ke-Min Jen

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

M. G. Killelea

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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Indications for Use

K121025 510(k) Number:

Device Name: YA HORNG ELECTRONIC CO., LTD.

Upper Arm Blood Pressure Monitor BP-700NW,

Upper Arm Blood Pressure Monitor, Bluetooth Transmission BP-700W

. Indications for use:

※ Optional model: BP-700W with Bluetooth module for the wireless communication function connects to the PC for record archiving and printing purposes.

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)

Cmesf Hillehem

Page

sion Sian-Off) Division of Cardiovascular Devices

510(k) Number_V12025

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).