BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.

The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.

It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

The cuff circumference is limited to 13.5cm - 21.5cm.

Device Description

BP210 Wrist Blood Pressure Monitor is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method is a well - known technique in the market called the "oscillometric method".

The device stores automatically 180 (2*90) sets of measurement values with the measuring date and time. You can read the stored data conveniently by pressing the memory button. If any irregular heartbeat is detected, the symbol IHB will be displayed on the LCD. Moreover, it has the function of averaging the last three measurement values. The memory data can be transferred to the PC by connecting the device with the PC via USB cable.

AI/ML Overview

The provided text describes the non-clinical and "clinical" testing for the BP210 Wrist Blood Pressure Monitor. However, it explicitly states that no new clinical study was performed for the BP210 device. Instead, the manufacturer argues that the BP210 is substantially equivalent to the predicate device (BP201) and that the previous clinical testing for the BP201 is sufficient.

Therefore, for the BP210 device specifically, there is no direct study described that proves its own acceptance criteria were met through a new clinical trial. The justification for its performance relies on the substantial equivalence to the predicate device.

Based on the provided text for the BP210, here's a breakdown of the requested information, focusing on what is available and noting what is not for this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or reported device performance in the format of a clinical validation study for the BP210. Instead, it refers to compliance with standards.

For blood pressure monitors, the primary performance standard referenced is ANSI/AAMI SP10: 2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers."
While the text states "The BP210 met all relevant requirements of this standard," it doesn't provide specific numerical performance metrics from a new clinical study for the BP210.

It should be noted that for a blood pressure monitor to meet ANSI/AAMI SP10, its accuracy requirements typically relate to the mean difference and standard deviation between the device readings and a reference measurement (e.g., auscultation by trained observers).

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

Sample Size: Not applicable. No new test set for clinical validation was used for the BP210.
Data Provenance: Not applicable, as no new clinical data was collected. The device's performance relies on the equivalence to the predicate device (BP201). The provenance of the predicate device's data is not detailed in this submission.

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

Number of Experts: Not applicable. No new test set for clinical validation was used for the BP210.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No new test set for clinical validation was used for the BP210.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, with or without AI assistance, for the BP210. This type of study is more common for diagnostic imaging AI devices, rather than a standalone blood pressure monitor.

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

Standalone Performance: The BP210 is a standalone device that provides blood pressure and heart rate measurements using an oscillometric method. Its "performance" refers to its accuracy against a gold standard. The manufacturer asserts this performance remains identical to the predicate device (BP201). The text states, "the measurement algorithm and its program codes of the BP210 remain unchanged." This implies the algorithm's standalone performance is assumed to be the same as the predicate.

7. The Type of Ground Truth Used

Ground Truth Type: Not applicable for a new clinical study of the BP210. For the predicate device (BP201) or any device validated under ANSI/AAMI SP10, the ground truth for blood pressure measurements is typically established through simultaneous auscultatory measurements by trained observers using a mercury sphygmomanometer (or an equivalent validated reference device), following a specific protocol.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. The document does not describe the development of a new algorithm that would require a separate training set. The existing "oscillometric method" algorithm is stated to be unchanged from the predicate device.

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

Ground Truth Establishment for Training Set: Not applicable, as no new training set or algorithm development is described for the BP210.

Summary of the Study that Proves the Device Meets Acceptance Criteria (for BP210):

The manufacturer's argument for the BP210 meeting acceptance criteria relies entirely on substantial equivalence to the predicate device, BP201 (K083043).

Rationale: The document states, "The BP210 is, from a technical point of view, identical to the predicate device, Model BP201. Moreover, the measurement algorithm and its program codes of the BP210 remain unchanged. The fundamental scientific technology of the modified BP210 device is the same as the predicate BP201 device."
Conclusion: "Therefore the performance of the BP210 in terms of blood pressure measurement would be identical with performance of the predicate BP201 device. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject BP210 device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device."

In essence, the "study" proving the BP210 meets acceptance criteria is the original clinical validation study performed on the BP201 (predicate device), which satisfied the requirements of ANSI/AAMI SP10: 2002. The details of that study are not included in this 510(k) summary for the BP210. The changes in the BP210 (PC link, classification, memory) were deemed not to affect the core measurement performance by the manufacturer.

Summary

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KI12042

SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP210 Wrist Blood Pressure Monitor

Annex 04

510(k) Summary

(as required by 21 CFR 807.92)

1. Submitter's Identification

Submitter's Name:	Shenzhen Kingyield Technology Co.,Ltd.
Address:	Section C1 C2, Fuhai Industrial Zone, Fuhai Road,Fuyong Town, Baoan District, Shenzhen, PR China
Phone:	+86-755-27326734
Fax:	+86-755-27331856
E-mail:	kingyield@kingyield.com
Contact person:	Mr. Dacheng Gong, General Manager
Date of Summary:	Jan, 10,2012

2. Product Classification

Trade Name:	BP210 Wrist Blood Pressure Monitor
Common Name:	Wrist Blood Pressure Monitor
Classification Name:	System, Measurement, Blood Pressure, Non-Invasive
Class:	II
Regulation number:	870.1130
Product code:	DXN
Panel:	Cardiovascular

3. Identification of the legally marketed device

510(k) number:	083043
Trade Name:	BP201 Wrist Blood Pressure Monitor
Product Code:	DXN

4. Device Description:

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the device with the PC via USB cable.

5. Indications for Use:

BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.

The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.

It can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

The cuff circumference is limited to 13.5cm - 21.5cm.

6. Summary of Technological Characteristics Compared to the Predicate Device:

The modified device BP210 and the predicate device BP201 use the well-known oscillometric method within the software algorithm to determine the systolic and diastolic blood pressure and pulse rate. Wrist cuff is inflated with the constant speed automatically, and the inflation pressures are transferred via tubing to one sensor.

The major differences between the two models are the additional features such as PC link function, blood pressure classification and bigger memory size.

Predicate Device:

Cleared Device Model: BP201, K083043 which is designed and manufactured by the same company and facility as the BP210 Wrist Blood Pressure Monitor

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Testing information demonstrating safety and effectiveness of BP210 Wrist Digital Blood Pressure Monitor in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements.

The following testing was conducted:

a. Reliability Test Storage test according to ANSI/AAMI SP10:2002/A1:2003/4.2.1 and EN 1060-1:1996/7.1.2.1
b. Reliability Test Operating test according to ANSI/AAMI SP10:2002/A1:2003/4.2.2 and EN 1060-1:1996/7.1. 1
c. Reliability Test Vibration test according to ANSI/AAMI SP10:2002/A1:2003/4.2.3 and EN 1060-1:1996/7.2. 2

7/3

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SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP210 Wrist Blood Pressure Monitor

d. Reliability Test Drop test according to ANSI/AAMI SP10:2002/A1:2003/4.5.4.1B and EN 1060-3:1996/7.4. 1
e. Reliability Test Life test according to ANSI/AAMI SP10:2002/A1:2003/4.2.4.2 and EN 1060-3:1997/7.6
EMC Test according to IEC 60601-1-2:2007 (Third edition) f.
Safety Test according to IEC 60601-1:1988+A1:1991+A2:1995 ದ.
Performance Test-according to EN1060-1:1995/A1:2002 and EN 1060-3:1997/A1:2005 ﻏ
Biocompatibility Test Report according to ISO 10993-5:2009 and ISO ..... 10993-10:2002/Amd.1:2006

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that BP210Wrist Blood Pressure Monitor tested met all relevant requirements of the aforementioned tests.

8. Discussion of Clinical Tests Performed:

ANSI/AAMI SP10: 2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers" testing was performed. All relevant sections were addressed and testing conducted. The BP210 met all relevant requirements of this standard, as applicable to our modified device. The BP210 is, from a technical point of view, identical to the predicate device, Model BP201. Moreover, the measurement algorithm and its program codes of the BP210 remain unchanged. The fundamental scientific technology of the modified BP210 device is the same as the predicate BP201 device. Therefore the performance of the BP210 in terms of blood pressure measurement would be identical with performance of the predicate BP201 device. Repeat clinical testing in accordance with the standard ANSI/AAMI SP10 for the subject BP210 device is therefore not necessary as clinical testing results were not affected by the changes to the subject modified device.

9. Conclusions:

We have demonstrated that there are no significant differences between BP210 Wrist Blood Pressure Monitor and the predicate devices, Model BP201, in terms of safety and effectiveness based on electrical, mechanical and environmental test results per the FDA DCRND November 1993

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized strokes forming the body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB 1 0 2012

Shenzhen KingYield Technology Co., Ltd c/o Mr. Michael S. Ogunleye TUV Rheinland of North America, Inc. 12 Commerce Road Newtown, CT 06470

K112042 Re:

Trade/Device Name: King Yield Wrist Blood Pressure Monitor, Model 210 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (Two) Product Code: DXN Dated: January 13, 2012 Received: January 24, 2012

Dear Mr. Ogunleye:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments, or to Commerce prior to may 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices mat have been recuired in assessment approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, therefore, market the device, bacycer to the connects for annual registration, listing of general controls provisions of the rice labeling, and prohibitions against misbranding and devices, good manufacturing places, as othing in and information related to contract liability adulteration. Tease note: CDTCP does not over labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) investigations affecting your device can be

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Page 2 - Mr. Michael S. Ogunleye

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. Page 2 – Ms. Sarah Su

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be devised that I DTT 3 lesames a sour device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must of any I coeral statures and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of it Fart 607), acceing (21 CFR 803); good manufacturing practice requirements as set de rice-relation daverse overse overse) (2) CFR Part 820); and if applicable, the electronic form in the quality by evens (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 11 you desire specific ad rios or you /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 note the regulations 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 Tou may obtain other generers, 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,

R. Fletcher, M.D.

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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SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP210 Wrist Blood Pressure Monitor

Annex 03

Indications for Use Statement

12042

510(k) number: Device Name: Indications for Use:

BP210 Wrist Blood Pressure Monitor

BP210 Wrist Blood Pressure Monitor is intended to be used to measure blood pressure (systolic and diastolic) and heart rate from the wrist by using the oscillometric method.

The device is intended for using in only adult population, not applied to the other populations such as neonatal baby.

lt can't be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

The cuff circumference is limited to 13.5cm - 21.5cm.

(Part 21 CFR 801 AND/OR Over-The-Counter Use Prescription Use _ 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 On)
Division of Cardiovascular Devices

03-1

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).