KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201

K083043 · Shenzhen Kingyield Technology Co., Ltd. · DXN · Oct 27, 2008 · Cardiovascular

Device Facts

• Record ID: K083043
• Device Name: KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
• Applicant: Shenzhen Kingyield Technology Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

BP201 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 not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

Device Story

Fully automatic wrist-worn blood pressure monitor; uses oscillometric method to measure systolic/diastolic blood pressure and heart rate. Device features built-in air pump to inflate cuff; MCU controls inflation rate at 2-5mmHg/second. User operates device via START/STOP button; results displayed on LCD. Intended for home or clinical use by adults. Provides non-invasive monitoring; aids in health assessment. Differences from predicate include physical size, shape, and weight.

Clinical Evidence

Clinical comparison study performed against auscultatory method using trained observers. Demonstrated statistically and clinically acceptable repeatability. Device complies with ANSI/AAMI SP10:2002 and BS EN1060-4:2004 standards.

Technological Characteristics

Oscillometric measurement principle; built-in air pump; LCD display. MCU-controlled inflation (2-5mmHg/s). Standards: ANSI/AAMI SP10:2002, BS EN1060-4:2004, IEC60601-1, IEC60601-1-2.

Indications for Use

Indicated for adult population for measuring systolic and diastolic blood pressure and heart rate at home or in medical centers. Contraindicated for neonatal patients and individuals with bleeding or wounds on the wrist/arm.

Regulatory Classification

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.

Predicate Devices

• IEM-609N Digital Blood Pressure Monitor with Intelligence (K042505)

Submission Summary (Full Text)

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K083043
P1/4

SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Annex35 510K Summary

# 510(k) Summary

l . Submitter's Name: Mr. Dacheng Gong, Manager

OCT 2 7 2008

#### SHENZHEN KINGYIELD TECHNOLOGY CO., LTD.

Address: Section CI-2, Fu'Hai Industrial Zone, Fu'Yong Street,

Bao'An District, Shenzhen, PR China

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

### Contact person:

Name1: Mr. Dacheng Gong,

Title: Manager

Name2: Ms. Xuecai Wang

Title; Asistant manager

Phone: [phone]

Fax: [phone]

e-mail: [e-mail]

Date of Summary: Jan. 12 2007

2. Trade Name: BP201 Wrist Blood Pressure Monitor

3. Classification Name

Non-invasive Blood Pressure Measurement System.

Regulation Number: 21 CFR 870.1130

Class: II

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4. Product Code: DXN

5. Classification Panel: Cardiovascular

6. Predicate Device: IEM-609N Digital Blood Pressure Monitor with Intelligence marketed by Omron Healthcare INC.

K 042505 (Predicate)

### 7. Device Description:

BP201 Wrist Blood Pressure Monitor is a fully automatic non-invasive blood pressure monitor which measures systolic and diastolic blood pressure and heart rate of adult population using the oscillometric method by inflating an inflatable cuff on the wrist.

#### The Intended use:

BP201 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 not be used while the wrist (arm) has bleeding or wound to avoid the blood flowing from the wound in pressurizing.

## 8. Performance and Technological Characteristics :

## 8.1 Performance Summary

In terms of operating specification, Safety & EMC requirements, the

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#### SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Annex35 510K Summary

device conform to applicable standards including ANSI/AAMI SP10:2002, BS EN1060-4: 2004, IEC60601-1:1998+A1:1991+A2:1995 IEC 60601-1-2:2001/A1:2004. A comparison study with a device that uses auscultatory method used by trained observers was performed to validate the performance of BP201. The comparison study demonstrated that the clinical repeatability of BP201 is statistically and clinically acceptable.

### 8.2 Technological Characteristics

BP201 Wrist Blood Pressure Monitor uses an inflated cuff which is wrapped around the wrist .The cuff is inflated by a built-in air pump. The systolic and diastolic blood pressures are determined by Oscillometric method. The inflation rate is controlled by MCU at a constant rate 2~5mmHg/second. The user can release the cuff to stop measuring by pressing the "START/STOP" button at any time while measuring. The measuring result is displayed in LCD.

## 9. Substantial equivalence discussion

#### 9.1. About the non-clinical tests

BP201 Digital Wrist Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate device HEM-609N, such as Measurement localization, Measuring parameters, Measurement range, Measurement Accuracy, Inflation, Deflation, Measurable

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circumference of wrist, Power source, Battery life, Operate environment, Preservation environment.

The main differences are the physical size, shape and weight, and there is no any new issue of safety and effectiveness.

So the non-clinical performance information demonstrates the equivalence of the non-clinical performance.

In a word, BP201 is equivalent to the predicate device for the non-clinical performance.

### 9.2. About the clinical tests

The device complies with the ANSI/AAMI SP10:2002 standard and BS EN1060-4: 2004 in its entirety. Thus BP201 & the predicate device HEM-609N are substantially equivalent.

### 10. Conclusion

BP201 Wrist Blood Pressure Monitor has the same intended use, the same technological characteristics as the predicate devicc HEM-609N Moreover, non-clinical testing & clinical testing contained in this submission demonstrated that any difference in their technological characteristics does not raise any new issues of safety and effectiveness. In a word, BP201 is substantial equivalent to the predicate device HEM-609N

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 7 2008

Shenzhen Kingyield Technology Co., Ltd. c/o TUV Rheinland of North America, Inc. Mr. Tamas Borsai Division Manager, Medical Division 12 Commerce Rd. Newton, CT 06470

Re: K083043

Trade/Device Name: BP201 Wrist Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 10, 2008 Received: October 14, 2008

#### Dear Mr. Borsai:

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. 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

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Page 2 - Mr. Tamas Borsai

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 [phone]. Also, please note the regulation entifled, "Misbranding by reference to promarket 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

R. Wachner

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 KINGY(ELD TECHNOLOGY CO., LTD. BP201 Wrist Blood Pressure Monitor Anne37 Indication for Use Statement

# Indications for Use Statement

510(k) Number (if known): K083043

Device Name: BP201 Wrist Blood Pressure Monitor

Indications For Use:

It can be used as medical assistant instrument at home or in medical center for adult population for measuring systolic and diastolic blood pressure and heart rate.

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

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

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)

uma R. Schmer

(Division Sign-Off)
Division of Cardiovascular Devices

KOB3043 510(k) Number