Wrist - Type Fully Automatic Digital Blood Pressure Monitor

K152426 · Sejoy Electronics & Instruments Co., Ltd. · DXN · Nov 9, 2015 · Cardiovascular

Device Facts

• Record ID: K152426
• Device Name: Wrist - Type Fully Automatic Digital Blood Pressure Monitor
• Applicant: Sejoy Electronics & Instruments Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 9, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with cuff circumference of 13.5 - 21.5 cm.

Device Story

Wrist-worn, fully automatic digital blood pressure monitor; uses inflatable cuff and internal pump. Operates via oscillometric method with silicon integrated pressure sensor. Mechanical valve controls deflation; automatic pressure release at end of cycle. Safety limit set at 300 mmHg. Device displays systolic, diastolic, and pulse rate on LCD. Models BP-2220, BSP-21, and BSP-22 include irregular heartbeat detection and average of last three measurements; BP-2116 lacks these features. Results compared against WHO blood pressure classifications (Optimal to Severe Hypertension) with corresponding LCD segments. Used by patients or clinicians in home or clinical settings. Provides objective blood pressure data to assist in monitoring and hypertension management.

Clinical Evidence

Clinical validation performed per ISO 81060-2:2013 (non-invasive sphygmomanometers - clinical validation of automated measurement type). Results confirmed accuracy requirements met.

Technological Characteristics

Wrist-type oscillometric monitor; silicon integrated pressure sensor; internal pump; mechanical deflation valve. Materials biocompatible per ISO 10993-5 and ISO 10993-10. Complies with AAMI/ANSI/IEC 80601-2-30:2009. LCD display. Battery-powered. No connectivity specified.

Indications for Use

Indicated for adults and adolescents aged 12-21 years with wrist circumference 13.5-21.5 cm for measurement of systolic/diastolic blood pressure and pulse rate.

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

• Blood Pressure Monitor (Model BP-2206) (K121355)

Submission Summary (Full Text)

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

November 9, 2015

Sejoy Electronics & Instruments Co., Ltd. Mr. Ren Yunhua General Manager Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone Hangzhou. 310030 CN

Re: K152426

> Trade/Device Name: Wrist - Type Fully Automatic Digital Blood Pressure Monitor (BP-2116, BP-2220, BSP-21, BSP-22) Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: December 15, 2014 Received: September 8, 2015

Dear Mr. Ren Yunhua,

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman -S

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

510(k) Number (if known) K152426

Device Name

Wrist - Type Fully Automatic Digital Blood Pressure Monitor (BP-2116, BP-2220, BSP-21, BSP-22)

Indications for Use (Describe)

Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with cuff circumference of 13.5 - 21.5 cm.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K152426 Page 1 of 4

# 510(k) Summary

The assigned 510(k) number is:

#### 2.1. Date Prepared:

2015.07.27

#### 2.2. Submitter's Identification:

Name: Sejoy Electronics & Instruments Co., Ltd.

Add .: Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone,

Hangzhou, China 310030

Contact Person: Yunhua Ren

Phone: [phone]

Fax: [phone]

Email: [e-mail]

#### 2.3. Name of the Device:

Trade Name: The Wrist-type Fully Automatic Digital Blood Pressure Monitor

Including the following models: BP-2116,BP-2220,BSP-21,BSP-22

Common Name: Blood Pressure Monitor

Classification name: Non-invasive blood pressure measurement System

21 CFR 870-1130, Class II, 74-DXN.

## 2.4. Classification Information:

Regulation Number: 870.1130 Product Code: DXN Device Class: II Panel: 74 Cardiovascular

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K152426 Page 2 of 4

#### 2.5. Predicate Device Information:

The Wrist-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following device: Blood Pressure Monitor (Model BP-2206), FDA 510(k) number: K121355 , manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD..

#### 2.6. Device Description:

The wrist-type Fully Automatic Digital Blood Pressure Monitor uses an inflatable cuff which is wrapped around the patient's wrist. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by "oscillometric method" and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure in the cuff is completely released automatically at the end of the measurement. At the same time, the measurements are displayed on the LCD display for three minutes. There is a maximum pressure safety setting at 300 mmHg, the device will not inflate the pressure of cuff higher than 300 mmHg.

For BP-2220, BSP-22, 120 memories are divided into two groups as the predicate device BP-2206, with 60 memories each group. For BP-2116, BSP-21, 120 memories are for one group. For BP-2116, BP-2220, BSP-21, BSP-22, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic and pulse rate information. BP-2220 , BSP-21 , BSP-22 can calculate the average of the last three measurements as the predicate device BP-2206. BP-2220, BSP-21, BSP-22 will display an irregular heartbeat symbol "(♥)" if an irregular heartbeat was detected during the measurement process. BP-2116 cancels Irregular Heartbeat Detection and "Last 3 results average". For BP-2220, BSP-22, there are 3 optional functions and there is 2 optional functions for BSP-21 as BP-2206, and there is no optional function for BP-2116.

The devices are all designed and manufactured according to AAMI / ANSI / IEC 80601-2-30:2009, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

## 2.7.Indications for Use:

Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with cuff circumference of 13.5 - 21.5 cm.

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K152426

Page 3 of 4

# 2.8.Summary comparing technological characteristics with predicate device:

| Technological Characteristics | Comparison result |
|-------------------------------|-------------------|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Mechanical Safety | Identical |

The difference of technological characteristics between the predicate device and the submit wrist-type fully automatic blood pressure monitors is the appearance and the function.

## 2.9. Non-clinical Tests:

Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2007;

General Safety Provisions Test according to AAMI/ANSI ES 60601-1:2005/(R) 2012 and C1:2009/(R) 2012 and A2:2010/(R)2012;

Performance Test according to IEC 80601-2-30:2009, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

The test result all meet or exceed the requirement of the standards.

Biocompatibility Test according to FDA Bluebook Memorandum G95-1Use of International Standard ISO 10993, ISO 10993-5: 2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.

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Image /page/6/Picture/0 description: The image shows the word "SEJOY" in blue font. There is a small orange triangle above the "J" in the word. The font is bold and the letters are close together. The background is white.

世佳电子有限公司 Sejoy Electronics & Instruments Co., Ltd.

> K152426 Page 4 of 4

#### 2.10. Discussion of Clinical Tests Performed:

Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

#### 2.11. Conclusions:

The Wrist-type Fully Automatic Blood Pressure Monitors BP-2116, BP-2220, BSP-21, BSP-22 have the same intended use and similar technological characteristics as the Blood Pressure Monitor manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. (Model BP-2106, FDA 510(k) number: K121355).

Moreover, verification and validation tests as part of this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared devices.

In the other words, those engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device, and the new models as mentioned on this submission are considered substantial equivalent to the predicate devices.