ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR

K120554 · Sejoy Electronics & Instruments Co., Ltd. · DXN · Aug 10, 2012 · Cardiovascular

Device Facts

• Record ID: K120554
• Device Name: ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
• Applicant: Sejoy Electronics & Instruments Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Aug 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Fully Automatic Blood Pressure Monitors BP series and BM 40 are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.

Device Story

Arm-type digital blood pressure monitors use an inflatable cuff wrapped around the upper arm. An internal pump automatically inflates the cuff; a preset mechanical valve controls deflation at a constant rate. The device utilizes the oscillometric method and silicon integrated pressure sensor technology to determine systolic and diastolic blood pressure and pulse rate. Measurements are displayed on an LCD for three minutes. Safety features include a 300 mmHg maximum pressure limit and automatic shut-off after three minutes of inactivity. Select models (BP-103H, BP-1304, BP-1305, BP-1307, BM 40) compare results against WHO blood pressure classifications (Optimal to Severe Hypertension) and display an irregular heartbeat symbol if detected. Certain models (BM 40, BP-1307) provide average results for all, AM, or PM measurements; others (BP-103H, BP-1304, BP-1305) calculate the average of the last three measurements. The device is intended for adult self-use or clinical use to monitor blood pressure, aiding in the management of hypertension.

Clinical Evidence

Clinical tests were performed to verify accuracy requirements in accordance with ANSI/AAMI SP10:2002/(R) 2008, ANSI/AAMI SP10:2002/A1:2003/(R) 2008, and ANSI/AAMI SP10:2002/A2:2006/(R) 2008. The devices met or exceeded the requirements of these standards.

Technological Characteristics

Arm-type digital sphygmomanometer; oscillometric measurement principle; silicon integrated pressure sensor; powered by 4 AA batteries or AC adapter; LCD display; automatic inflation/deflation; biocompatible patient-contact materials; compliant with ANSI/AAMI SP10, IEC/EN 60601-1, and ISO 10993 standards.

Indications for Use

Indicated for adults 12 years and older to measure 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

• Premier Blood Pressure Monitor (Model: UA-1020) (K111686)

Submission Summary (Full Text)

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PS lot 5

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

## 510(k) Summary

AUG 1 0 2012

The assigned 510(k) number is: K120554

#### 1. Date Prepared:

2011.11.25

### 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]

#### 3. Name of the Device:

Trade Name: Fully Automatic Digital Blood Pressure Monitor Including the following models:

- BP series

- BP-102, BP-103, BP-103H, BP-1209, BP-1303A, BP-1304, BP-1305, BP-1307 for Arm-type Fully Automatic Digital Blood Pressure Monitor and
- BM 40 for Arm-type Fully Automatic Digital Blood Pressure Monitor

Common Name: Blood Pressure Monitor

Classification name: Non-invasive blood pressure measurement System 21 CFR 870-1130, Class II, 74-DXN.

#### Classification Information: 4.

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

### Predicate Device Information: న.

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

The Arm-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following device:

Premier Blood Pressure Monitor (Model: UA-1020), FDA 510(k) K111686, manufactured by A&D Company, Limited.

#### 6. Device Description:

The arm-type uses an inflatable cuff which is wrapped around the patient's upper arm. 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 of 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 minute. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. For BP-103H, BP-1304, BP-1305, BP-1307, BM 40, the blood pressure results are compared with WHO (World Health Organization) Blood Pressure classification, which are severe Hypertension, Moderate Hypertension, Mild Hypertension, High-normal, Normal, and Optimal. The corresponding LCD segment will be turned on along with the systolic, diastolic, and pulse rate information. BP-103H, BP-1304, BP-1307, BM 40 will display an irregular heartbeat symbol "( if an irregular heartbeat was detected during the measurement process. BM 40, BP-1307 can display average results in three ways: the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements. BP-103H, BP-1304, BP-1305 can calculates the average of the last three measurements. In addition, BP-1307 has LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.

| Features<br>Models | A | B | C | D | E | F | G | H | I | J | K | L |
|--------------------|---|---|--------------------------------|---|---|---|---|---|------------|---------|-----------|---|
| BP-102 | ● | ● | 120 Memories | ○ | ○ | ○ | ○ | ○ | 150×112×56 | 22-36cm | 83×35 | ○ |
| BP-103 | ● | ● | 120 Memories in<br>four groups | ● | ○ | ○ | ○ | ○ | 110×155×70 | 22-36cm | 84.1×55.1 | ○ |
| BP-103H | ● | ● | 120 Memories in<br>four groups | ● | ○ | ● | ● | ● | 110×99×66 | 22-36cm | 84.1×55.1 | ○ |
| BP-1209 | ● | ● | 120 Memories | ● | ○ | ○ | ○ | ○ | 134×99×66 | 22-36cm | 62.7×46.4 | ○ |
| BP-1303A | ● | ● | 120 Memories in<br>four groups | ● | ○ | ○ | ○ | ○ | 110×155×70 | 22-36cm | 62.7×46.4 | ○ |
| BP-1304 | ● | ○ | 120 Memories in<br>four groups | ● | ○ | ● | ● | ● | 110×155×70 | 22-36cm | 62.7×46.4 | ○ |

The detail comparisons among devices are listed below:

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| BP-1305 | • | • | 120 Memories in<br>two groups | • | o | • | • | • | 166×114×72 | 22-36cm | 84.1×55.1 | o |
|---------|---|---|-------------------------------|---|---|---|---|---|------------|-----------------------|------------|---|
| BP-1307 | • | • | 120 Memories in<br>two groups | • | • | o | • | • | 166×114×72 | 22-36cm | 102.1×68.9 | • |
| BM 40 | • | • | 120 Memories in<br>two groups | • | • | o | • | • | 119×109×60 | 22-35cm or<br>30-42cm | 83.4×54.41 | o |

世佳电子有限公司

A = Powered by 4 AA size batteries

B= Powered by AC adaptor

C = Memory Size

D = Time & Date

E = Results Average in Three way

F = WHO (World Health Organization) Classification Indicator

G = Last 3 Results Average

H = Irregular Heartbeat Detection

I = Outside Demission (L x W x H in mm)

J = Cuff Size

K = LCD Size (Viewing Area in mm)

L = LCD Backlight

• = Yes

o = No

The devices are all designed and manufactured according to ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008, manual, electronic or automated sphygmanometers.

# 7. Intended Use:

The Fully Automatic Blood Pressure Monitors BP series and BM 40 are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.

The intended user and the indication for use of the Fully Automatic Blood Pressure Monitors BP series and BM 40 as described in the labeling are nearly the same as their predicated devices, Premier Blood Pressure Monitor (Model: UA-1020).

#### 8. Summary comparing technological characteristics with predicate device:

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

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

| Biocompatibility | Identical |
|-------------------|-----------|
| Mechanical Safety | Identical |
| Energy Source | Similar |
| Standards Met | Identical |
| Electrical Safety | Identical |
| EMC | Identical |
| Function | Similar |

The difference of technological characteristic between the predicate device and the submit arm-type fully automatic blood pressure monitors is the appearance, the performance, energy source and the function.

# 9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards including ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 as well as IEC/EN 60601-1: 2005+CORR.1 (2006) +CORR.2 (2007) / EN 60601-1:2006 /AC: 2010, IEC/EN 60601-1-2:2007, 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.

Guidance documents include the "FDA Non-invasive Blood Pressure (NIBP) Monitor Guidance" and "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "FDA Bluebook Memorandum G95-1Use of International Standard ISO 10993."

### Non-clinical Tests:

- Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2007 .
- . General Safety Provisions Test according to IEC/EN 60601-1: 2005+CORR.1 (2006) +CORR.2 (2007) / EN 60601-1:2006 /AC: 2010
- . Performance Test according to ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008. 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.

### 10. Discussion of Clinical Tests Performed:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI

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Image /page/4/Picture/1 description: The image shows the word "SEJOY" in bold, black letters. The letters are slightly spaced apart, and the font appears to be sans-serif. There is a small, indistinct mark above the "J" in the word. The overall impression is a simple, clear logo or brand name.

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

SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 "National Standard for Manual, Electronic or Automated Sphygmomanometers".

### 11. Conclusions:

Our Arm-type Fully Automatic Blood Pressure Monitors BP-102, BP-103, BP-103H, BP-1209, BP-1303A, BP-1304, BP-1305, BP-1307 and BM 40 have the same intended use and similar technological characteristics as the A&D Premier Blood Pressure Monitor (Model: UA-1020) whose 510 (k) number is K111686.

Moreover, verification and validation tests contained in 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 difference 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.

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Image /page/5/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion.

### Public Health Service

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

AUG 1 0 2012

Sejoy Electronics & Instruments Co., Ltd. c/o Mr. Edmondo Roark 1259 Monten Street #4 Cincinnati, OH 45208

Re: K120554

> Trade/Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor - (Nine Models: BP-102, BP-103, BP-103H, BP-1209, BP-1303A, BP-1304, BP-1305, BP-1307 and BM 40)

Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN Dated: July 23, 2012 Received: July 23, 2012

Dear Mr. Roark:

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 r ou may) are so revisions 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 – Mr. Roark

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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely yours,

C. Bram D. Zuckerman, 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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EJO

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

# Indications for Use

510(k) Number (if known):

Blood Pressure Monitors BP series and BM 40 Device Name:

Indications For Use:

Measure blood pressure (systolic and diastolic) and pulse rate.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use V (21 CFR 801 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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sion Sign-Off) sion of Cardiovascular Devices

510(k) Number