AUTOMATIC BLOOD PRESSURE MONITOR

K140762 · Jawon Medical Co., Ltd. · DXN · Jul 2, 2015 · Cardiovascular

Device Facts

• Record ID: K140762
• Device Name: AUTOMATIC BLOOD PRESSURE MONITOR
• Applicant: Jawon Medical Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.

Device Story

Device measures blood pressure/pulse via non-invasive oscillometric technique using inflatable cuffs on single or dual upper arms. Microprocessor-controlled system includes air pump, electronic deflation valve, and pressure sensors. Device processes pressure oscillations to calculate systolic, diastolic, mean blood pressure, and heart rate; compares inter-arm readings. Used in clinical or home settings by medical professionals or patients. Output displayed on LCD screen; thermal printer included for hard copies. Facilitates monitoring of cardiovascular status and inter-arm pressure variance. Device essentially integrates two units of the predicate device into one enclosure.

Clinical Evidence

No clinical testing conducted. Substantial equivalence established via bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance validation against ANSI/AAMI SP-10:2008. Device utilizes identical software and hardware components as the predicate device.

Technological Characteristics

Oscillometric measurement method; microprocessor-controlled; AC adapter-powered (110-120 VAC). Includes air pump, electronic deflation valve (3-5 mmHg/sec), and pressure sensors. Digital LCD display. Thermal printer. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI SP-10:2008. Form factor: dual-unit enclosure for simultaneous dual-arm measurement.

Indications for Use

Indicated for adult individuals (18+ years) requiring measurement of systolic/diastolic blood pressure, pulse rate, mean blood pressure, and inter-arm pressure difference. Contraindicated for patients with known arrhythmia, insufficient peripheral circulation, acute hypotension, low temperature, pacemakers, seizures, artificial hearts, or those where arterial palpation is impossible or arm-based measurement is inappropriate.

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

• Automatic Blood Pressure Monitor, Jawon Model EASY X 900(R/L) (K092432)

Submission Summary (Full Text)

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Public Health Service

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

July 2, 2015

Jawon Medical Co., Ltd. % Woo Park Director Medmonts Co., Ltd. Life-Officetel 320, 40, 63-ro Youngdeungpo-Gu Seoul, 150-731 KR

Re: K140762

Trade/Device Name: Automatic Blood Pressure Monitor, Model EX PLUS 1300 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 20, 2014 Received: May 20, 2015

Dear Woo Park,

We have reviewed vour 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

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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 of medical devicerelated 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 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,

Mitchell Stein

for 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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Doc.No.: 012

Image /page/2/Picture/2 description: The image contains the logo for Jawon Medical. The word "JAWON" is in large, blue, bold letters. Below that, the word "MEDICAL" is in smaller, red letters. The website address, "www.jawon.com" is in red letters below the word "MEDICAL".

# Indications for Use

510(k) Number: 140762

Device Name: Jawon Automatic Blood Pressure Monitor Model EX PLUS 1300

#### Indications for use

The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.

## Contraindications for use

As with any non-invasive measurement device, there are clinical conditions which can influence the accuracy of the results. Also, the subject's position, physiological condition and other environmental factors can affect the measurement/calculation.

The EX PLUS 1300 Non-Invasive Blood Pressure Monitor should not be used with patients who have the following conditions:

- 1. Patients with a known arrhythmia.
- 2. Patients with insufficient peripheral circulation, acute cases of low blood pressure or low temperature.
- 3. Patients who use a pacemaker.
- 4. Patients experiencing a seizure.
- 5. Children younger than 18 years old.
- 6. Patients who should not have blood pressure measurements taken from their arms.

AND/OR

- 7. Patients with an artificial heart.
- 8. Patients whose artery cannot be found by palpation.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

Over-The-Counter Use _ √

(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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Doc. No.: 004

#1208-12, Sinsang-ri, Jinryang-eup, Kyungsan-city, Kyungsang-Bukdo, 712-830, Republic of Korea Tel: [phone], Fax: [phone]

Image /page/3/Picture/2 description: The image contains the logo for Jawon Medical. The word "JAWON" is written in large, blue, bold letters. Below that, the word "MEDICAL" is written in smaller, white letters on a red background. The website address "www.jawon.com" is written in red below the logo.

# 510(k) Summary

[As Required by 21 CFR 807.92]

# K140762

| Date Prepared: | Mar.20, 2014 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Jawon Medical Co., Ltd.<br>#1208-12, Sinsang-ri, Jinryang-eup, Kyungsan-city, Kyungsang-<br>Bukdo, 712-830, Republic of Korea<br>Tel:[phone], Fax:[phone]<br>Establishment Registration Number: 9616164 |
| Contact Person: | MEDMONTS Co., Ltd. (Mr. W.S.Park)<br>Life-officetel 320, 40 63-ro, Youngdeungpo-gu, Seoul, 150-731,<br>Republic of Korea<br>Tel:[phone], Fax: [phone]<br>E-mail: [e-mail] |
| Trade Name: | Automatic Blood Pressure Monitor<br>Model EX PLUS 1300 |
| Common Name: | Non-invasive Blood Pressure Monitor |
| Classification Name: | Noninvasive Blood Pressure Measurement System, 74 DXN |
| Predicate Device: | Automatic Blood Pressure Monitor<br>Jawon Model EASY X 900(R/L) (K092432) |

## Device descriptions:

The EX PLUS 1300 is a blood pressure monitor to non-invasively measure blood pressures and heart rate at the brachial site(s). The device employs oscillometric method. The device is a microprocessor-controlled and includes an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, LCD display of systolic and diastolic pressure readings and heart rate, and push buttons. The device employs a pressurement algorithm designed to detect, filter, process, and store pressure readings. The electronic deflation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy.

The EX PLUS 1300 is an AC adapter-powered.

## Indications for use

The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure systolic and diastolic blood pressures, pulse rate and mean blood pressure, and inter-arm pressure difference of an adult individual using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.

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Image /page/4/Picture/2 description: The image contains the logo for Jawon Medical. The word "JAWON" is written in large, blue, bold letters. Below that, the word "MEDICAL" is written in smaller, white letters on a red background. The website address "www.jawon.com" is written in red below the logo.

## Contraindications for use

As with any non-invasive measurement device, there are clinical conditions which can influence the accuracy of the results. Also, the subject's position, physiological condition and other environmental factors can affect the measurement/calculation.

The EX PLUS 1300 Non-Invasive Blood Pressure Monitor should not be used with patients who have the following conditions:

- 1. Patients with a known arrhythmia.
- 2. Patients with insufficient peripheral circulation, acute cases of low blood pressure or low temperature.
- 3. Patients who use a pacemaker.
- 4. Patients experiencing a seizure.
- 5. Children younger than 18 years old.
- 6. Patients who should not have blood pressure measurements taken from their arms.
- 7. Patients with an artificial heart.
- 8. Patients whose artery cannot be found by palpation.

#### Technologic characteristics:

The modified device EX PLUS 1300 has the same intended use and technology characteristics as predicate device EASY X 900 (R/L). The differences in this submission don't raise new questions concerning either safety or effectiveness.

## Comparison with

Predicate Device: The EX PLUS 1300 was compared with the EASY X 900(R/L) of which is the predicate device. The intended use of both models are same except that the subject device EX PLUS 1300 can measure both arms at the same time. Patient and/or physician can compare the blood pressures between right and left arms. The principle of operation and operating features are identical. Both the subject device and the predicate device incorporate a thermal printer. In terms of the product construction, the model EX PLUS 1300 is comprised of two (2) sets of model EASY X 900(R/L) in one enclosure.

| Subject device | Predicate Device |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| (model-Jawon EX PLUS 1300) | (model-Jawon EASY X 900(R/L) |
| One or two inflatable cuff(s) is (are) wrapped<br>around the single (or dual) upper arm(s). | One inflatable cuff is wrapped around the<br>single upper arm |

#### Non-clinical and Clinical Tests:

The modified device EX PLUS 1300 meets the requirements of IEC 60601-1 and IEC 60601-1-2. The EX PLUS 1300 was not clinically tested because the device uses the identical software codes and pressure detection related hardware as the predicate device to determine systolic, diastolic, and pulse rate.

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Image /page/5/Picture/2 description: The image contains the logo for Jawon Medical. The logo has the word "JAWON" in large blue letters. Below that, the word "MEDICAL" is in white letters on a red background. The website address, www.jawon.com, is in red letters below the red background.

#### Performance Specifications:

| Characteristic | Model EX PLUS 1300 |
|--------------------------------|--------------------|
| Measurement method | Oscillometric |
| Measurement range - pressure | 30 to 280 mmHg |
| Measurement range - heart rate | 30 to 200 bpm |
| Accuracy - pressure | +/- 2mmHg |
| Accuracy - heart rate | +/- 3% |
| Temperature limits | +10°C to 40°C |
| Humidity limits | Less than 95% |
| Power | 110-120 VAC, 60Hz |
| Display mode | Digital LCD screen |

Software Testing Software for the Model EX PLUS 1300 was designed and developed according to a robust software development process, and was rigorously verified and validated.

- Clinical Performance: As the modified device EX PLUS 1300 comprises of two sets of EASY X 900(R/L) of which are predicate device, no clinical test was conducted.
# Conformance

Assessment:

Risk analysis and necessary V&V activities was performed to demonstrate that the design outputs of the modified device meet the design input requirements.

#### Conclusions:

We have demonstrated that there are no significant differences between the Jawon Upper both arm automatic digital blood pressure monitor, Model EX PLUS 1300 and the predicate device, Model EASY X 900(R/L), in terms of safety and effectiveness based on electrical, and EMC test results per IEC 60601-1 and IEC 60601-1-2, and the ANSI/AAMI Voluntary Standard, SP-10:2008.