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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Jawon Automatic Blood Pressure Monitor, Model EX PLUS 1300:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with the ANSI/AAMI Voluntary Standard, SP-10:2008. While the specific numerical acceptance criteria for blood pressure monitors according to this standard are not fully detailed in this document, the performance specifications provided are implicitly part of meeting this standard.

Characteristic	Acceptance Criteria (Implicitly per ANSI/AAMI SP-10:2008)	Reported Device Performance (Model EX PLUS 1300)
Accuracy - Pressure	Typically Mean Difference ≤ 5 mmHg, Std Dev ≤ 8 mmHg (per AAMI SP-10)	+/- 2mmHg (as specified in performance table)
Accuracy - Heart Rate	Typically +/- 5% or 5 bpm (depending on standard criteria)	+/- 3% (as specified in performance table)
Measurement Range - Pressure	(Not explicitly stated, but within typical human physiological range)	30 to 280 mmHg
Measurement Range - Heart Rate	(Not explicitly stated, but within typical human physiological range)	30 to 200 bpm

Important Note: The stated "Accuracy - pressure: +/- 2mmHg" is often interpreted as the device's inherent precision or resolution. The actual AAMI SP-10 standard for accuracy involves statistical analysis of the difference between device readings and a reference method (auscultation by trained observers), where the mean difference and standard deviation of differences are the key metrics. The document implies compliance with the standard but does not provide these specific statistical results for validation of the EX PLUS 1300 model itself.

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

Test Set Sample Size: No new clinical test data for the EX PLUS 1300 is provided. The document explicitly states: "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." And "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."
Data Provenance: Not applicable as no new clinical data was collected for this specific device. The clinical validation of the predicate device (EASY X 900(R/L)) would have involved data, but its provenance is not detailed here.

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

Not applicable as no new clinical study was conducted for the EX PLUS 1300. The ground truth method for the predicate device's validation (likely expert auscultation according to AAMI SP-10) is not detailed here.

4. Adjudication Method:

Not applicable as no new clinical study was conducted for the EX PLUS 1300.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The device's validation relies on its substantial equivalence to a predicate device and engineering/non-clinical testing.

6. Standalone Performance Study:

A standalone clinical performance study was not done for the EX PLUS 1300. The submission argues that because the EX PLUS 1300 uses "identical software codes and pressure detection related hardware" as the predicate device (Jawon Model EASY X 900(R/L)), and is essentially "two (2) sets of model EASY X 900(R/L) in one enclosure," a new clinical test was not required. The performance specifications are given for the EX PLUS 1300, but they are based on the proven performance of the predicate device.

7. Type of Ground Truth Used:

For the EX PLUS 1300, no new clinical ground truth was established. For the original predicate device validation (EASY X 900(R/L)), the ground truth for blood pressure measurement according to ANSI/AAMI SP-10 typically involves simultaneous auscultation by multiple trained observers using a mercury sphygmomanometer as the reference standard.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. It's an oscillometric blood pressure monitor.

9. How the Ground Truth for the Training Set Was Established:

Not applicable as this is not an AI/ML device requiring a training set.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

AND/OR

1. Patients with an artificial heart.
1. 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: 82-53-856-0993, Fax: 82-53-856-0995

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.#1208-12, Sinsang-ri, Jinryang-eup, Kyungsan-city, Kyungsang-Bukdo, 712-830, Republic of KoreaTel:82-53-856-0993, Fax:82-53-856-0995Establishment Registration Number: 9616164
Contact Person:	MEDMONTS Co., Ltd. (Mr. W.S.Park)Life-officetel 320, 40 63-ro, Youngdeungpo-gu, Seoul, 150-731,Republic of KoreaTel:82-2-6264-9001, Fax: 82-2-6269-9001E-mail: wpark19@gmail.com
Trade Name:	Automatic Blood Pressure MonitorModel EX PLUS 1300
Common Name:	Non-invasive Blood Pressure Monitor
Classification Name:	Noninvasive Blood Pressure Measurement System, 74 DXN
Predicate Device:	Automatic Blood Pressure MonitorJawon Model EASY X 900(R/L) (K092432)

Device descriptions:

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

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.
1. Patients with insufficient peripheral circulation, acute cases of low blood pressure or low temperature.
1. Patients who use a pacemaker.
1. Patients experiencing a seizure.
1. Children younger than 18 years old.
1. Patients who should not have blood pressure measurements taken from their arms.
1. Patients with an artificial heart.
1. 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) wrappedaround the single (or dual) upper arm(s).	One inflatable cuff is wrapped around thesingle 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.

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).