Measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age with arm circumference of 22- 42cm.

Device Description

The Arm-Type Fully Automatic Digital Blood Pressure Monitor 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-35, 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-35 will display an irregular heartbeat symbol " (♥) " if an irregular heartbeat was detected during the measurement process. It can display average results in three ways.

AI/ML Overview

The provided text describes the Arm-Type Fully Automatic Digital Blood Pressure Monitor, BP-35. Here's a breakdown of the acceptance criteria and the study information:

Acceptance Criteria and Reported Device Performance

The device's performance is assessed against the accuracy requirements of ISO 81060-2:2013-05-01, "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type."

Acceptance Criteria (Standard Reference: ISO 81060-2:2013)	Reported Device Performance
Defined accuracy requirements of ISO 81060-2:2013-05-01	Clinical tests were performed, and the device "comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01." (Specific quantitative performance metrics like mean difference and standard deviation are not provided in this document, but the statement indicates compliance with the standard's outlined accuracy thresholds.)

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for the clinical test set.
- Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). However, the clinical validation study would inherently be prospective in nature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated in the provided text. ISO 81060-2 typically requires measurements from trained observers using mercury sphygmomanometers or an equivalent calibrated standard device as the reference (ground truth).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated in the provided text. ISO 81060-2 specifies a protocol for obtaining reference blood pressure measurements, often involving multiple observers.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The clinical tests were performed to validate the accuracy of the automated device itself, which operates without human intervention during the measurement process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for blood pressure monitor validation studies is typically established by trained observers using a calibrated reference method, such as a mercury sphygmomanometer or an equivalent standard. This is an implied requirement of ISO 81060-2.
The sample size for the training set:
- This is not applicable as the device is a standalone blood pressure monitor based on oscillometric technology and does not involve machine learning algorithms that require a separate training set. The "training" in this context refers to the development and calibration of the device's internal algorithms, not a data-driven machine learning training set.
How the ground truth for the training set was established:
- Not applicable for the reason stated above. The device's internal algorithms are based on established physiological principles and engineering design, not a machine learning training process with an external ground truth dataset.

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

October 16, 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: K152687

Trade/Device Name: Arm-Type Fully Automatic Digital Blood Pressure Monitor, BP-35 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-Invasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: September 15, 2015 Received: September 18, 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

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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 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 (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 vours.

Mitchell Stein

forBram 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) K152687

Device Name

The Arm-Type Fully Automatic Digital Blood Pressure Monitor, BP-35

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 arm circumference of 22- 42cm.

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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K152687

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510(k) Summary

The assigned 510(k) number_

2.1. Date Prepared:

2015.08.31

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: +86-571-81957767

Fax: +86-571-81957750

Email: renyh@sejoy.com

2.3. Name of the Device:

Trade Name: The Arm-Type Fully Automatic Digital Blood Pressure Monitor

Including the following models: BP-35

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

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K152687

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Product Code: DXN Device Class: II

Panel: 74 Cardiovascular

2.5. Predicate Device Information:

The Arm-Type Fully Automatic Digital Blood Pressure Monitor are substantially equivalent to the following device: device: Blood Pressure (Model BP-35) , FDA 510(k) number: K141755, manufactured ELECTRONICS & INSTRUMENTS CO., LTD.

2.6. Device Description:

For BP-35, 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-35 will display an irregular heartbeat symbol " (♥) " if an irregular heartbeat was detected during the measurement process. It can display average results in three ways.

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Image /page/5/Picture/0 description: The image shows the logo for SEJOY. The logo is in blue, with the letters "SEJOY" in a bold, sans-serif font. There is a small orange triangle above the "J" in the logo. The logo is simple and modern.

K152687

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The device is 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 arm circumference of 22- 42cm.

2.8. Difference of comparison with predicate device:

The difference between the predicate device and submit Arm-type fully automatic blood pressure monitor is one new arm-cuff (Size: 22.0-42cm) added as optional.

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 logo for SEJOY. The logo is blue and has an orange triangle above the "J". The logo is simple and modern.

<152687 age 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 submit Arm-type Fully Automatic Blood Pressure Monitor is itself of the predicate device BP-35 manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. (FDA 510(k) number: K141755). The addition of new arm-cuff (Size: 22cm-42cm) will not: (1) affect the intended use or (2) alter the fundamental scientific technology of the devices

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).