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 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.

AI/ML Overview

The document describes a 510(k) submission for the Sejoy Electronics & Instruments Co., Ltd. Wrist - Type Fully Automatic Digital Blood Pressure Monitors (models BP-2116, BP-2220, BSP-21, BSP-22). The submission aims to demonstrate substantial equivalence to a predicate device (Blood Pressure Monitor, Model BP-2206, K121355).

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that clinical tests were performed to 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.

While the specific numerical acceptance criteria (e.g., mean difference and standard deviation between device and reference measurements) are not explicitly stated in a table within this document, ISO 81060-2 outlines detailed requirements for blood pressure device accuracy. Generally, for blood pressure measurement devices, the acceptance criteria are related to:

Mean Difference: The average difference between the device readings and reference measurements (typically auscultation with a sphygmomanometer performed by trained observers). The standard usually requires this to be within a few mmHg (e.g., ±5 mmHg).
Standard Deviation (or Variance): The variability of these differences. The standard usually requires this to be below a certain threshold (e.g., 8 mmHg).
Individual Differences: A certain percentage of individual differences must fall within predefined limits.

The document reports that the "Clinical tests were performed and comply with the accuracy requirements of ISO 81060-2 Second edition 2013-05-01." This statement serves as the reported device performance, indicating that the device met the specified accuracy criteria defined by the ISO standard.

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

Sample Size for Test Set: The document does not explicitly state the sample size used for the clinical validation study. ISO 81060-2, however, specifies minimum sample sizes for clinical validation (e.g., typically a minimum of 85 subjects with specific distributions across age, gender, and blood pressure ranges). The assertion of compliance implies these minimums were met.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Clinical validation studies according to ISO 81060-2 are typically prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: The document does not explicitly state the number of experts used. However, for clinical validation studies of blood pressure devices generally performed according to ISO 81060-2, at least two trained observers (experts) are required to take independent auscultatory measurements simultaneously to establish the reference blood pressure.
Qualifications of Experts: The document does not explicitly state the specific qualifications of the experts. In the context of ISO 81060-2, these experts would typically be trained clinicians (e.g., physicians, nurses, or technicians) competent in the auscultatory method of blood pressure measurement.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not explicitly describe the adjudication method. For blood pressure validation studies using two observers, if there are significant disagreements between their readings, a third observer might be involved, or a specific predefined method for resolving discrepancies is used (e.g., averaging, excluding outliers). ISO 81060-2 provides guidelines for such situations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document pertains to a blood pressure monitor, which is a measurement device, not an imaging interpretation tool. Therefore, an MRMC study with "human readers improve with AI vs without AI assistance" is not applicable in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the clinical validation described is essentially a standalone performance assessment of the device's accuracy against a known reference standard (auscultatory measurements). The device operates automatically without direct human intervention in the measurement process after initiation. The comparison is between the automated device's output and the expert human measurements, making it an assessment of the algorithm/device's performance on its own.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used is expert auscultatory blood pressure measurements. These are considered the gold standard for clinical validation of automated blood pressure devices according to ISO 81060-2.

8. The Sample Size for the Training Set

Training Set Sample Size: The document does not provide information about a training set size. Blood pressure monitors typically do not involve "training sets" in the same way as AI/ML algorithms that learn from data. The device's algorithm for determining blood pressure (oscillometric method) is typically pre-programmed and validated, rather than continuously "trained" on new data in the field.

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

Training Set Ground Truth: As there's no mention of a traditional "training set" in the context of an AI/ML algorithm that learns from data, this question is not applicable in the same way it would be for an AI-powered diagnostic tool. The "ground truth" for calibrating or developing the oscillometric algorithm during its initial design would have been established through controlled experimental settings and comparisons to invasive arterial measurements or highly accurate auscultatory methods. However, this document pertains to the validation of a finished device against the ISO standard, not its internal development process.

Summary

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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 (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.

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: +86-571-81957767

Fax: +86-571-81957750

Email: renyh@sejoy.com

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:

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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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.

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).