Blood pressure monitor model BP series are designed to measure the systolic, diastolic pressure and pulse rate of people by using a non-invasive technique. which is a well-known technique in the market called the "oscillometric method". BP-102 and BP-103 are the arm-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at upper-arm, and BP-201 and BP-202 are the wrist-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at wrist, and the devices are reusable for clinical and home use.

Device Description

Based on oscillometric and silicon integrate pressure sensor technology, blood pressure monitor model BP series ( BP-102, BP-103, BP-201, BP-202) are used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on the LCD. BP-102 and BP-103 are the arm-type Blood pressure monitors, which can measure the systolic, diastolic pressure and pulse rate at upper-arm. BP-102 could measure the systolic, diastolic pressure and pulse, and it could display last measurement. Base on the BP-102, the BP-103 is designed as a function expanding product. which have 120 times memories with date and time and the date and time can be reset too. BP-201 and BP-202 are the wrist-type Blood pressure monitors, which can measure the blood pressure and pulse rate at wrist. The devices are reusable for clinical and home use. BP-201 could measure the systolic, diastolic pressure and pulse, and it could display last measurement. Base on the BP-201. the BP-202 is designed as a function expanding product, which have 120 times memories with date and time and the date and time can be reset

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Blood Pressure Monitor Model BP series, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state the numerical acceptance criteria from ANSI/AAMI SP10:2002 in a table format, nor does it provide specific numerical performance results. However, it does state that the device meets or exceeds these accuracy requirements.

Acceptance Criteria (from ANSI/AAMI SP10:2002)

Parameter	Acceptance Criteria (from ANSI/AAMI SP10:2002)	Reported Device Performance
Blood Pressure Accuracy	The ANSI/AAMI SP10:2002 standard dictates specific accuracy requirements for electronic sphygmomanometers, typically concerning the mean difference and standard deviation of blood pressure measurements when compared to a reference standard (e.g., auscultatory method). The standard specifies that the mean difference between the device and the reference method should be within ±5 mmHg, with a standard deviation of no more than 8 mmHg.	"meet or exceed the accuracy requirements of the standards" and "meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002."
Clinical Bias	(Implicit in ANSI/AAMI SP10:2002 accuracy criteria)	Clinical data was presented which evaluated clinical bias, and the results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002.
Clinical Uncertainty	(Implicit in ANSI/AAMI SP10:2002 accuracy criteria)	Clinical data was presented which evaluated clinical uncertainty, and the results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002.
Clinical Repeatability	(Implicit in ANSI/AAMI SP10:2002 accuracy criteria)	Clinical data was presented which evaluated clinical repeatability per the Sejoy Clinical Test Protocol outline, and the results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002.

Note: While the exact numerical criteria for ANSI/AAMI SP10:2002 are not provided in this document, the standard typically requires a mean difference of +/- 5 mmHg and a standard deviation of 8 mmHg when compared to a reference method. The submission explicitly states the device meets or exceeds these.

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

Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Controlled human clinical studies were conducted using the Blood Pressure Monitor model BP series."
Data Provenance: Not explicitly stated in the provided text (e.g., country of origin, retrospective/prospective). It only mentions "Controlled human clinical studies were conducted." Given the submitter's location (China), it's plausible the studies were conducted there, but this is not confirmed.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. For blood pressure devices conforming to ANSI/AAMI SP10, ground truth is typically established by trained observers using the auscultatory method, but no details are provided here.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated in the provided text.

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

Was an MRMC study done? No. This type of study is more common for imaging devices where human readers interpret images with and without AI assistance. For a blood pressure monitor, the performance is typically evaluated as a standalone device against a reference method.
Effect Size of Human Readers' Improvement: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10:2002" indicates that the device's measurements were evaluated directly against a reference standard to assess its accuracy without human intervention in the measurement process itself (though human observers would be involved in obtaining the reference measurement). The "Performance Test according to ANSI/AAMI SP10:2002" also confirms a standalone performance evaluation.

7. Type of Ground Truth Used

For blood pressure monitors conforming to ANSI/AAMI SP10:2002, the ground truth is typically established using the auscultatory method (manual measurement by trained observers using a stethoscope and sphygmomanometer) as the reference standard against which the automated device's readings are compared. The document states "Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline," which implies comparison against a gold standard.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated. The document refers to "Controlled human clinical studies," which would be the test set for performance evaluation, but does not distinguish between training and testing data for algorithm development. For a device based on oscillometric technology, the "training" aspect is more about calibrating the underlying algorithm to accurately interpret pressure oscillations rather than a large-scale supervised learning dataset as seen in modern AI/ML applications.

9. How Ground Truth for the Training Set Was Established

The document does not provide details on how ground truth was established for a "training set." Given the device's technology (oscillometric method), the "training" (or calibration) would likely involve comparing the device's derived blood pressure values against reference auscultatory measurements on a smaller set of subjects to optimize the oscillometric algorithm's interpretation parameters. However, this is not explicitly detailed in the provided text.

Summary

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080789 #//3

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of AAMI SP10:2002 and 21 CFR § 870-1130.

The assigned 510(k) number is:

】. Submitter's Identification:

Name: SEJOY ELECTRONICS &. INSTRUMENTS CO., LTD Add .: 4th Floor, B2 Building, Feng-Tan-Lu Industrial Zone, West Lake District, Hangzhou, P. R. China

Name of the Device: 2.

Proprietary Name: Blood Pressure Monitor Model BP Series

Including: Arm-Type Fully Automatic Digital Blood Pressure Monitor	BP-102
Arm-Type Fully Automatic Digital Blood Pressure Monitor	BP-103
Wrist-Type Fully Automatic Digital Blood Pressure Monitor	BP-201
Wrist-Type Fully Automatic Digital Blood Pressure Monitor	BP-203

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

Predicate Device Information: 3.

For submitted devices BP-102 and BP-103 :

Memory Automatic Electronic Blood Pressure Monitor (Model: KD-575) 510(k) number: K042418

Applicant: KODON (TIANJIN) ELECTRONIC&ELECTRICAL APPARATUS CO.

KODON (TIANJIN) ELECTRONIC&ELECTRICAL APPARATUS CO. Owner:

For submitted devices BP-201 and BP-202:

Memory Wrist Automatic Electronic Blood Pressure Monitor (Model: KD-726) 510(k) number: K030359

Applicant: KODON (TIANJIN) ELECTRONIC&ELECTRICAL APPARATUS CO. KODON (TIANJIN) ELECTRONIC&ELECTRICAL APPARATUS CO. Owner:

4. Device Description:

Page ! of 3

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BP-102 and BP-103 are the arm-type Blood pressure monitors, which can measure the systolic, diastolic pressure and pulse rate at upper-arm. BP-102 could measure the systolic, diastolic pressure and pulse, and it could display last measurement. Base on the BP-102, the BP-103 is designed as a function expanding product. which have 120 times memories with date and time and the date and time can be reset too.

BP-201 and BP-202 are the wrist-type Blood pressure monitors, which can measure the blood pressure and pulse rate at wrist. The devices are reusable for clinical and home use. BP-201 could measure the systolic, diastolic pressure and pulse, and it could display last measurement. Base on the BP-201. the BP-202 is designed as a function expanding product, which have 120 times memories with date and time and the date and time can be reset

ഗ് Intended Use:

Blood pressure monitor model BP series are designed to measure the systolic, diastolic pressure and pulse rate of people by using a non-invasive technique. which is a well-known technique in the market called the "oscillometric method". BP-102 and BP-103 are the arm-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at upper-arm, and BP-201 and BP-202 are the wrist-type Blood Pressure Monitors, which can measure the systolic. diastolic pressure and pulse rate at wrist, and the devices are reusable for clinical and home use.

6. Comparison to Predicate Devices:

The device models BP-102. BP-103 are similar in design and intended use to the KODON Memory Automatic Electronic Blood Pressure Monitor (Model: KD-575) Differing mostly in physical dimensions.

The device models BP-201. BP-202 are similar in design and intended use to the KODON Memory Wrist Automatic Electronic Blood Pressure Monitor (Model: KD-726). Differing is mostly in physical dimensions and appearance.

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

Compliance to applicable voluntary standards including ANSI/AAM1 SP10: 2002 as well as IEC60601-1 and IEC60601-1-2, EN 1060-1:1995 and EN1060-3:1997 requirement.

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"

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Non-clinical Tests:

Electromagnetic Compatibility Test according to EN60601-1-2:2001 General Safety Provisions Test according to EN60601: 2001 Performance Test according to EN1060-1:1995 & EN1060-3:1997 Performance Test according to ANSI/AAMI SP10:2002 The test result all meet or exceed the accuracy requirement of the standards.

8. Discussion of Clinical Tests Performed:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10:2002 "National Standard for Manual, Electronic or Automated Sphygmomanometers"

Controlled human clinical studies were conducted using the Blood Pressure Monitor model BP series. Clinical data was presented which evaluated clinical bias, clinical uncertainty and clinical repeatability per the Sejoy Clinical Test Protocol outline. The results meet or exceed the accuracy requirements of ANSI/AAMI SP10-2002.

Conclusions: த் .

The Blood Pressure Monitor model BP series, Model BP-102, BP-103 have the same intended use and similar technological characteristics as the Memory Automatic Electronic Blood Pressure Monitor (Model: KD-575). The Model BP-201 and BP-202 have the same intended use and similar technological characteristics as the Memory Wrist Automatic Electronic Blood Pressure Monitor (Model: KD-726). Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, the Blood Pressure Monitor Model BP Series are substantially equivalent to the predicate devices.

080789

3/3

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a human figure or a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 26 2008

Seiov Electronics and Instruments Co., Ltd. c/o Ms. Laura Danielson Program Manager TUV SUD AMERICA, INC. 1775 Old Highway 8 NW New Brighton, MN 55112-1891

Re: K080789

Blood Pressure Monitor, Models BP-102, BP-103, BP-201, BP-202 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: March 18, 2008 Received: March 20, 2008

Dear Ms. Danielson:

This letter corrects our substantially equivalent letter of April 03, 2008.

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 (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.

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.

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Page 2 - Ms. Laura Danielson

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vour

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):

Device Name:

Blood Pressure Monitor Model BP series

Indications For Use:

Blood pressure monitor model BP series are designed to measure the systolic, diastolic pressure and pulse rate of people by using & non-invasive technique. which is a well-known technique in the market called the "oscillometric method".

BP-102 and BP-103 are the arm-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at upper-arm, and BP-201 and BP-202 are the wrist-type Blood Pressure Monitors, which can measure the systolic, diastolic pressure and pulse rate at wrist, and the devices are reusable for clinical and home use.

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)

Bhumama

Division Sign-On)
Division of Cardiovascular Devices
510(k) Number Kox0789

Page 1 of 1

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).