The Wrist-type Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.

Measure blood pressure (systolic and diastolic) and pulse rate.

Device Description

The wrist-type fully automatic digital blood pressure monitors 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 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-202H, BP-2208, 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-202H, BP-2206, BP-2208 will display an irregular heartbeat symbol " if an irregular heartbeat was detected during the measurement process. BP-2208 can display average results in three ways: the average of all measurements, the average of all AM (5:00 AM-8:59AM) measurements, and the average of all PM (18:00 PM-19:59 PM) measurements. BP-202H, BP-2206 can calculate the average of the last three measurements. In addition, BP-2208 have LCD backlight. After three minutes without operation, the blood pressure monitors turn off automatically.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission references the ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 standard for performance and clinical accuracy requirements. However, the document does not explicitly list the specific numerical acceptance criteria from this standard nor does it present a detailed table of the device's reported performance against these criteria. It only states:

"The test result all meet or exceed the requirement of the standards." (Non-clinical tests)
"Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10..." (Clinical tests)

To provide a hypothetical example of what such a table would look like if the specific values were provided in the submission (based on general knowledge of NIBP standards like AAMI SP10):

Acceptance Criteria (from ANSI/AAMI SP10)	Reported Device Performance
Systematic Error (Mean Difference)
Systolic BP: ≤ ±5 mmHg	(Not specified in document)
Diastolic BP: ≤ ±5 mmHg	(Not specified in document)
Random Error (Standard Deviation)
Systolic BP: ≤ 8 mmHg	(Not specified in document)
Diastolic BP: ≤ 8 mmHg	(Not specified in document)
Individual Difference (Cumulative % within thresholds)
% of readings within 5 mmHg: ≥ 60%	(Not specified in document)
% of readings within 10 mmHg: ≥ 85%	(Not specified in document)
% of readings within 15 mmHg: ≥ 95%	(Not specified in document)

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

Sample Size for Test Set: Not explicitly stated in the provided document. The document only mentions that "Clinical tests were performed."
Data Provenance: Not explicitly stated. Given the manufacturer's location (Hangzhou, China), it is plausible the data was collected there, but this is not confirmed. The document does not specify if the study was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The ANSI/AAMI SP10 standard typically requires a minimum of two trained observers to establish reference blood pressure measurements.
Qualifications of Experts: Not explicitly stated. The standard generally requires observers to be trained and validated in auscultatory blood pressure measurement using a mercury sphygmomanometer.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. For clinical validation according to ANSI/AAMI SP10, referent blood pressure is typically determined by trained observers using an auscultatory method. If multiple observers are used, their readings are usually averaged or adjudicated if they differ significantly. The document does not detail this.

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

MRMC Study: No, this type of study was not conducted or mentioned. The device described is an automated blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.

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

Standalone Performance: Yes, the clinical tests performed evaluate the standalone performance of the device itself (the "algorithm only," as it's an automated device). The accuracy requirements of ANSI/AAMI SP10 validate the device's ability to measure blood pressure independently.

7. The Type of Ground Truth Used

Type of Ground Truth: For the clinical accuracy studies (as per ANSI/AAMI SP10), the ground truth for blood pressure measurements is established by expert auscultatory measurements (typically using a mercury sphygmomanometer) conducted by trained observers.

8. The Sample Size for the Training Set

Sample Size for Training Set: The document makes no mention of a "training set" in the context of machine learning or AI. This device is a traditional oscillometric blood pressure monitor, not an AI/ML-driven device that typically requires distinct training and testing datasets for algorithm development. The "training" of such a device is inherent in its design, calibration, and manufacturing process based on established oscillometric principles.

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

Ground Truth for Training Set: Not applicable, as there is no mention of a separate training set or AI/ML algorithm development in the provided document. The device operates on established physiological principles and engineering.

Summary

{0}------------------------------------------------

K121355

page 1/5

SEJOY

丰田子有限公司 Sejoy Electronics & Instruments Co., Ltd.

510(k) Summary

JUL 18 2012

The assigned 510(k) number is:

1. Date Prepared:

2011.11.25

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: info@sejoy.com

3. Name of the Device:

Trade Name: Wrist-type Fully Automatic Digital Blood Pressure Monitor Including the following models: - BP-201M, BP-202H, BP-202N, BP-2206, BP-2208 Common Name: Blood Pressure Monitor Classification name: Non-invasive blood pressure measurement System 21 CFR 870-1130, Class II, 74-DXN.

Classification Information: 4.

Regulation Number: 870.1130 Product Code: DXN Device Class: II Panel: 74 Cardiovascular

న్. Predicate Device Information:

The Wrist-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following device:

{1}------------------------------------------------

page 2/5

Image /page/1/Picture/2 description: The image shows the word "SEJOY" in a bold, sans-serif font. The letters are black against a white background. There is a small, triangle-like mark above the letter 'J'.

世佳电子有限公司 Sejoy Electronics & Instruments Co., Ltd.

AM/PM Memory Wrist Blood Pressure Monitor (Model: UB-512), FDA 510(k) K042967, distributed by A division of A&D Engineering, Inc.

Device Description: 6.

FeaturesModels	A	B	C	D	E	F	G	H	I	J	K
BP-201M	●	120 Memories	●	○	○	○	○	76×67.5×28.5	13.5-21.5 cm	45×30	○
BP-202N	●	120 Memories infour groups	●	○	○	○	○	76×67.5×28.5	13.5-21.5 cm	45×30	○
BP-202H	●	120 Memories infour groups	●	○	●	●	●	76×67.5×28.5	13.5-21.5 cm	45×30	○
BP-2206	●	120 Memories intwo groups	●	○	●	●	●	77×64×32.5	13.5-21.5 cm	45×30	○
BP-2208	●	120 Memories intwo groups	●	●	●	○	●	77×64×32	13.5-21.5 cm	49×38	●

The detail comparisons among devices are listed below:

A = Powered by 2 AAA batteries

B = Memory Size

C = Time & Date

{2}------------------------------------------------

K121355

SEJOY

世佳电子有限公司

Sejoy Electronics & Instruments Co., Ltd.

D = Results Average in Three way
E = WHO (World Health Organization) Classification Indicator
F = Last 3 Results Average
G = Irregular Heartbeat Detection
H = Outside Demission (L x W x H in mm)
I = Cuff Size
J = LCD Size (Viewing Area in mm)

K = LCD Backlight

• = Yes

o = No

The devices are all designed and manufactured according to ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008. manual, electronic or automated sphygmanometers.

7. Intended Use:

The Wrist-type Fully Automatic Blood Pressure Monitors BP series are intended for used by adults with 12 years and older to measure the systolic blood pressure and pulse rate.

The intended user and the indication for use of the Wrist-type Fully Automatic Blood Pressure Monitors BP series as described in the labeling are nearly the same as their predicated devices, AM/PM Memory Wrist Blood Pressure Monitor (Model: UB-512).

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
Energy Source	Similar
Standards Met	Identical
Electrical Safety	Identical
EMC	Identical
Function	Similar

The difference of technological characteristic between the predicate device and the submit

{3}------------------------------------------------

page 4/5

Image /page/3/Picture/2 description: The image shows the word "SEJOY" in bold, black letters. There is a small symbol above the "J" that resembles a triangle or arrow pointing upwards. The letters are closely spaced together, and the overall appearance is clean and simple.

世佳电子有限公 Sejoy Electronics & Instruments Co., Ltd.

wrist-type fully automatic blood pressure monitors is the appearance, the performance and the function.

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

Compliance to applicable voluntary standards including ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 as well as IEC/EN 60601-1: 2005+CORR.1 (2006) +CORR.2 (2007) / EN 60601-1:2006 /AC: 2010, IEC/EN 60601-1-2:2007, 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.

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" and "FDA Bluebook Memorandum G95-1Use of International Standard ISO 10993."

Non-clinical Tests:

. Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2007
General Safety Provisions Test according to IEC/EN 60601-1: 2005+CORR.1 (2006) +CORR.2 (2007) / EN 60601-1:2006 /AC: 2010
. Performance Test according to ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008. 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.

10. Discussion of Clinical Tests Performed:

Clinical tests were performed and complied the accuracy requirements of ANSI/AAMI SP10:2002/(R) 2008 & ANSI/AAMI SP10:2002/A1:2003/(R) 2008 & ANSI/AAMI SP10:2002/A2:2006/(R) 2008 "National Standard for Manual, Electronic or Automated Sphygmomanometers".

11. Conclusions:

Our Wrist-type Fully Automatic Blood Pressure Monitor BP-201M, BP-202H, BP-202N, BP-2206, BP-2208 have the same intended use and similar technological characteristics as the

1 ()

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "SEJOY" in bold, black letters. The letters are large and spaced closely together. The background is white, providing a strong contrast to the text.

K121355 电子有限公司 Sejoy Electronics & Instruments Co., Ltd.

A & D AM/PM Memory Wrist Blood Pressure Monitor (Model: UB-512) whose 510 (k) number is K042967.

Moreover, verification and validation tests contained in 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 difference 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.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

Public Health Service

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

JUL 18 2012

Sejoy Electronics & Instruments Co., Ltd. c/o Mr. Edmondo Roark 1259 Monten Street #4 Cincinnati, OH 45208

Re: K121355

Trade/Device Name: Wrist-type Fully Automatic Digital Blood Pressure Monitor Wrist-type Funy Automatio Digital (Five Models: BP-201M, BP-202H, BP-202N, BP-2206, BP-2208) Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN Dated: April 6, 2012 Received: May 4, 2012

Dear Mr. Roark:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premaited is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have ustchillied the arreed predicate devices marketed in interstate for use stated in the enclosure) to regally manced the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chacanene with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance that in proval application (PMA).
and Cosmetic Act (Act) that do not require approval or a provisions of the Act . The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The Act. The You may, therefore, market the device, subject to incements for annual registration, listing of general controls provisions of the Act mender reading and prohibitions against misbranding and devices, good manufacturing placity, label information related to contract liability.
adulteration. Please note: CDRH does not evaluate in trutiful and not mislead adulteration. Please note: CDRF does not evaluate information of the many of misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
and he If your device is classified (See above) into enner elass if (Spoth
may be subject to additional controls. Existing major regulations affecting your device can be

{6}------------------------------------------------

Page 2 - Mr. Roark

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

K121355

SFÍO

世佳电子有限公司 Sejoy Electronics & Instruments Co., Ltd.

Indications for Use

510(k) Number (if known): K 12 / 355

Device Name:

Blood Pressure Monitors BP series

Indications For Use:

Measure blood pressure (systolic and diastolic) and pulse rate.

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)

Page 1 of 1

Ivision Sign-Off) Division of Cardiovascular Devices

510(k) Number

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).