Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard oscillometric blood pressure monitor and its validation against an ISO standard. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.

Therapeutic

No

The device is intended for measuring blood pressure and pulse rate, which are diagnostic measurements for monitoring a patient's condition, not for providing therapy or treatment.

Diagnostic

No

The device is an electronic blood pressure monitor, which measures blood pressure and pulse rate. While it provides health data, it does not diagnose a medical condition; it simply provides a measurement.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as the main body (with screen display, buttons, and connectors), cuff, USB cable, air tube, and AA batteries. It also describes the physical mechanism of operation involving an inflatable cuff and pressure sensing.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
Device Function: The description clearly states that this device measures blood pressure and pulse rate by using an inflatable cuff wrapped around the arm. This is a non-invasive measurement taken directly from the patient's body, not from a specimen.
Intended Use: The intended use is to measure blood pressure and pulse rate in adult patients, which is a physiological measurement, not a diagnostic test performed on a sample.

Therefore, based on the provided information, this Electronic Blood Pressure Monitor is a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device Description

Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries.

Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body.

Electronic Blood Pressure Monitor can be divided into three models (YJ320、YJ321E、YJ326E) according to their appearance and functions.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Arm

Indicated Patient Age Range

Adult patient population

Intended User / Care Setting

medical professionals or at home

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical study: YJ320 was tested to ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. The Same Arm Sequential Method was chosen and performed on YJ320. This study included 86 adult subjects (49 females, 37 male) with an age range of 17 to 76 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.

Non-clinical testing: Non-clinical testing for Electronic Blood Pressure Monitor was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards. Tests included: Identification requirement, life span, Safety requirements (Maximum cuff pressure, venting), Performance index (Range, Resolution ratio, Repeatability, Pressure sensor accuracy, Pulse), Requirements for charging sources and pressure control valves (Aeration source, Pressure controlled air valve), Cuff with air bag (Size, compression resistance, Cuff interface, structure), System air leakage, function (display function, Automatic zeroing function, Error prompt function, Low voltage prompt function, Automatic shutdown function, memory function, Clock setting function, Arrhythmia prompt function, Voice broadcast prompt function, Cuff detection prompt function), Appearance and structure, Electrical safety requirements, electromagnetic compatibility, Environmental requirements. All reported "Pass". Biocompatibility testing (Cytotoxicity, Skin Sensitization, Skin Irritation), Electrical safety and electromagnetic compatibility (EMC) testing, Software Verification and Validation Testing, and Usability testing were also conducted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K222994

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 5, 2023

Zhuhai Yueja Medical Device Technology Co.,Ltd. Feng Yan Department Manager Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone Zhuhai, Guangdong 519000 China

Re: K232814

Trade/Device Name: Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: August 30, 2023 Received: September 13, 2023

Dear Feng Yan:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

2

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Stephen C. Browning -S

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K232814

Device Name Electronic Blood Pressure Monitor

Indications for Use (Describe)

Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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4

Section 3 510(k) Summary

l 510(k) Submitter

Device Submitter: Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone, Zhuhai, 519000, China

Contact Person: Feng yan Department Manager Phone: +86-18826906029 E-mail: fengy@myzr.com.cn

II Device

Trade Name of Device:	Electronic Blood Pressure Monitor
Regulation Number:	21 CFR 870.1130
Classification Name:	Electronic Blood Pressure Monitor
Product Code:	DXN
Regulation Number:	Electronic Blood Pressure Monitor
Regulatory Class	II
Review Panel	Cardiovascular

III Predicate Devices

510k Number	K222994
Trade Name of Device:	Electronic Blood Pressure Monitor
Regulation Number:	21 CFR 870.1130
Regulation Name:	Electronic Blood Pressure Monitor
Regulatory Class	II
Product Code:	DXN

IV Device Description

Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries.

Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body.

Electronic Blood Pressure Monitor can be divided into three models (YJ320、YJ321E、

5

YJ326E) according to their appearance and functions. The differences among these models are shown as below:

| Model | Air pumps and air
valves | Cuffs | Software Function | Hardware |
|--------|-----------------------------|-----------|----------------------------------------------------------------|-----------------------------------|
| YJ320 | Same | Same | Same | Black and white
backlit screen |
| YJ321E | Same | Same | Removed cuff detection
and misoperation prompt
functions | Black and white
backlit screen |
| YJ326E | Different | Different | Same | Color backlit
screen |

V Indications for use

Electronic Blood Pressure Monitor is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. lt can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

VI Technological Characteristics Comparison

VI-1: Comparison of Electronic Blood Pressure Monitor

| Device
Characteristic | Subject Device | Predicate Device
(K222994) | Discussion
n |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Type of Blood
Pressure
Monitor | Electronic Blood Pressure
Monitor
YJ320、YJ321E、YJ326E | Electronic Blood Pressure
Monitor
AOJ-33 series | - |
| Product Code | DXN | DXN | Same |
| Regulation No. | 21 CFR 870.1130 | 21 CFR 870.1130 | Same |
| Class | II | II | Same |
| Indications for
Use | Electronic Blood Pressure
Monitor is a digital monitor
intended for use in
measuring blood pressure
and pulse rate in adult | The Arm Blood Pressure
Monitor is intended to measure
the systolic and diastolic blood
pressure as well as the pulse
rate of adult person via | Same |
| patient population. It is non-invasive oscillometric intended to measure the technique in which an inflatable diastolic, systolic blood CUFF is wrapped around the pressures and pulse rate upper arm at medical facilities or through an inflatable cuff at home. wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm. | | | |
| Measurement site | Upper arm | Upper arm | Same |
| Patient Population | Adult | Adult | Same |
| Measurement Item | SYS, DIA, Pulse Rate | SYS, DIA, Pulse Rate | Same |
| Principle | Oscillometric | Oscillometric | Same |
| Blood pressure measurement range | pressure:0 to 295mmHg
SYS: 55 to 255 mmHg
DIA: 25 to 200 mmHg | 30 ~ 255 mmHg | Different 1 |
| Accuracy | $\pm$ 3 mmHg | $\pm$ 3 mmHg | Same |
| Pulse Rate Range | 40199beat/min | 40-199 bpm | Same |
| Accuracy | $\pm$ 5% of reading | $\pm$ 5% of reading | Same |
| Cuff size | 2242cm | 2242cm | Same |
| Power supply | 4 "AA" batteries(d.c.6v) or
USB-C INPUT 5V d.c6V d.c/600mA | Lithium-ion battery, D.C. 3.7V | Different 2 |
| Operation condition | +5°C~+40°C,
15%RH85%RH
80kPa105kPa | +5°C~+40°C
15%RH-90%RH
70 kPa -106 kPa | Different 3 |
| Storage condition | -20°C~+55°C,
15%RH85%RH,
80kPa105kPa | -20°C~+55°C
10%RH-93%RH
70 kPa -106 kPa | Different 4 |
| Patient Contacting | Surface-contacting,
Less than 24 h | Surface-contacting,
Less than 24 h | Same |
| Biocompatibility evaluation | Cytotoxicity, skin sensitization and irritation | Cytotoxicity, skin sensitization and irritation | Same |
| Electrical
Safety | IEC 60601-1
IEC 60601-1-11
ISO 80601-2-30 | IEC 60601-1
IEC 60601-1-11
ISO 80601-2-30 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Biocompatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Different 5 |
| Clinical data | ISO 81060-2: 2018 | ISO 81060-2: 2018 | Same |

6

7

Different 1- Blood pressure measurement range

The Blood Pressure Range of the subject device includes the blood pressure range of predicate devices and meets the requirements of IEC 80601-2-30. Therefore, the difference will not affect the safety and effectiveness of the subject device.

Different 2- Power supply

The difference between subject device and predicate device (K222994) is the batteries, the predicate device use Lithium-ion battery, D.C. 3.7V while the subject device use 4 "AA" batteries (d.c.6v) or USB-C INPUT 5V d.c-6V d.c/600mA, but the power supply safety of subject device is justified by the IEC60601-1 electricity test reports. Thus this difference will not affect the safety and effectiveness, therefore this item is considered as substantial equivalence.

Different 3- Operation condition

The difference between subject device and predicate device (K222994) is the humidity and Atmospheric pressure, the predicate device is 15%RH-90%RH, 70 kPa -106 kPa, while the subject device is 15%RH-85%RH, 80kPa~105kPa, it is included in predicate device. Therefore, this item is considered as substantial equivalence.

Different 4- Storage condition

The difference between subject device and predicate device (K222994) is the humidity

Section 3-4

8

K232814

and Atmospheric pressure, the predicate device is 15%RH-90%RH, 70 kPa -106 kPa, while the subject device is 15%RH-85%RH, 80kPa~105kPa, it is included in predicate device. Therefore, this item is considered as substantial equivalence.

Different 5- Biocompatibility

The predicate device (K222994) was tested by ISO 10993-5, ISO 10993-10, and the testing part included the battery.

While the main part of subject device that comes into contact with the patient is the cuff, the part that comes into contact with the operator is mainly the cover and cuff. The material of cover is ABS, which is a commonly used material in the market. It has Limited contact with intact skin. Per FDA's 2020 guidance document, Use of International Standard ISO 10993-1, ABS materials are exempt from biological testing. In addition, the cuff has tested by ISO 10993-5 and ISO 10993-10.

Based on the above description, these differences do not affect the achievement of the product's intended use, nor do they compromise the safety of patients and operators.

9

VII Summary of Non-Clinical Testing and Clinical Testing

Non-Clinical Data:

Non-clinical testing for Electronic Blood Pressure Monitor was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.

Inspecting item	Inspection content and acceptance standard	Conclusion
1. Identification requirement	Meets the requirements of IEC 60601-1:2005 in 7.2	Pass
2. life span	After at least 10,000 full scale cycles, the sphygmomanometer should still meet the safety requirements and performance requirements in the standard.	Pass
	A full scale cycle is when the pressure rises from 2.67kPa(20mmHg) or less to a maximum pressure value and then falls to 2.67kPa(20mmHg) or less.
3. Safety requirements	The sphygmomanometer should have overpressure protection function. When the pressure display exceeds 39.33kPa(295mmHg), the sphygmomanometer's vent valve should be opened, and the gas path pressure should be reduced to less than 2kPa(15mmHg) within 10s. In addition, the equipment should	Pass
	3.1 Maximum cuff pressure
4.
Performance
index
		ensure that the cuff pressure is
above 2kPa(15mmHg) for no more
than 3 minutes.
	3.2 venting	The sphygmomanometer should
provide a simple and clearly
marked measure allowing the user
to deflate the cuff. When the valve
of the charging system is fully open
and quickly deflated, the time for
the pressure to drop from
34.67kPa(260mmHg) to
2kPa(15mmHg) should not exceed
10s.	Pass
	4.1 Range	A blood pressure monitor has a
range of at least 0kPa(0mmHg) to
39.3kPa(295mmHg).	Pass
	4.2 Resolution
ratio	The display resolution of the
sphygmomanometer should be
0.1kPa/1mmHg.	Pass
	4.3
Repeatability	For a sphygmomanometer,
measured at static continuous low
pressure, the difference between
repeated readings measured at
each point within the scale range
should be no greater than 0.533
kPa(4mmHg). All readings shall
comply with the requirements in 4.4	Pass
	4.4 Pressure
sensor
accuracy	The maximum error of the pressure
measurement in the cuff should be
$\pm$ 0.4kPa( $\pm$ 3mmHg) at any
measuring point in the range,
regardless of whether the pressure
is increased or decreased.	Pass
		(a) The pulse measurement range	Pass
	4.5 Pulse	of the sphygmomanometer should
		be (40 ~ 199) times/min, and the
		resolution should be 1 time/min.
			(b) Pulse accuracy: ±5%.
	5.1 Aeration
source	The sphygmomanometer inflation	Pass
		source should provide enough air
		within 10 seconds to reach
		40kPa(300mmHg) in a 200(12
		cubic inch) container.
5
Requirements
for charging
sources and
pressure
control
valves.	5.2 Pressure
controlled air
valve	5.2.1 air leakage	Pass
		The sphygmomanometer valve is
		closed, and the maximum pressure
		drop in a container with a volume
		not exceeding 80 at initial
		pressures of 33.33kPa(250mmHg),
		20kPa (150 MMHG) and
		6.67kPa(50mmHg) should not
		exceed 0.133kPa(1mmHg) for 10s.
		5.2.2 Valve/cuff bleed rate
		When the valve is in the pressure
control position, the pressure drop
rate from 33.33kPa(250mmHg) to
6.67kPa(50mmHg) should not be
less than 0.267kPa/s (2mmHg/s);
5.2.3 Venting
The rapid venting of a gas-filled
		system when the valve is fully open
should not take longer than 10s for
the pressure to drop from
34.67kPa(260 mmHg) to
2kPa(15mmHg).


6 Cuff with air
bag	6.1 Size	The length of the cuff air bag is
about 0.8 times the circumference
of the limb measured at the median
line of the cuff's intended use area,
and the width of the cuff air bag is
about half the length;	Pass
	6.2
compression
resistance	The cuff, the integrated air bag and
the entire pipeline should be able to
withstand the internal pressure
equal to the maximum pressure
expected to be used by the cuff;	Pass
	6.3 Cuff
interface,
structure	After 1,000 opening and closing
cycles and 10,000
40kPa(300mmHg) pressure cycles,
the closure and sealing off the cuff
and the integrated airbag shall
remain intact enough to meet the
other requirements of this standard.	Pass
	7 System air leakage		The rate of pressure drop caused
by air leakage of the entire system
of the sphygmomanometer should
not be greater than
0.133kPa/s(1mmHg/s).

8 function		8.1 display
function	The liquid crystal display of the
sphygmomanometer should be
able to display systolic blood

	pressure, diastolic blood pressure
and pulse rate, and there should be
"kPa" or "mmHg" blood pressure
display form.
	8.2 Automatic
zeroing
function	The sphygmomanometer should be
able to automatically return to zero
after each turn on, and
automatically open to test blood
pressure.	Pass
	8.3 Error
prompt
function	The sphygmomanometer should
display an incorrect indication if it
fails to measure blood pressure
correctly or fails to measure pulse
rate correctly.	Pass
8.4 Low
voltage
prompt
function	When the sphygmomanometer is
turned on, when the battery voltage
is low to 4.2V±0.2V, the battery
symbol "☐" should flash on the
display screen.	Pass
8.5 Automatic
shutdown
function	The sphygmomanometer will
automatically shut down if no
operation is performed within 2
minutes after the measurement is
completed.	Pass
8.6 memory
function	The sphygmomanometer can
memory store 2*99 groups of
measurement data, 99 groups of
users A and B, in the memory state,
press the [Start/Stop] key and the
[memory/read] key at the same
time, 3 seconds later the screen will
display CLR, release the double
key can clear all the memory data.	Pass
8.7 Clock
setting
function	The sphygmomanometer should be
able to display time and set time,
including year, month, day, hour
and minute.	Pass
8.8	The sphygmomanometer should be	Pass
	Arrhythmia
prompt
function
8.9
Voice
broadcast
prompt
function	able to indicate the irregular
heartbeat of the human body and
can display the "♥" symbol.
In the "mmHg" unit display mode,
sphygmomanometer should
the
have a voice broadcast prompt
function.	Pass
	Cuff
8.10
detection
prompt
function	The sphygmomanometer has cuff
detection function, and the display
" "
screen displays "
symbol
cuff is connected
the
when
correctly, If an exception occurs,
4 " symbol is displayed
the "	Pass
	9.1 Sphygmomanometer shape should be correct,
the surface should be bright, clean, color should be
uniform.
9.2 The characters and symbols of the blood		Pass
Pass
9 Appearance
and structure	pressure monitor should be clear, accurate and firm.
9.3 The function keys of the sphygmomanometer
should be flexible and reliable, and the fasteners
should not be loose.		Pass
	9.4 The cuff should not be damaged.		Pass
	9.5 There should be no missing strokes in the LCD
display process.		Pass
Electrical
10
safetv
requirements		The
sphygmomanometer shall
meet the requirements specified in
IEC 60601-1.	Pass
11
compatibility	electromagnetic	sphygmomanometer should
The
meet the requirements specified in
IEC60601-1-2 Medical electrical
1-2:General
equipment-Part - Part
requirements for basic safety and
performance-Collateral
essential	Pass
standard: Electromagnetic
compatibility-Requirements and
tests.
12 Environmental
requirements	The environmental test of the
sphygmomanometer shall comply
with IEC 60601-1-11 Part
1-11:General requirements for
basic safety and essential
performance-Collateral Standard:
Requirements for medical electrical
equipment and medical electrical
systems used in the home
healthcare environment.	Pass

Table VII-1: Performance testing was conducted on the subject device

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11

12

13

14

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Biocompatibility Testing

The main part of subject device that comes into contact with the patient is the cuff, the part that comes into contact with the operator is mainly the cover and cuff. The material of cover is ABS, which is a commonly used material in the market. It has Limited contact with intact skin. Per FDA's 2020 guidance document, Use of International Standard ISO 10993-1, ABS materials are exempt from biological testing.

In addition, the material of cuff is Nylon, it has Limited contact with intact skin and has tested by ISO 10993-5 and ISO 10993-10.

Cytotoxicity
Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Electronic Blood Pressure Monitor.

16

The device complies with the IEC60601-1. IEC60601-1-2. IEC 60601-1-8 and IEC60601-1-11.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

Performance testing

The Electronic Blood Pressure Monitor were test according to the standard which is IEC 80601-2-30, and the cuff to monitor connector was tested based on IEC 80369-5:2016 + C1:2017, the test result meets the requirements.

Usability

Usability was conducted on the Electronic Blood Pressure Monitor. The device complies with the IEC60601-1-6.

Clinical data:

YJ320 was tested to ISO 81060-2:2018 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type. the clinical validation data on YJ320 can cover YJ321E、YJ326E. The Same Arm Sequential Method was chosen and performed on YJ320. This study included 86 adult subjects (49 females, 37 male) with an age range of 17 to 76 years. All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018. No adverse effect and/or complication is found in this study.

VIII Conclusion

The conclusions drawn from the non-clinical tests and clinical test demonstrate that the Electronic Blood Pressure Monitor is as safe as effective, and performs as well as or better than the legally marketed device.