The Fully Automatic Digital Blood Pressure Monitors are intended to measure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

Device Description

The Arm-type and Wrist-type Fully Automatic Digital Blood Pressure Monitor (BPM) series is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment . The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During measurements, an electric pump within the main unit slowly inflates the arm/wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min.

The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.

Meanwhile, these blood pressure monitor devices can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JoyHealth" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.

Unlimited readings can be stored in the app for archiving and review by the user.

AI/ML Overview

The provided document is a 510(k) summary for Joytech Healthcare Co., Ltd.'s Fully Automatic Digital Blood Pressure Monitors. It describes the device, its intended use, comparison with predicate devices, and performance data to demonstrate substantial equivalence.

Based on the provided text, the device in question is a Fully Automatic Digital Blood Pressure Monitor (both arm-type and wrist-type). The study described is a clinical investigation to assess the accuracy of blood pressure and pulse rate measurements. This is not an AI/ML study, but rather a traditional medical device accuracy study. Therefore, several of the requested sections related to AI/ML specific criteria (like effect size of human readers with vs. without AI, training set details, ground truth establishment for training set) are not applicable or cannot be extracted from this document.

Here's the information that can be extracted from the provided text:

Device Under Evaluation: Joytech Healthcare Co., Ltd.'s Fully Automatic Digital Blood Pressure Monitors (Arm-type and Wrist-type models)

Purpose of the Study: To demonstrate the accuracy of the blood pressure monitor measurements against a reference device, in accordance with ISO 81060-2:2018+AMD2020. This is to support the substantial equivalence claim for 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standard ISO 81060-2:2018+AMD2020 (Non-invasive sphygmomanometers --Part 2: Clinical investigation of intermittent automated measurement type). The document states that the results "showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020." Specific numerical performance metrics (e.g., mean difference and standard deviation of differences as per ISO 81060-2) and the exact acceptance thresholds are not explicitly listed in this summary, but rather referred to the standard.

Metric	Acceptance Criteria (as per ISO 81060-2:2018+AMD2020)	Reported Device Performance
Blood Pressure Measurement Accuracy	"within acceptable scope specified in ISO 81060-2:2018+AMD2020" (Specific numerical thresholds not provided in this document)	"the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020."
Pulse Rate Measurement Accuracy	"within acceptable scope specified in ISO 81060-2:2018+AMD2020" (Specific numerical thresholds not provided in this document)	"the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020."

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

Test Set Sample Size:
- Arm-type: 85 patients (46 females and 39 males)
- Wrist-type (Model DBP-8278B representative): 85 patients (43 females and 42 males)
- Wrist-type (Model DBP-8276H representative): 85 patients (41 females and 44 males)
Data Provenance: The document does not explicitly state the country of origin. It indicates "clinical investigation," implying prospective data collection for the purpose of the study. All subjects were volunteers.

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

This information is not explicitly provided in the document. For blood pressure measurement accuracy studies following ISO 81060-2, the ground truth is typically established by trained and certified observers using a reference sphygmomanometer (e.g., manual mercury sphygmomanometer) following a strict protocol. The number of observers and their specific qualifications are not detailed here.

4. Adjudication Method for the Test Set

The document states, "The manual Mercury Sphygmomanometer was used as a reference device." It describes a "Same arm sequential method" (for arm-type) and "Same wrist sequential method" (for wrist-type) for the clinical testing. This implies direct comparison rather than an adjudication process typically seen in image-based AI studies where multiple readers interpret cases. The reference device measurement is considered the ground truth.

5. 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

Not Applicable. This is a medical device accuracy study, not an AI/ML study, nor an MRMC study involving human readers and AI assistance.

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

N/A. The device is a blood pressure monitor that directly provides readings, not an AI algorithm that generates an interpretation for a human to review. The "standalone" performance here refers to the device's accuracy in measuring blood pressure against a reference.

7. The Type of Ground Truth Used

Type of Ground Truth: Measurements obtained from a manual Mercury Sphygmomanometer.

8. The Sample Size for the Training Set

Not Applicable. This is a medical device accuracy study, not an AI/ML study that involves training a model.

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

Not Applicable. (See point 8)

Summary

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Image /page/0/Picture/0 description: The image shows 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.

Jan 5, 2022

Joytech Healthcare Co.,ltd Ren Yunhua General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou city Hangzhou, Zhejiang 311100 China

Re: K212115

Trade/Device Name: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 27, 2021 Received: December 7, 2021

Dear 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. 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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K212115

Device Name

Fully Automatic Digital Blood Pressure Monitor Including Arm-type: DBP-6179, DBP-6173, DBP-6173, DBP-6273B, DBP-6175, DBP-6277B, DBP-6177, DBP-6181, DBP-6281B, DBP-6182, DBP-6282B, DBP-6185, DBP-6285B, DBP-6186, DBP-6286B, DBP-6191 Wrist-type: DBP-8276H, DBP-8176H, DBP-8278B, DBP-8178, DBP-8288B, DBP-8188, DBP-8189

Indications for Use (Describe)

The Fully Automatic Digital Blood Pressure Monitors are intended to measure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

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

□ Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are three Chinese characters in blue.

510(k) Summary

The assigned 510(k) number is:

K212115

2.1 Subiectter's Identification:

Name: JOYTECH Healthcare Co., Ltd.

Add.: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, 311100

Zhejiang, China.

Contact Person: Yunhua Ren

Phone: +86-571-81957767

Fax: +86-571-81957750

Email: renyh@sejoy.com

2.2 Name of the Device:

Trade Name: Fully Automatic Digital Blood Pressure Monitor

Arm-type	DBP-6279B, DBP-6179, DBP-6173, DBP-6273B, DBP-6275B, DBP-6175,DBP-6277B, DBP-6177, DBP-6181, DBP-6281B, DBP-6182, DBP-6282B,DBP-6185, DBP-6285B, DBP-6186, DBP-6286B, DBP-6191
Wrist-type	DBP-8276H, DBP-8176H, DBP-8278B, DBP-8178, DBP-8288B, DBP-8188,DBP-8189

Common Name: Blood Pressure Monitor

Classification name: Non-invasive blood pressure measurement System

21 CFR 870-1130, Class II, 74-DXN.

2.3 Classification Information:

Regulation Number: 870.1130

Product Code: DXN

Device Class: II

Panel: 74 Cardiovascular

2.4 Predicate Device Information:

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Image /page/4/Picture/2 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text "JOYTECH" is in blue, with a red arrow pointing to the right above the "O" and "Y". The "I" is red. To the right of "JOYTECH-I" is Chinese text in blue.

The Arm-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following predicate device:

510(k) number	Predicate device model	Product code	Manufacturer
K161886	H-BP100SBP	DXN	Guangdong Transtek Medical Electronics Co.,Ltd.

The Wrist-Type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the following prdicate devices:

510(k) number	Predicate device model	Product code	Manufacturer
K182127	BP6100	DXN	OMRON HEALTHCARE Co., Ltd.
K182166	BP4350	DXN	OMRON HEALTHCARE Co., Ltd.

2.5 Device Description:

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measured systolic and diastolic blood pressure and pulse rate, which does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making.

Unlimited readings can be stored in the app for archiving and review by the user.

The detail comparisons among the Arm-Type series are listed in table below:

FeaturesModels	A	B	C	D	E	F	G	H	I (mm)	J(cm)	K(mm)	L	M	N	O	P	Q	R	S	T
DBP-6179	Y	O	60Memories×2	Y	N	Y	Y	Y	142.5107.244	22-36	112*62	O	O	N	N	N	N	O	Y	Y
DBP-6279B	Y	O	60Memories×2	Y	N	Y	Y	Y	142.5107.244	22-36	112*62	O	O	N	N	Y	N	O	Y	Y
DBP-6173	Y	O	60Memories×2	Y	N	Y	Y	Y	142.5107.244	22-36	95.5*54.5	O	O	N	N	N	N	O	Y	Y
DBP-6273B	Y	O	60Memories×2	Y	N	Y	Y	Y	142.5107.244	22-36	95.5*54.5	O	O	N	N	Y	N	O	Y	Y
DBP-6175	Y	O	60Memories×2	Y	N	Y	Y	Y	128130144	22-36	118*65	O	O	N	N	N	N	O	Y	Y
DBP-6275B	Y	O	60Memories×2	Y	N	Y	Y	Y	128130144	22-36	118*65	O	O	N	N	Y	N	O	Y	Y
DBP-6177	Y	O	60Memories×2	Y	N	Y	Y	Y	149.880.445.7	22-36	83.1*53.1	O	O	N	N	N	N	O	Y	Y
DBP-6277B	Y	O	60Memories×2	Y	N	Y	Y	Y	149.880.445.7	22-36	83.1*53.1	O	O	N	N	Y	N	O	Y	Y
DBP-6181	Y	O	60Memories×2	Y	N	Y	Y	Y	155.5108.575	22-36	87.5*85	O	O	N	N	N	N	O	Y	Y
DBP-6281B	Y	O	60Memories×2	Y	N	Y	Y	Y	155.5108.575	22-36	87.5*85	O	O	N	N	Y	N	O	Y	Y
DBP-6182	Y	O	60Memories×2	Y	N	Y	Y	Y	15010865	22-36	87.5*85	O	O	N	N	N	N	O	Y	Y
DBP-6282B	Y	O	60Memories×2	Y	N	Y	Y	Y	15010865	22-36	87.5*85	O	O	N	N	Y	N	O	Y	Y
DBP-6185	Y	O	60Memories×2	Y	N	Y	Y	Y	15010865	22-36	87.5*85	O	O	N	N	N	N	O	Y	Y
DBP-6285B	Y	O	60Memories×2	Y	N	Y	Y	Y	15010865	22-36	87.5*85	O	O	N	N	Y	N	O	Y	Y
DBP-6186	Y	O	60Memories×2	Y	N	Y	Y	Y	15010865	22-36	87.5*85	O	O	N	N	N	N	O	Y	Y
DBP-6286B	Y	O	60Memories×2	Y	N	Y	Y	Y	15010865	22-36	87.5*85	O	O	N	N	Y	N	O	Y	Y
DBP-6191	Y	O	60Memories×2	Y	N	Y	Y	Y	13694.557	22-36	50*62	O	O	N	N	N	N	O	Y	Y

A = Powered by 3 AAA size batteries

B= Powered by AC adaptor
C = Memory Size
D = Time & Date
E = Results Average in Three way
F = WHO (World Health Organization) Classification Indicator

G = Last 3 Results Average

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H = Irregular Heartbeat Detection I = Outside Demission (L x W x H in unit mm) J = Cuff Size K = LCD Size (Viewing Area in unit mm) L = LCD Backlight M= Voice N= PC connecter O=Music P=Bluetooth Function Q=mmHg/kPa Switchable R=Beep buzzer S= Cuff Loose Detection T= Arm Shake Detection Note: Y= Yes N = No O= Optional function depending on clients' needs

The detail comparisons among the Wrist-Type series are listed in table below:

FeaturesModels	A	B	C	D	E	F	G	H (mm)	I (cm)	J(mm)	K	L	M	N	O	P	Q	R	S	T
DBP-8176H	Y	60 Memories×2	Y	Y	Y	Y	Y	6255.219	13.5-21.5	34*34.6	Y	N	N	N	N	Y	O	Y	N	O
DBP-8276H	Y	60 Memories×2	Y	Y	Y	Y	Y	6255.219	13.5-21.5	34*34.6	Y	N	N	Y	N	Y	O	Y	N	O
DBP-8178	Y	60 Memories×2	Y	Y	Y	Y	Y	736627.5	13.5-21.5	44*42	O	O	N	N	N	O	O	Y	N	N
DBP-8278B	Y	60 Memories×2	Y	Y	Y	N	Y	736627.5	13.5-21.5	44*42	O	O	N	Y	N	O	O	Y	N	N
DBP-8188	Y	60 Memories×2	Y	Y	Y	Y	Y	846225	13.5-21.5	43.7*40	O	O	N	N	N	O	O	Y	N	N
DBP-8288B	Y	60 Memories×2	Y	Y	Y	Y	Y	846225	13.5-21.5	43.7*40	O	O	N	Y	N	O	O	Y	N	N
DBP-8189	Y	60 Memories×2	Y	Y	Y	Y	Y	846223.6	13.5-21.5	32*40.5	O	N	N	N	N	Y	O	Y	N	N

Note: DBP-8276H, DBP-8176H are equipped with lithium battery. Other models equipped with alkaline battery.

A = Powered by AAA Batteries / Lithium battery

(DBP-8276H, DBP-8176H equipped with rechargeable lithium battery)

B= Memory Size
C= Time & Date
D = WHO (World Health Organization) Classification Indicator
E = Last 3 Results Average
F = Irregular Heartbeat Detection
G = Low Voltage detection
H= Outside Dimension (L x W x H in unit mm)
I = Cuff Size
J = LCD Size (Viewing Area in unit mm)
K= LCD Backlight
L= Voice
M= PC connecter
N=Bluetooth function
O=mmHg/kPa Switchable
P=Beep buzzer
Q=Heart Zone indicator

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Image /page/7/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are three Chinese characters in blue.

R= Arm Shake indicator S= Cuff Loose indicator T=Powered by AC adaptor Note: Y= Yes N = No O= Optional function depending on clients' needs

The devices are all designed and manufactured according to AAMI/ANSV/IEC80601-2-30:2018, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

2.6 Intended Use:

The Arm-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

The Wrist-type Fully Automatic Digital Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age.

2.7 Comparison of Technological Characteristics with predicate device:

2.7.1 Arm-type

The arm-type blood pressure monitor manufactured by JOYTECH have the same arm cuff type, features and specifications with the Welch Allyn blood pressure monitor H-BP100SBP which 510k number is K161886, therefore we choose the device act as the predicate device. The detail comparison of technical characteristic as below:

Comparison item	Subject device in present application	Predicate device K161886 (model:H-BP100SBP)	Comparison result / Explanation
The trade name	Arm-type Fully AutomaticDigital Blood Pressure Monitor	Welch Allyn Blood PressureDevice	/
Manufacturer	JOYTECH Healthcare Co.,Ltd.	Guangdong Transtek MedicalElectronics Co., Ltd	/
Recommendedclassificationregulation	21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem	21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem	Identical
Regulatory class	II	II	Identical
Panel	74 Cardiovascular	74 Cardiovascular	Identical
Product code	DXN	DXN	Identical
Indication for use	The Arm-type Fully Automatic	Welch Allyn Blood Pressure	Similar

	Blood Pressure Monitors areintended to measure bloodpressure (systolic and diastolic)and pulse rate of adults andadolescents over 12 years ofage.	Device H-BP100SBP is digitalmonitor intended for use inmeasuring blood pressure andheartbeat rate in adult patientpopulation with armcircumference ranging from 15cm to 54 cm (about 6-21 inches).These devices detect theappearance of irregularheartbeats during measurementand give a warning signal withreadings.	Note1
Measuringprinciple	Oscillometric method	Oscillometric method	Identical
Measurementtype	Determined during inflation	Determined during inflation	Identical
Cuff location	Upper arm	Upper arm	Identical
Specification
Measuring range	Systolic Pressure: 60mmHg ~~260 mmHgDiastolic Pressure:30mmHg~~200 mmHgPulse:30~180 Beats/Minute	Systolic Pressure: 50mmHg ~~260 mmHgDiastolic Pressure:25mmHg~~220 mmHgPulse:40~199 Beats/Minute	Similar.Note2
Max cuff pressure	299 mmHg	300mmHg	Similar
Accuracy	Static Pressure: $\pm$ 3mmHgPulse: $\pm$ 5%	Pressure: $\pm$ 0.4kPa (3mmHg)Pulse value: $\pm$ 5%	Identical
Inflation	By air pump	By air pump	Identical
Pressure release	By solenoid valve	By solenoid valve	Identical
OperatingTemp. &humidity	Temp.: 10℃~~40℃Humidity: 15~~93%RHAtmospheric:800hPa~1060hPa	Temp.:5℃~40℃Relative humidity 85%RHAtmosphericpressure:86kPa to 106kPa	SimilarNote 3
Storage Temp.& humidity	Temp.: -25℃~55℃Humidity:$\le$ 93% RH	Temp.:-20℃~60℃Relative Humidity:10% RH - 93% RHAtmosphericPressure: 50kPa to106 kPa	SimilarNote 4
Cuffcircumference	Fits arm circumference 22-36cm	The three preformed cuff units,which areapplicable to arm circumferencebetween 15-24cm, 22-42cm and40-54cm to meet differentPopulation's need.	Similar.Note 5
Supplypowersource	3x1.5V AAA battery or 2MOPPMedical AC adaptor (DC 5V,1A, recommend but notprovide)	powered by four AA alkalinebatteries or by a AC adapter (DC6V,1A)(not include)	SimilarThe different in thespecification isdocumentedand tested
PCB or Electricalscheme	BP73PCBBP75PCB	Unknown	SimilarThe different in the
	BP77PCBBP81PCBBP91PCB		specification isdocumented and tested
Displaycomponent	1.Device LCD;2.iOS device or Android device	1.Device LCD;2.iOS device or Android device	Identical
BluetoothModule version	V5.0	V4.0	Similar.Note6
Systemrequirement	Bluetooth 4.0 or later/Android 5.0 or later/IOS 9.0 or later	Platform which supportBluetooth 4.0 technology	SimilarNote 7
Bluetoothfeatures	Transmit data tosmart phone viaBluetooth	Transmit data tosmart phone viaBluetooth	Identical
Function on APP	Storage test result/Announce test result/ Readmemories in App/ Emptymemories in App/ Draw curve/Set the personalinformation in app	Unknown	Different.Note8
Wirelesscommunication	Frequency range: 2.4 GHz(2400 - 2483.5 MHz)Modulation type: GFSKAntenna gain: 0.5dBi	Frequency range: 2.4 GHz (2402- 2480 MHz)Modulation type: GFSKAntenna gain: 0dBi	EquivalentThe difference haveverified by FCC test.
Sterilization	Not applicable	Not applicable	Identical
FeaturesIrregularheartbeat	Irregular heart beat is displayedon the LCD.	Irregular heart beat is displayedon the LCD.	Identical
BloodPressurecategories	WHO classification	Blood pressure high and lowdistinguish	SimilarNote9
Armshakeindicator	Yes	Yes	Identical
Cufflooseindicator	Yes	None	Different.Note10
Memory	2*60 Memories in Two Groupswith Date and Time	Have memory function	Similar.Note11
Material	ABS for the case and plasticfoil for the labels of the device.Bio-compatibility materials areused for the applied parts (Cuffcontaining a interal bladder)	ABS is used to outer housing ofthe main unit.	Similar.Note12

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Image /page/8/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is Chinese characters.

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Image /page/9/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, with a red triangle above the "O". To the right of "JOYTECH" are some Chinese characters in blue.

Notel: The intended use of subject device and predicate device are the same. The clinical accuracy of subject device applied to adolescents over 12 years of age population have been verified and validation , which comply with the requirements of ISO 81060-2. And the clinical safety also have been validated as for without any AE or side-effect in clinical investigation.

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Image /page/10/Picture/2 description: The image shows the logo for JOYTECH-I. The logo is in blue and red. The text "JOYTECH-I" is in English, and there are three Chinese characters to the right of the English text.

Note2: The measuring range of the subject device have been verified by IEC60601-1 and IEC 80601-2-30 standard test.

Note3: The operation environment of the subject device have been verified by IEC 60601-2-30 standard test.

Note4: The storage environment of the subject device have been verified by IEC 60601-1 and IEC 80601-2-30 standard test.

Note5: The safety and effective for fits arm circumference 22-36cm of subject device have been verified and validation by bench test according to IEC 60601-1-11 and IEC 80601-2-30. Meanwhile, the clinical accuracy of cuff size 22-36cm have been validation according to the ISO 81060-2:2018, which cannot raise new safety and effective issue.

Note 6: The subject device adopt new BT version and it could compatible for BT 4.0. The cybersecurity risk has been considered and the overall residual risk is acceptable.

Note7: All over of subject models have passed FCC, EN301489-17, EN 300328 and wireless coexistence test.

Note8: The change in the specification is documented, and the cybersecurity risk has been considered and the overall residual risk is acceptable. The change does not affect the intended use or the fundamental scientific technology.

Note9: The blood pressure WHO classification function have been verified by software verified and validation report.

Note10: The cuff loose indicator function of subject device have been verified and validation through Software verified and validation report. And this function adding cannot bring new risks.

Note 11: The quantity of storage readings is different between the subject device and predicate device. The change in the specification is documented, and The change does not affect the intended use or the fundamental scientific technology.

Note12:The materials of cuff from subject device have been tested and found to comply with requirements of ISO 10993-5: 2009 and ISO 10993-10:2010, which cannot result in cytotoxicity, sensitization or intracutaneous reacticity.

2.7.2 Wrist-type

The wrist-type blood pressure monitor manufactured by JOYTECH have the same wrist cuff type, features and specifications with the Omron wrist blood pressure monitor BP6100 which 510k number is K182127, therefore we choose the device act as the predicate device. While BP6100 model has no bluetooth function, Omron wrist blood pressure monitor BP4350 (K182166) was chosen to be predicate device 2 with bluetooth function. The detail comparison of technical characteristic as below:

Comparisonitem	Subject device inpresent application	Predicate device 1K182127	Predicate device 2K182166	Comparisonresult /
--------------------	------------------------------------------	-------------------------------	-------------------------------	------------------------

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		(Model:BP6100)	(Model: BP4350)	Explanation
The trade name	Wrist-typeAutomaticBloodPressureMonitor	Wrist Blood PressureMonitor Model BP6100	Wrist Blood PressureMonitor Model BP4350	/
Manufacturer	JOYTECHHealthcare Co., Ltd.	OMRON HEALTHCARECo., Ltd	OMRONHEALTHCARE Co., Ltd	/
Recommendedclassificationregulation	21CFR 870.1130,Noninvasive BloodPressureMeasurementSystem	21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem	21CFR 870.1130,Noninvasive BloodPressure MeasurementSystem	Identical
Regulatoryclass	II	II	II	Identical
Panel	74 Cardiovascular	74 Cardiovascular	74 Cardiovascular	Identical
Product code	DXN	DXN	DXN	Identical
Indication foruse	The Fully AutomaticBlood PressureMonitors areintended to measureblood pressure(systolic anddiastolic) and pulserate of adults andadolescents over 12year of age.	The device is a digitalmonitor intended for usein measuring bloodpressure and pulserate in adult patientpopulation with wristcircumference rangingfrom 5.3 inches to8.5 inches (13.5 cm to21.5 cm).The device detects theappearance of irregularheartbeats duringmeasurement and gives awarning signal withreadings.	The device is a digitalmonitor intended for usein measuring bloodpressure and pulserate in adult patientpopulation with wristcircumference rangingfrom 5.3 inches to 8.5inches (13.5cm to21.5cm). The devicedetects the appearance ofirregular heartbeatsduring measurement andgives a warning signalwith readings.	SimilarNote1
Measuringprinciple	Oscillometricmethod	Oscillometric method	Oscillometric method	Identical
Measurementtype	Determined duringinflation	Determined duringinflation	Determined duringinflation	Identical
Cuff location	Wrist	Wrist	Wrist	Identical
Specification
Measuringrange	Systolic Pressure:60mmHg~~260mmHgDiastolic Pressure:30mmHg~~200mmHgPulse:30~180Beats/min	Systolic Pressure:60mmHg~~260 mmHgDiastolic Pressure:40 mmHg~~215 mmHgPulse:40~180 Beats/min	Systolic Pressure:60mmHg~~260 mmHgDiastolic Pressure:40 mmHg~~215 mmHgPulse:40~180 Beats/min	Similar.Note 2
Maxpressure	cuff 299 mmHg	299 mmHg	299 mmHg	Identical

circumference	circumference 13.5-21.5cm	13.5-21.5cm	13.5-21.5cm
Accuracy	Static Pressure: ±3mmHgPulse: ± 5%	Static Pressure: ± 3mmHgPulse: ± 5% of displayreading	Static Pressure: ±3mmHgPulse: ± 5% of displayreading	Identical
Inflation	By air pump	By air pump	By air pump	Identical
Pressure release	By solenoid valve	By solenoid valve	By solenoid valve	Identical
OperatingTemp. &humidity	Temp.: 10°C~~40°CHumidity:15~~93%RHAtmospheric:800hPa~1060hPa	Temp.: 10°C~~40°CHumidity: 15~~90%RHAtmospheric:800hPa~1060hPa	Temp.: 10°C~~40°CHumidity: 15~~90%RHAtmospheric:800hPa~1060hPa	SimilarNote 3
Storage Temp.& humidity	Temp.: -25°C~55°CHumidity:≤93% RH	Temp.:-20°C~60°CRelative Humidity:10% RH - 90% RHAtmospheric	Temp.:-20°C~60°CRelative Humidity:10% RH - 90% RHAtmospheric	SimilarNote 4
Supplypowersource	For models DBP-8178, DBP-8278B,DBP-8188, DBP-8288B, DBP-8189:2x1.5V AAA batteryDBP-8276H andDBP-8176H arepowered by 3.7 Vrechargeable lithiumbattery or 2MOPPMedical AC adaptor(DC 5V,1A,recommend but notprovide )	Two "AAA" batteries 1.5v	Two "AAA" batteries1.5v	Similar.Note 5
Displaycomponent	1.Device LCD;2.iOS device orAndroid device	Device LCD	1.Device LCD;2.iOS device or Androiddevice	Identicaltopredicatedevice 2.
BluetoothModule version	V5.0	None	Unknown	Note 6
Wirelesscommunication	Frequency range: 2.4GHz (2400 - 2483.5MHz)Modulation type:GFSKAntenna gain:0.5dBi	None	Frequency range: 2.4GHz (2400 - 2483.5MHz)Modulation: GFSKEffective radiated power:< 20 dBm	EquivalentThedifferencehave beenverified byFCC test.
Bluetoothfeatures	Transmit data tosmart phone viaBluetooth	None	Transmit data tosmart phone viaBluetooth	Identicaltothe predicatedevice 2.
Function onAPP	Storage test result/Announce test result/Read memories inApp/ Emptymemories in App/	None	Storage test result/Readmemories in App/ Emptymemories in App/etc.	SimilarNote 7
	Draw curve/ Set thepersonalinformation in app
Sterilization	Not applicable	Not applicable	Not applicable	Identical
Features
Irregular heart beat	Irregular heart beat is displayed on the LCD.	Irregular heart beat is displayed on the LCD.	Irregular heart beat is displayed on the LCD.	Identical
Body movement detection	Yes	Yes	Yes	Identical
Cuff loose detection	No	Yes	Yes	DifferentNote 8
Heart zone indicator	Prompt the user whether the cuff is located in correct height when measurement.	Yes	Yes	Identical
WHO /ACC AHA classification indicator	Yes	Yes	Yes	Identical
Memory	2*60 Memories in Two Groups with Date and Time	60 memories in one groups	2*100 Memories in Two Groups with Date and Time	SimilarNote 9

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Image /page/12/Picture/0 description: The image shows the logo for JOYTEC-I. The logo is in blue and red. The text "JOYTEC" is in blue, and the "I" is in red. There are some Chinese characters to the right of the "I".

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Note 2: The measuring range of the subject device have been verified by IEC 60601-1 and IEC 80601-2-30 standard test.

Note 3: The operation environment of the subject device have been verified by IEC 60601-1 and IEC80601-2-30 standard test.

Note 4: The storage environment of the subject device have been verified by IEC 60601-2-30 standard test.

Note 5: The supplied power of subject device model DBP-8278B, DBP-8288B, DBP-8188, DBP-8188, DBP-8189 are the same as the predicate device 1 and 2. The model DBP-8276H and DBP-8176H equipped with rechargeable lithium battery or powered by 2MOPP medical AC adaptor (Recommend but not provide ). The lithium battery have pass the IEC 62133-2:2017 test. The Adaptor interface have been verified through safety and EMC test. The risk from lithium battery have been analysis and evaluation in risk management report , and the overall residual risk is acceptable.

Note 6: Although the Bluetooth module version of predicate device BP4350 was unknown, The subject device adopt new BT version 5.0 and it could compatible for BT 4.0. The cybersecurity risk has been considered and the overall residual risk is acceptable.

Note 7: The change in the specification is documented, and the cybersecurity risk has been considered and the overall residual risk is acceptable. The change does not affect the intended use or the fundamental scientific technology.

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JOYTECH-I健拓石

Note 8: Comparing with the predicate device, cuff loose indicate function does not affect the the intended use or the fundamental scientific technology. And this function have been verification and validation report. This function adding cannot bring new risks.

Note 9: The quantity of storage readings is different between the subject device and predicate device. The change in the specification is documented, and The change does not affect the intended use or the fundamental scientific technology.

2.8. Performance Data:

Testing information demonstrating safety and effectiveness of the device in the intended environment of use is supported by testing that was conducted.

The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate devices.

The following National and International Standards were utilized for testing the subject device.

Electrical Safety and performance requirements:

ES60601-1:2005/(R)2012 AAMI And A2:2010/(R)2012 Medical Electrical Equipment.
IEC 80601-2-30:2018, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

Home-used medical equipment requirements and environmental test:

IEC 60601-1-11:2015 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
Electromagnetic compatibility requirements:
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
EN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;
EN ETSI 301489-1: Electromagnetic compatibilityand Radio spectrum Matters(ERM);ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements;
ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM); ●

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ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems;

Bio-compatibility Evaluation for patient contacting components:

ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and ● skin sensitization

FCC Test

FCC Part15 Subpart C ●
RF Exposure Evaluation

Guidance Document:

The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.

The test result all meet or exceed the requirement of these standards.

2.10. Discussion of Clinical Tests Performed:

Clinical Validation:

ISO81060-2:2018+AMD2020 Non-invasive sphygmomanometers --Part 2: Clinical investigation of intermittent automated measurement type.

Arm-type:

In the Arm-type fully automatic digital blood pressure clinical investigation, 85 patients (46 females and 39 males) participated in the clinical study. Same arm sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020.

Wrist-type:

Even through the wrist circumference size of cuff is the same (13.5-21.5cm)among these subject wrist-type blood pressure monitors, but the the air bag size inside the wrist cuff have tiny difference, therefore we have conduct two clinical accuracy investigation which choose two

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different representative models.

In the Wrist-type fully automatic digital blood pressure clinical investigation, Model DBP-8278B was selected as representative for testing. 85 patients (43 females and 42 males) participated in the clinical study. Same wrist sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020.

In the Wrist-type fully automatic digital blood pressure clinical investigation, Model DBP-8276H was selected as representative for testing. 85 patients (41 females and 44 males) participated in the clinical study. Same wrist sequential method was adopted during the clinical testing. The manual Mercury Sphygmomanometer was used as a reference device. All the subjects were volunteer to take part in the clinical study, all the subjects completed the clinical study without any AE or side-effect. The results showed the accuracy of the blood pressure monitor is within acceptable scope specified in ISO 81060-2:2018+AMD2020.

2.11. Conclusions:

This submitted arm-type series manufactured by JOYTECH Healthcare Co., Ltd. have been found to be respectively substantially equivalent to the predicate device (Welch Allyn Blood Pressure device H-BP100SBP) manufactured by Guangdong Transtek Medical Electronics Co., Ltd .(K161886). Based on the information provided in this submission, differences between the subject device and predicate device have been tested and documented, it has been demonstrated that the subject devices are as safe and effective as the predicate device.

This submitted wrist-type series manufactured by JOYTECH Healthcare Co., Ltd. have been found to be respectively substantially equivalent to the predicate device 1 (Omron wrist blood pressure monitor BP6100) manufactured by OMRON HEALTHCARE Co., Ltd (K182127) and the predicate device 2 (Omron wrist blood pressure monitor BP4350) manufactured by OMRON HEALTHCARE Co., Ltd (K182166) . Based on the information provided in this submission, differences between the subject device and predicate devices have been tested and documented, it has been demonstrated that the subject devices are as safe and effective as the predicate device.

In the other words, the difference between the subject and the predicate devices does not: (1)

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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.

--- End of this section---

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).