The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

Device Description

The arm-type series use an inflatable cuff which wraps around the patient's upper arm. 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.

AI/ML Overview

The provided document describes the acceptance criteria and a clinical study conducted to demonstrate the substantial equivalence of the JOYTECH Fully Automatic Digital Blood Pressure Monitor (K173024) to its predicate devices. The study aimed to prove the accuracy of the blood pressure monitors.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on the ISO 81060-2 Standard.
There are two methods for evaluation:

Method 1: Mean difference and standard deviation of differences.

Metric	Acceptance Criteria	Arm-type Device Performance (Systolic/Diastolic)	Wrist-type Device Performance (Systolic/Diastolic)
Mean difference (mmHg)	< ±5 mmHg	-0.57 / -1.61	0.84 / 0.21
Standard deviation of differences (mmHg)	< 8 mmHg	4.63 / 5.30	5.25 / 4.92

Method 2: Standard deviation of averaged paired determinations.

Metric	Acceptance Criteria (Max permissible Sm, mmHg)	Arm-type Device Performance (Systolic/Diastolic)	Wrist-type Device Performance (Systolic/Diastolic)
Mean difference (mmHg)	< ±5 mmHg	-0.57 / -1.61	0.84 / 0.21
Standard deviation of differences (mmHg)	Varies based on averaged mean difference (e.g., < 6.91 mmHg for systolic, < 6.73 mmHg for diastolic for arm-type model)	3.71 / 4.94	4.52 / 4.36

Note on Method 2 Acceptance Criteria: The specific maximum permissible standard deviation (Sm) values are derived from "Tab 1" in the document, which provides a lookup table based on the averaged mean difference ($\overline{x}_n$). The reported values for the device performance (e.g., 3.71 mmHg for arm-type systolic) are compared against the corresponding values from this table (e.g., < 6.91 mmHg if the mean difference is around -0.57 mmHg). The document states that "the averages difference... and the corresponding standard deviation fall are within the range of the standard."

2. Sample size used for the test set and the data provenance

Sample Size: 85 subjects for the arm-type blood pressure monitor and 85 subjects for the wrist-type blood pressure monitor.
Data Provenance: The studies were conducted "in the hospital." The country of origin is implied to be China, as JOYTECH Healthcare Co., Ltd. is based in Hangzhou, China. The studies are prospective in nature, as they involved actively recruiting and measuring subjects for the clinical validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Two doctors were used to perform the simultaneous and blinded blood pressure determinations.
Qualifications of Experts: The document does not explicitly state the specific qualifications (e.g., years of experience, specialization like radiologist) of these "two doctors." However, by performing manual blood pressure measurements using a standard mercury sphygmomanometer in a clinical validation setting, it is implied they are medically trained professionals competent in such procedures.

4. Adjudication method for the test set

The ground truth was established by "Simultaneous and blinded blood pressure determinations were performed by two doctors." This implies a form of dual-reader reading with a reference standard, where both doctors likely took independent measurements, and these were then compared against each other and the test device. The document does not specify a formal adjudication process if there were discrepancies between the two doctors' readings, such as a third reader or a specific consensus method. However, the ISO 81060-2 standard typically requires such a process or agreement between observers.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical validation of the device's accuracy against a reference standard, not a study evaluating human reader performance with or without AI assistance. The device is a blood pressure monitor, not an AI-driven diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, a standalone performance evaluation was done. The clinical study directly tested the accuracy of the automated blood pressure monitor (the algorithm/device itself) against manual measurements by human experts (using a standard mercury sphygmomanometer). The results provided in the tables above represent the standalone performance of the device without human intervention in the measurement process itself, other than applying the cuff and initiating the measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was expert measurements (made by two doctors) using a standard mercury sphygmomanometer, which serves as the reference method in accordance with clinical validation standards for blood pressure devices (ISO 81060-2). This is a form of expert consensus or highly accurate direct measurement.

8. The sample size for the training set

The document does not provide information on a training set sample size. This is expected because the device in question is a traditional blood pressure monitor, not an AI/ML-based device that typically requires a distinct training set. The clinical study described is for validation/testing, not for training.

9. How the ground truth for the training set was established

As the document does not refer to a training set or an AI/ML component requiring training, this information is not applicable to the provided context.

Summary

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

Please wait...

If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.

You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.

For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.

Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.

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

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" above the words "U.S. FOOD & DRUG ADMINISTRATION."

August 22, 2018

JOYTECH Healthcare Co., Ltd. Yunhua Ren General Manager No. 365. Wuzhou Road, Yuhang Economic Development Zone Hangzhou, 311100, CN

Re: K173024

Trade/Device Name: 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: July 20, 2018 Received: July 20, 2018

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.

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

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

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

JOYTECH-I健祐拓

510(k) Summary

The assigned 510(k) number is:

2.1 Subjectter's Identification:

Name: JOYTECH Healthcare Co., Ltd.. Add .: No. 365. Wuzhou Road, Yuhang Economic Development Zone, Hangzhou,311100, 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 Including:All models as table below

Type	Models
Arm-type	DBP-1314,DBP-1313,DBP-1303,DBP-1334,DBP-1305,DBP-1307,DBP-1209,DBP-1211,DBP-1312,DBP-1318,DBP-1319,DBP-1326,DBP-1231,DBP-1332,DBP-1333,DBP-1335,DBP-1346,BM40,DBP-1254,DBP-1330,DBP-1257,DBP-1358,DBP-1359,DBP-1204,DBP-1210,
Wrist-Type	DBP-2160,DBP-2261

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:

The Arm-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the Predicate device of Sejoy, BP-1307 (K Number: K120554), with a reason that their cuff is of the same size (22-36cm).

The Wrist-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the Predicate device of Sejoy, BP-2208 (K Number: K121355).

2.5 Device Description:

2.5.1 The detail comparisons among arm-type series are listed in table below:

		Table2.2- Characteristics of Arm-type blood pressure monitor
FeaturesModels	A B	C	D E F G H I (mm)	J (cm)	K(mm)	L M N O
		DBP-1211 Y Y 120 Memories×1 Y N Y N N 131×102×65		22-36	45×30	INININI NI
		DBP-1312 Y Y 60 Memories×2 Y N Y Y 131×102×65		22-36	62.7×46.4 N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N N

File No.: JM-DBP00-02

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

DBP-1318	Y	Y	60 Memories×2	Y	N	Y	Y	Y	139×88× 43	22-36	66 ×43	N	N	N
DBP-1326	Y	Y	30 Memories×4	Y	N	Y	Y	Y	139×88×44	22-36	65.9×42.8	N	N	N
DBP-1305	Y	Y	60 Memories×2	Y	N	Y	Y	Y	166×114×72	22-36	84.1×55.1	O	O	O
DBP-1307	Y	Y	60 Memories×2	Y	Y	Y	N	Y	166×114× 72	22-36	102.1×68.9	O	O	O
DBP-1319	Y	Y	60 Memories×2	Y	N	Y	Y	Y	166×114× 72	22-36	102×68.9	O	O	O
DBP-1231	Y	Y	120 Memories×1	Y	N	Y	Y	Y	140 ×98× 48	22-36	62.3× 46	N	O	N
DBP-1332	Y	Y	60 Memories×2	Y	N	Y	Y	Y	148×100× 56	22-36	84.1×55.1	O	O	O
DBP-1333	Y	Y	60 Memories×2	Y	N	Y	Y	Y	164×111×60	22-36	102.1×68.9	O	O	O
DBP-1314	Y	Y	30 Memories×4	Y	N	Y	Y	Y	110×155×70	22-36	84.1×55.1	N	N	N
DBP-1313	Y	Y	30 Memories×4	Y	N	N	N	N	110×155×70	22-36	84.1×55.1	N	N	N
DBP-1209	Y	Y	120 Memories×1	Y	N	N	N	N	134×99×66	22-36	62.7×46.4	N	N	N
DBP-1303	Y	Y	30Memories×4	Y	N	N	N	N	110×155×70	22-36	62.7×46.4	N	N	N
DBP-1334	Y	O	30Memories×4	Y	N	Y	Y	Y	110×155×70	22-36	62.7×46.4	N	N	N
DBP-1335	Y	N	60 Memories×2	Y	Y	Y	N	Y	135×105×53	22-36	59.9×50.9	N	N	N
DBP-1346	Y	Y	30Memories×4	Y	Y	Y	Y	Y	140×98×53	22-36	78 × 71	Y	N	N
BM40	Y	Y	30Memories×4	Y	Y	Y	N	Y	119×109×60	22-36	83.4×54.4	N	N	N
DBP-1254	Y	Y	60 Memories×2	Y	N	Y	N	Y	134×99×66	22-36	62.7×46.4	N	N	N
DBP-1257	Y	Y	120 Memories×1	Y	N	Y	N	N	131×102×44	22-36	45 × 30	N	N	N
DBP-1358	Y	Y	60 Memories×2	Y	N	Y	Y	Y	131×102×44	22-36	45.7×62	N	O	N
DBP-1359	Y	Y	60 Memories×2	Y	N	Y	Y	Y	131×102×44	22-36	67 × 67	O	O	N
DBP-1204	Y	Y	120 Memories×1	N	N	N	N	N	150×112×56	22-36	83 × 35	N	N	N
DBP-1210	Y	Y	120 Memories×1	N	N	N	N	N	132×100×63	22-36	45 × 30	N	N	N

148×100×56

22-36

84.1×54.1

A = Powered by 4 AA size batteries

B= Powered by AC adaptor

C = Memory Size

DBP-1330

D = Time & Date

E = Results Average in Three way

F = WHO (World Health Organization) Classification Indicator
60 Memories×2

Y N Y

G = Last 3 Results Average

H = Irregular Heartbeat Detection

I = Outside Dimension (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

Y= Yes

N = No

O= Optional function depending on clients' needs

N N N N

N N N N N

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

JOYTECH Healthcare Co., Ltd.,

2.5.2 The detail comparisons between Wrist-type series are listed in table below:

Table2.3- Characteristics of Wrist-type Blood Pressure Monitor

Features	A	B	C	D	E	F	G	H (mm)	I (cm)	J(mm)	K	L	M
Models
DBP-2160	Y	Y	60 Memories×2	Y	N	Y	Y	85×62×25	13.5×21.5	30.6×45	N	O	N
DBP-2261	Y	Y	60 Memories×2	Y	N	Y	Y	85×62×25	13.5×21.5	43×40	O	O	N

A = Powered by AAA Batteries

B= Memory Size

C= Time & Date

D = WHO (World Health Organization) Classification Indicator

E = Results Average in Three way

F = Irregular Heartbeat Detection

G = Last 3 Results Average

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

Y= Yes

N = No

O= Optional function depending on clients' needs

The devices are all designed and manufactured according to AAMI/ANSI/IEC80601-2-30:2009/ A1:2013, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.

2.6 Intended Use:

The Fully Automatic Blood Pressure Monitors are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents age 12 through 21 years of age.

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

Compliance to applicable voluntary standards including AAMI/ANSI/IEC80601-2-30:2009/ A1:2013, medical electrical equipment - part 2-30 as well as AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012, AAMI/ANSV/IEC 60601-1-2:2014, 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 guidance Use of International Standard ISO 10993."

2.8 Non-clinical Tests:

Electromagnetic Compatibility Test according to IEC/EN 60601-1-2:2014

General Safety Provisions Test according to AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, a2:2010/(r)2012

Performance Test according to AAMI/ANSI/IEC80601-2-30:2009/ A1:2013, medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers The test result all meet or exceed the requirement of the standards.

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

JOYTECH Healthcare Co., Ltd..

Biocompatibility Test according to FDA Use 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.

2.9 Discussion of Clinical Tests Performed:

Clinical tests were performed and complied the accuracy requirements of ISO 81060-2 Second edition 2013-05-01, non-invasive sphygmomanometers - part 2: clinical validation of automated measurement type.

2.9.1 Arm-type blood pressure monitor

Subjects:

Eighty-five subjects in the hospital were participated in clinical study.

Method:

A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors.

Criteria:

The ISO81060-2 Standard recommended :

A. a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg between test device and reference method.

B.For the systolic and diastolic blood pressures for each of the m subjects, the standard deviation, of the averaged paired determinations per subject of the sphygmomanometer-under-test and of the reference sphygmomanometer shall meet the criteria listed in Tab 1 when calculated according to Equation(3).

	Maximum permissible standard deviation, $s_m$ , as function of, $\overline{x}_n$ ,mmHg
	0,0	0,1	0,2	0,3	0,4	0,5	0,6	0,7	0,8	0,9
± 0.	6,95	6,95	6,95	6,95	6,93	6,92	6,91	6,90	6,89	6,88
± 1,	6,87	6,86	6,84	6,82	6,80	6,78	6,76	6,73	6,71	6,68
± 2.	6,65	6,62	6,58	6,55	6,51	6,47	6,43	6,39	6,34	6,30
± 3.	6,25	6,20	6,14	6,09	6,03	5,97	5,89	5,83	5,77	5,70
± 4.	5,64	5,56	5,49	5,41	5,33	5,25	5,16	5,08	5,01	4,90
± 5.	4,79	-	-	-	-	-	-	-	-	-

Table 1 - Averaged subject data acceptance (criterion 2) in mmHg

4) Result

Through clinical research, we can convinced that the clinical device is safe and effective. The results of the clinical data refer the follow two tables.

	Average(mmHg)	Standard deviation(mmHg)
Criterion 1
Systolic blood pressure	-0.57	4.63
Diastolic blood pressure	-1.61	5.30
Criterion 2
Systolic blood pressure	-0.57	3.71
Diastolic blood pressure	-1.61	4.94

According to table, the statistical results are as follows: Method 1:

Average of systolic blood pressure is -0.57 mmHg (<±5 mmHg), standard deviation of systolic blood

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

pressure is 4.63 mmHg (<8 mmHg)

Average of diastolic blood pressure is -1.61 mmHg (<±5 mmHg), standard deviation of diastolic blood pressure is 5.30 mmHg (<8 mmHg)

Method 2:

Average of systolic blood pressure is -0.57 mmHg (<±5 mmHg), standard deviation of systolic blood pressure is 3.71 mmHg (<6.91mmHg)

Average of diastolic blood pressure is -1.61 mmHg (<±5 mmHg), standard deviation of diastolic blood pressure is 4.94 mmHg (<6.73 mmHg)

After comparing, the conclusion is that the averages difference in systolic and diastolic pressure and the corresponding standard deviation fall are within the range of the standard.It meets the requirements of clinical program.

2.9.2 Wrist-type blood pressure monitor

Subjects:

Eighty-five subjects in the hospital were participated in clinical study.

Method:

A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors.

3) Criteria:

The ISO81060-2 Standard recommended :

A. a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg between test device and reference method.

Maximum permissible standard deviation, $s_m$ , as function of, $\overline{x}_n$mmHg
$\overline{x}_n$	0,0	0,1	0,2	0,3	0,4	0,5	0,6	0,7	0,8	0,9
± 0.	6,95	6,95	6,95	6,95	6,93	6,92	6,91	6,90	6,89	6,88
± 1,	6,87	6,86	6,84	6,82	6,80	6,78	6,76	6,73	6,71	6,68
± 2,	6,65	6,62	6,58	6,55	6,51	6,47	6,43	6,39	6,34	6,30
± 3.	6,25	6,20	6,14	6,09	6,03	5,97	5,89	5,83	5,77	5,70
± 4,	5,64	5,56	5,49	5,41	5,33	5,25	5,16	5,08	5,01	4,90
± 5.	4,79	-	-	-	-	-	-	-	-	-

Table 1 - Averaged subject data acceptance (criterion 2) in mmHg

4) Result

Through clinical research, we can convinced that the clinical device is safe and effective. The results of the clinical data refer the follow two tables.

	Average(mmHg)	Standard deviation(mmHg)
Criterion 1
Systolic blood pressure	0.84	5.25
Diastolic blood pressure	0.21	4.92
Criterion 2
Systolic blood pressure	0.84	4.52
Diastolic blood pressure	0.21	4.36

{8}------------------------------------------------

According to table, the statistical results are as follows: Method 1:

Average of systolic blood pressure is 0.84 mmHg (<±5 mmHg), standard deviation of systolic blood pressure is 5.25 mmHg (<8 mmHg)

JOYTECH Healthcare Co., Ltd..

Average of diastolic blood pressure is 0.21 mmHg (<±5 mmHg), standard deviation of diastolic blood pressure is 4.92 mmHg (<8 mmHg)

Method 2:

Average of systolic blood pressure is 0.84mmHg (< ± 5 mmHg), standard deviation of systolic blood pressure is 4.52 mmHg (<6.95mmHg)

Average of diastolic blood pressure is 0.21 mmHg (<±5 mmHg), standard deviation of diastolic blood pressure is 4.36 mmHg (<6.879 mmHg)

2.10 Summary comparing technological characteristics with predicate devices: 2.10.1 Summary of subject models on comparison with BP-1307 (K120554)

Item	Predicate DeviceBP-1307 (K120554)	All models of arm-type blood pressure monitor	Result
Indication forUse	The Fully Automatic Blood Pressure Monitors are intended to measure the systolicand diastolic blood pressure and pulse rate of adults and adolescents age 12through 21 years of age.		Identical
MeasurementMethod	Oscillometric Method		Identical
Materials	ABS housing and Nylon Fleece cuff		Identical
Power Source	4 AA batteries orMedical AC Adapter(DC6. 0V, 600mA)	DBP-1314, DBP-1313, DBP-1303, DBP-1334, DBP-1305,DBP-1307, DBP-1209, DBP-1211, DBP-1312, DBP-1318,DBP-1319, DBP-1326, DBP-1231, DBP-1332, DBP-1333,BM40, DBP-1254, DBP-1330, DBP-1257, DBP-1358,DBP-1359, DBP-1204, DBP-1210,	4 AAbatteries orMedical ACAdapter(DC6. 0V,600mA)Similar
		DBP-1346	1.5V AA×4
		DBP-1335	1.5V AAA×4
Cuff	22-36cm		Identical
PCB	DBP-1204	BP04PCB	Similar
	DBP-1210	BP10PCB
	DBP-1313, DBP-1314, DBP-1209, DBP-1254, DBP-1334,DBP-1231, DBP-1303,	SBM22PCB
	DBP-1307, DBP-1305, DBP-1318, DBP-1319, DBP-1332,DBP-1333, DBP-1257, DBP-1358, DBP-1359	BP07PCB
	DBP-1330	BP07YPCB
	DBP-1211, DBP-1312,	BP11PCB
	DBP-1346	BP46PCB
	DBP-1326	BP07SPCB
	BM40	BM40PCB
	DBP-1335	BP35PCB
USB port	No	DBP-1305, DBP-1307, DBP-1319, DBP-1332, DBP-1333	YesSimilar

{9}------------------------------------------------

JOYTECH Healthcare Co., Ltd..


IngressProtection Rating	IP20	Identical
Accuracy Pressure	$\pm$ 3mmHg	Identical
Accuracy Pulse	$\pm$ 5%	Identical
MeasurementPressure Range	0mmHg~300mmHg	Identical
MeasurementPulse Range	30~180 beats/minute	Identical
Electrical Safety	According to IEC60601-1-2 According to IEC60601-1	Identical

2.10.2 Summary of subject models on comparison with BP-2208 (K121355)

Item	Predicate DeviceBP-2208 (K121355)	Subject DeviceDBP-2160	Subject DeviceDBP-2261	Result
Indication for Use	The Fully Automatic Blood Pressure Monitors are intended to measure thesystolic and diastolic blood pressure and pulse rate of adults and adolescentsage 12 through 21 years of age.			Identical
Measurement Method	Oscillometric Method			Identical
Materials	ABS housing and Nylon Fleece cuff			Identical
Power Source	1.5V AAA×2			Identical
Cuff	13.5-21.5cm			Identical
PCB	BP08sPCB	BP61PCB	BP61PCB	Identical
Ingress ProtectionRating	IP22			Identical
Accuracy Pressure	±3mmHg			Identical
Accuracy Pulse	±5%			Identical
MeasurementPressure Range	0mmHg~300mmHg			Identical
Measurement PulseRange	30~180 beats/minute			Identical
Electrical Safety	According to IEC60601-1-2	According to IEC60601-1		Identical

There are no difference of technological characteristics between the predicate devices and the subject devices fully automatic blood pressure monitors.

2.12 Conclusions:

The Automatic Blood Pressure Monitors arm-type series have the same intended use and similar technological characteristics as the Predicate Device: BP-1307 (K Number: K120554);

The Wrist-type Blood Pressure Monitors DBP-2160,DBP-2261 have the same intended use and similar technological characteristics as the Predicate Device:BP-2208(K Number:K121355)

BP-1307(K Number:K120554) and BP-2208(K Number:K121355) are manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.

Moreover, verification and validation tests contained in this submission demonstrate that the difference in the subject models could maintain the same safety and effectiveness as that of predicate devices.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the word "JOYTECH" in blue and red letters, followed by two Chinese characters in blue. The word "JOYTECH" is written in a bold, sans-serif font. The "JOY" part of the word is in blue, while the "TECH" part is in red. The two Chinese characters are written in a traditional style. The image is likely a logo for a company or product.

In the other words, the difference between the subject and the predicate devices does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device, and the new models as mentioned on this submission are considered substantial equivalent to the predicate devices.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).