Non-invasive blood pressure measurement systems
Device Facts
| Record ID | K173024 |
|---|---|
| Device Name | Non-invasive blood pressure measurement systems |
| Applicant | Joytech Healthcare Co. , Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Aug 22, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
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.
Device Story
Fully automatic digital blood pressure monitors (arm and wrist types) measure systolic/diastolic blood pressure and pulse rate; utilize oscillometric method with silicon integrated pressure sensors; cuff automatically inflated by internal pump; deflation controlled by preset mechanical valve; measurements displayed on LCD for three minutes; maximum pressure safety limit 300 mmHg; operated by patient; output used for monitoring blood pressure; benefits include non-invasive, automated home or clinical blood pressure tracking.
Clinical Evidence
Clinical validation study performed on 85 subjects per ISO 81060-2:2013. Arm-type: systolic mean difference -0.57 mmHg (SD 4.63), diastolic -1.61 mmHg (SD 5.30). Wrist-type: systolic mean difference 0.84 mmHg (SD 5.25), diastolic 0.21 mmHg (SD 4.92). Results met all ISO 81060-2 acceptance criteria for mean difference and standard deviation.
Technological Characteristics
Oscillometric measurement; silicon integrated pressure sensor; ABS housing; nylon fleece cuff; 22-36cm (arm) or 13.5-21.5cm (wrist) cuff sizes; powered by AA/AAA batteries or AC adapter; LCD display; IP20/IP22 ingress protection; pressure range 0-300 mmHg; pulse range 30-180 bpm; compliant with AAMI/ANSI/IEC 80601-2-30, IEC 60601-1, and ISO 10993 biocompatibility standards.
Indications for Use
Indicated for adults and adolescents aged 12-21 years for the measurement of systolic and diastolic blood pressure and pulse rate.
Regulatory Classification
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.
Predicate Devices
- Sejoy BP-1307 (K120554)
- Sejoy BP-2208 (K121355)
Related Devices
- K152687 — Arm-Type Fully Automatic Digital Blood Pressure Monitor · Sejoy Electronics & Instruments Co., Ltd. · Oct 16, 2015
- K170666 — The Wrist-Type Fully Automatic Digital Blood Pressure Monitors · Joytech Healthcare Co. , Ltd. · Nov 22, 2017
- K190886 — Non-invasive blood pressure measurement systems · Joytech Healthcare Co. , Ltd. · Jul 29, 2019
- K100940 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 · Andon Health Co, Ltd. · Jun 29, 2010
- K162230 — Fully Automatic Electronic Blood Pressure Monitor · Adon Health Co., Ltd. · Nov 18, 2016
Submission Summary (Full Text)
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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
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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
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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:
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.
2.5.1 The detail comparisons among arm-type series are listed in table below:
| | | Table2.2- Characteristics of Arm-type blood pressure monitor | | | | | | | | |
|--------------------|-----|---------------------------------------------------------------|--|--|-------------------|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|
| Features<br>Models | 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
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| 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 |
Y
Y
148×100×56
22-36
84.1×54.1
A = Powered by 4 AA size batteries
Y
Y
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
N
N
N
N
N
N
N
N
N N N N N
Y
Y
Y
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#### 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.
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#### 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
1) Subjects:
Eighty-five subjects in the hospital were participated in clinical study.
2) 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.
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, $\overline{x}_n$ ,<br>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
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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
1) Subjects:
Eighty-five subjects in the hospital were participated in clinical study.
2) 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.
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, $\overline{x}_n$<br>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 |
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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)
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.
#### 2.10 Summary comparing technological characteristics with predicate devices: 2.10.1 Summary of subject models on comparison with BP-1307 (K120554)
| Item | Predicate Device<br>BP-1307 (K120554) | All models of arm-type blood pressure monitor | Result |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Indication for<br>Use | The Fully Automatic Blood Pressure Monitors are intended to measure the systolic<br>and diastolic blood pressure and pulse rate of adults and adolescents age 12<br>through 21 years of age. | | Identical |
| Measurement<br>Method | Oscillometric Method | | Identical |
| Materials | ABS housing and Nylon Fleece cuff | | Identical |
| Power Source | 4 AA batteries or<br>Medical AC Adapter<br>(DC6. 0V, 600mA) | DBP-1314, DBP-1313, DBP-1303, DBP-1334, DBP-1305,<br>DBP-1307, DBP-1209, DBP-1211, DBP-1312, DBP-1318,<br>DBP-1319, DBP-1326, DBP-1231, DBP-1332, DBP-1333,<br>BM40, DBP-1254, DBP-1330, DBP-1257, DBP-1358,<br>DBP-1359, DBP-1204, DBP-1210, | 4 AA<br>batteries or<br>Medical AC<br>Adapter<br>(DC6. 0V,<br>600mA)<br>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,<br>DBP-1231, DBP-1303, | SBM22PCB | |
| | DBP-1307, DBP-1305, DBP-1318, DBP-1319, DBP-1332,<br>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 | Yes<br>Similar |
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#### JOYTECH Healthcare Co., Ltd..
| | | DBP-1314, DBP-1313, DBP-1303, DBP-1334, DBP-1209,<br>DBP-1211, DBP-1312, DBP-1318, DBP-1326, DBP-1231,<br>DBP-1346, BM40, DBP-1254, DBP-1330, DBP-1257,<br>DBP-1358, DBP-1359, DBP-1204, DBP-1210, DBP-1335 | No | |
|-------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-----------|
| Ingress<br>Protection Rating | IP20 | | | Identical |
| Accuracy Pressure | $\pm$ 3mmHg | | | Identical |
| Accuracy Pulse | $\pm$ 5% | | | Identical |
| Measurement<br>Pressure Range | 0mmHg~300mmHg | | | Identical |
| Measurement<br>Pulse 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 Device<br>BP-2208 (K121355) | Subject Device<br>DBP-2160 | Subject Device<br>DBP-2261 | Result |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|-----------|
| Indication for Use | The Fully Automatic Blood Pressure Monitors are intended to measure the<br>systolic and diastolic blood pressure and pulse rate of adults and adolescents<br>age 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 Protection<br>Rating | IP22 | | | Identical |
| Accuracy Pressure | ±3mmHg | | | Identical |
| Accuracy Pulse | ±5% | | | Identical |
| Measurement<br>Pressure Range | 0mmHg~300mmHg | | | Identical |
| Measurement Pulse<br>Range | 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.
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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.
