(328 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology and does not mention any AI or ML components.
No
The device measures blood pressure and pulse rate; it does not provide therapy or treatment.
Yes
Explanation: The device measures blood pressure (systolic and diastolic) and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly details hardware components such as an inflatable cuff, internal pump, silicon integrate pressure sensor, mechanical valve, and LCD display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves things like blood, urine, tissue, etc., and the tests are performed outside of the body (in vitro).
- This device measures blood pressure and pulse rate directly from the patient's body. It uses a cuff on the arm or wrist and the oscillometric method to determine these values. This is a direct physiological measurement, not an analysis of a biological specimen.
The description clearly indicates a device that interacts directly with the patient's body to obtain measurements, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for 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.
Product codes
DXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm, wrist
Indicated Patient Age Range
adults and adolescents age 12 through 21 years of age.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical 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.
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).
Result:
Criterion 1: Systolic blood pressure Average -0.57 mmHg, Standard deviation 4.63 mmHg. Diastolic blood pressure Average -1.61 mmHg, Standard deviation 5.30 mmHg.
Criterion 2: Systolic blood pressure Average -0.57 mmHg, Standard deviation 3.71 mmHg. Diastolic blood pressure Average -1.61 mmHg, Standard deviation 4.94 mmHg.
Comparison results: 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.
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.
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).
Result:
Criterion 1: Systolic blood pressure Average 0.84 mmHg, Standard deviation 5.25 mmHg. Diastolic blood pressure Average 0.21 mmHg, Standard deviation 4.92 mmHg.
Criterion 2: Systolic blood pressure Average 0.84 mmHg, Standard deviation 4.52 mmHg. Diastolic blood pressure Average 0.21 mmHg, Standard deviation 4.36 mmHg.
Comparison results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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:
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 | ||||||||||
| 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
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 |
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
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 (