(153 days)
No
The description details a standard oscillometric blood pressure monitor using established methods and hardware components, with no mention of AI/ML terms or data processing beyond basic measurement and display.
No
The device is intended to measure blood pressure and pulse rate, not to treat or cure any condition.
Yes
The device measures blood pressure (systolic and diastolic) and pulse rate, which are physiological parameters used to assess and monitor health conditions.
No
The device description explicitly states it consists of a "sphygmomanometer main body and cuff" and details hardware components like an ABS housing, LCD, keys, measurement control module, pneumatic control module, and power supply module. It also describes the physical process of cuff inflation and deflation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Wrist-type Fully Automatic Digital Blood Pressure Monitor measures blood pressure and pulse rate by applying a cuff to the wrist and using the oscillometric method. This is a non-invasive measurement taken directly from the patient's body.
- Lack of Sample Analysis: The device does not collect or analyze any biological samples from the patient.
Therefore, based on the provided information, the device is a non-invasive medical device for measuring physiological parameters, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DXN
Device Description
The Wrist-type Fully Automatic Digital Blood Pressure Monitor is consist of sphygmomanometer main body and cuff. The mainbody contains ABS housing, LCD, keys, measurement control module, pneumatic control module, power supply module.
The Wrist-type Fully Automatic Digital Blood Pressure Monitor is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The device with an inflatable cuff wrapping around the patient's wrist and 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 minutes. The cuff can measure pressure range from 0 to 300mmHg, and the pulse rate range from 30 to 180 beats/min.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wrist
Indicated Patient Age Range
adults and adolescents over 12 years of age.
Intended User / Care Setting
Home and Clinical environment (OTC)
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 Validation: ISO81060-2:2018+AMD2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type.
2.9.1 Fit cuff circumstance 13.5-21.2cm for all models
- Study type: Clinical investigation
- Sample size: 85 patients (43 females and 42 males) participated.
- Key results:
- Statistic Methods:
- Eligibility criteria 1: The mean value of difference is equal or within to ± 5mmHg and the standard deviation of no greater than 8 mmHg between subject device and reference device.
- Eligibility criteria 2: According the known mean value of difference to determine the standard deviation required on the basis of table below. If the standard deviation is less than the corresponding standard deviation limit, the data set is judged as acceptable.
- Statistic results (Method 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.
- Statistic results (Method 2):
- Systolic blood pressure: Average 0.84mmHg, Standard deviation 4.52 mmHg.
- Diastolic blood pressure: Average 0.21 mmHg, Standard deviation 4.36 mmHg.
- Conclusion: 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.
- Statistic Methods:
2.9.2 Fit cuff circumstance 12.5-23cm for DBP-2242
- Study type: Clinical investigation
- Sample size: 85 patients (43 females and 42 males) participated.
- Key results:
- Statistic Methods: The same as clause 2.9.1.
- Statistic Results (Method 1):
- Systolic blood pressure: Average 0.87 mmHg, Standard deviation 5.22 mmHg.
- Diastolic blood pressure: Average 0.20 mmHg, Standard deviation 4.93 mmHg.
- Statistic Results (Method 2):
- Systolic blood pressure: Average 0.87 mmHg, Standard deviation 4.48 mmHg.
- Diastolic blood pressure: Average 0.20 mmHg, Standard deviation 4.38 mmHg.
- Conclusion: 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)
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 1, 2022
Joytech Healthcare Co., Ltd Dandan Huang Regulatory Engineer No.365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou, Zhejiang 311100 China
Re: K213189
Trade/Device Name: 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: January 20, 2022 Received: January 26, 2022
Dear Dandan Huang:
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
1
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,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213189
Device Name
Wrist-type Fully Automatic Digital Blood Pressure Monitor Including DBP-2101, DBP-2202, DBP-2116, DBP-2206, DBP-2220, DBP-2242, DBP-2141, DBP-2152, DBP-2253, DBP-2228, DBP-2229, DBP-2127, DBP-2261, DBP-2160
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
JOYTEC-I健玮拓
510(k) Summary
The assigned 510(k) number is:
Subjectter's Identification: 2.1
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
Name of the Device: 2.2
Trade Name: Wrist-type Fully Automatic Digital Blood Pressure Monitor
Including all models DBP-2101, DBP-2202, DBP-2116, DBP-2206, DBP-2208, DBP-2220, DBP-2242, DBP-2141, DBP-2152, DBP-2253, DBP-2229, DBP-2127, DBP-2127, DBP-2261, DBP-2160
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 Wrist-type Fully Automatic Digital Blood Pressure Monitors are substantially equivalent to the Predicate device of Wrist-type blood pressure monitor DBP-2261(K173024)
4
Image /page/4/Picture/2 description: The image shows the logo for JOYTEC-I. The logo is in blue and red. The text is in a sans-serif font. The logo is simple and modern.
manufactured by JOYTECH Healthcare Co., Ltd..
2.5 Device Description:
The Wrist-type Fully Automatic Digital Blood Pressure Monitor is consist of sphygmomanometer main body and cuff. The mainbody contains ABS housing, LCD, keys, measurement control module, pneumatic control module, power supply module.
The Wrist-type Fully Automatic Digital Blood Pressure Monitor is automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use in home and clinical environment. The device with an inflatable cuff wrapping around the patient's wrist and 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 minutes. The cuff can measure pressure range from 0 to 300mmHg, and the pulse rate range from 30 to 180 beats/min. The detail comparisons between Wrist-type series are listed in table below:
| Features | A | B | C | D | E | F | G | H (mm) | I (cm) | J(mm) | K | L | M | N | O |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Models | |||||||||||||||
| DBP-2101 | Y | 120 | |||||||||||||
| Memories×1 | N | N | N | N | N | 76×67.5×29 | 13.5-21.5 | 30×36 | N | N | N | Y | Y | ||
| DBP-2202 | Y | 30 Memories×4 | Y | N | N | N | N | 79×64×29 | 13.5-21.5 | 42×34 | N | N | N | Y | Y |
| DBP-2116 | Y | 120 | |||||||||||||
| Memories×1 | Y | Y | N | N | N | 79×66×28 | 13.5-21.5 | 45×30 | N | N | N | Y | Y | ||
| DBP-2229 | Y | 30 Memories×4 | Y | Y | N | Y | Y | 76×67.5×28.5 | 13.5-21.5 | 45×30 | N | N | N | Y | Y |
| DBP-2228 | Y | 30 Memories×4 | Y | N | N | N | N | 76×67.5×28.5 | 13.5-21.5 | 45×30 | N | N | N | Y | Y |
| DBP-2127 | Y | 120 | |||||||||||||
| Memories×1 | N | N | N | N | N | 76×67.5×28.5 | 13.5-21.5 | 45×30 | N | N | N | Y | Y | ||
| DBP-2206 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 77×64×32.5 | 13.5-21.5 | 45×30 | N | O | N | Y | O |
| DBP-2208 | Y | 60 Memories×2 | Y | Y | Y | Y | N | 77×64×32.5 | 13.5-21.5 | 49×38 | O | O | N | Y | O |
| DBP-2220 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 77×64×32 | 13.5-21.5 | 49×38 | O | O | N | Y | O |
| DBP-2141 | Y | 120 | |||||||||||||
| Memories×1 | Y | Y | N | Y | Y | 84×64×29 | 13.5-21.5 | 45×30 | N | O | N | Y | O | ||
| DBP-2242 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 84×64×29 | 13.5-21.5 | ||||||
| or | |||||||||||||||
| 12.5-23cm | |||||||||||||||
| (Optional) | 49×38 | O | O | N | Y | O |
Table 2.1 Characteristics of Wrist-type Blood Pressure Monitor
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| DBP-2152 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 77×64×32 | 13.5-21.5 | 45×30 | N | O | N | Y | O |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DBP-2253 | Y | 60 Memories×2 | Y | Y | Y | Y | N | 77×64×32.5 | 13.5-21.5 | 49×38 | O | O | N | Y | O |
| DBP-2261 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 85×62×25 | 13.5-21.5 | 43×40 | O | O | N | Y | O |
| DBP-2160 | Y | 60 Memories×2 | Y | Y | N | Y | Y | 85×62×25 | 13.5-21.5 | 30.6×45 | O | O | N | Y | O |
Note:
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= Backlight
L= Voice function
M= PC Interface
N=Low voltage detection
O=Beep
Y= Yes
N = No
O= Optional function depending on clients' needs
The devices are all designed and manufactured according to AAMVANSI/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 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:
The PCB and Main chip of blood pressure monitor device inside were changed based on the marketed products which applied to K170666 including models DBP-2101, DBP-2202, DBP-2116, DBP-2206, DBP-2208, DBP-2220, DBP-2242, DBP-2141, DBP-2152, DBP-2228, DBP-2229, DBP-2127 and marketed products which applied to K173024 including models
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DBP-2261, DBP-2160 manufacturing by JOYTECH Healthcare Co., Ltd. , which is considered to be significant change affectiveness and safety. Therefore it had to resubmitted 510(k) application. As for intended use, operation principle, features and specification have been keep the same, the device DBP-2261(K173024) was selected as predicate device. The detail comparison of technical characteristic as table below:
| Comparison item | Subject device in present application | Predicate device K173024
(Model:DBP-2261) | Comparison result / Explanation |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| The trade name | Wrist-type Fully Automatic Digital Blood Pressure Monitor | Wrist-type Fully Automatic Digital Blood Pressure Monitor | Identical |
| Manufacturer | JOYTECH Healthcare Co., Ltd. | JOYTECH Healthcare Co., Ltd. | Identical |
| Recommended classification regulation | 21CFR 870.1130,
Noninvasive Blood Pressure Measurement System | 21CFR 870.1130,
Noninvasive Blood Pressure Measurement System | Identical |
| Regulatory class | II | II | Identical |
| Panel | 74 Cardiovascular | 74 Cardiovascular | Identical |
| Product code | DXN | DXN | Identical |
| 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 over 12 year of age. | The device is intended for used by adults and adolescents age 12 through 21 years of age to measure the systolic and diastolic blood pressure and pulse rate. | Identical |
| Environment of Use | Home and Clinical environment (OTC) | Home and Clinical environment (OTC) | Identical |
| Measuring principle | Oscillometric method | Oscillometric method | Identical |
| Measurement type | Determined during deflation | Determined during deflation | Identical |
| Cuff location | Wrist | Wrist | Identical |
| Measuring range | Systolic Pressure: 60mmHg~
260 mmHg
Diastolic Pressure:
30mmHg200 mmHg180 Beats/min | Systolic Pressure: 60mmHg~
Pulse:30
260 mmHg
Diastolic Pressure:
30 mmHg200 mmHg180 Beats/min | Identical |
Pulse:30
| Max cuff pressure | 300 mmHg | 300 mmHg | Identical |
| Cuff circumference | Other models: Fits wrist
circumference 13.5-21.5cm
DBP-2242 Fits wrist
circumference 13.5-21.5cm and
12.5-23cm (optional) | Fits wrist circumference
13.5-21.5cm | Similar
Note1 |
| Table 2.2 The comparison of subject device and Predicate device | |||||
|---|---|---|---|---|---|
| -- | -- | ----------------------------------------------------------------- | -- | -- | -- |
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Image /page/7/Picture/1 description: The image shows the logo for JOYTECH. The logo is in blue and red. The text is in English and Chinese.
| JOYTECH Healthcare Co., Ltd.. | |||
|---|---|---|---|
| Pulse: ± 5% | Pulse: ± 5% | Identical | |
| Inflation | By air pump | By air pump | Identical |
| Pressure release | By solenoid valve | By solenoid valve | Identical |
| Operating Temp. & | |||
| humidity | Temp.: 10°C~40°C | ||
| Humidity: 15~93%RH | |||
| Atmospheric: | |||
| 800hPa~1060hPa | Temp.: 10°C~40°C | ||
| Humidity: 15~93%RH | |||
| Atmospheric: | |||
| 700hPa~1060hPa | Similar | ||
| Note 2 | |||
| Storage Temp. | |||
| & humidity | Temp.: -25°C~55°C | ||
| Humidity: | |||
| ≤93% RH | Temp.: -25°C~70°C | ||
| Humidity: | |||
| ≤93% RH | Similar | ||
| Note 3 | |||
| Pressure sensor | Silicon integrate pressure | ||
| sensor | Silicon integrate pressure sensor | Identical | |
| Air Pump | DC3V Micro air pump | DC3V Micro air pump | Identical |
| Solenoid valve | DC3V solenoid-controlled | ||
| valve | DC3V solenoid-controlled | ||
| valve | Identical | ||
| Main Chip | SZC900 | uPD78F0485w | Different |
| Note 4 | |||
| Display component | Device LCD | Device LCD | Identical |
| PCB | DBP-2101: BP01SNPCB | ||
| DBP-2202: BP02SNPCB | |||
| DBP-2206: BP06SNPCB | |||
| DBP-2208, DBP-2220: | |||
| BP08SNPCB | |||
| DBP-2116: BP16SNPCB | |||
| DBP-2228, DBP-2229, | |||
| DBP-2220: BP20SNPCB | |||
| DBP-2261, DBP-2160: | |||
| BP61SNPCB | |||
| DBP-2242, DBP-2141, | |||
| DBP-2152, DBP-2253: | |||
| BSP22SNPCB | BP61PCB | Similar | |
| Note 5 | |||
| Supply power source | 2*1.5V AAA batteries | 2*1.5V AAA batteries | Identical |
| PC Interface | No | No | Identical |
| Ingress Protection Rating | IP22 | IP22 | Identical |
| Material | ABS housing and Nylon Fleece | ||
| cuff | ABS housing and Nylon Fleece | ||
| cuff | Identical | ||
| Sterilization | Not applicable | Not applicable | Identical |
| Device Functions | |||
| Irregular heart beat | Irregular heart beat is displayed | ||
| on the LCD (some models see | |||
| table 2.1) | Irregular heart beat is displayed | ||
| on the LCD. | Same | ||
| There is no | |||
| new risks for | |||
| deleting the | |||
| function. | |||
| WHO classification | |||
| indicator | None: DBP-2101, DBP-2202, | ||
| DBP-2228, DBP-2127 | Yes | Same | |
| There is no |
8
| JOXTEC-IIIT | |
|---|---|
| ------------- | -- |
| | Yes: other models | | new risks for
deleting the
function. |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--------------------------------------------|
| | DBP-2101, DBP-2127,
DBP-2116, DBP-2141:
$120 \text{ Memories } \times 1$
DBP-2202, DBP-2228,
DBP-2229: $30 \text{ Memories } \times 4$
Other models: $60 \text{ Memories } \times 2$ | 2*60 Memories | Similar
Note6 |
| Memory function | DBP-2208 own this function,
while other models none. | None | Similar
Note 7 |
| Results Average in Three
way | DBP-2208 own this function,
while other models none. | None | Similar
Note 7 |
| Last 3 Results Average | Yes: DBP-2229, DBP-2206,
DBP-2220, DBP-2141,
DBP-2242, DBP-2152,
DBP-2261, DBP-2160
Other models none | Yes | Identical |
| Backlight | Optional: DBP-2208,
DBP-2220, DBP-2242,
DBP-2253, DBP-2261,
DBP-2160
Other model none | Optional | Identical |
| Voice | Optional: DBP-2206,
DBP-2208, DBP-2220,
DBP-2141, DBP-2242,
DBP-2152, DBP-2253,
DBP-2261, DBP-2160
Other models none | Optional | Identical |
Note 1: The device DBP-2242 adding the fit wrist circumstance 12.5cm-23cm is not change the cuff material and device specification and feature. The accuracy and new cuff size have been verified and validated by safety and clinical test report. It cannot be bring new risks.
Note 2: The operation atmospheric pressure is relate to the altitude. An increase in altitude is accompanied by a decrease in atmospheric pressure. The storage environment of the subject device modified have been verified by IEC 60601-1 and IEC80601-2-30 standard test.
Note 3: The storage environment of the subject device have been verified by IEC 60601-2-30 standard test.
Note 4: The main chip affect the accuracy and safety of the blood pressure monitor device.The safety and accuracy of the subject device have been verified by IEC 60601-2-30 and IEC81060-2 standard test.
Note 5: The PCB affect the accuracy and safety of the blood pressure monitor device. The safety and accuracy of the subject device have been verified by IEC 60601 series , IEC 80601-2-30 and IEC81060-2 standard test.
Note 6: Memory group setting does not influence the accuracy, and the memory function have been verified by
9
software verification and validation report.
Note 7: Results average in three way function indicate three ways to evaluate blood pressure monitor average value. This function have been validated by Software verification and validation report.
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:
AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009(R)2012 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
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
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" and "FDA guidance Use of International Standard ISO 10993."
The test result all meet or exceed the requirement of these standards.
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Image /page/10/Picture/2 description: The image shows the logo for JOYTECH. The logo is in blue and red, with the word "JOYTECH" in large letters. To the right of the word "JOYTECH" are three Chinese characters. The logo is simple and modern.
2.9 Discussion of Clinical Tests Performed:
Clinical Validation:
- ISO81060-2:2018+AMD2020 Non-invasive sphygmomanometers — Part 2: Clinical investigation of intermittent automated measurement type.
2.9.1 Fit cuff circumstance 13.5-21.2cm for all all models
In the Wrist-type fully automatic digital blood pressure clinical investigation, Model DBP- 2208 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.
The clinical investigate statistic results in detail as below:
1) Statistic Methods:
Eligibility criteria 1: The mean value of difference is equal or within to 土 5mmHg and the standard deviation of no greater than 8 mmHg between subject device and reference device.
Eligibility criteria 2 : According the known mean value of difference to determine the standard deviation required on the basis of table below. If the standard deviation is less than the corresponding standard deviation limit, the data set is judged as acceptable.
| $ x ¯ $ | Maximum permissible standard deviation, $s_m$ , as function of, $ x ¯ $ 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
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2) Statistic results
| Average(mmHg) | Standard deviation(mmHg) | |
|---|---|---|
| Method 1 | ||
| Systolic blood pressure | 0.84 | 5.25 |
| Diastolic blood pressure | 0.21 | 4.92 |
| Method 2 | ||
| Systolic blood pressure | 0.84 | 4.52 |
| Diastolic blood pressure | 0.21 | 4.36 |
According to Table above, the statistical results are as follows:
Method 1:
Average of systolic blood pressure is 0.84 mmHg (