Arm-Type Fully Automatic Digital Blood Pressure Monitor
Device Facts
| Record ID | K200649 |
|---|---|
| Device Name | Arm-Type Fully Automatic Digital Blood Pressure Monitor |
| Applicant | Joytech Healthcare Co. , Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Aug 3, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
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.
Device Story
Arm-type digital blood pressure monitor; uses inflatable cuff and oscillometric method with silicon integrated pressure sensor; internal pump inflates cuff; mechanical valve controls deflation; device measures systolic/diastolic pressure and pulse rate; detects irregular heartbeats (rhythm variation ≥25% from average). Operated by patient or clinician in home or clinical settings. Features LCD display; optional Bluetooth 5.0 module transmits data to "JOYTECH healthcare" app. App displays trend graphs; does not provide diagnostic/measurement functions or medical interpretation. Benefits include convenient, non-invasive blood pressure monitoring and data tracking for users.
Clinical Evidence
Bench testing only. Compliance with AAMI/ANSI/IEC 80601-2-30:2009/A1:2013, IEC 60601-1-11:2015, IEC 60601-1-2:2014, and biocompatibility standards (ISO 10993-5, ISO 10993-10). No new clinical testing performed; equivalence established via core algorithm and cuff design similarity to predicate DBP-1307 (K173024).
Technological Characteristics
Oscillometric measurement; silicon integrated pressure sensor; 2.4GHz BLE v5.0 connectivity; LCD display; powered by 4x AA batteries or 6V DC adapter. Materials: PC/ABS housing, biocompatible cuff materials. Standards: AAMI/ANSI/IEC 80601-2-30, IEC 60601-1-11, IEC 60601-1-2, ISO 10993. Software: Embedded firmware with Bluetooth data transmission.
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
Submission Summary (Full Text)
{0}------------------------------------------------
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.
August 3, 2020
Joytech Healthcare Co., Ltd Ren Yunhua General Manager No.365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou City, Hangzhou, Zhejiang, China 311100
Re: K200649
Trade/Device Name: Arm-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: June 28, 2020 Received: July 6, 2020
#### 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
{1}------------------------------------------------
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 mediation-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,
LT 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}------------------------------------------------
{3}------------------------------------------------
# 510(k) Summary
The assigned 510(k) number is:
## 2.1 Subiectter'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: Arm-type Fully Automatic Digital Blood Pressure Monitor
Including: DBP-1307b,DBP-1305b,DBP-1318b,DBP-1332b,DBP-1333b,DBP-1257b,
DBP-1358b,DBP-1359b
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 following devices:
| 510(k) number | model | Product code | Manufacturer |
|---------------|------------|--------------|---------------------------------------------------|
| K173024 | DBP-1307 | DXN | JOYTECH HEALTHCARE CO., LTD. |
| K161886 | H-BP100SBP | DXN | Guangdong Transtek Medical Electronics<br>Co.,Ltd |
{4}------------------------------------------------
### 2.5 Device Description:
The Arm-Type series use an inflatable cuff which is wrapped 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.
An irregular heartbeats rhythm is defined as a rhythm that varies by 25% less or more than the average rhythm detected while the monitor is measuring the systolic and diastolic blood pressure.
AND, these subject device can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the "JOYTECH healthcare" APP through the embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD of the device displays results. And the device will start to transmit data to the pair-up terminal automatically. This app is only intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate, does not provide any diagnostic or measurement functions, and does not interpret or analyze the data for medical decision making. Unlimited readings can be stored in the app for archiving and review by the user.
| Features<br>Models | A | B | C | D | E | F | G | H | I (mm) | J (cm) | K(mm) | L | M | N | O |
|--------------------|---|---|---------------|---|---|---|---|---|-------------|--------|------------|---|---|---|---|
| DBP-1307b | Y | Y | 60 Memories×2 | Y | Y | Y | N | Y | 166×114× 72 | 22-36 | 102.1×68.9 | O | O | N | Y |
| DBP-1305b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 166×114×72 | 22-36 | 84.1×55.1 | O | O | N | Y |
| DBP-1318b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 139× 88× 43 | 22-36 | 66×43 | N | N | N | Y |
| DBP-1319b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 166×114× 72 | 22-36 | 102×68.9 | O | O | N | Y |
| DBP-1332b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 148×100× 56 | 22-36 | 84.1×55.1 | O | O | N | Y |
| DBP-1333b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 164×111× 60 | 22-36 | 102.1×68.9 | O | O | N | Y |
| DBP-1257b | Y | Y | 120Memories×1 | Y | N | Y | N | N | 131×102×44 | 22-36 | 45 × 30 | N | N | N | Y |
| DBP-1358b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 131×102×44 | 22-36 | 45.7 × 62 | N | O | N | Y |
| DBP-1359b | Y | Y | 60 Memories×2 | Y | N | Y | Y | Y | 131×102×44 | 22-36 | 69 × 67 | O | O | N | Y |
The detail comparisons among the Arm-Type series are listed in table below:
{5}------------------------------------------------
A = Powered by 4 AA size batteries B= Powered by AC adaptor C = Memory Size D = Time & Date E = Results Average in Three way F = WHO (World Health Organization) Classification Indicator G = Last 3 Results Average H = Irregular Heartbeat Detection I = Outside Demission (L x W x H in unit mm) J = Cuff Size K = LCD Size (Viewing Area in unit mm) L = LCD Backlight M= Voice N=Music O=Bluetooth Function 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.
| Comparison item | Subject device in present application | Predicate device 1<br>K173024<br>(model:DBP-1307) | Predicate device 2<br>K161886<br>(model:H-BP100SBP) | Comparison result / Explanation |
|------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|---------------------------------|
| The trade name | Arm-type Fully Automatic Blood Pressure Monitor | Arm-type Fully Automatic Digital Blood Pressure Monitor | Welch Allyn Blood Pressure Device | / |
| Recommended classification on regulation | 21CFR 870.1130, Noninvasive Blood Pressure Measurement System | 21CFR 870.1130, Noninvasive Blood Pressure Measurement System | 21CFR 870.1130, Noninvasive Blood Pressure Measurement System | Identical |
| Regulatory class | II | II | II | Identical |
| Panel | 74 Cardiovascular | 74 Cardiovascular | 74 Cardiovascular | Identical |
| Product code | DXN | DXN | DXN | Identical |
| Intended | The Fully | The Fully Automatic | Welch Allyn Blood | Similar |
| | 2.7 Comparison of Technological Characteristics with predicate device: | | | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| use | Automatic<br>Blood | Blood<br>Pressure | Pressure Device H- | |
| | Pressure Monitors | Monitors are | BP100SBP is digital | |
| | are intended to | intended to measure | monitor intended for | |
| | measure blood | blood pressure | use in measuring | |
| | pressure (systolic | (systolic and | blood pressure and | |
| | and diastolic) and | diastolic) and pulse | heartbeat rate in adult | |
| | pulse rate of adults | rate of adults and | patient population | |
| | and adolescents age | adolescents age 12 | with arm | |
| | 12 through 21 years | through 21 years of | circumference ranging | |
| | of age. | age. | from 15 cm to 54 cm<br>(about 6-21 inches). | |
| | | | These devices detect | |
| | | | the appearance of | |
| | | | irregular heartbeats | |
| | | | during measurement | |
| | | | and give a warning | |
| | | | signal with readings. | |
| Measuring<br>principle | Oscillometric<br>method | Oscillometric<br>method | Oscillometric method | Identical |
| Cuff<br>location | Upper arm | Upper arm | Upper arm | Identical |
| | Performance Attributes | | | |
| Measuring<br>range | Systolic Pressure:<br>60mmHg ~ 280<br>mmHg | Systolic Pressure:<br>60mmHg ~ 280<br>mmHg | Systolic Pressure:<br>50mmHg ~ 260<br>mmHg | Identical as<br>predicate<br>device 1 |
| | Diastolic Pressure:<br>30mmHg ~ 200<br>mmHg | Diastolic Pressure:<br>30mmHg ~ 200<br>mmHg | Diastolic Pressure:<br>25mmHg ~ 220<br>mmHg | |
| | Pulse:30~180<br>Beats/Minute | Pulse:30~180<br>Beats/Minute | Pulse:40~199<br>Beats/Minute | |
| Max cuff<br>pressure | 300mmHg | 300mmHg | 300mmHg | Identical |
| Accuracy | Static Pressure: ±<br>3mmHg<br>Pulse: ± 5% | Static Pressure: ±<br>3mmHg<br>Pulse: ± 5% | Pressure: ± 0.4kPa<br>(3mmHg)<br>Pulse value: ± 5% | Identical |
| | Physical Attributes | | | |
| Blood<br>Pressure<br>categories | WHO classification | WHO classification | None | Identical |
| Display<br>component | 1.Device LCD;<br>2.iOS device or<br>Android device | Device LCD | 1.Device LCD;<br>2.iOS device or<br>Android device | Identical as<br>predicate<br>device 2 |
| Inflation | By air pump | By air pump | By air pump | Identical |
| Pressure<br>release | By solenoid valve | By solenoid valve | By solenoid valve | Identical |
| Cuff<br>circumference | Fits arm<br>circumference 22-36 | Fits arm<br>circumference 22-36 | The three preformed<br>cuff units, which are | Identical as<br>predicate<br>device 1 |
| | | | | |
| Bluetooth<br>Module<br>version | v5.0 | None | circumference<br>between 15-24cm, 22-42cm and 40-54cm to<br>meet different<br>Population's need.<br>V4.0 | Different |
| System<br>requirement | Bluetooth 4.0 or<br>later/<br>Android 5.0 or later/<br>IOS 9.0 or later | None | Platform which<br>support Bluetooth 4.0<br>technology | Similar |
| Bluetooth<br>features | Transmit data to<br>smart phone via<br>Bluetooth | None | Transmit data to<br>smart phone via<br>Bluetooth | Identical as<br>predicate<br>device 2 |
| PCB or<br>Electrical<br>scheme | BP07BT PCB | BP07 PCB | Unknow | Similar |
| Apps on smart device<br>Funtion on<br>APP | Storage test result/<br>Announce test<br>result/<br>Read<br>memories in App/<br>Empty memories in<br>app/ Draw curve/<br>Set the personal<br>information in app | None | Unknow | Different,<br>The change<br>in the<br>specification<br>is<br>documented,<br>the<br>cybersecurity risk has<br>been<br>considered<br>and the<br>overall<br>residual risk<br>is<br>acceptable.<br>The change<br>does not<br>affect the<br>intended use<br>or the<br>fundamental<br>scientific<br>technology. |
| Environmental | | | | |
| Operating<br>Temp. &<br>humidity | Temp.: 10℃~40℃<br>Humidity:<br>15~93%RH | Temp.: 10℃~40℃<br>Humidity:<br>15~93%RH | Temp.:5℃~40℃<br>Relative humidity<br>85%RH | Identical as<br>predicate<br>device 1 |
| | 700hPa~1060hPa | 700hPa~1060hPa | pressure:86kPa to 106kPa | |
| Storage<br>Temp.<br>&<br>humidity | Temp.: -25°C~55°C<br>Humidity:<br>≤90% RH | Temp.: -25°C~70°C<br>Humidity:<br>≤90% RH | Temp.:-20°C~60℃<br>Relative Humidity:<br>10% RH - 93% RH<br>Atmospheric<br>Pressure: 50kPa to<br>106 kPa | Similar |
| Electrical Power | | | | |
| Supply<br>power<br>source | For models DBP-<br>1318b,DBP-1257b,<br>DBP-1358b,DBP-<br>1359b:<br>4x1.5V AAA battery<br>or Medical AC<br>adapter (DC 6V,<br>600mA)(recommen<br>ded, not provided)<br>For other models:<br>4x1.5V AA battery<br>or Medical AC<br>adapter (DC 6V,<br>600mA)(recommen<br>ded, not provided) | 4x1.5V AA battery<br>or Medical AC adapter (DC 6V, 600mA)(recommended, not provided) | powered by four AA alkaline batteries or by a AC adapter(DC 6V,1A)(not include) | Equivalent<br>The<br>different in<br>the<br>specification<br>is<br>documented<br>and tested |
| Other Attributes | | | | |
| Sterilizati<br>on | Not applicable | Not applicable | Not applicable | Identical |
| Material | PC and ABS for the<br>case and plastic foil<br>for the labels of the<br>device.<br>Biocompatible<br>materials are used<br>for the applied parts<br>(Cuff containing a<br>interal bladder) | PC and ABS for the<br>case and plastic foil<br>for the labels of the<br>device.<br>Biocompatible<br>materials are used<br>for the applied parts<br>(Cuff containing a<br>interal bladder) | ABS is used to outer<br>housing of the main<br>unit. | Identical as<br>predicate<br>device 1 |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is two Chinese characters.
{7}------------------------------------------------
Image /page/7/Picture/0 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.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the text 'K200649' in a simple, sans-serif font. The text is black against a white background. The letters and numbers are evenly spaced and clearly legible.
## 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
{9}------------------------------------------------
device.
Electrical Safety and performance requirements:
- AAMI ● A2:2010/(R)2012 Medical Electrical Equipment.
- IEC 80601-2-30:2009(First Edition) and A1:2013, medical electrical equipment part 2-● 30: particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers.
Home-used medical equipment requirements and environmental test:
- IEC 60601-1-11:2015 General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Electromagnetic compatibility requirements:
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- EN300328:Electromagnetic compatibility and Radio spectrum Matters (ERM); . Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;
- ETSI Radio spectrum Matters(ERM);ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1:Common technical requirements;
- ETSI EN 301489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions or Broadband Data Transmission Systems;
Bio-compatibility Evaluation for patient contacting components:
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for ● irritation and skin sensitization
FCC Test
- FCC Part15 Subpart C
- RF Exposure Evaluation
{10}------------------------------------------------
Guidance Document:
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
The test result all meet or exceed the requirement of these standards.
### 2.10. Discussion of Clinical Tests Performed:
Clinical Validation:
- ISO81060-2:2013 Non-invasive sphygmomanometers -- Part 2: Clinical validation of automated measurement type.
Based on the core algorithm and same cuff circumference are completely equivalent to the Predicate device of Joytech, DBP-1307 (K Number: K173024), clinical testing was not required to establish equivalency of the device.
### 2.11. Conclusions:
This submitted Arm-type series have been found to be substantially equivalent to the predicate device. Based on the information provided in this submission, differences between the subject device and predicate device have been tested and documented, it has been demonstrated that the subject devices are as safe and effective as the predicate device.
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.
--- End of this section---
