Automatic Wrist Bluetooth Blood Pressure Monitor
Device Facts
| Record ID | K170545 |
|---|---|
| Device Name | Automatic Wrist Bluetooth Blood Pressure Monitor |
| Applicant | Truly Instrument , Ltd. |
| Product Code | DXN · Cardiovascular |
| Decision Date | Nov 21, 2017 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.1130 |
| Device Class | Class 2 |
Indications for Use
Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702 , DW703 intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication .
Device Story
Device measures systolic/diastolic blood pressure and pulse rate using oscillometric method; utilizes inflatable wrist cuff, pressure sensor, microprocessor, pump, and deflation valve. Input: cuff pressure oscillations; Output: blood pressure/pulse readings on LCD and via Bluetooth 4.0 to external devices. Used in home setting by adult patients. Detects irregular pulse rhythm (defined as >25% variation from mean pulse interval) and displays alert. Powered by 4 AAA batteries. Provides objective data for patient monitoring.
Clinical Evidence
Clinical study conducted with 85 subjects using mercury sphygmomanometer as reference. Evaluated against ISO 81060-2 standards. Results: Systolic mean difference -2.8 mmHg (SD 5.0 mmHg); Diastolic mean difference -2.9 mmHg (SD 4.8 mmHg). Criterion 2 testing showed mean errors of 4.27 mmHg (systolic) and 4.16 mmHg (diastolic) against permissible standard deviations of 6.34 and 6.30 respectively. Device met all clinical accuracy requirements.
Technological Characteristics
Materials: ABS housing, nylon cuff shell. Sensing: Electronic pressure sensor. Energy: 4x 1.5V AAA batteries. Connectivity: Bluetooth 4.0. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993 (cuff biocompatibility). Algorithm: Oscillometric method.
Indications for Use
Indicated for adult individuals to measure systolic and diastolic blood pressure and pulse rate via non-invasive wrist cuff. Includes irregular pulse rhythm detection and Bluetooth data transmission.
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
- Truly Automatic Wrist Blood Pressure Monitor Model: DW702M (K091415)
- Truly Automatic Arm Bluetooth Blood Pressure Monitor DB Series, Model DB62 (K161846)
Submission Summary (Full Text)
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November 21, 2017
Truly Instrument Ltd. % Max Wong Official Correspondent Truly (U.S.A.) Inc. 2620 Concord Avenue Suite 106 Alhambra, California 91801
Re: K170545
Trade/Device Name: Automatic Wrist Bluetooth Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 16, 2017 Received: October 18, 2017
Dear Max Wong:
We have reviewed vour 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
M.A. Wilhelm
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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### Indications for Use
510(k) Number (if known) K170545
Device Name
Automatic Wrist Bluetooth Blood Pressure Monitor
Indications for Use (Describe)
Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702, DW703 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.
The devices' features include irregular pulse rhythm detection during measurement, and will display an alert signal with the reading when irregular heartbeat is detected.
The devices' features include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
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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# 510(k) Summary
V1.0
Date of Summary Preparation: Jan.05.2017
### 1. Submitter's Identifications
| Submitter's Name: | Truly Instrument Limited |
|-------------------|---------------------------------------------------------------------------|
| Address: | Site 2, Truly Industrial Area, Shanwei City,<br>Guangdong Province, China |
| Contact Person: | Manager Yang Jian-Hao |
| Telephone: | 86-0660-3380070 |
| Fax: | 86-0660-3380377 |
### 2. Name of the Device
| | Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive |
|------------------------|-------------------------------------------------------------------------------|
| Trade Name: | Automatic Wrist Bluetooth Blood Pressure Monitor |
| Models: | DW702,DW703 |
| Classification Panel: | cardio-vascular |
| Common/Usual Name: | Automatic Wrist Blood Pressure Monitor |
| Product Code: | DXN |
| Device Classification: | Class II |
| Contraindications : | N/A |
### 3. The Predicate Devices
- 3-1. Truly Instrument.Limited
Automatic Wrist Blood Pressure Monitor Model: DW702M K Number : K091415
- 3-2. Truly Instrument Limited. Automatic Arm Bluetooth Blood Pressure Monitor DB Series, Model DB62 K Number : K161846
### 4. Device Description
Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702, DW703 are designed to measure the systolic and diastolic blood pressure and pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well-known technique in the market called the "oscillometric method".
The main components of the Truly Automatic Wrist Blood Pressure Monitor Dw series are the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to Wrist circumference approximately between 135 and 220 mm, includes the inflatable bladder and nylon shell. All models of the Wrist blood pressure monitor use a single size of cuff. The device consists of the microprocessor, the pressure sensor, the operation
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keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA alkaline batteries.
The devices also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular pulse rhythm when the difference of the time intervals is over 25%.
The devices embed a Bluetooth 4.0 Wireless network connections module that allows it to connect to nearby receiving end. Once measurement is over, the LCD of device displays results, and the device will start to send out data such as systolic, diastolic, pulse, date, time with Wireless method and protocol. .
### 5. Intended use of device
Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702 , DW703 intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the Wrist.
The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected.
The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication .
### 6. Technological Characteristics of our new DEVICE COMPARED TO THE
### PREDICATE DEVICE:
6-1:The technological characteristics of Truly Automatic Wrist Bluetooth Blood Pressure Monitor. models DW702 , DW703 are substantially equivalent to Truly Automatic Wrist Blood Pressure Monitor DB Series, Model DW702M.( K091415). There is the same Owner, TRULY instrument Limited. Which FDA owner number is 9055362. our new devices DW702, DW703 are the upgraded version to include the Bluetooth 4.0 Wireless function. In addition, there are the same dseign specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices.
| Parameter | Predicate Devices<br>DW702M(K091415) | DW702 | DW703 | Result |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Indications for<br>use | Measuring systolic and<br>diastolic blood pressure<br>and pulse rate of adult<br>individual by using a<br>non-invasive technique in<br>which an inflatable cuff is<br>wrapped around the<br>Wrist ,The devices features<br>include irregular pulse<br>rhythm detection during | Truly Automatic Wrist Bluetooth Blood Pressure<br>Monitor DW702, DW703 intended to measure<br>the systolic and diastolic blood pressure and<br>pulse rate of an adult individual by using a<br>non-invasive technique in which an inflatable<br>cuff is wrapped around the Wrist.<br>The devices' features include irregular pulse<br>rhythm detection during measurement, and will<br>display a alert signal with the reading when<br>irregular heartbeat is detected. | Truly Automatic Wrist Bluetooth Blood Pressure<br>Monitor DW702, DW703 intended to measure<br>the systolic and diastolic blood pressure and<br>pulse rate of an adult individual by using a<br>non-invasive technique in which an inflatable<br>cuff is wrapped around the Wrist.<br>The devices' features include irregular pulse<br>rhythm detection during measurement, and will<br>display a alert signal with the reading when<br>irregular heartbeat is detected. | Same |
#### Table-6-1: The comparison table
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| 1<br>L<br>11<br>1 | CR |
|-------------------|----|
|-------------------|----|
| Parameter | Predicate Devices<br>DW702M(K091415) | DW702 | DW703 | Result |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------|
| | measurement, and display a<br>warning signal with the<br>reading once the irregular<br>heartbeat is detected..<br>Over-The-Counter Use | The devices' feature include Bluetooth function<br>to transmit data to an external Bluetooth device<br>with wireless communication..<br>Over-The-Counter Use | | |
| Target<br>Population | Adult | Adult | Adult | Same |
| Anatomical sites | Wrist | Wrist | Wrist | Same |
| Where used<br>(hospital, home,<br>ambulance. etc) | Home | Home | Home | Same |
| Energy used and<br>/ or delivered | 2x 1.5V AAA Battery | 2x 1.5V AAA Battery | 2x 1.5V AAA Battery | Same |
| Human factors | Blood pressure | Blood pressure | Blood pressure | Same |
| Measurement<br>algorithm<br>Method | Oscillometric method | No change ,all same | No change ,all same | Same |
| Cuff | No change ,all same According to ISO-10993 | | | |
| Irregular heartbeat<br>detection | More than ±25% to the mean interval of pulse intervals. | | | |
| Measurement<br>Pressure Range | 20 ~ 280 mmHg | No change ,all same | No change ,all same | Same |
| Measurement<br>Pulse Range | 40 ~ 195 beats/min | No change ,all same | No change ,all same | Same |
| Mesauring<br>resolution | 1 mmHg | No change ,all same | No change ,all same | Same |
| Accuracy<br>Pressure | ±3mmHg | No change ,all same | No change ,all same | Same |
| Accuracy Pulse | ±5% | No change ,all same | No change ,all same | Same |
| PCB | 1. The major PCB is all all same.<br>There is BLE module to direct connect to major PCB via the port RX and TX<br>on the new Bluetooth model DW702,DW703 | | | |
| Software | Upgrade the software to include the data transmit with Uart protocol on the new<br>Bluetooth model DW702. DW703 | | | |
| Compatibility<br>with the<br>environment and<br>other devices | Operation Environment:<br>10°C~40°C,15%~90%RH<br>Storage Environment:<br>-20°C~ 55°C,10%~95%RH | | | Same |
| Electrical safety | According to IEC60601-1-2<br>According to IEC60601-1<br>According to IEC60601-1-11 | | | Same |
| Mechanical | Same | Same | Same | Same |
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| Parameter | Predicate Devices<br>DW702M(K091415) | DW702 | DW703 | Result |
|-----------|--------------------------------------|-------|-------|--------|
| safety | | | | |
6-2: Besides, the devices DW702 ,DW703and the predicate device Automatic Arm Bluetooth Blood Pressure Monitor, Model DB62 with the wireless communication function connect to an external Bluetooth enable device for data receiving and storage.
| Parameter | Predicate Devices<br>DB62(K161846) | DW702 | DW703 | Result |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Indications<br>for use | Truly Automatic Arm<br>Bluetooth Blood Pressure<br>Monitor DB series, Models<br>DB62, DB63, DB85 are a<br>series devices intended to<br>measure the systolic and<br>diastolic blood pressure<br>and pulse rate of an adult<br>individual by using a<br>non-invasive technique in<br>which an inflatable cuff is<br>wrapped around the upper<br>arm.<br>The devices' features<br>include irregular pulse<br>rhythm detection during<br>measurement, and will<br>display a alert signal with<br>the reading when irregular<br>heartbeat is detected.<br>The devices' feature<br>include Bluetooth function<br>to transmit data to an<br>external Bluetooth device<br>with wireless<br>communication.<br>Over-The-Counter Use | Automatic Wrist Bluetooth Blood<br>Pressure Monitor<br>intended to measure the systolic and<br>diastolic blood pressure and pulse rate of<br>an adult individual by using a<br>non-invasive technique in which an<br>inflatable cuff is wrapped around the<br>wrist.<br>The devices' features include irregular<br>pulse rhythm detection during<br>measurement, and will display a alert<br>signal with the reading when irregular<br>heartbeat is detected.<br>The devices' feature include Bluetooth<br>function to transmit data to an external<br>Bluetooth device with wireless<br>communication.<br>Over-The-Counter Use | DW702,DW703<br>The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature include Bluetooth function to transmit data to an external Bluetooth device with wireless communication. Over-The-Counter Use | Same |
| Target<br>Population | Adult | Adult | Adult | Same |
| Anatomical<br>sites | Upper Arm | wrist | wrist | Same |
| Where used<br>(hospital,<br>home,<br>ambulance | Home | Home | Home | Same |
| Parameter<br>(etc) | Predicate Devices<br>DB62(K161846) | DW702 | DW703 | Result |
| Energy used<br>and / or<br>delivered | 4x 1.5V AA Battery | 2x 1.5V AAA Battery | 2x 1.5V AAA<br>Battery | Same |
| Human<br>factors | Blood pressure | Blood pressure | Blood pressure | Same |
| Measurement<br>algorithm<br>Method | Oscillometric method | No change ,all same | No change ,all same | Same |
| Cuff | Size: 220mm~340mm<br>According to ISO-10993 | Size: 135mm~220mm<br>According to ISO-10993 | | Slightly<br>different |
| Irregular<br>heartbeat<br>detection | More than ±25% to the mean interval of pulse intervals. | | | |
| Measurement<br>Pressure<br>Range | 20 ~ 280 mmHg | No change ,all same | No change ,all same | Same |
| Measurement<br>Pulse Range | 40 ~ 195 beats/min | 40 ~ 195 beats/min | 40 ~ 195 beats/min | Slightly<br>different |
| Mesauring<br>resolution | 1 mmHg | No change ,all same | No change ,all same | Same |
| Accuracy<br>Pressure | ±3mmHg | No change ,all same | No change ,all same | Same |
| Accuracy<br>Pulse | ±5% | No change ,all same | No change ,all same | Same |
| Electrical<br>safety | According to IEC60601-1-2<br>According to IEC60601-1<br>According to IEC60601-1-11 | | | Same |
| Mechanical<br>safety | Same | Same | Same | Same |
Table-6-1: The comparison table
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#### K170545
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### Truly Instrument Limited
## 7. Summary of Clinical study
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.
- For the systolic and diastolic blood pressures for each of the m subjects, the standard B.
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Sm, of determinations per subject deviation, the averaged paired the of sphygmomanometer-under-test and of the reference sphygmomanometer shall meet the criteria listed in Tab 1 when calculated according to Equation(3).
| $\overline{x}_n$ | Maximum permissible standard deviation, $s_m$ , as function of mean error, $\overline{x}_n$<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 | - | - | - | - | - | - | - | - | - |
| EXAMPLE For mean error of ± 4.2, the maximum permissible standard deviation is 5.49. | | | | | | | | | | |
#### Table 1 - Averaged subject data acceptance (criterion 2)
#### 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.
| | Criterion 1 | | | Criterion 2 | | |
|------|----------------|------------------|----------------------------|----------------|------------------|--|
| | Diff(Systolic) | Diff (diastolic) | | Diff(Systolic) | Diff (diastolic) | |
| Mean | -2.8mmHg | -2.9mmHg | Std | 4.27mmHg | 4.16mmHg | |
| Std. | 5.0mmHg | 4.8mmHg | Criteria in<br>the Table 1 | 6.34mmHg | 6.30mmHg | |
| | | | | | | |
#### 8. Test Summary:
8-1. Electric Safety , EMC and FCC test reports.
| General safety | IEC/EN 60601-1:2007<br>IEC/EN60601-1-11<br>EN60950-1:2011 |
|----------------|-----------------------------------------------------------|
| EMC conformity | IEC/EN 60601-1-2:2010 |
| FCC conformity | FCC 47 part 15 subject B class B |
| ERM conformity | EN30148-1:2008,<br>EN30148-17:2009 |
| RF conformity | EN300328:2015 |
| Health | EN62479:2010 |
- 8-2. Performance & Clinical Test ANSI/AAMI SP10:2002 ANSI/AAMI ISO 81060-2:2009
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### 9. Conclusions
The new subject devices of Truly Automatic Wrist Bluetooth Blood Pressure Monitor continue to follow principles design of the predicate device DW702M (K091415), only upgraded to include the Bluetooth module . for the wireless communication function connects to an external Bluetooth enable device for data receiving and storage purposes . and the addition function Bluetooth substantially is equivalent to the predicate produce Truly Automatic Arm Bluetooth Blood Pressure Monitor DB62(K161846) ه
