(114 days)
No
The description details the use of the oscillometric method and basic signal analysis for blood pressure and pulse rate measurement, including a simple comparison of pulse wave intervals for irregular rhythm detection. There is no mention of AI or ML algorithms, training data, or complex pattern recognition beyond standard signal processing techniques for this type of device.
No.
The device is intended to measure blood pressure and pulse rate, and detect irregular pulse rhythms, which are diagnostic/monitoring functions, not therapeutic.
No
The device measures blood pressure and pulse rate, and it detects irregular pulse rhythm. While irregular rhythm detection provides an alert, it does not provide a definitive diagnosis of a medical condition. It prompts the user to consult a healthcare professional for diagnosis.
No
The device description explicitly details hardware components such as an inflatable cuff, pressure sensor, pump, electromagnetic deflation control valve, LCD, and batteries. It is a physical device that measures blood pressure using an oscillometric method.
Based on the provided information, 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.
- Device Function: The description clearly states that this device measures blood pressure and pulse rate using a non-invasive technique involving a cuff wrapped around the wrist. It does not analyze samples taken from the body.
- Method: The method described is the oscillometric method, which is a physical measurement of pressure changes, not a chemical or biological analysis of a sample.
Therefore, this device falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Truly Automatic Wrist Blood Pressure Monitor ,Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 display a warning signal with the reading once the irregular heartbeat is detected.
Product codes
DXN
Device Description
Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW700, DW701M, DW702M, 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".
Truly Automatic Wrist Blood Pressure Monitor DW series are single-mounted devices of 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 circumfernan 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 keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by two AAA alkaline batteries.
The device 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%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adult
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)
Not Found
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).
0
K091415
510(k) Summary
Date of Summary Preparation: 4.20.2009
SFP - 4 2009
1. Submitter's Identifications
Submitter's Name: Truly Instrument Limited
Address: Truly Industrial Area, Shanwei City, 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, 1
Non-invasive
Models: DW100, DW200, DW500, DW700, DW701M, DW702M, 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 Perdicate Devices
a. Digibio Digital Blood Pressure Monitor, Model D11, K014141
- b. Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW100), K073398
4. Device Description
Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW700, DW701M, DW702M, 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".
Truly Automatic Wrist Blood Pressure Monitor DW series are single-mounted devices of 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 circumfernan approximately between 135 and 220 mm, includes the inflatable bladder and
1
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 keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by two AAA alkaline batteries.
The device 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%.
5. Intended use of device
Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 display a warning signal with the reading once the irregular heartbeat is detected.
6. Summary of Substantial Equivalence
Table 1: The difference between Truly Automatic Wrist Blood Pressure Monitor DW series and Digibio Digital Blood Pressure Monitor, Model D11.
| Parameter | Predicate
Devices D11 | DW
100 | DW
200 | DW
500 | DW
700 | DW
701M | DW
702M | DW
703 |
|-------------------------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|-----------|------------|------------|-----------|
| Measurement
algorithm
Method | Oscillometric
method | No change ,all same | | | | | | |
| Measurement
site of body | Arm | Wrist | | | | | | |
| Pressure Sensor | MPS-2107 | No change ,all same | | | | | | |
| Cuff | Arm cuff | Wrist cuff. | | | | | | |
| Software | | D11 software + Irregular heartbeat detection. | | | | | | |
| Irregular
heartbeat
detection | | More than ±25% to the mean interval of pulse intervals:
About the more detailed description of the IH detection algorithm,
please refer to "Software validation report I-5. Algorithm description
4. Determination method of irregular heartbeat".
DW701M, DW702M and DW703 have the IH feature. | | | | | | |
| Memory Size | 2 x 60 | 2 x 60 | 2 x 60 | 1 x 99 | 1 x 99 | 4 x 99 | 4 x 99 | 1 x 99 |
| Measurement
Pressure Range | 20 ~ 280 mmHg | No change ,all same | | | | | | |
| Measurement
Pulse Range | 40 ~ 195
beats/min | No change ,all same | | | | | | |
| Measuring | 1 mmHg | No change ,all same | | | | | | |
Page 2 of 4
21
2
| Parameter | Predicate
Devices D11 | DW
100 | DW
200 | DW
500 | DW
700 | DW
701M | DW
702M | DW
703 | |
|------------------------------------------|-----------------------------------------|---------------------|------------------------------------------------------------------------------------------------------|-----------|-----------|------------|------------|-----------|--|
| resolution | | | | | | | | | |
| Accuracy
Pressure | $\pm$ 3mmHg | No change ,all same | | | | | | | |
| Accuracy Pulse | $\pm$ 5% | No change ,all same | | | | | | | |
| Pressurization
Source | Automatic
internal pump | No change ,all same | | | | | | | |
| Cuff Deflation | Automatic
deflation | No change ,all same | | | | | | | |
| Operating
Environment | 1040℃90%RH | No change ,all same | | | | | | | |
15
| Power | 4X 1.5V AAA | | 2 x 1.5V AAA | | | | | | |
| Hardware power
circuit | 6V power
voltage change
to 4V | | 3V power voltage change to 4V | | | | | | |
| Hardware other
circuit | | | No change ,all same | | | | | | |
| Electronic
element
(power circuit) | DC-DC BL8503
and relation
element | | DC-DC BL8530 and relation element | | | | | | |
| Electronic
element
(other circuit) | | | No change ,all same | | | | | | |
| PCB | difference | | There is difference from D11, but all PCB are same in the wrist blood
pressure monitor DW series. | | | | | | |
| Display Type | Liquid crystal
display | No change ,all same | | | | | | | |
| Cover | | Difference | | | | | | | |
Table 2: The difference between Truly Automatic blood pressure monitor DW series and Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW100).
| Parameter | Predicate Devices
BP3MK1-3
(BPW100) | DW
100 | DW
200 | DW
500 | DW
700 | DW
701M | DW
702M | DW
703 |
|--------------------------|-------------------------------------------|----------------------|-----------|-----------|-----------|------------|------------|-----------|
| Measurement
Method | Oscillometric
Method | No change - the same | | | | | | |
| Pressure Sensor | Capacitive | No change - the same | | | | | | |
| Measurement
Range: BP | 30280mmHg | 20 ~ 280 mmHg | | | | | | |200 beats/min | 40 ~ 195 beats/min | | | | | | |
| Measurement
Range: BP | 40
Page 3 of 4
.
22
.
........
3
| Parameter | Predicate Devices
BP3MK1-3
(BPW100) | DW
100 | DW
200 | DW
500 | DW
700 | DW
701M | DW
702M | DW
703 |
|----------------------------------|--------------------------------------------------------------|-----------------------------------------------|----------------------|----------------------|----------------------|----------------------|----------------------|----------------------|
| Measuring
resolution | 1mmHg | No change - the same | | | | | | |
| Accuracy
Pressure | ±3mmHg | No change - the same | | | | | | |
| Accuracy
Pulse | ±5% | No change - the same | | | | | | |
| Pressurization
Source | Automatic internal
pump | No change - the same | | | | | | |
| Cuff Deflation | Automatic deflation | No change - the same | No change - the same | No change - the same | No change - the same | No change - the same | No change - the same | No change - the same |
| Memory Size | 99 | 2 × 60 | 2 × 60 | 1 × 99 | 1 × 99 | 4 × 99 | 4 × 99 | 1 × 99 |
| Irregular Heartbeat
Detection | More than ±25% to
the mean interval of
pulse intervals | DW701M, DW702M and DW703 have the IH feature. | | | | | | |
| Power Source | 2 X1.5V AAA
batteries | No change - the same | | | | | | |
| Operating
Environment | 1040℃90%RH | No change - the same | | | | | | |
15
| Cuff Attachment
Method | By plastic hose
connected to
monitor | No change - the same | | | | | | |
| Display Type | Liquid
crystal
display | Liquid crystal display | | | | | | |
7. Conclusions
The subject devices have all features of the predicate device D11 except the new features of irregular heartbeat detection, wrist cuff and the battery power. These differences do not affect the safety and effectiveness of the subject devices.
l rregular heartbeat detection technology is same as what is used Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BPW100), K073398.
Thus, the subject devices are substantially equivalent to the predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Truly Instrument Co., Ltd. c/o Mr. Yang Jian-Hao Manager Truly Industrial Area Shanwei. Guangdong 516600 China
SEP - 4 2009
Re: K091415
Trade/Device Name: Truly Automatic Wrist Blood Pressure Monitor Models DW100. DW200, DW500, DW700, DW701M, DW702M and DW703 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: August 7, 2009
Dear Mr. Yang:
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 confrols 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.
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.
5
Page 2 - Mr. Yang Jian-Hao
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
TRULY®
Indication for Use
510(k) Number (if known):
Device Name: Truly Automatic Wrist Blood Pressure Monitor DW Series, Models DW100,DW200,DW500,DW700,DW701M,DW702M,DW703
Indication For Use:
Truly Automatic Wrist Blood Pressure Monitor ,Models DW100, DW200, DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 display a warning signal with the reading once the irregular heartbeat is detected.
Prescription Use
OR Over the Counter Use
(21 CFR Part 801 Subpart D)
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
W.M.D.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091415
HongKong: 2/F, Chung Shun Knitting Centre, 1-3 Wing Yip Street, Kwai Chung, N.T., Hong Kong, TEL: (852) 2487 9803 (20 Lines) FAX: (852) 2146 5756 URL: http://www.trulyinstrument.com E-MAIL: healthcare@truly.com.hk China: Truly Industrial Area .ShanWei City. Guangdong Province ,China . TEL:86-0660-3380070 FAX · 86- 0660- 33 803 77