(114 days)
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.
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%.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Truly Automatic Wrist Blood Pressure Monitor DW series:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states the accuracy acceptance criteria for both pressure and pulse rate measurements.
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (Pressure) | ± 3 mmHg | ± 3 mmHg (Stated as "No change, all same" compared to predicate device K014141, which had this accuracy) |
| Accuracy (Pulse) | ± 5% | ± 5% (Stated as "No change, all same" compared to predicate device K014141, which had this accuracy) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that the measurement methods are "No change, all same" as the predicate devices, implying that their performance is expected to be similar.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any tests performed specifically for this device. Blood pressure monitor studies typically compare device readings against reference measurements taken by trained professionals using a mercury sphygmomanometer, but this specific information is absent.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Blood pressure monitors are typically assessed for agreement with a gold standard, not for their impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
Yes, implicitly. The listed "Accuracy Pressure" and "Accuracy Pulse" of ±3 mmHg and ±5% respectively are standalone performance metrics of the device's algorithm and hardware, without human intervention in the measurement process itself, beyond initiation. The document states that the calibration and measurement algorithms are the same ("No change, all same") as the predicate device K014141, which itself would have undergone standalone performance testing to meet its accuracy claims.
7. Type of Ground Truth Used
The document inherently refers to the auscultatory method as the ground truth. It states, "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." While not explicitly detailed for this specific device's testing, the standard for validating oscillometric blood pressure monitors involves comparing their readings against those obtained by trained observers using a mercury sphygmomanometer (auscultatory method).
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for a training set. This is typical for oscillometric blood pressure monitors, which often rely on well-established algorithms that may have been developed and validated over many years, rather than requiring re-training on new data for each new device model. The document states the measurement algorithm is "No change, all same" as the predicate.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for a training set was established. Given that the measurement algorithm is stated as "No change, all same" as the predicate device (Digibio Digital Blood Pressure Monitor, Model D11), it implies that the core algorithm was previously established and validated with a ground truth likely derived from the auscultatory method. The only detail provided is on the irregular heartbeat detection algorithm, where it refers to a "Software validation report I-5. Algorithm description 4. Determination method of irregular heartbeat," which would presumably detail its development and validation, but this report is not included.
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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
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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 | PredicateDevices D11 | DW100 | DW200 | DW500 | DW700 | DW701M | DW702M | DW703 |
|---|---|---|---|---|---|---|---|---|
| MeasurementalgorithmMethod | Oscillometricmethod | No change ,all same | ||||||
| Measurementsite of body | Arm | Wrist | ||||||
| Pressure Sensor | MPS-2107 | No change ,all same | ||||||
| Cuff | Arm cuff | Wrist cuff. | ||||||
| Software | D11 software + Irregular heartbeat detection. | |||||||
| Irregularheartbeatdetection | 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 description4. 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 |
| MeasurementPressure Range | 20 ~ 280 mmHg | No change ,all same | ||||||
| MeasurementPulse Range | 40 ~ 195beats/min | No change ,all same | ||||||
| Measuring | 1 mmHg | No change ,all same |
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| Parameter | PredicateDevices D11 | DW100 | DW200 | DW500 | DW700 | DW701M | DW702M | DW703 | |
|---|---|---|---|---|---|---|---|---|---|
| resolution | |||||||||
| AccuracyPressure | $\pm$ 3mmHg | No change ,all same | |||||||
| Accuracy Pulse | $\pm$ 5% | No change ,all same | |||||||
| PressurizationSource | Automaticinternal pump | No change ,all same | |||||||
| Cuff Deflation | Automaticdeflation | No change ,all same | |||||||
| OperatingEnvironment | 10 | No change ,all same | |||||||
| Power | 4X 1.5V AAA | 2 x 1.5V AAA | |||||||
| Hardware powercircuit | 6V powervoltage changeto 4V | 3V power voltage change to 4V | |||||||
| Hardware othercircuit | No change ,all same | ||||||||
| Electronicelement(power circuit) | DC-DC BL8503and relationelement | DC-DC BL8530 and relation element | |||||||
| Electronicelement(other circuit) | No change ,all same | ||||||||
| PCB | difference | There is difference from D11, but all PCB are same in the wrist bloodpressure monitor DW series. | |||||||
| Display Type | Liquid crystaldisplay | 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 DevicesBP3MK1-3(BPW100) | DW100 | DW200 | DW500 | DW700 | DW701M | DW702M | DW703 |
|---|---|---|---|---|---|---|---|---|
| MeasurementMethod | OscillometricMethod | No change - the same | ||||||
| Pressure Sensor | Capacitive | No change - the same | ||||||
| MeasurementRange: BP | 30~280mmHg | 20 ~ 280 mmHg | ||||||
| MeasurementRange: BP | 40~200 beats/min | 40 ~ 195 beats/min |
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| Parameter | Predicate DevicesBP3MK1-3(BPW100) | DW100 | DW200 | DW500 | DW700 | DW701M | DW702M | DW703 |
|---|---|---|---|---|---|---|---|---|
| Measuringresolution | 1mmHg | No change - the same | ||||||
| AccuracyPressure | ±3mmHg | No change - the same | ||||||
| AccuracyPulse | ±5% | No change - the same | ||||||
| PressurizationSource | Automatic internalpump | 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 HeartbeatDetection | More than ±25% tothe mean interval ofpulse intervals | DW701M, DW702M and DW703 have the IH feature. | ||||||
| Power Source | 2 X1.5V AAAbatteries | No change - the same | ||||||
| OperatingEnvironment | 10 | No change - the same | ||||||
| Cuff AttachmentMethod | By plastic hoseconnected tomonitor | No change - the same | ||||||
| Display Type | Liquidcrystaldisplay | 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.
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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.
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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
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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
§ 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).