(86 days)
Not Found
No
The description details standard oscillometric blood pressure measurement and basic irregular pulse detection based on time interval analysis, without mentioning AI or ML techniques.
No.
The device is intended to measure and monitor blood pressure, not to treat or cure a disease or condition.
Yes
The device is intended to measure systolic and diastolic blood pressure and pulse rate and features irregular pulse rhythm detection, which provides information on a patient's health status, qualifying it as a diagnostic device.
No
The device description explicitly lists hardware components such as a main unit, cuff unit, microprocessor, pressure sensor, operation keys, pump, electromagnetic deflation control valve, and LCD. It also mentions being powered by batteries. This indicates it is a physical device with integrated software, not a software-only medical device.
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 Truly Automatic Wrist Blood Pressure Monitor DW series measures blood pressure and pulse rate using a non-invasive technique involving a cuff wrapped around the wrist. It analyzes pressure changes and electrical signals from a sensor.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the body. It directly measures a physiological parameter (blood pressure and pulse) externally.
Therefore, while it is a medical device, it falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 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 (comma separated list FDA assigned to the subject device)
DXN
Device Description
Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 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 arm 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 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
Home
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)
Study Type: Clinical study
Subjects: Ninety subjects including 15 hypertensive patients in the hospital were participated in clinical study.
Method: A standard mercury sphygmomanometer was used as a reference standard. Simultaneous and blinded blood pressure determinations were performed by two doctors.
Criteria: The ANSI/AAMI SP10 Standard recommended:
- a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg A. between test device and reference method,
-
- Between-observer agreement should be:95% or more of readings made simultaneously by observers agree to within x10mmHg and 85% or more agree to within x5 mmHg.
Results:
- Between test device and reference method:
- Systolic Pressure: Mean differences -3.5 mmHg, SD differences 3.5 mmHg
- Diastolic Pressure: Mean differences -3.2 mmHg, SD differences 3.5 mmHg
- Between-observer agreement:
- Systolic Pressure: At least 95% of readings agree to within x 10mmHg (100%), At least 85% of readings agree to within x 5mmHg (99%)
- Diastolic Pressure: At least 95% of readings agree to within x 10mmHg (100%), At least 85% of readings agree to within x 5mmHg (99%)
Conclusion: Through clinical research, we can convinced that the clinical device is safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy Pressure: ± 3mmHg
Accuracy Pulse: ± 5%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Truly Instrument Limited
K113085
510(k) Summary
JAN 1 2 2012
Date of Summary Preparation: August.16.2011
1. Submitter's Identifications
| Submitter's Name: | Truly Instrument Limited |
|---|---|
| Address: | Site 2, 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, Non-invasive Truly Automatic Wrist Blood Pressure Monitor Trade Nam: DW801, DW802, DW803, DW805, DW806, DW807, DW808, Models: DW901, DW902, DW903 cardio-vascular Classification Panel: Automatic Wrist Blood Pressure Monitor Common/Usual Name: DXN Product Code: Device Classification: Class II N/A Contraindications :
3. The Predicate Devices
Truly Automatic Wrist Blood Pressure Monitor, Model DW700, K091415
4. Device Description
Truly Automatic Wrist Blood Pressure Monitor DW series, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 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 arm 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 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 Page 1 of 6
代—1
1
Truly Instrument Limited
(113,085
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 DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 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.
2
Truly Instrument Limited TRULY®
KII3085
6. Summary of Substantial Equivalence
| Parameter | Predicate Device DW700 | DW
801 | DW
802 | DW
803 | DW
805 | DW
806 | DW
807 | DW
808 | DW
901 | DW
902 | DW
903 | Result | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|-----------|-----------|-----------|-----------|-----------|-----------|-----------|--------|--|
| Intended use | Measuring systolic and diastolic blood pressure
and pulse rate of adult individual | Measuring systolic and diastolic blood pressure and pulse rate of adult individual | | | | | | Same | | | | | |
| Indications for use | Measuring systolic and diastolic blood pressure
and pulse rate of adult individual, Including
irregular pulse rhythm detection.
Over-The-Counter Use | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection.
Over-The-Counter Use | | | | | | Same | | | | | |
| Target Population | Adult | Adult | | | | | | Same | | | | | |
| Anatomical sites | Wrist | Wrist | | | | | | Same | | | | | |
| Where used (hospital, home, ambulance. etc) | Home | Home | | | | | | Same | | | | | |
| Energy used and / or delivered | 2x 1.5V AAA Battery | 2x 1.5V AAA Battery | | | | | | Same | | | | | |
| Human factors | Blood pressure | Blood pressure | | | | | | Same | | | | | |
| Design | Refer to Table-2 | Refer to Table-2 | | | | | | Same | | | | | |
| Performance | Measuring systolic and diastolic blood pressure
and pulse rate of adult individual, Including
irregular pulse rhythm detection | Measuring systolic and diastolic blood pressure and pulse rate of adult individual, Including irregular pulse rhythm detection | | | | | | Same | | | | | |
| Materials | Refer to Table-2 | Refer to Table-2 | | | | | | Same | | | | | |
| Biocompatibility | Cuff
According to ISO-10993 | Cuff
According to ISO-10993 | | | | | | Same | | | | | |
| Compatibility with the environment and other devices | Operation Environment:
10°C ~ 40°C, 15% ~ 90%RH
Storage Environment: | Operation Environment:
10°C ~ 40°C, 15% ~ 90%RH
Storage Environment: | | | | | | Same | | | | | |
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| Result | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| DW | |||||||||||
| 801 | DW | ||||||||||
| 802 | DW | ||||||||||
| 803 | DW | ||||||||||
| 805 | DW | ||||||||||
| 806 | DW | ||||||||||
| 807 | DW | ||||||||||
| 808 | DW | ||||||||||
| 901 | DW | ||||||||||
| 902 | DW | ||||||||||
| 903 | |||||||||||
| Truly Instrument Limited | |||||||||||
| K113085 | |||||||||||
| Parameter | Predicate Device DW700 | ||||||||||
| sterility | N/A | -20°C ~ 60°C, 10%~95%RH | Same | ||||||||
| Electrical safety | According to IEC60601-1-2 | Same | |||||||||
| Mechanical safety | According to IEC60601-1 | Same | |||||||||
| Chemical safety | Same | Same | |||||||||
| Thermal safety | N/A | Same |
.
ble ಿ ವಿ riso
| Parameter | Predicate Device DW700 | DW
801 | DW
802 | DW
803 | DW
805 | DW
806 | DW
807 | DW
808 | DW
901 | DW
902 | DW
903 | |
|---------------------------------|----------------------------------------------------|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|-----------|-----------|-----------|-----------|-----------|-----------|-----------|
| Measurement algorithm
Method | Oscillometric method | | No change, all same | | | | | | | | | |
| Measurement site of body | Wrist | | No change, all same | | | | | | | | | |
| Pressure Sensor | MSP-2107 | | No change, all same | | | | | | | | | |
| Cuff | | | No change, all same | | | | | | | | | |
| Software | | | No change, all same | | | | | | | | | |
| Irregular
detection | heartbeat | | 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 1-5. Algorithm description 4. Determination method of irregular heartbeat". | | | | | | | | | |
| Memory Size | | | | | | | | | | | | |
| Measurement
Range | Pressure
20 ~ 280 mmHg | | No change, all same | | | | | | | | | |
| Measurement
Range | Pulse
40 ~ 195 beats/min | | No change, all same | | | | | | | | | |
| Parameter | Truly Instrument Limited
Predicate Device DW700 | K113085 | DW
801 | DW
802 | DW
803 | DW
805 | DW
806 | DW
807 | DW
808 | DW
901 | DW
902 | DW
903 |
| Measuring resolution | 1 mmHg | No change, all same | | | | | | | | | | |
| 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℃ | No change,all same | | | | | | | | | | |90%RH | No change,all same | | | | | | | | | | |
| Power Voltage | 15
| Hardware circuit | 2 x 1.5V | No change,all same | | | | | | | | | | |
| Electronic element | | No change,all same | | | | | | | | | | |
| PCB | | No change,all same | | | | | | | | | | |
| Display Type | Liquid crystal display | Liquid crystal display ,Only difference size | | | | | | | | | | |
| Cover | | Difference | | | | | | | | | | |
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:
4
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Page 5 of 6
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:
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5
7. Summary of Clinical study
-
I). Subjects:
Ninety subjects including 15 hypertensive patients 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 ANSI/AAMI SP10 Standard recommended : -
a mean difference of x5mmHg, with standard deviation of differences of x8 mmHg A. between test device and reference method,
-
- Between-observer agreement should be:95% or more of readings made simultaneously by observers agree to within x10mmHg and 85% or more agree to within x5 mmHg.
-
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.
| Criteria | Test Result | ||
|---|---|---|---|
| Systolic Pressure | Diastolic Pressure | ||
| Mean differences | x 5 mmHg | -3.5 mmHg | -3.2 mmHg |
| SD differences | x 8 mmHg | 3.5 mmHg | 3.5 mmHg |
Table-1 Between test device and reference method
| Table-2 Betwee-observer agreement | ||
|---|---|---|
| -- | ----------------------------------- | -- |
| Criteria | Test Result | |
|---|---|---|
| Systolic Pressure | Diastolic Pressure | |
| At least 95% of readings agree to | ||
| within x 10mmHg | 100% | 100% |
| At least 85% of readings agree to | ||
| within x 5mmHg | 99% | 99% |
6. Conclusions
The new subject series devices of Truly Automatic Wrist Blood Pressure Monitor continue to follow principles of hardware and software design of the predicate device DW700(K091415), and the feature, safety, effectiveness are also as same as Dw700., just only in case and LCD''s size changes. Thus, the subject devices are substantially equivalent to the predicate devices.
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 2 2012
Truly Instrument Co., Ltd. c/o Mr. Yang Jian-Hao Manager Site 2. Truly Industry Area Shan Wei, Guang Dong 516600 China
Re: K113085
Trade/Device Name: Truly Automatic Wrist Blood Pressure Monitor Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 16, 2011 Received: October 18, 2011
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 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.
7
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.
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Truly Instrument Limited
Indications for Use
K113085 510(K) Number (if Known)
Device Name: Truly Automatic Wrist Blood Pressure Monitor DB Series:
Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903
Indication For Use:
Truly Automatic Wrist Blood Pressure Monitor, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 are a series device 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 _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1510{k} Number