(114 days)
Not Found
No
The description details a standard oscillometric blood pressure measurement method and irregular pulse detection based on simple time interval comparisons, with no mention of AI or ML technologies.
No
The device is used for measuring blood pressure and pulse rate, which are diagnostic functions, not therapeutic ones. It does not actively treat or mitigate a disease or condition.
Yes
The device is intended to measure blood pressure and pulse rate, and it also features irregular pulse rhythm detection, which are all diagnostic indicators of health status.
No
The device description explicitly lists hardware components such as a main unit, cuff unit, microprocessor, pressure sensor, pump, valve, and LCD, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the 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 an inflatable cuff wrapped around the upper arm. It analyzes pressure changes and electrical signals from a sensor.
- No mention of specimens: There is no indication that this device analyzes any biological specimens taken from the body.
Therefore, the Truly Automatic Arm Blood Pressure Monitor DB series is a non-invasive medical device used for physiological measurement, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Truly Automatic Arm Blood Pressure Monitor, Models DB21, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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 upper arm.
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 Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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 upper arm. 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 Arm Blood Pressure Monitor DB 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 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm 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 four AAA or AA 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
upper arm
Indicated Patient Age Range
adult individual
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): 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
K091434
Truly Instrument Limited.
510(k) Summarv
SEP - 4 2009
Date of Summary Preparation: 4.20.2009
1. Submitter's Identifications
Submitter's Name: Truly Instrument Limited
Truly Industrial Area, Shanwei City, Guangdong Province, Address: 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
Models: DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M Classification Panel: cardio-vascular Common/Usual Name: Automatic Arm Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications : N/A
3. The Predicate Devices
a. Digibio Digital Blood Pressure Monitor, Model D11, K014141 b. Microlife Blood Pressure Monitor, Model BP3BT0-AP, K041411
4. Device Description
Truly Automatic Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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 upper arm. 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 Arm Blood Pressure Monitor DB 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 220 and 340 mm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor use a single size of
20
1
Truly Instrument Limited.
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 four AAA or AA 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 Arm Blood Pressure Monitor DB series, Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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 upper arm.
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 Arm Blood Pressure Monitor DB series and Digibio Digital Blood Pressure Monitor, Model D11.
| Parameter | Predicate
Devices D11 | DB
21 | DB
22 | DB
23 | DB
31 | DB
32 | DB
61M | DB
62M | DB
63M | DB
71M |
|-------------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------|----------|-----------|-----------|-----------|-----------|
| Measurement
algorithm | Oscillometric
method | No change ,all same | | | | | | | | |
| Method | | | | | | | | | | |
| Measurement
site of body | Arm | No change ,all same | | | | | | | | |
| Pressure
Sensor | MSP-2107 | No change, all same | | | | | | | | |
| Cuff | | No change ,all same | | | | | | | | |
| 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".
DB22, DB23, DB61M, DB62M, DB63M, DB71M have the IH feature. | | | | | | | | |
| Memory Size | 2 x 60 | 2X60 | 2X50 | 4X99 | 2X60 | 1X99 | 4X99 | 4X99 | 4X99 | 4X99 |
| Measurement
Pressure
Range | 20280195
mmHg | No change ,all same | | | | | | | | |
| Measurement
Pulse Range | 40
beats/min | No change ,all same | | | | | | | | |
2
Truly Instrument Limited.
| Parameter | Predicate
Devices D11 | DB
21 | DB
22 | DB
23 | DB
31 | DB
32 | DB
61M | DB
62M | DB
63M | DB
71M |
|--------------------------|----------------------------|---------------------|----------|----------|----------|----------|-----------------------------------------------------------------------------|-----------|-----------|-----------|
| Mesauring
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 | | | | | | | | |
| Ciff Deflation | Automatic
deflation | No change, all same | | | | | | | | |
| Operating
Environment | 1040℃90%RH | No change, all same | | | | | | | | |
15
| Power
Vovtage | 4X 1.5V | No change, all same | | | | | | | | |
| Hardware
circuit | | No change, all same | | | | | | | | |
| Electronic
element | | No change, all same | | | | | | | | |
| PCB | | Only | DB22 | | PCB | is | solely, other PCB of model
DB21/23/31/32/61M/62M/63M/71M are same to D11 | | | |
| Display Type | Liquid crystal
display | No change, all same | | | | | | | | |
| Cover | | Difference | | | | | | | | |
Table 2: The difference between Truly Automatic Arm Blood Pressure Monitor DB series and Microlife Blood Pressure Monitor, Model BP3BT0-AP
| Parameter | Predicate
Devices
BP3BT0-AP | DB
21 | DB
22 | DB
23 | DB
31 | DB
32 | DB
61M | DB
62M | DB
63M | DB
71M |
|-------------------------|-----------------------------------|----------------------|----------|----------|----------|----------|-----------|-----------|-----------|-----------|
| Measurement
Method | Oscillometric
Method | No change - the same | | | | | | | | |
| Pressure
Sensor | Capacitive | No change - the same | | | | | | | | |
| Measurement
Range:BP | 30280mmHg | 20 ~ 280 mmHg | | | | | | | | |200
| Measurement
Range:BP | 40
beats/min | 40 ~ 195 beats/min | | | | | | | | |
| Measuring
resolution | 1mmHg | No change - the same | | | | | | | | |
Page 3 of 4
:
22
3
Truly Instrument Limited.
| Parameter | Predicate
Devices
BP3BT0-AP | | DB
21 | DB
22 | DB
23 | DB
31 | DB
32 | DB
61M | DB
62M | DB
63M | DB
71M |
|-------------------------------------|-------------------------------------------------------------------------|--|-------------------------------------------------------------|----------|----------|----------|----------|-----------|-----------|-----------|-----------|
| Accuracy
Pressure | $\pm 3mmHg$ | | No change - the same | | | | | | | | |
| Accuracy
Pulse | $\pm 5%$ | | No change - the same | | | | | | | | |
| Pressurization
Source | Automatic
internal pump | | No change - the same | | | | | | | | |
| Cuff Deflation | Automatic
deflation | | No change - the same | | | | | | | | |
| Memory Size | 99 | | 2X60 | 2X50 | 4X99 | 2X60 | 1X99 | 4X99 | 4X99 | 4X99 | 4X99 |
| Irregular
Heartbeat
Detection | More than
$\pm 25%$ to the
mean interval
of pulse
intervals | | DB22, DB23, DB61M, DB62M, DB63M, DB71M have the IH feature. | | | | | | | | |
| Power Source | 4 X1.5V | | 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 such as irregular heartbeat detection. These differences do not affect the safety and effectiveness of the subject devices.
Irregular heartbeat detection technology is same as what is used Microlife Blood Pressure Monitor, Model BP3BT0-AP, K041411
Thus, the subject devices are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three bodies, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP - 4 2009
Truly Instrument Co., Ltd. c/o Mr. Yang Jian-Hao Manager Truly Industrial Area Shanwei, Guangdong 516600 China
Re: K091434
Trade/Device Name: Truly Automatic Arm Blood Pressure Monitor Models DB21, DB22, DB23, DB31, DB32, DB61M, DB62M, DB63M and DB71M. 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 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.
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,
W.M.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
09 14 34
TRULY®
Truly Instrument Limited
Indication for Use
510(k) Number (if known):
Device Name: Truly Automatic Arm Blood Pressure Monitor DB Series,
Models DB21,DB22,DB23,DB31,DB32,DB61M,DB62M,DB63M,DB71M Indication For Use:
Truly Automatic Arm Blood Pressure Monitor ,Models DB21, DB23, DB31, DB32, DB61M, DB62M, DB63M, DB71M 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 upper arm.
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
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)
And
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
K.M.D.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091434
HongKong: 2/F, Chung Shun Knitting Centre, 1-3 Wing Yip Street, Kwai Chung, N.T., Hong Kong FAX: (852) 2146 5756 TEL: (852) 2487 9803 (20 Lines) E-MAIL: healthcare@truly.com.hk URL: http://www.trulyinstrument.com China: Truly Industrial Area .ShanWei City. Guangdong Province ,China FAX:86-0660-3380377 TEL:86-0660-3380070