TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M

K091434 · Truly Instrument Co., Ltd. · DXN · Sep 4, 2009 · Cardiovascular

Device Facts

• Record ID: K091434
• Device Name: TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M
• Applicant: Truly Instrument Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 4, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

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.

Device Story

Automatic arm blood pressure monitor; uses oscillometric method to measure systolic/diastolic blood pressure and pulse rate. Input: pressure signals from inflatable cuff via electronic pressure sensor. Processing: microprocessor analyzes pressure alterations to calculate BP and pulse; compares pulse wave time intervals to detect irregular rhythm (threshold >25% difference). Output: BP/pulse readings and irregular heartbeat warning on LCD. Used in home or clinical settings by adults. Benefits: non-invasive monitoring of BP and detection of irregular heartbeats.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Oscillometric measurement; electronic pressure sensor; automatic pump and deflation valve; LCD display; ABS housing; nylon cuff (220-340mm circumference); powered by 4x AAA or AA alkaline batteries. Microprocessor-based control. Software includes irregular heartbeat detection algorithm.

Indications for Use

Indicated for adult individuals requiring non-invasive measurement of systolic and diastolic blood pressure and pulse rate via an upper arm cuff. Includes irregular pulse rhythm detection.

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

• Digibio Digital Blood Pressure Monitor, Model D11 (K014141)
• Microlife Blood Pressure Monitor, Model BP3BT0-AP (K041411)

Submission Summary (Full Text)

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# 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: [phone] Fax: [phone]

## 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

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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<br>Devices D11 | DB<br>21 | DB<br>22 | DB<br>23 | DB<br>31 | DB<br>32 | DB<br>61M | DB<br>62M | DB<br>63M | DB<br>71M |
|-------------------------------------|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------|----------|----------|-----------|-----------|-----------|-----------|
| Measurement<br>algorithm | Oscillometric<br>method | No change ,all same | | | | | | | | |
| Method | | | | | | | | | | |
| Measurement<br>site of body | Arm | No change ,all same | | | | | | | | |
| Pressure<br>Sensor | MSP-2107 | No change, all same | | | | | | | | |
| Cuff | | No change ,all same | | | | | | | | |
| Software | | D11 software + Irregular heartbeat detection. | | | | | | | | |
| Irregular<br>heartbeat<br>detection | | More than ±25% to the mean interval of pulse intervals.<br>About the more detailed description of the IH detection algorithm, please<br>refer to "Software validation report I-5. Algorithm description 4. Determination<br>method of irregular heartbeat".<br>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<br>Pressure<br>Range | 20~280<br>mmHg | No change ,all same | | | | | | | | |
| Measurement<br>Pulse Range | 40~195<br>beats/min | No change ,all same | | | | | | | | |

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# Truly Instrument Limited.

| Parameter | Predicate<br>Devices D11 | DB<br>21 | DB<br>22 | DB<br>23 | DB<br>31 | DB<br>32 | DB<br>61M | DB<br>62M | DB<br>63M | DB<br>71M |
|--------------------------|----------------------------|---------------------|----------|----------|----------|----------|-----------------------------------------------------------------------------|-----------|-----------|-----------|
| Mesauring<br>resolution | 1 mmHg | No change, all same | | | | | | | | |
| Accuracy<br>Pressure | $\pm$ 3mmHg | No change, all same | | | | | | | | |
| Accuracy<br>Pulse | $\pm$ 5% | No change, all same | | | | | | | | |
| Pressurization<br>Source | Automatic<br>internal pump | No change, all same | | | | | | | | |
| Ciff Deflation | Automatic<br>deflation | No change, all same | | | | | | | | |
| Operating<br>Environment | 10~40℃<br>15~90%RH | No change, all same | | | | | | | | |
| Power<br>Vovtage | 4X 1.5V | No change, all same | | | | | | | | |
| Hardware<br>circuit | | No change, all same | | | | | | | | |
| Electronic<br>element | | No change, all same | | | | | | | | |
| PCB | | Only | DB22 | | PCB | is | solely, other PCB of model<br>DB21/23/31/32/61M/62M/63M/71M are same to D11 | | | |
| Display Type | Liquid crystal<br>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<br>Devices<br>BP3BT0-AP | DB<br>21 | DB<br>22 | DB<br>23 | DB<br>31 | DB<br>32 | DB<br>61M | DB<br>62M | DB<br>63M | DB<br>71M |
|-------------------------|-----------------------------------|----------------------|----------|----------|----------|----------|-----------|-----------|-----------|-----------|
| Measurement<br>Method | Oscillometric<br>Method | No change - the same | | | | | | | | |
| Pressure<br>Sensor | Capacitive | No change - the same | | | | | | | | |
| Measurement<br>Range:BP | 30~280mmHg | 20 ~ 280 mmHg | | | | | | | | |
| Measurement<br>Range:BP | 40~200<br>beats/min | 40 ~ 195 beats/min | | | | | | | | |
| Measuring<br>resolution | 1mmHg | No change - the same | | | | | | | | |

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| Parameter | Predicate<br>Devices<br>BP3BT0-AP | | DB<br>21 | DB<br>22 | DB<br>23 | DB<br>31 | DB<br>32 | DB<br>61M | DB<br>62M | DB<br>63M | DB<br>71M |
|-------------------------------------|-------------------------------------------------------------------------|--|-------------------------------------------------------------|----------|----------|----------|----------|-----------|-----------|-----------|-----------|
| Accuracy<br>Pressure | $\pm 3mmHg$ | | No change - the same | | | | | | | | |
| Accuracy<br>Pulse | $\pm 5%$ | | No change - the same | | | | | | | | |
| Pressurization<br>Source | Automatic<br>internal pump | | No change - the same | | | | | | | | |
| Cuff Deflation | Automatic<br>deflation | | No change - the same | | | | | | | | |
| Memory Size | 99 | | 2X60 | 2X50 | 4X99 | 2X60 | 1X99 | 4X99 | 4X99 | 4X99 | 4X99 |
| Irregular<br>Heartbeat<br>Detection | More than<br>$\pm 25%$ to the<br>mean interval<br>of pulse<br>intervals | | DB22, DB23, DB61M, DB62M, DB63M, DB71M have the IH feature. | | | | | | | | |
| Power Source | 4 X1.5V | | No change - the same | | | | | | | | |
| Operating<br>Environment | 10~40℃<br>15~90%RH | | No change - the same | | | | | | | | |
| Cuff<br>Attachment<br>Method | By plastic hose<br>connected to<br>monitor | | No change - the same | | | | | | | | |
| Display Type | Liquid crystal<br>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.

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#### 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.

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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 [phone] or [phone] 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

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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: [phone] TEL: [phone] (20 Lines) E-MAIL: [e-mail] URL: http://www.trulyinstrument.com China: Truly Industrial Area .ShanWei City. Guangdong Province ,China FAX:[phone] TEL:[phone]