BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE

K091553 · Ningbo Diaier Electronic Co., Ltd. · DXN · Sep 21, 2009 · Cardiovascular

Device Facts

• Record ID: K091553
• Device Name: BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
• Applicant: Ningbo Diaier Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

WA400 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician) AA300 blood pressure monitor measures automatically human being systolic, diastolic blood. pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).

Device Story

Non-invasive blood pressure monitors (WA400 wrist, AA300 upper arm) utilize oscillometric method to measure systolic/diastolic blood pressure and heart rate. System components include pressure sensor, pneumatic pump, inflation/deflation system, LCD display, and software. Device operates by inflating cuff to estimated pressure, then automatically deflating while recording pressure changes over time. Data processed to calculate blood pressure and heart rate; results displayed on LCD and stored in memory. AA300 includes USB port for data transfer. Intended for home use by patients (age 18+) without physician involvement. Provides patients with self-monitoring capability for blood pressure management.

Clinical Evidence

Bench testing only. Compliance with voluntary standards (ANSI/AAMI SP 10-2002, EN 60601-1, EN 60601-1-2) and software verification performed per FDA guidance. No clinical trial data provided.

Technological Characteristics

Oscillometric measurement principle; pressure sensor; pneumatic pump; LCD display; USB connectivity (AA300). Complies with ANSI/AAMI SP 10-2002, EN 60601-1, and EN 60601-1-2. Software verification conducted per FDA guidance.

Indications for Use

Indicated for individuals over 18 years old for automatic measurement of systolic/diastolic blood pressure and heart rate. WA400 is for wrist use; AA300 is for upper arm use. Intended for home care use without professional physician involvement.

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

• Zen Strong model ZSBP-001 (K070473)
• Zen Strong model ZSBP-101 (K070473)

Submission Summary (Full Text)

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| SEP 21 2009 |
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| 510(K) SUMMARY |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

091553 彩112

The assigned 510(k) number is:

1. Submitter's Identifications: Ningbo Diaier Electronic Co., Ltd. No.1, Beixing Rd., Yaoxi Industrial Zone, Yuyao City, Zhejiang, China Contact: Lao XiKun Phone: [phone] Fax: [phone] E-mail: [e-mail] Date of Summary Preparation: May 25, 2009

- 2. Name of the Device: Blood Pressure Monitor, models WA400 for wrist type and AA300 for upper arm type.
- 3. Classification information: Regulation Number 870.1130 Medical Specialty Neurology Product Code DXN Device Class Tier

## 4. Device Description:

Basically the measuring system were composite of blood pressure measuring circuit via Oscillometric method, pressure sensor, measuring cuff at arm, pneumatic pump, inflation and deflation system, housing, display LCD, and measuring software ... and so on,

The main operation for the blood pressure measurement is carried out in such a way that the measuring cuff at arm is inflated to the estimated pressure level, then deflated to zero automatically. During the inflation and deflation, the pressure change with respective of time were recorded as the data base of measurement. Then the following measuring results will be calculated against the measurement data base :

- Blood pressure information including systolic and diastolic pressure (calculated via Oscillometric method)

- Heart beat rate.

For this submission, two different type of blood pressure monitors are to be included in this 510(K) submission, the wrist type/model WA400 and upper arm type/model AA300. The main intended use for these two type of blood pressure monitor is as the description of the following section:

In addition to the main blood pressure and heart beat rate measuring function, the WA400 and AA300 blood pressure monitors provide also the memory function for user to store the result of measurement. AA300 also provides the USB connection port for the transformation of measuring data.

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#### 5. Intended Use:

WA400 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician)

09/553

AA300 blood pressure monitor measures automatically human being systolic, diastolic blood. pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).

- Comparison to the 510(k) Cleared Device (Predicate Device): 6.
- 1> Zen Strong model ZSBP-001 (K070473) for wrist model model WA400.
- 2> Zen Strong model ZSBP-101 (K070473) for upper arm model AA300.
- 7. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

Compliance to applicable voluntary standards includes ANSI/AAMI. SP 10-2002, as well as EN 60601-1, and EN 60601-1-2 requirement.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software quidance.

### Conclusions

The Diaier model WA400 blood pressure monitor (measurement at wrist) has the same intended use and technical characteristics as the cleared Zen Strong model ZSBP-001 (K070473) . and AA300 blood pressure monitor (measured at upper arm) has the same intended use and technical characteristics as the Zen Strong cleared model ZSBP-101 (K070473).

Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared devices.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device, and the new models as mentioned on this submission are considered substantial equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a bird with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Ningbo Diaier Electronic Co., Ltd. c/o Mr. Lao Xikun · General Manager and Official Correspondent No. 1 Beixing Road, Yaoxi Industrial Zone Yuyao City, Zheijang

CHINA

Re: K091553

> Trade/Device Name: Blood Pressure Monitor, Model WA400 for wrist type and model AA300 for upper arm type

Regulatory Number: 21 CFR 870.1130

Regulation Name: Non-Invasive Blood Pressure Measurement System

Regulatory Class: Class II (Two)

Product Code: DXN

Dated: August 13, 2009

Received: August 18, 2009

Dear Mr. Xikun:

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.

SEP 2 1 2009

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Page 2 - Mr. Lao Xikun

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 aft 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/ResourcesforYou/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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K09/553

# Indications For Use

## 510(k) Number (if known):

Device Name: Blood Pressure Monitor, models WA400 for wrist type, and AA300 for upper

arm type.

Indications For Use:

WA400 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from wrist by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel and kept in the memory for home care use( without the involvement of professional physician)

AA300 blood pressure monitor measures automatically human being systolic, diastolic blood pressure and heart beat rate from upper arm by using the Oscillometric method for the individual of the age over 18 years old. The measurement values can be read out on the LCD panel, kept in the memory, and then transferred to the other data memory media through USB connection port for home care use( without the involvement of professional physician).

Prescription Use (Part 21 CFR 801 Subpart D)

OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.W. Watt.

Division Sian-Off) Division of Cardiovascular Devices Page 1 of

510(k) Number.