BLOOD PRESSURE MONITOR/ MODELS

K093739 · Ningbo Diaier Electronic Co., Ltd. · DXN · May 7, 2010 · Cardiovascular

Device Facts

• Record ID: K093739
• Device Name: BLOOD PRESSURE MONITOR/ MODELS
• Applicant: Ningbo Diaier Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: May 7, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

WA100/WA200/WB100/WB200/WB200/WD100/WE100/WF100 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) AA100/AA200/AB100/AC100/AD100 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 for home care use( without the involvement of professional physician)

Device Story

Device is an automated blood pressure monitor (wrist or upper arm models). Input: pressure changes over time recorded via cuff during automatic inflation/deflation cycles. Operation: Oscillometric method; pneumatic pump/inflation/deflation system; pressure sensor; measuring circuit. Output: systolic/diastolic blood pressure and heart rate displayed on LCD; results stored in internal memory. Used in home care settings by patients (self-use). Benefits: enables non-professional, independent monitoring of blood pressure and heart rate.

Clinical Evidence

Bench testing only. Compliance with voluntary standards (ANSI/AAMI SP 10-2002, EN 60601-1, EN 60601-1-2) and software verification per FDA guidance.

Technological Characteristics

Oscillometric measurement principle. Components: pressure sensor, pneumatic pump, inflation/deflation system, LCD display. Connectivity: internal memory storage. Standards: ANSI/AAMI SP 10-2002, EN 60601-1, EN 60601-1-2. Software: verification performed per FDA guidance.

Indications for Use

Indicated for individuals over 18 years old for automatic measurement of systolic/diastolic blood pressure and heart rate via wrist (W series) or upper arm (A series) using the oscillometric method. 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

• Diaier model WA400 (K091553)
• Diaier model AA300 (K091553)

Submission Summary (Full Text)

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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.

The assigned 510(k) number is: K093739 .

MAY - 7 2010

1. Submitter's Identifications: Ningbo Dialer Electronic Co., Ltd. No.1, Beixing Rd., Yaoxl 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; W & A series including the following models;

- WA100/WA200/WB100/WB100/WB200/WD100/WE100/WF100 for wrist type, and -
- AA100/AA200/AB100/AC100/AD100 for upper arm type.

3. Classification information: Regulation Number 870.1130 Medical Specialty Cardiovascular Devices Product Code DXN Device Class II 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 W series wrist type/model WA100/WA200/WA300/WB100/ WB200/WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/ AB100/AC100/AD100. The main intended use for these two type of blood pressure monitor is as the description of the following section:

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In addition to the main blood pressure and heart beat rate measuring function, the W series wrist type/model WA100/WA200/WA300/WB100/WB200/ WD100/WE100/WF100 and A series upper arm type/model AA100/AA200/AC100/AC100/AD100 blood pressure monitors provide also the memory function for user to store the result of measurement.

## 5. Intended Use:

"WA100/WA200/WB100/WB200/WB200/WD100/WE100/WF100 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)"

"AA100/AA200/AB100/AC100/AD100 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 for home care use( without the involvement of professional physician)"

- 6. Comparison to the 510(k) Cleared Device (Predicate Device):
- 1> Diaier model WA400 (K091553) for W series wrist model models: WA100/WA200/ WA300/WB100/WB200/WD100/WE100/WF100 .
- 2> Diaier model AA300(K91553) for A series upper arm model : AA100/AA200/AB100 IAC100/AD100.
- 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.

#### 8. Conclusions

The Diaier W series model WA100/WA200/WA300/WB100/WB200/WD100/WF100 blood pressure monitor (measurement at wrist) has the same intended use and technical characteristics as the Diaier 510K cleared model WA400(K091553) , and A series model AA100/AA200/AB100/AC100/AD100 blood pressure monitor (measured at upper arm) has the same intended use and technical characteristics as the Diaier 510K cleared model AA300(K091553).

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 (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ningbo Diaier Electronic, Co., Ltd. c/o Mr. Lao XiKun Official Correspondent No 1., Beixing Rd., Yaoxi Industrial Zone Yuyao City, Zhejiang CHINA

MAY - 7 2010

Re: K093739

Device Name: Blood Pressure Monitor, Models WA100, WA200, WA300, WB100, WB200, WD100, WE100, WF100, AA100, AA200, AB100, AC100, and AD100 Regulation Number: 21 CFR 870.1130 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (Two) Product Code: DXN Dated: April 16, 2010 Received: April 21, 2010

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. 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.

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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 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. Wood

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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# Indications For Use

510(k) Number (if known):

K0937339

Device Name: Blood Pressure Monitor, W series wrist type models : WA100/WA200/ WA300/WB100/WB200/ WD100/WE100/WF100 and A series upper arm type models: AA100/AA200/AB100/AC100/AD100

Indications For Use:

"WA100/WA200/WA300/WB100/WB200/WD100/WE100/WF100 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)"

"AA100/AA200/AB100/AC100/AD100 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 for home care use( without the involvement of professional physician)"

Prescription Use (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use V (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.M.R.

diovascular Devices

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510(k) Number