WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200

K123839 · Ningbo Diaier Electronic Co., Ltd. · DXN · Jan 11, 2013 · Cardiovascular

Device Facts

• Record ID: K123839
• Device Name: WA SERIES: WA100; WA200; WD100; WE100, WF100; WB200
• Applicant: Ningbo Diaier Electronic Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 11, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

WA100/WA200/WD100/WE100/WB200 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/AD100/AB100/AC100/AF100/AC200/AC300 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 non-invasive blood pressure monitor (wrist or upper arm models). Input: pressure changes over time during cuff inflation/deflation. Operation: pneumatic pump inflates cuff; system records pressure oscillations; software calculates systolic/diastolic pressure and heart rate using oscillometric method. Output: results displayed on LCD and stored in memory. Used in home settings by patients for self-monitoring. Benefits: enables convenient, independent tracking of blood pressure and heart rate trends for personal health management.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI SP 10-2002 for blood pressure accuracy and EN 60601-1/EN 60601-1-2 for electrical safety and electromagnetic compatibility. Software verification performed per FDA guidance.

Technological Characteristics

Oscillometric measurement system comprising pneumatic pump, inflation/deflation system, pressure sensor, and LCD display. Powered by internal electronics. Software-based calculation of systolic/diastolic pressure and heart rate. Complies with ANSI/AAMI SP 10-2002, EN 60601-1, and EN 60601-1-2.

Indications for Use

Indicated for individuals aged 18+ for automatic measurement of systolic/diastolic blood pressure and heart rate via oscillometric method at the wrist or upper arm. 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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K123839 pg lap2

# JAN 1 1 2013

## 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: (

## 1) Submitter's Identifications:

Ningbo Diaier Electronic Co., Ltd.

NO 55, Beixing Rd., Mazhu Town, Yuyao City, Zhejiang Province, P. R. China

Contact: Lao XiKun

Phone: [phone]

Fax: [phone]

E-mail: [e-mail]

Date of Summary Preparation: Dec. 10, 2012

### 2) Name of the Device:

Blood Pressure Monitor; WA & AA Series including the following models:

Wrist type: WA100; WA200; WD100; WE100; WF100; WF100; WB200

Arm type: AA100; AA200; AD100; AB100; AC100; AF100; AE100; AC200; AC300

#### 3) Classification information:

| Regulation Number : | 870.1130 |
|---------------------|------------------------|
| Medical Specialty : | Cardiovascular Devices |
| Product Code : | DXN |
| Device Class : | II |
| Tier : | II |

#### Device Description: 4)

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 types of blood pressure monitors are to be included in this 510(K) submission, the W series wrist type/model WA100/WA200/WD100/WE100/WF100/WB200 and A series upper arm type/model AÁÍ00/AA200/AD100/AC100/AF100/AE100/AC200/AC300. The

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main intended use for these two types 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 W series wrist type/model WA100/WA200WA300/WB100/WB200/ WD100/WE100/WF100 and A series opper arm type/model AA100/AA200/AB100/AC100/AD100 blood pressure monitors provide also the mpen an function for user to store the result of measurement.

- 5) Intended Use:
- WA100/WA200WD100/WE100/WB200 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 invalvement of professional physician).
- AA100/AA200/AD100/AB100/AC100/AF100/AC200/AC300 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).
- Comparison to the 510(K) Cleared Device (Predicate Device): 6) Diaier model WA400 (K091553) for W series wrist model models: . WA100/WA200/WD100/WE100/WF100/WB200
- Diaier model AA300(K091553) for A series upper arm model : . AA100/AA200/AD100/AB100/AC100/AF100/AE100/AC200/AC300
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence is as 7) 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/WA200WD100/WE100/WF100/WB200 blood pressure monitor (measurement at wrist) has the same intended use and technical characteristics as the Dia nor (10(K) cleared model WA400 (K091553), and A series model

AA100/AA200/AD100/AB100/AC100/AE100/AC200/AC300 blood pressure monitor (measured at upper arm) has the same intended use and technical characteristics as the Diaier 510(() 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 maintiain 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
- alter the fundamental scientific technology of the device, and the new models as mentioned on 2) this submission are considered substantial equivalent to the predicate devices

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 1 1 2013

Ningbo Diaier Electronic Co., LTD c/o Mr. Lao Xikun Yaoxi Industrial Zone, Yuyao City, Zhejiang China 315400

Re: K123839

Trade/Device Name: Blood Pressure Monitor wa100, wa200, wd100, we100, wf100, wb200, aa100, aa200, ab100, ac100, af100, ac200, ac200, ac300 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II Product Code: DXN Dated: December 4, 2012 Received: December 13, 2012

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 r lease be 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,

**Owen** P. Faris -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indication for use statement

510(K) Number (if known):

Device Name: Blood Pressure Monitor

WA series wrist models: WA100/WA200/WD100/WE100/WF100/WB200 and

AA series upper arm models: AA100/AA200/AD100/AC100/AC100/AC100/AC200/AC300

Indications for use:

"WA100WA200MA300/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_ or (Part 21 CFR 801 Subpart D)

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)

(Division Sign-Off) Division of Cardiovascular Devices

123859 510(k) Number

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