TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM

K061452 · Tung FU Electric Co., Ltd. · DXN · Jul 12, 2006 · Cardiovascular

Device Facts

• Record ID: K061452
• Device Name: TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM
• Applicant: Tung FU Electric Co., Ltd.
• Product Code: DXN · Cardiovascular
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

The TF-BP01"" blood pressure monitor is intended for use in the home to measure systolic and diastolic blood pressures and pulse rate on adults aged 18 and older. Measurements are obtained using a non-invasive technique by placing an inflatable cuff around the wrist. The cuff circumference is 5.25 to 7.75 inches.

Device Story

Wrist-worn oscillometric blood pressure monitor; uses pressure sensors to detect pulse waves; computes systolic/diastolic blood pressure, mean arterial pressure, pulse pressure, and pulse rate. Intended for home use by adult patients. Device features LCD display for results (systolic, diastolic, pulse, date/time) and memory recall. Healthcare providers use output to monitor patient blood pressure status. Benefits include convenient, non-invasive self-monitoring of cardiovascular metrics.

Clinical Evidence

Clinical testing demonstrated that the device met the criteria specified in the SP10 standard, consistent with the predicate device performance.

Technological Characteristics

Oscillometric measurement principle using pressure sensors. Wrist-worn form factor with inflatable cuff (5.25-7.75 inch circumference). LCD display for data output. Conforms to SP10 standard.

Indications for Use

Indicated for adults aged 18 and older for home measurement of systolic/diastolic blood pressure and pulse rate via non-invasive wrist cuff (5.25-7.75 inch circumference).

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

• CLEVER TD-3018A Blood Pressure Monitor (K051703)

Submission Summary (Full Text)

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K061452

JUL 1 2 2006

## 510(k) Summary

## Submitter's Information

Submitter's Name: Contact person: Address:

TUNG FU ELECTRIC CO., LTD. Shu-Mei Wu, Ph.D. No.11, Shin Chung Road, An Ping Industrial District, Tainan, CHINA (TAIWAN) 70252 [phone] [phone] [e-mail] May 8, 2006

## 1. Device

Date Prepared:

Phone:

E-mail:

Fax:

Trade Name: TF-BP01 TM Blood Pressure Monitor Common Name: Noninvasive Blood Pressure Measurement System Classification Name: blood pressure monitor Class II devices, 21 CFR 870,1130

Product Code: DXN

### 2. Predicate Device

Trade /Proprietary Name: CLEVER TD-3018A Blood Pressure Monitor, TD-3018A Common Name: Noninvasive Blood Pressure Measurement System Classification Name: blood pressure monitor

Class II devices, 21 CFR 870.1130

Manufacturer: TaiDoc Technology Corporation

510 (k) Number: K051703

### 3. Device Description

The TF-BP01™ Blood Pressure Monitor is a wrist blood pressure monitor and uses the oscillometric method to measure the blood pressure. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and

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wrist cuff.The symbols display on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, memory record.

Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.

#### 4. Intended Use

The intended use of TF-BP01"M Blood Pressure Monitor is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the wrist of the subject.

## 5. Technology Characteristics Comparison

Both devices determine values of blood pressure by using oscillometric method. In this method, pulse waves are detected by using pressure sensors. Then the diastolic blood pressure, mean average pressure, and pulse pressure are derived. Furthermore, the systolic blood pressure and pulse rate are computed based on the information.

### 6. Non-clinical Performance

The results for non-clinical trials as presented in this document demonstrated the conformance to the SP10 standard that is also the reference standard for the predicate device. Therefore, the substantial equivalence between the devices is determined.

## 7. Clinical Performance

As the predicate device, the clinical test results of the TF-BP01™ showed the functions of the device met the criteria in the SP10 standard. Hence, it is reasonable to conclude the substantial equivalence between the devices.

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K061452

8. Conclusions

The TF-BP01™ Blood Pressure Monitor demonstrates satisfactory performance and is suitable for its intended use.

V

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Tung Fu Electric Co., Ltd. c/o Dr. Shu-Mei Wu Project Manager Taidoc Technology Corporation 4F, No. 88, Sec 1, Kwang Fu Road San Chung, Taipei Hsien 241 TAIWAN

Re: K061452

Trade Name: TF-BP01TM Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: May 8, 2006 Received: May 25, 2006

Dear Dr. Wu:

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 for abo atatorior 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 such 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 - Dr. Shu-Mei Wu

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised hat I Dri 3 issuance or our device complies with other requirements of the Act that I DA has made a averalations administered by other Federal agencies. You must of ally it catal statutes and regarations and limited to: registration and listing (21 Comply with an the Prece Prequent Part 801); good manufacturing practice requirements as set CITY art 607), adoning (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (overing your device as described in your Section 510(k) I ins letter will anow you to ough finding of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you doan't specific at realiance at [phone]. Also, please note the regulation entitled, Connect the Office of Conce to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational on your responser Assistance at its toll-free number [phone] or Manufacturers, International and Oriess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blummenhofer

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: K061452

Device Name: TF-BP01TM Blood Pressure Monitor

Indications For Use:

"The TF-BP01"" blood pressure monitor is intended for use in the home to measure systolic and diastolic blood pressures and pulse rate on adults aged 18 and older. Measurements are obtained using a non-invasive technique by placing an inflatable cuff around the wrist. The cuff circumference is 5.25 to 7.75 inches."

Prescription Use ____________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ X (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)

AND/OR

Blinver

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(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number k C ii