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 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 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.

AI/ML Overview

The provided 510(k) summary for the TF-BP01™ Blood Pressure Monitor indicates that the device's performance was assessed against the SP10 standard. This standard is used to validate the accuracy of non-invasive blood pressure monitors.

Here's a breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from SP10 standard)	Reported Device Performance (TF-BP01™)
Criteria specified in SP10 standard for non-invasive blood pressure measurement devices. (Specific values for accuracy, bias, and standard deviation are not provided in this summary but are inherent to the SP10 standard)	The clinical test results met the criteria in the SP10 standard.

Important Note: The provided 510(k) summary does not explicitly state the numerical acceptance criteria or the specific numerical performance results (e.g., mean difference, standard deviation) for systolic and diastolic blood pressure measurements as defined by the SP10 standard. It only states that the device "met the criteria in the SP10 standard." To get these specific values, one would need to refer to the full SP10 standard document and the complete test report submitted for the 510(k).

2. Sample Size Used for the Test Set and Data Provenance

The document states "clinical test results of the TF-BP01™ showed the functions of the device met the criteria in the SP10 standard." However, it does not specify the sample size used for the clinical test (test set) or the country of origin of the data. It also does not state whether the study was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth. For blood pressure monitor validation against a standard like SP10, typically, ground truth is established through simultaneous measurements by trained medical professionals using a reference (auscultatory or invasive) method.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. In the context of blood pressure monitor validation to a standard, adjudication methods are not typically described in the same way as for AI-driven image analysis. Instead, the SP10 standard outlines specific protocols for data collection and comparison to a reference method, which implicitly handles discrepancies.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

A Multi-reader Multi-case (MRMC) comparative effectiveness study was not done for this device. The document describes a validation against a recognized standard (SP10), not a comparison of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was done. The entire premise of testing a blood pressure monitor against the SP10 standard is to evaluate the device's (algorithm's) accuracy in autonomously measuring blood pressure without human intervention influencing the measurement process itself. The "clinical test results of the TF-BP01™" refer to the automated performance of the device.

7. The Type of Ground Truth Used

The ground truth used would be simultaneous measurements by trained medical professionals using a reference method (likely auscultatory measurement with a mercury sphygmomanometer or an equivalent validated reference device), as per the SP10 standard. The SP10 standard dictates how these reference measurements are obtained and used to compare against the device's readings. The document refers to "clinical test results" meeting the "criteria in the SP10 standard," which implies this type of ground truth.

8. The Sample Size for the Training Set

The document does not mention a separate training set or its sample size. Blood pressure monitors using the oscillometric method are typically developed using algorithms trained and refined with various pressure waveforms and physiological data. However, the 510(k) summary does not provide details on the development or training phase of the algorithm, focusing solely on its validation against a standard.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned, there is no information provided on how ground truth for a training set was established.

Summary

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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 +886-6-2617105 +886-6-2633822 shumei@taidoc.com.tw 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

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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

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

Conclusions

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

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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 (240) 276-0120. 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 (800) 638-2041 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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).