The FORA P20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor is intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate by using a non-invasive technique in which an inflatable cuff is wrapped on the upper arm. This system should only be used for the testing on people over 18 years of age and over.

Device Description

The TD-3132 is an arm type blood pressure monitor. The device includes setting button, function button, LCD display, start/stop button, recall memory button, and arm cuff. The symbols displayed on LCD include month, date, hour, minute, systolic rate, diastolic rate, pulse rate, pulse symbol, blood pressure unit, battery display, error symbol, and memory record.

AI/ML Overview

Here is an analysis of the provided text regarding the FORA P20 Blood Pressure Monitor / U-RIGHT TD-3132 Blood Pressure Monitor:

Acceptance Criteria and Device Performance Study

The provided document describes the non-clinical and clinical performance of the device against the SP10 standard. This standard typically refers to the ANSI/AAMI/ISO 81060-2 standard for non-invasive sphygmomanometers, which specifies the clinical validation requirements for accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on SP10 Standard for Non-Invasive Sphygmomanometers)	Reported Device Performance (TD-3132)
Accuracy Standard 1: Mean difference (bias)	Conformed to SP10 standard.
For systolic and diastolic blood pressure, the mean difference between the device and the reference method should be ≤ ± 5 mmHg.
Accuracy Standard 2: Standard deviation of differences	Conformed to SP10 standard.
For systolic and diastolic blood pressure, the standard deviation of the differences between the device and the reference method should be ≤ 8 mmHg.
Additional Criteria (Implied by SP10 conformance)	Conformed to SP10 standard.
Meets requirements for specific age groups (though in this document, it specifies "over 18 years of age and over").
Meets requirements for various cuff sizes (implied during validation).
Meets general safety and effectiveness requirements.	Satisfactory performance (safety and effectiveness).

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

Sample Size: The document does not explicitly state the numerical sample size for the clinical test set. It only mentions "The clinical test results of the TD-3132 showed the functions of the device met the criteria in the SP10 standard." The SP10 standard (ANSI/AAMI/ISO 81060-2) typically requires a minimum of 85 participants for a clinical validation study to assess accuracy.
Data Provenance: The document does not specify the country of origin of the data. However, the submitter's address is in Taipei County, Taiwan, which could potentially be the location of the clinical study, but this is not explicitly stated. The study is prospective, as it's a "clinical test" designed to validate the device's performance.

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

Number of Experts: The document does not explicitly state the number of experts used. For a clinical validation according to the SP10 standard, typically three independent observers (often trained clinicians or technicians) are involved in performing the reference measurements.
Qualifications of Experts: The document does not explicitly state the qualifications of the experts. In the context of the SP10 standard, these observers would be trained and certified to perform auscultatory blood pressure measurements using a mercury sphygmomanometer or validated equivalent. They would undergo specific training and demonstrate minimal inter-observer variability.

4. Adjudication Method for the Test Set

Adjudication Method: The document does not explicitly describe an adjudication method. In SP10 clinical validations, if multiple observers are used, their measurements are typically averaged or analyzed in comparison to the device's readings. There isn't typically a "2+1" or "3+1" adjudication method in the sense of resolving discrepancies, but rather parallel measurements taken by trained observers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is usually conducted for imaging devices where human readers interpret images (e.g., radiologists reading X-rays), often comparing AI-assisted vs. unassisted human performance. For a blood pressure monitor, the performance metric is direct measurement accuracy, not interpretive performance.
Effect size of human readers improving with AI vs. without AI assistance: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, the "clinical performance" described in the document is essentially a standalone study of the device's algorithm. The TD-3132's oscillometric method and its calculation of systolic, diastolic, and pulse rates are evaluated directly against reference measurements (the "ground truth" as derived from experts). There isn't a human-in-the-loop component being evaluated for a blood pressure monitor's core function.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth used for these types of blood pressure monitor validations is typically expert auscultatory measurements (often using a mercury sphygmomanometer or a validated equivalent) performed simultaneously or near-simultaneously with the device's readings. This is the standard reference method outlined in the SP10 standard.

8. Sample Size for the Training Set

Sample Size: The document does not mention a training set sample size. Blood pressure monitors using the oscillometric method are typically developed and calibrated through extensive engineering and testing, which might involve internal datasets for algorithm refinement. However, the regulatory submission usually focuses on the validation (test set) rather than the development/training process.

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

How Ground Truth Was Established: As no specific training set is discussed or required to be reported in this context, the method of establishing ground truth for any internal development/calibration datasets is not mentioned in the document. It would similarly involve reference blood pressure measurements.

Summary

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Attachment 2

510(k) Summary

1. Submitter's Information

Name: TaiDoc Technology Corporation Address: 6F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, Taiwan Phone: 886-2-6625-8188 Fax: 886-2-6625-0288 Contact Person: Erica Li Prepared Date: 06/22/2009

2. Name of Device

Trade Name: FORA P 20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor

Common Name: blood pressure monitor

Classification Name: Noninvasive Blood Pressure Measurement System (per 21 CFR 870.1130)

3. Predicate Device

Trade/Proprietary Name:A&D Medical UA-851 THW Digital Blood Pressure Monitor

Common/Usual Name: blood pressure monitor

Manufacturer: A&D Engineering, Inc.

510 (k) Number: K082734

4. Device Description

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5. Intended Use

The intended use of TD-3132 is to measure human systolic, diastolic blood pressure and heart rate by using the oscillometric method. The measurement position of the device is the upper arm of the subject. This system should only be used for the testing on people over 18 years of age and over.

6. Comparison to Predicate Device

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.

7. 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.

8. Clinical Performance

The clinical test results of the TD-3132 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.

9. Conclusions

TD-3132 demonstrates satisfactory performance (safety and effectiveness) and is suitable for its intended use.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 5 2010

Taidoc Technology Corporation c/o Ms. Erica Li Management Representative 6F, No. 127, Wugong 2nd Rd Wugu Township Taipei County China (Taiwan) 24888

Re. K092106

Trade/Device Name: FOR A P20 Blood Pressure Monitor/U-RIGHT TD-3132 Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: January 3, 2010 Received: January 8, 2010

Dear Ms. Li:

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.

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Page 2 - Ms. Erica Li

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-rclated 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 dcsire 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 (800) 638-2041 or (301) 796-7100 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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Attachment 1

Indications for Use Statement

Applicant: TaiDoc Technology Corporation

510(k) Number (if known): K092106

Device Name: FORA P20 Blood Pressure Monitor /U-RIGHT TD-3132 Blood Pressure Monitor

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Number

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Olvision Sign-Off)
ivision of Cardiovascular Devices

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).