The U-RIGHT TD-3135 Blood Pressure Monitoring System is intended to be used to measure 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 kit of U-RIGHT TD-3135 Blood Pressure Monitoring System consists of two main products: the Blood Pressure Monitor and the pressure cuff. The product has been designed and tested to work together as a system to produce accurate blood pressure measurements.

AI/ML Overview

The provided text describes a 510(k) summary for the U-RIGHT TD-3135 Blood Pressure Monitoring System, which states that "The U-RIGHT TD-3135 Blood Pressure Monitoring System has the same performance characteristics as the predicate device." and that "Software verification and validation, and design validation confirmed that the performance, safety and effectiveness of the U-RIGHT TD-3135 Blood Pressure Monitoring System are equivalent to the predicate device."

Therefore, the acceptance criteria and the study proving the device meets those criteria are implicitly aligned with the predicate device (FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System, K092106). However, the document does not explicitly provide the specific acceptance criteria or details of the study for either the current device or the predicate device.

Based on the provided text, the following information can be extracted:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided document. It is implied that the acceptance criteria are met if the device performs equivalently to the predicate device (FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System, K092106).
- Reported Device Performance: "The U-RIGHT TD-3135 Blood Pressure Monitoring System has the same performance characteristics as the predicate device."
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified in the provided document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a blood pressure monitoring system, not an AI-assisted diagnostic device for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The document describes a "non-invasive blood pressure (systolic, diastolic blood pressure and pulse rate) measuring technology" using an oscillometric method. This implies a standalone algorithm for measurement, but no specific study details are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for the U-RIGHT TD-3135 or its predicate. For blood pressure monitors, ground truth is typically established using a reference standard like auscultation by trained observers.
The sample size for the training set:
- Not specified in the provided document.
How the ground truth for the training set was established:
- Not specified in the provided document.

Summary of what is known:

The U-RIGHT TD-3135 Blood Pressure Monitoring System achieved substantial equivalence based on having the "same performance characteristics" as its predicate device (FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System, K092106). The document mentions "Software verification and validation, and design validation confirmed that the performance, safety and effectiveness..." but does not detail the specifics of these validations (e.g., sample sizes, methods, acceptance criteria).

Summary

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DEC 2 1 2011

Section 11. 510(k) Summary

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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 21 CFR 807.92.

The Assigned 510(k) number is: __ 长川2274

l . Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan
Correspondence: Linda Ko Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1158 Fax: +886-2-6625-0288 Email: kolinda@taidoc.com.tw

Date of submission: 08/05/2011

1. Device name:
  Proprietary name: U-RIGHT TD-3135 Blood Pressure Monitoring System

Regulatory information:

A. Regulation section: 21 CFR §870.1130, Noninvasive blood pressuremeasurement system
B. Classification: Class II (Blood Pressure Measurement System)

B. Classification: Class II (Blood Pressure Measurement System)
ﺰ Product Code: DXN, System, Measurement, Blood-Pressure, Non-Invasive
D. Panel: 74, Cardiovascular - Blood Pressure Measurement System

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Intended Use:

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1. Device Description:
  The kit of U-RIGHT TD-3135 Blood Pressure Monitoring System consists of two main products: the Blood Pressure Monitor and the pressure cuff. The product has been designed and tested to work together as a system to produce accurate blood pressure measurements.
1. Substantial Equivalence Information:
- A. Predicate device name:

FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System

Predicate K number: K092106 B.

ﻥ Comparison with predicate:

The modified U-RIGHT TD-3135 Blood Pressure Monitoring System has the following similarities to the predicate device:

same operating principle,
. same fundamental scientific technology,
incorporate the same basic circuit design,
. incorporate the same materials,
. same shelf life
packaged using the same materials, and
manufactured by the same process.

The modifications encompass:

Modification of the devices physical appearance
비 Decreased memory storage capacity
트 Removed the data transmission function
. Labeling change due to the above modifications

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1. Test Principle:
  The measurement is by using oscillometric, non-invasive blood pressure (systolic, diastolic blood pressure and pulse rate) measuring technology.

7. Performance Characteristics:

The U-RIGHT TD-3135 Blood Pressure Monitoring System has the same performance characteristics as the predicate device.

Software verification and validation, and design validation confirmed that the performance, safety and effectiveness of the U-RIGHT TD-3135 Blood Pressure Monitoring System are equivalent to the predicate device.

8. Conclusion:

Based on the information provided in this submission, the U-RIGHT TD-3135 Blood Pressure Monitoring System is substantially equivalent to the predicate FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three distinct segments forming its body and wings. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", arranged in a circular fashion around the bird.

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

DEC 2 1 2011

TaiDoc Technology Corporation c/o Ms. Linda Ko Regulatory Affairs Specialist 6F, No. 127, Wugong 2nd Rd. Wugu Township, New Taipei City TAIWAN 24888

Re: K112274

Trade/Device Names: TaiDoc U-RIGHT TD-3135 Blood Pressure Monitoring System Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: November 30, 2011 Received: December 1, 2011

Dear Ms. Ko:

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 1 - Ms. Linda Ko

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/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 vours.

Mark Fellman for

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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Section 8.

Indications for Use

510(k) Number: K1/2274

Device Name: U-RIGHT TD-3135 Blood Pressure Monitoring System

Indications for Use:

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mink Keller for Bram fuckerman
Division Sign Off Director DCD

510(K

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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).