The U-RIGHT TD-3127 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-3127 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 the U-RIGHT TD-3127 Blood Pressure Monitoring System and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typically found in a comprehensive study report.

The document primarily focuses on establishing substantial equivalence to a predicate device (FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System, K092106). It states:

"The U-RIGHT TD-3127 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-3127 Blood Pressure Monitoring System are equivalent to the predicate device."

This implies that the acceptance criteria and performance data for the predicate device would be relevant, but they are not detailed in this specific submission.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text for the U-RIGHT TD-3127. The document implies that the device meets the performance characteristics of its predicate, which presumably met certain acceptance criteria.
Reported Device Performance: Not detailed in the provided text. The submission states the device has "the same performance characteristics as the predicate device" but doesn't quantify them for either device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified.
Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable, as no external expert-driven ground truth determination is described.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable, as no expert review or adjudication process for a test set is described.

5. 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

MRMC Study: No, this device is a non-invasive blood pressure monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to interpretation improvement with AI is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: The device itself is a standalone blood pressure monitoring system. Its performance would be assessed without a human "in-the-loop" for interpretation, but rather for measurement accuracy directly. However, the details of such a standalone performance study are not provided.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Type of Ground Truth: For blood pressure monitors, the "ground truth" typically involves comparison against a reference standard (e.g., direct arterial measurement) or another validated device according to international standards (e.g., ISO 81060-2). The specific method used to establish ground truth for this device (or its predicate) is not detailed in the provided text.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/specified. This type of device does not typically involve a "training set" in the context of machine learning. The performance is based on hardware and embedded software design and validation.

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided submission is a 510(k) summary primarily focused on demonstrating "substantial equivalence" to a predicate device for regulatory clearance. It asserts that the new device has "the same performance characteristics" as the predicate, but it does not delve into the underlying studies, acceptance criteria, or ground truth establishment in detail. To obtain that information, one would typically need to refer to the regulatory submission for the predicate device (K092106) or a more comprehensive performance testing report for either device, neither of which is included in this extract.

Summary

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Section 11. 510(k) Summary

– 9 2010

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.

K100658

The Assigned 510(k) number is:

1. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan
  Correspondence: Nicky Pan Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1196 Fax: +886-2-6625-0288 Email: nicky @taidoc.com.tw

Date of submission: 03/05/2010

1. Device name:
  Proprietary name: U-RIGHT TD-3127 Blood Pressure Monitoring System

Regulatory information:

	A. Regulation section: 21 CFR §870.1130, Noninvasive blood pressure
		measurement system
		The support of the state of the state of the state of the state of the states of the states of the states of the

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

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Intended Use:

4. Device Description:

Substantial Equivalence Information:

A. Predicate device name:

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

Predicate K number: K092106 B.

C. Comparison with predicate:

The modified U-RIGHT TD-3127 Blood Pressure Monitoring System has the following similarities to the predicate device:

same operating principle.
. same fundamental scientific technology,
I incorporate the same basic circuit design,
. incorporate the same materials,
. same shelf life

1 packaged using the same materials, and
manufactured by the same process.

The modifications encompass:

Removed the functions for speaking and data transmission 1
. Labeling change due to the software modification

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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.

12 11:11 11:11 11:11 11:11 11:11

1. Performance Characteristics:
  The U-RIGHT TD-3127 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-3127 Blood Pressure Monitoring System are equivalent to the predicate device.

1. Conclusion:
  Based on the information provided in this submission, the U-RIGHT TD-3127 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/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

JUL - 9 2010

TaiDoc Technology Corporation c/o Ms. Nicky Pan Regulatory Affairs Specialist 3F, 5F, No. 127, Wugong 2nd Road Wugu Township, Taipei County 248 TAIWAN

Re: K100658 Trade/Device Name: U-Right TD-3127 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: Undated Received: June 11, 2010

Dear Ms. Pan:

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. Nicky Pan

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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W.M.

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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K10065-f

Section 8. Indications for Use

Indications for Use

510(k) Number:

Device Name: U-RIGHT TD-3127 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 In Vitro Diagnostic Device Evaluation and Safety (OIVD)

W.M. Wood.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 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).