The U-RIGHT TD-3124B 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-3124B 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

Here's an analysis of the provided text regarding the U-RIGHT TD-3124B Blood Pressure Monitoring System, focusing on the acceptance criteria and study information:

Summary of Acceptance Criteria and Study Findings for U-RIGHT TD-3124B Blood Pressure Monitoring System

The provided 510(k) summary for the U-RIGHT TD-3124B Blood Pressure Monitoring System does not contain specific acceptance criteria or details of a de novo clinical study proving the device meets those criteria. Instead, it relies on a demonstration of substantial equivalence to a predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274).

The core of the submission is that the U-RIGHT TD-3124B 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... are equivalent to the predicate device." This implies that the predicate device likely met certain performance criteria, and the new device is demonstrated to be equivalent to that. However, the details of those original performance criteria or the studies that established them for the predicate are not included in this document.

Therefore, many of the requested sections below cannot be fully populated as they would be for a direct study demonstrating compliance with de novo acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state acceptance criteria or direct performance results for the U-RIGHT TD-3124B outside of its established equivalence to the predicate. Therefore, this section will reflect that the device's performance is considered equivalent to its predicate.

Acceptance Criterion (Implicit, based on equivalence to predicate)	Reported Device Performance (vs. Predicate)
Accuracy of Systolic Blood Pressure Measurement	Performance confirmed to be equivalent to the predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274) through software verification/validation and design validation.
Accuracy of Diastolic Blood Pressure Measurement	Performance confirmed to be equivalent to the predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274) through software verification/validation and design validation.
Accuracy of Pulse Rate Measurement	Performance confirmed to be equivalent to the predicate device (U-RIGHT TD-3135 Blood Pressure Monitoring System, K112274) through software verification/validation and design validation.
Safety and Effectiveness	Confirmed to be equivalent to the predicate device.

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

Sample Size for Test Set: Not specified in this document. The submission references "software verification and validation, and design validation" implying testing was conducted, but the specific sample sizes for clinical performance evaluation (if any were performed on the new device, beyond equivalence testing) are not provided.
Data Provenance: Not specified. Given the reliance on substantial equivalence, any clinical data supporting the new device's performance would likely be comparative, but no details are given. The predicate device's data provenance is not mentioned.

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

Not applicable. The document does not describe a study involving expert-established ground truth for the U-RIGHT TD-3124B's performance. Its performance is based on equivalence to a predicate.

4. Adjudication Method for the Test Set

Not applicable. No details of a direct clinical study with adjudication are provided for the U-RIGHT TD-3124B.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a key component.

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

Yes, in essence, the "performance characteristics" and "software verification and validation, and design validation" would pertain to the standalone operation of the device. The U-RIGHT TD-3124B is a non-invasive blood pressure monitoring system, so its performance is evaluated as a standalone algorithm/device without human-in-the-loop assistance in the sense of a diagnostic interpretation task.

7. Type of Ground Truth Used

For the U-RIGHT TD-3124B itself, the "ground truth" for its performance is implicitly derived from its established equivalence to the predicate device. For blood pressure monitors, ground truth typically involves simultaneous measurements using a highly accurate reference method (e.g., intra-arterial measurement or a validated auscultatory method by trained observers). This document does not detail how the predicate's original ground truth was established, nor does it specify direct ground truth measurements for the new device beyond its validation as equivalent.

8. The Sample Size for the Training Set

Not applicable. The U-RIGHT TD-3124B is a blood pressure monitor based on oscillometric technology, not an AI/machine learning device that would require a "training set" in the conventional sense for model development. Its verification and validation would involve engineering and design validation, and potentially clinical studies comparing it to a reference standard or predicate, rather than training an algorithm.

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

Not applicable. As explained in point 8, there is no "training set" for this type of device in the context of machine learning.

Summary

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Section 11. 510(k) Summary

JUL 3 2012

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: K120634

1. Submitter's Identification: TaiDoc Technology Corporation 6F, No.127, Wugong 2nd Rd., Wugu District, New Taipei City, 24888, Taiwan
  Correspondence: Pinjung Chen Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1176 Fax: +886-2-6625-0868 Email: pinjung.chen(@)taidoc.com.tw

Date of submission: 02/24/2012

1. Device name:
  Proprietary name: U-RIGHT TD-3124B Blood Pressure Monitoring System

Regulatory information:

A. Regulation section: 21 CFR §870.1130, Noninvasive blood pressure
measurement system
B. Classification: Class II (Blood Pressure Measurement System)
C. Product Code: DXN, System, Measurement, Blood-Pressure,Non-Invasive
D. Panel: 74. Cardiovascular- Blood Pressure Measurement System

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Intended Use:

Device Description:

1. Substantial Equivalence Information:
- A. Predicate device name: U-RIGHT TD-3135 Blood Pressure Monitoring System
- B. Predicate K number: K112274

C. Comparison with predicate:

The modified U-RIGHT TD-3124B Blood Pressure Monitoring System has the following similarities to the predicate device:

. Same indications for use.
Same operating principle. .
. Same fundamental scientific technology.
Incorporate the same basic circuit design.
. Incorporate the same materials.
트 Same shelf life.
트 Packaged using the same materials.
I Manufactured by the same process.

The modifications encompass:

Modifications of the devices physical appearance.
B Minor software modification of the meter.
I Decreased memory storage capacity and user number.
트 Removed the speaking function.

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Labeling change due to the above modifications

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-3124B 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-3124B Blood Pressure Monitoring System are equivalent to the predicate device.

Conclusion:

Based on the information provided in this submission, the U-RIGHT TD-3124B Blood Pressure Monitoring System is substantially equivalent to the predicate U-RIGHT TD-3135 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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

3 2012 JUL

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

Re: K120634

Trade/Device Names: U-RIGHT TD-3124B 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: May 31, 2012 Received: June 4, 2012

Dear Ms. Chen:

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. Pinjung Chen

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/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/Resourcesfor You/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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Section 8. Indications for Use

Indications for Use K120634 510(k) Number:

Device Name: U-RIGHT TD-3124B Blood Pressure Monitoring System

Indications for Use:

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

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

And/Or

Concurrence of CDRH Office of Device Evaluation (ODE)

Division Sign-Off Office of Device Evaluation (ODE) 510(k) K 12 06 34

Page 1 of _ 1

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).