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K Number
K112216
Device Name
U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM
Manufacturer
TaiDoc Technology Corporation
Date Cleared
2011-12-22

(142 days)

Product Code
DXN
Regulation Number
870.1130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The U-RIGHT TD-3128 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-3128 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.
More Information

K092106

Not Found

No
The document describes a standard blood pressure monitoring system and does not mention any AI or ML components or capabilities.

No
The device is described as a "Blood Pressure Monitoring System" intended to "measure" blood pressure and pulse rate, indicating a diagnostic or monitoring function rather than a therapeutic one.

Yes
Explanation: The device is intended to measure blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status, making it a diagnostic device.

No

The device description explicitly states the system consists of a Blood Pressure Monitor and a pressure cuff, which are hardware components.

Based on the provided information, the U-RIGHT TD-3128 Blood Pressure Monitoring System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to measure blood pressure and pulse rate using a non-invasive technique on the upper arm. This is a physiological measurement taken directly from the body, not a test performed on a sample of bodily fluid or tissue in vitro (outside the body).
  • Device Description: The device consists of a monitor and a cuff, which are typical components of a non-invasive blood pressure monitor.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure monitor does not fit that description.

N/A

Intended Use / Indications for Use

The U-RIGHT TD-3128 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.

Product codes (comma separated list FDA assigned to the subject device)

DXN

Device Description

The kit of U-RIGHT TD-3128 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper arm

Indicated Patient Age Range

over 18 years of age and over

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Software verification and validation, and design validation confirmed that the performance, safety and effectiveness of the U-RIGHT TD-3128 Blood Pressure Monitoring System are equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K092106

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

Section 11. 510(k) Summary

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.

K112216 The Assigned 510(k) number is:

  • 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: 07/28/2011

    1. Device name:
      Proprietary name: U-RIGHT TD-3128 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 |

  • 74, Cardiovascular Blood Pressure Measurement System D. Panel:

1

  1. Intended Use:

The U-RIGHT TD-3128 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.

    1. Device Description:
      The kit of U-RIGHT TD-3128 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:
      Predicate device name: A.

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

  • Predicate K number: K092106 B.
    C. Comparison with predicate:

The modified U-RIGHT TD-3128 Blood Pressure Monitoring System has the following similarities to the predicate device:

  • same operating principle,
  • same fundamental scientific technology, 그
  • . 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:

  • 동 Removed the function of speaking
  • . Modification of the devices physical appearance
  • 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.
    1. Performance Characteristics:
      The U-RIGHT TD-3128 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-3128 Blood Pressure Monitoring System are equivalent to the predicate device.

    1. Conclusion:
      Based on the information provided in this submission, the U-RIGHT TD-3128 Blood Pressure Monitoring System is substantially equivalent to the predicate FORA P20/U-RIGHT TD-3132 Blood Pressure Monitoring System.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

DEC 2 2 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: K112216

Trade/Device Names: TaiDoc U-RIGHT TD-3128 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 16, 2011 Received: November 22, 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 2 - 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/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

K112216 510(k) Number:

Device Name: U-RIGHT TD-3128 Blood Pressure Monitoring System

Indications for Use:

The U-RIGHT TD-3128 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.

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 ODRH, Office of Device Evaluation (ODE)

Atutste/m Blackman
Division Sign-Off/ 12/22/2004

Division Sign-Off/ 12/22/0
Office of Device Evaluation (ODE)
510(k) K1122/6

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