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K Number
K112274
Device Name
U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM
Manufacturer
TaiDoc Technology Corporation
Date Cleared
2011-12-21

(135 days)

Product Code
DXN,SYS
Regulation Number
870.1130
Type
Special
Panel
Cardiovascular
Reference & Predicate Devices
K092106
Predicate For
K120634
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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:

  1. 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."

  2. 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.

  3. 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.

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

    • Not specified in the provided document.

  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:

    • Not applicable. This is a blood pressure monitoring system, not an AI-assisted diagnostic device for human readers.

  6. 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.

  7. 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.

  8. The sample size for the training set:

    • Not specified in the provided document.

  9. 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).

§ 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).