Clinical Trial of Blood Pressure Monitor in Conformance With the ANSI/AAMI ISO 81060-2 Standard (CT_1591-A)

Assess the Accuracy of Transtek TMB-1591-A-002 Blood Pressure Monitor in Conformance With the ANSI/AAMI ISO 81060-2 Standard

The clinical protocol of the trial:

1. Objective of the trial: To assess the accuracy of device.
2. Test methods and procedures: Perform comparation test on seated position by two devices at the same time.
3. DUT: Transtek Blood Pressure Monitor, Model TMB-1591-A-002, with Cuff (sizes, cm) 15-21, 20-26, 25-34, 25-34(L), 32-43, 32-43(L), 40-55.
4. Reference device: Baumanometer Desk Mercury Sphygmomanometer.
5. Study endpoints: Comply with ANSI/AAMI ISO 81060-2:2013 standard.
6. Statistical methodology used: Standard deviation, Mean error.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Diagnostic test: Blood Pressure Measurement

Detailed Description

1. Introduction:

   Automated blood pressure cuff measurement is the standard of care in numerous medical settings today. This study was designed to assess the accuracy of a previously cleared automated blood pressure cuff system using the same arm sequential dual observer auscultation method. The study was conducted in accordance to ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type, the Code of Federal Regulations requirements for Non-Significant Risk Device Investigations and as appropriate ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice.

2. Purpose of Clinical Investigation:

   The purpose of this study is to provide supporting documentation for non-invasive blood pressure measurement Accuracy claims for the TMB-1591-A-002 Blood Pressure System with Reusable Cuffs on the intended adult and pediatric population.

3. Clinical Investigation Population:

   Following Salus Independent Review Board (IRB) approval, a total of 90 subjects were screened and enrolled into the study and data was collected. Two subjects were withdrawn from the study and the data was not used in the data analysis. These subjects were removed due to difficulty in hearing the reference blood pressure range (systolic and/or diastolic) and the other was removed due an unstable systolic range. A total of 88 healthy subjects, (53 adult / adolescent and 35 pediatric) ages 3-75yr, arm circumference 15-49.5 cm, systolic blood pressures ranges 79-176.5 and diastolic blood pressure ranges of 49-116 were included in the study for analysis. The study was conducted May 30 - June 16, 2017 to perform an accuracy validation on TMB-1591-A-002 Blood Pressure System with FlexiPortTM Reusable Cuffs.

4. Method:

The requirements for the study were to include a minimum of 85 subjects with a minimum of 35 pediatric subjects 3-12 years of age and the remainder over 12 years of age, with at least 30% being male and 30% being female, and an arm circumference range of 15-55cm where at least six subjects were evaluated in each of the seven cuffs. For the data collection, at least 90% of the subjects needed to contribute 3 paired observations allowing the remaining 10% to be 2 paired observations. A minimum of 255 valid paired observations were needed for the analysis.

This study utilized the same arm sequential method (Dual Observer) in which the observers alternated the measurements for the reference sphygmomanometer and the sphygmomanometer-under test. Each paired reading incorporated the average of the reference reading prior to the device under test and after the device under test. (ANSI/AAMI/ISO 81060-2:2013, Section 5.2.4.2).

The TMB-1591-A-002 Blood Pressure System with FlexiPortTM Reusable Cuffs, (sphygmomanometer-under-test) was designed for use on the upper arm of patients with arm circumferences that range from 15-55cm. Seven cuff sizes were included in the investigation requiring that each cuff size have data collection on at least 6 subjects. Two trained observers (auscultators) simultaneously observed (listened to) the Korotkoff sounds at the brachial artery during the automated blood pressure cuff measurement. The 5th Korotkoff (K5) sound was used to identify diastole for the adult/adolescent subjects and the 4th Korotkoff (K4) sound was used for the pediatric subjects.

The reference sphygmomanometer used in this study [Baumanometer Desk Mercury Sphygmomanometer, SN: CT1573] complied with the requirements of ISO 81060-1 (the maximum error was 1 mmHg per NIST traceable calibration verification.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Clinimark, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: male,female. Exclusion Criteria: below 3 years old.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPM, TMB-1591-A-002 and Reference Device; DUT: Transtek Blood Pressure Monitor TMB-1591-A-002 Reference Device: Baumanometer Desk Mercury Sphygmomanometer. Blood Pressure Measurement with the Transtek BPM TMB-1591-A-002 and with reference device.	Diagnostic test: Blood Pressure Measurement; Measurement blood pressure by Transtek BPM TMB-1591-A-002 and reference device.; Other Names: Transtek TMB-1591-A-002 and reference device, blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure measurement data	Systolic Pressure and Diastolic Pressure	30 minutes

Collaborators and Investigators

• Sponsor: BTS International
• Collaborators: Clinimark, LLC; Guangdong Transtek Medical Electronics Co., Ltd.
• Investigators: Study Chair: Nagulinie Shukla, Clinimark, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): June 16, 2017
• Study Completion (Actual): April 23, 2018

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 4, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Monitors, Blood Pressure
• Other Study ID Numbers: TM-BPM-1801; BTS-TM-BPM-1801 (Other Identifier: BTSInternational)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No