Clinical Trial of Blood Pressure Monitor in Conformance With the ANSI/AAMI ISO 81060-2 Standard
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 3 - Any |
| Updated: | 7/19/2018 |
| Start Date: | May 30, 2017 |
| End Date: | April 23, 2018 |
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.
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.
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.
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.
Inclusion Criteria: male,female. Exclusion Criteria: below 3 years old.
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