Fresenius Noninvasive Blood Pressure Validation

This study is a comparative, single-center, non-randomized comparative study. After IRB approval, the study will be conducted in three Phases. The Fresenius 5008S BPM Module and Cuffs will be evaluated on a minimum of 120 subjects. Three reports will be generated and submitted to different regulatory bodies with the following minimum subject demographics:

• Phase 1: The submission to the United States Food and Drug Administration will include 85 adult and adolescents ages 13 and older.
• Phase 2: The submission to European agencies will contain 50 adult and adolescents ages 13 and older and 35 pediatric subjects ages 3-12.
• Phase 3: The submission to the China Food and Drug Administration will contain 73 adult and adolescents ages 13 and older and 12 pediatric subjects ages 3-12.

Each subject test is expected to take up to 1 hour. Data collection is expected to take 3-6 weeks for Phase 1. Phase 2 and 3 are expected to take an additional 2-4 weeks.

The Auscultator will have a normal audiogram before the study begins. All experimenters will review the protocol prior to test.

Testing will be conducted under normal office environment conditions.

Each subject or their legally authorized representative will be provided an IRB approved Informed Consent. Additionally, subject ages 7 to 17 years, a discussion about the study will be conducted to complete the Assent process for their participation. As applicable, subjects / authorized representatives will be told about any new information that might change their decision to participate. Representatives / subjects who have completed the informed consent and health questionnaire form and meet inclusion/exclusion criteria will be enrolled in the study if they meet desired blood pressure demographics. For Phase 3, an attempt will be made to enroll a person of Chinese origin in each of the cuffs used in the study.

Two trained observers will listen to the Korotkoff sounds at the brachial artery of the arm. The reference blood pressure measurements by the observers will be performed sequentially with the Device Under Test. The Device Under Test memory will be cleared prior to the next determination. In some cases, this may mean powering down the device to clear the previous readings.

The blood pressure measurements will be such that a reference measurement will be alternated with the Device Under Test measurement. The auscultator will wait a minimum of 60 seconds between each blood pressure determination. Each observer's recording of observations of the reference sphygmomanometer shall not be visible to the other observer. The observers will record the exact measurement heard during auscultation and will not round the blood pressure readings. The readings of the Device Under Test shall not be visible to either of these observers.

The observers will complete 1 or 2 initial baseline blood pressure measurements and then 3 to 8 NIBP measurements to be collected for the Accuracy evaluation.

• For Phase 1 and 2, any pair of observers' determinations with a difference greater than 4 mmHg shall be excluded per ANSI/AAMI/ISO 81060-2:2018.
• For Phase 3, any pair of observers' determinations with a difference greater than 10 mmHg shall be excluded and 90% of the observers' determinations shall be within 5 mmHg per YY 0670-2008.

If any determinations are excluded, additional pair(s) of determinations shall be taken to ensure that the needed number of valid test-reference pairs is available (up to a maximum of 8 paired readings) A minimum of 3 valid paired NIBP measurements are needed for the Accuracy analysis. Each subject test is expected to take up to 60 minutes for the enrollment / data collection process.

There are no deviations expected from this investigation plan, should deviations be needed, discussions will be conducted with the sponsoring company, Principal investigator and the IRB will be notified.