Custom tests helped ensure FDA approval

Rasmus Høst Pedersen

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TRV stol i testsetup

Custom tests helped ensure FDA approval

CASE: FUNCTIONAL TEST OF TRV CHAIR

In connection with an FDA approval for the US market, Interacoustics faced a demand for validation of the mechanical calculations for the company's TRV chair. Dynamic load tests at the Danish Technological Institute documented that the chair was safe to use, and therefore the application was approved.

The Danish company Interacoustics supplies health technology equipment for the treatment of problems with the balance nerve and other ear problems, and the product portfolio includes a TRV chair which is used to treat otoliths - the treatment is done by moving the chair in some well-defined directions while the patient is strapped in it.

Mand i teststolInteracoustics had a desire to sell the TRV chair on the US market, but in connection with the application for FDA approval, which is a prerequisite for selling and marketing health technology in the US, the mechanical calculations on the chair were questioned. The FDA (Food and Drug Administration) wanted a validation of the calculations through physical tests that could simulate an accumulated load on the chair throughout its lifetime - a so-called accelerated lifetime test.

To ensure approval of the FDA application, Interacoustics wanted to provide the best possible documentation. Therefore, they contacted the Danish Technological Institute in Aarhus, which has an accredited test laboratory and expert competencies to document product quality.

Custom test plan
In collaboration with Interacoustics, the Danish Technological Institute prepared a test plan for how to simulate a worst-case mechanical load on the chair throughout its lifetime.

- The test plan consisted of two different types of dynamic loads on the chair, followed by a review of the chair's functionality. The first test simulated a person weighing 150kg sitting in the chair 2,000 times, while the second simulated repeated shaking while using the chair with a 150 kg person sitting in it - a total of 100,000 repetitions, explains Rasmus Høst Pedersen, consultant at the Danish Technological Institute and expert in mechanical tests.

Each test was repeated in two different positions to have a solid documentation base.

TRV stolDocumentation led to approval
Following the implementation of the test plan, the Danish Technological Institute provided a report documenting that the TRV chair was safe to use throughout its lifetime, and that there were no significant structural errors following the load tests performed. After submitting the report, Interacoustics got their FDA application approved, and the TRV chair is now approved for sale in the US market.

- With the Danish Technological Institute, we found a competent and independent partner who could professionally investigate the constructive safety of our product through daily clinical use over a number of years. The tests conducted and their documentation have fully lived up to our expectations and have subsequently formed the basis for approval of patient safety by relevant authorities, including the US FDA, says Julius Born of Interacoustics.