GyroStim
GyroStim is FDA-cleared with an indication for use for treatment of vestibular dysfunction.
GyroStim is the 47th medical device in FDA history to receive both 510(k)-clearance for clinical use and Breakthrough Medical Device designation. This remarkable achievement underscores the clinical importance and transformative potential of GyroStim. It highlights the urgent need to advance the standard of care and marks the emergence of a new paradigm in the treatment of vestibular dysfunction. With its technologically advanced therapeutic capabilities, GyroStim stands at the forefront of innovation—delivering improved outcomes across a broad spectrum of conditions associated with vestibular dysfunction.
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FDA Status
FDA Decision:
August 10, 2021
FDA Designates GyroStim as a
Breakthrough Medical Device -
Q200178/S002
On August 10th, 2021, following an extensive review process, the FDA designated GyroStim as a Breakthrough Medical Device. In its decision, the FDA stated that GyroStim has “a reasonable expectation for providing more effective treatment relative to the current standard of care for balance disorders and vestibular dysfunction.”
The Breakthrough Device designation is a monumental achievement and a powerful distinction that sets GyroStim apart from all other devices in its category. It is the first and only medical device for the treatment of balance disorders and vestibular dysfunction to receive this prestigious breakthrough device designation from the FDA.
While over a thousand medical devices have managed to qualify for breakthrough device designation, approximately only 10% have survived the extensive scrutiny of the FDA for subsequent marketing authorization.
FDA Decision:
April 27, 2022
GyroStim Receives FDA Clearance -
K220231
On April 27, 2022, the FDA granted UltraThera authorization to market GyroStim as an FDA-cleared medical device with the following indications for use (IFU) statement:
The GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction.
Vestibular dysfunction is a ‘general indication’ that can result from a wide range of 'specific conditions' disrupting peripheral and or central processing of vestibular sensory information. Proper vestibular function is critical not only for balance and spatial orientation but also for cognitive performance and overall quality of life. Disruptions to vestibular processing are commonly associated with conditions such as concussion (mTBI), Autism Spectrum Disorder (ASD), stroke, Down Syndrome, cerebral palsy, MdDS, MS, Parkinson's Disease, and many others. Individuals affected by these and similar conditions who are diagnosed with symptoms of vestibular dysfunction may benefit from treatment with GyroStim therapy.
As stated in the IFU, GyroStim is a medical device with a ‘general indication’ which can be used for a ‘specific condition’ within the scope of its intended use, provided that the manufacturer's labeling and instructions for use are followed. Ultimately, the healthcare provider must exercise their clinical judgement when considering whether the use of GyroStim for treatment of a specific condition is within the scope of its intended use.
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Standards of Conformity
GyroStim has undergone rigorous third-party safety testing at Intertek Testing Laboratories, Inc. for regulatory compliance and FDA clearance.
The table below (not viewable with smartphone) provides information on the device's conformance with regulatory and FDA consensus standards related to design, development, and manufacturing.
Standard # & Edition | Standard Title | FDA Requirement |
|---|---|---|
AAMI HE 75:2009 | Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing | 5-57 |
ISO 10993-1 Fifth Edition 2018-08 | Human Factors Engineering – Design of Medical Devices, Section 9 – Usability Testing | 2-256 |
ISO 10993-5:2009/(R)2014 | Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | 2-245 |
ISO 10993-10 Third Edition 2010-08-01 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | 2-174 |
IEC 63266-1:2015 | Medical Devices – Part 1: Application of usability engineering to medical devices | - |
IEC 60601-1-6 Edition 3.1 2013-10 | Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Usability | 5-89 |
ANSI/AAMI/IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 19-8 |
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment—Part 1: General requirements for basic safety and essential performance | 19-4 |