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Determination of Device Safety
Device Characteristics and Intent
Since the magnetic energy that is produced by this device is in the picoTesla range, the magnetic energy that is delivered to the body is a fraction of the magnetic energy produced by the earth on a constant basis. There are no other hazards identified with this device. The device is not intended as an implant, it is not purported or represented to be for a use in supporting or sustaining life, and it is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health.
For more information, please refer to the ‘Non-Significant Risk Determination’ report contained in Appendix A.
IRB Determination of Non-Significant Risk (NSR) Status
Independent Review Consulting, Inc.’s Institutional Review Board has determined the Resonator to be a non-significant risk (NSR) device when applied to Parkinson's disease patients for three independent studies, as follows:
- Jacobson Resonator: Efficacy of the Application of Magnetic Fields to the Treatment of Parkinson’s Disease Pilot Study Protocol, APPLIED MAGNETICS, LLC. Version 1.6, February 20, 2007. IRC # 07021-02.
- Jacobson Resonator: A double-blind, sham-stimulation controlled study of the application of magnetic fields using the Jacobson Resonator for the treatment of Parkinson’s Disease: phase two pilot study protocol. Version 2.5, Oct 2007. IRC# 07102-01
- An open label extension study for subjects previously treated in either pilot I or pilot II studies of the application of magnetic fields using the Resonator for the treatment of Parkinson's disease: Extension pilot study protocol, Version 4.0, March 14, 2008. IRC# 06052-01.
- IRC Resonator Device NSR#: DAM-003.
FDA Determination of Non-Significant Risk (NSR) Status
Through its pre-IDE review of a clinical study of the Resonator’s application to Parkinson's disease (pre-IDE#I080297), the US FDA determined the study to be appropriately classified as NSR.
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