Device Information
Indications
The Masimo MightySat-OTC is intended for spot-checking functional oxygen saturation (SpO2) of arterial hemoglobin and pulse rate (PR).
- Indication with MedDRA code: Oxygen saturation monitoring (MedDRA code: 10031868).
Intended Use (Including Who Can Use This Device)
The device is intended for use by individuals 18 years or older, either healthy or poorly perfused.
Availability
The device is available over-the-counter (OTC).
Contraindications
The Masimo MightySat-OTC is not intended for the diagnosis or screening of lung disease, and treatment decisions using the device should only be made under the advice of a healthcare provider.
Limitations
Use only under no-motion conditions. Decisions using the device must be made under the advice of a healthcare provider.
Study Results
Clinical studies show the device performs well across different skin tones and genders, with a bias of less than 1.5% across 70%-100% oxygen saturation.
Regulatory Information
The device is cleared for over-the-counter use, with no performance standards under Section 514.
Manufacturer Information
- Name: Masimo Corporation
- Address: 52 Discovery, Irvine, California 92618
- Contact Person: Kertana Shankar, Regulatory Specialist II
Predicate Device Information
- Predicate Device Name: Masimo MightySat Fingertip Pulse Oximeter
- K Number: K181956
- Is the Predicate Device an Earlier Version of the Same Device? Yes
- Difference Between Predicate and Current Device: The predicate was cleared for prescription use only, while the current device is OTC. The new device does not include RRp and PVi features, and it has updated calibration for improved accuracy across different skin tones and genders.
Implications
The device provides more accessible oxygen saturation monitoring for laypersons, facilitating easier use in everyday environments without a prescription.
References
- MightySat – OTC. K214115. FDA summary link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K214115
- https://www.masimo.com
- https://professional.masimo.com/products/monitors/spot-check/mightysatrx/
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