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The purpose and function of the Omni Express patient monitor is to monitor basic physiological parameters including, ECG, heart rate. NIBP (systolic, diastolic, and mean arterial pressures), SpO2, respiration, and temperature for adult, neonate and pediatric patients. It may be used as a bedside or portable monitor and be used in all hospitals anf hospital-type facilities such as clinics and emergency room facilities.

The OMNI Express patient monitor is a comprehensive monitoring system with two or three traces compiling, processing, analyzing and displaying data from up to eight different patient parameters. It integrates parameter measuring modules, display and recorder in one device, featuring in compactness, lightweight and portability. Built-in battery facilitates transportation of patient.

The OMNI Express monitor can be powered by an internal battery pack that provides 3 hours of monitoring from fully charged batteries. The batteries are continuously recharged when AC power is connected to the monitor.

This submission K103268 is a Special 510(k), which means it relies on the predicate device's performance data. The provided text does not contain a new study conducted to establish acceptance criteria or to prove the device meets these criteria. Instead, the submission asserts substantial equivalence to a previously cleared device.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm-only performance) study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Explanation of the Submission Type:

A Special 510(k) is used when a modification to an applicant's own previously cleared device does not affect the intended use or the fundamental scientific technology of the device. In such cases, the manufacturer generally relies on a comparison to their own predicate device and does not need to submit new clinical or performance data as extensively as a Traditional 510(k). The regulatory review focuses on whether the modifications introduce new questions of safety or effectiveness.

Information from the Provided Text Regarding Substantial Equivalence:

The document states:

"The proposed device is substantially equivalent to the Infinium OMNI III Patient monitor which has been cleared under K101052. The proposed device has the same intended use and similar technological characteristics as compared to the predicate device."

This means that the Omni Express Patient Monitor is considered to meet the same performance standards as its predicate device, the OMNI III Patient Monitor (K101052), due to their similar intended use and technological characteristics. The performance of the predicate device would have been established during its own clearance process.

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