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The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using Doppler ultrasound imaging.

The PlasiaTEK™ Actuator Device is a small, non-invasive, battery operated vibrating accessory with an on/off switch that is attached to the ventilation circuit connector on the proximal end of an endotracheal tube. The PlasiaTEK Actuator is used in combination with a previously cleared-to-market endotracheal tube and standard Doppler ultrasound system to locate the endotracheal tube within the trachea. When turned on, the Actuator slightly vibrates the tube. An imaging Doppler ultrasound system can detect the endotracheal tube position because of the gentle small motion caused by the PlasiaTEK Actuator.

This 510(k) summary (K041917) for the PlasiaTEK™ Actuator does not contain the kind of detailed information about acceptance criteria or specific study results you're asking for.

Here's why and what we can infer:

• 510(k) Summaries vs. Full Submissions: A 510(k) summary is a brief overview submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically focuses on the device's intended use and technological characteristics, and how these compare to the predicate. It does not usually include the full depth of clinical or performance testing data that would be found in the complete 510(k) submission.
• "Substantial Equivalence" Focus: The core of a 510(k) is proving substantial equivalence. This means the device is as safe and effective as a legally marketed device (the predicate device, in this case, the PosiTube Esophageal Intubation Detection Device). The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This implies that the testing performed was sufficient to demonstrate this equivalence, but the specifics are not in this summary.

Therefore, I cannot provide the requested information because it is not present in the provided document.

The document does include:

• Device Name: PlasiaTEK™ Actuator
• Intended Use: "The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using standard Doppler ultrasound imaging."
• Predicate Device: PosiTube Esophageal Intubation Detection Device (K000045)
• Comparison to Predicate: Both are non-invasive, applied to the proximal connector end of the endotracheal tube, and must be activated to work. The PlasiaTEK Actuator uses vibration and Doppler ultrasound, while the PosiTube device is described as an "Esophageal Intubation Detection Device" (its specific mechanism isn't detailed in this document, only that it's the predicate).

To answer your questions about acceptance criteria and study details, you would need access to the full 510(k) submission (which is generally proprietary and not publicly released in full detail without specific FOIA requests or publicly available summaries that contain more information).

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