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The ID Power Infuser™ Model M100B is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.

The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.

The ID Power Infuser™ Model M100B is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.

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This document is a 510(k) premarket notification approval letter for the Infusion Dynamics Power Infuser Model M100B. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms substantial equivalence to a predicate device and allows the manufacturer to market the device for specific indications of use, focusing on fluid resuscitation therapy. Therefore, I cannot answer your request based on the provided text.

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