Search Results

The ID Power Infuser® Model M100B-3A is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with Clinical Shock, hypovolemic shock, and septic shock. The device is intended for use by medical, paramedical, and EMT personnel in the field and in pre-hospital and hospital environments. When used with the Crystalloid/Colloid Cartridge (K992044), the ID Power Infuser® Model M100B-3A is intended to deliver crystalloid and colloid fluids. The ID Power Infuser® Model M100B-3A is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge, the ID Power Infuser® Model M100B-3A is intended to deliver resuscitative fluids, whole blood and packed red blood cells. The ID Power Infuser® Model M100B-3A is not intended to support the delivery of any pharmaceutical or other medications.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to complete the request. The document is a 510(k) clearance letter for a medical device (Infusion Dynamics (ID) Power Infuser® Model M100B-3A). While it states that the device is "substantially equivalent" to predicate devices, it does not provide:

• A table of specific acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Information on sample sizes, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

The document primarily focuses on the regulatory clearance based on substantial equivalence, rather than a detailed technical performance evaluation or study results.

Ask a specific question about this device