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510(k) Data Aggregation
(310 days)
INFUSION DYNAMICS, INC.
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.
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(83 days)
INFUSION DYNAMICS, INC.
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.
Not Found
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.
Ask a specific question about this device
(111 days)
INFUSION DYNAMICS, INC.
The ID Power Infuser™ 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™ 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.
Not Found
The provided text describes a 510(k) premarket notification for a device named "ID Power Infuser™." However, the document is a regulatory approval letter and an 'Indications For Use Statement'. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the ID Power Infuser™.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
Ask a specific question about this device
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