(175 days)
Navigator Applications Suite (Navigator) is a software package that includes Navigator Therapy, Navigator Protocol and Navigator Device. Navigator software is loaded into a medical grade PC physically mounted to the Anesthesia Delivery System and receives data from supported Anesthesia Delivery Systems, Anesthesia Patient Monitors and Intravenous Drug Infusion Pumps.
Navigator Therapy displays pharmacokinetic, pharmacodynamic (PK/PD) and synergistic PD modeling information. Navigator Therapy provides the heath care provider with information about the modeled effect of supported anesthesia pharmaceuticals delivered to the patient.
Models only apply to the following patient populations:
| Age: | 18 – 90 years old |
|---|---|
| Weight: | 40Kg – 140 Kg |
| Height: | 150cm - 190cm |
Calculated drug concentrations and effects are based on published models, and do not represent actual measurements from a patient. Drug models are calculated and displayed assuming a healthy patient.
Navigator Protocol allows facilities to load electronic versions of care protocols. This feature can be configured with selected patient monitoring parameters available for viewing in conjunction with the care protocol.
Navigator Device is a troubleshooting aid with access to certain Anesthesia Delivery System alarm information.
The system is designed for facility use and should only be used under the orders of a clinician.
The Navigator Applications Suite is o product that integrates information from a anesthesia delivery system, intravenous drug infusion pumps, and patient monitor. The three main functions of the Navigator are:
- Navigator Therapy: Visualization of the modeled effect of the anesthesia drugs on the patient . displayed on a point-of-care Navigator computer. The visualization is based on phormacokinetic and pharmacodynamic (PK/PD) models and multi-drug models for propofol and four analgesic drugs. Novigator also supports automatic data capture from supported intravenous drug infusion pumps to minimize manual data entry
- Navigator Protocol: Framework to enable access to facility-selected care protocols at the . point of care.
- . Navigator Device: Electronic and interactive instructions for users to address technical issues with anesthesia delivery systems.
The provided text is a 510(k) Premarket Notification for the "Navigator Applications Suite." It describes the device, its intended use, and its similarities and differences to predicate devices for the purpose of demonstrating substantial equivalence.
However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria. The 510(k) summary focuses on general company information, device description, intended use, and comparison to predicate devices, as required for regulatory submission. It does not include specific performance data, clinical study results, or a detailed breakdown of acceptance criteria as would be found in a performance testing report or clinical trial summary.
Therefore, I cannot extract the requested information as it is not present in the provided text. The tables for acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are all absent from this document.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).