(145 days)
NAVOYCDS is intended to be used with patient data from already cleared patient monitoring devices which measure respiratory rate, systolic blood pressure, and Glasgow Coma Scale (GCS) in adult patients being monitored in a healthcare facility. The device uses an algorithm to calculate a qSOF A score (also known as quickSOFA) which indicates adult patients with suspected infection who are at greater risk for a poor outcome. It uses three criteria, assigning one point for low blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min), or altered mentation (Glasgow coma scale
NAVOYCDS consists of:
• A gateway module for handling clinical data supporting the HL7 format FHIR.
• A qSOFA score module to calculate patients' qSOFA scores and offer their last 72 hours history data.
· A web-based dashboard to render patients' qSOFA scores in a visually distinctive way depending on their value and enable intended users to view patients with suspected infection.
The NAVOYCDS system works in the following sequence:
- · Receive patient data from the HL7 gateway system.
- · Extract 3 vital signs from the patient data and store them in the database.
· The Glasgow Coma Scale (GCS) of a patient is stored in the database when a user submits it.
· NAVOYCDS calculates the qSOFA score automatically and stores the result in the database.
· NAVOYCDS delivers 3 vital signs. gSOFA score, GCS to users.
· The qSOFA score is presented in a visually distinctive way depending on the value and enables users to view patients with suspected infection.
The provided document is a 510(k) summary for the device NAVOYCDS, a software that calculates qSOFA scores. Based on the content, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The document states that NAVOYCDS uses an algorithm to calculate a qSOFA score based on three criteria: low blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per minute), or altered mentation (Glasgow Coma Scale
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).