(83 days)
No
The document describes a standard medical device for monitoring respiratory parameters and does not mention any AI or ML capabilities.
No
The device is a monitor that measures and displays breathing parameters; it does not provide therapeutic intervention.
No
The device measures and displays breathing parameters (flow, volume, pressure) and provides alarms, but it does not diagnose medical conditions. It provides data for monitoring, not for diagnostic conclusions.
No
The device description explicitly states it is contained in a rectangular metal enclosure, has a front panel LCD screen, and includes hardware components like sensors and electronics, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the StarTrack Infant Graphics Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- StarTrack's Function: The StarTrack Infant Graphics Monitor directly measures and displays physiological parameters (breathing flow, volume, and pressure) within the patient's airway via an endotracheal tube. It does not analyze samples taken from the patient's body.
- Intended Use: The intended use clearly states the measurement and display of breathing parameters delivered through the patient's endotracheal tube, not the analysis of bodily fluids or tissues.
Therefore, the StarTrack Infant Graphics Monitor is a medical device used for monitoring physiological parameters in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The StarTrack Infant Graphics Monitor's intended use is the measurement and display of breathing flow, volume and pressure as delivered trough the patient's endotracheal tube. The intended patient population comprises neonatal and pediatric patients requiring an endotracheal tube
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).
0
3274
DEC 9 1998
Section 16, 510(k) Summary
Section 16.a Date Summary Prepared
30 November 1998
Section 16.b Company Information
Establishment:
Official Correspondent:
Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588
David A.C. Green Manager, Requiatory Affairs Nelicor Puritan Bennett Inc. 2200 Faraday Avenue Carlsbad, CA 92008 (760) 603-5978 (direct phone) (760) 603-5907 (fax)
Section 16.c Name of Device
Proprietary:
Common/Usual:
StarTrack Infant Graphics Monitor
Volume Monitor
Classification:
Monitoring Spirometer(§868.1850/73BZK)
Section 16.d Equivalent Devices
Substantial equivalence to the following legally marketed predicate device with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for the predicate device and the StarTrack Infant Graphics Monitor, StarTrack. Safety and environmental testing to accepted industry sfandards has been conducted as well as in-vitro testing to confirm the accuracy of StarTrack. The predicate device is as follows:
Bear Medical Systems Neonatal Volume Monitor, model NVM-1, K890724.
Section 16.e Device Description
The StarTrack Infant Graphics Monitor, StarTrack is contained in a rectangular metal enclosure measuring 9.25 inches wide by 6 inches high by 5.7 inches deep and weighing 7.2 Ibs.
A front panel LCD screen enables the presentation of graphics, numeric breath data and alarm settings. User-selectable graphics screens present Flow and Volume vs Time. Pressure and Volume vs Time, Flow and Pressure vs Time, Flow / Volume Loop and Pressure / Volume Loop. Numeric breath data are Expiratory Tidal Volume, Expiratory Minute Volume, ET Tube Leak, Breath Rate and Dynamic Compliance. Alarm Settings are High Minute Volume, Low Minute Volume, High ET Tube Leak, High Breath Rate and Breath Interval.
1
StarTrack also provides visual and audible indicators. Alarms are divided into two categories: patient-related alams and system-related alarms. A patient alarm causes a flashing bell to display next to the violated alarm setting. This is accompanied by an audible sound and the flashing Patient-Related Alarm LED. When the alarm condition is corrected, the audible sound ceases and the bell and LED stop flashing. These displays will turn off when the operator presses the Visual Reset button. Patient-related alarms can be silenced for sixty seconds by pressing the Alarm Silence button.
System-related alarms concem problems with the hardware, such as the sensor, sensor cable and the StarTrack electronics. System-related alarms have both visual and audible indicators. The audible indicators cannot be silenced. The System-Related alarms are Sensor Disconnect, Sensor Defect, Sensor Contaminated, AC Power Loss and System Failure.
Section 16.f Intended Use
StarTrack is intended for prescription use only for the measurement and display of breathing flow, volume and pressure as delivered from a ventilator through the patient's endotracheal tube. StarTrack is not an Apnea Monitor. The intended patient population comprises neonatal and pediatric patients who require an endotracheal tube