| Device |
ventilator waveform analysis software |
| Definition |
Ventilator waveform analysis software is a prescription device that uses software algorithms to analyze mechanical ventilation waveform data to detect, display, and summarize patient-ventilator interactions. The device provides results to healthcare providers as an aid to monitoring or clinical assessment. |
| Physical State |
Software-only device, such as a standalone application or clinical software module, with no direct patient-contacting hardware or ventilator-control function. |
| Technical Method |
Algorithm-based software analyzes ventilator pressure and flow waveforms to segment breath cycles, extract waveform features, and classify breaths for evidence of patient-ventilator asynchrony. |
| Target Area |
Respiratory system; mechanically ventilated patients. |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Anesthesiology |
|---|
| Product Code | QVC |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.5896
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
