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Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Page Type
Product Code
Definition
The software feature is indicated for use with the anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The software feature is indicated for adult patients, 18 years of age and older. The anesthesia system and the software feature are intended for prescription use only.
Physical State
Software medical device intended to work with anesthesia gas machine. User interfaces are on the anesthesia gas machine touch screen display.
Technical Method
The software feature is an optional feature which allows the clinician to directly set the desired target End Tidal Oxygen (EtO2) and End Tidal Anesthetic Agent (EtAA) on the host anesthesia machine. The software feature utilizes breath-by-breath measurements from the respiratory gas module and interfaces with the anesthesia machine to titrate the electronic gas mixer and electronic anesthetic agent vaporizer to help achieve and maintain the target end tidal concentrations set by the clinician.
Target Area
Breathing gas pathway.
Review Panel
Anesthesiology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QSF to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Page Type
Product Code
Definition
The software feature is indicated for use with the anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The software feature is indicated for adult patients, 18 years of age and older. The anesthesia system and the software feature are intended for prescription use only.
Physical State
Software medical device intended to work with anesthesia gas machine. User interfaces are on the anesthesia gas machine touch screen display.
Technical Method
The software feature is an optional feature which allows the clinician to directly set the desired target End Tidal Oxygen (EtO2) and End Tidal Anesthetic Agent (EtAA) on the host anesthesia machine. The software feature utilizes breath-by-breath measurements from the respiratory gas module and interfaces with the anesthesia machine to titrate the electronic gas mixer and electronic anesthetic agent vaporizer to help achieve and maintain the target end tidal concentrations set by the clinician.
Target Area
Breathing gas pathway.
Review Panel
Anesthesiology
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code QSF to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.