Last synced on 24 June 2022 at 11:05 pm

Electrical Tumor Treatment Fields

Page Type
Product Code
Definition
The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy.
Physical State
The device consists of sets of contact electrodes that are applied to the patient's shaved chest, a connecting cable, battery pack and signal generator.
Technical Method
This is a portable, battery powered device. Electric fields are continuously applied to the target chest area for a pre-specified duration of time.
Target Area
Chest/upper torso
Review Panel
Anesthesiology
Submission Type
HDE - Humanitarian Device Exemption
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 QGZ 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.

Electrical Tumor Treatment Fields

Page Type
Product Code
Definition
The device is intended to treat patients with inoperable malignant pleural mesothelioma (MPM) concurrent to chemotherapy.
Physical State
The device consists of sets of contact electrodes that are applied to the patient's shaved chest, a connecting cable, battery pack and signal generator.
Technical Method
This is a portable, battery powered device. Electric fields are continuously applied to the target chest area for a pre-specified duration of time.
Target Area
Chest/upper torso
Review Panel
Anesthesiology
Submission Type
HDE - Humanitarian Device Exemption
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 QGZ 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.