Last synced on 2 May 2025 at 11:05 pm

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

Page Type
Product Code
Definition
Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.
Physical State
Comprised of an electric field generator and insulated transducer arrays.
Technical Method
Transducer arrays are placed on the patient’s chest which produce alternating electrical fields within the body. These electrical fields physically disrupt the rapid cell division of cancer cells.
Target Area
Chest/Lungs
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 SDA 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 For Non-Small Cell Lung Cancer

Page Type
Product Code
Definition
Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.
Physical State
Comprised of an electric field generator and insulated transducer arrays.
Technical Method
Transducer arrays are placed on the patient’s chest which produce alternating electrical fields within the body. These electrical fields physically disrupt the rapid cell division of cancer cells.
Target Area
Chest/Lungs
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 SDA 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.