Last synced on 24 June 2022 at 11:05 pm

One-Way Air-Leak Valve

Page Type
Product Code
Definition
To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
Physical State
This device is a small nitinol frame that has a polyurethane membrane over the Nitinol frame that acts as a plug to the targeted section of the lung.
Technical Method
The device is a nitonal frame with a polyurethane membrane over the Nitinol frame. The valve does not allow air into the targeted segment of the lung, but does allow air and mucus out of that lung section.
Target Area
The device is intended to occlude a section of lung.
Review Panel
Anesthesiology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code OAZ 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.

One-Way Air-Leak Valve

Page Type
Product Code
Definition
To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
Physical State
This device is a small nitinol frame that has a polyurethane membrane over the Nitinol frame that acts as a plug to the targeted section of the lung.
Technical Method
The device is a nitonal frame with a polyurethane membrane over the Nitinol frame. The valve does not allow air into the targeted segment of the lung, but does allow air and mucus out of that lung section.
Target Area
The device is intended to occlude a section of lung.
Review Panel
Anesthesiology
Submission Type
HDE - Humanitarian Device Exemption
Device Classification
F
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code OAZ 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.