Humanitarian Device Exemption (HDE)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: IBV VALVE SYSTEM
• Classification Name: one-way air-leak valve
• Generic Name: one-way air-leak valve
• Applicant: Gyrus ACMI, Inc.; 6675 185th avenue ne; redmond, WA 98052
• HDE Number: H060002
• Date Received: 03/20/2006
• Decision Date: 10/24/2008
• Product Code: OAZ [ Registered Establishments with OAZ ]
• Docket Number: 08M-O579
• Advisory Committee: Anesthesiology
• Supplement Type: hde original
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the ibv® valve system. This device is indicated 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. Ibv® valve system use is limited to 6 weeks per prolonged air leak.

Approval Order

Approval Order

Summary

Summary of Safety and Probable Benefit

Labeling

Labeling

Post-Approval Study

Show Report Schedule and Study Progress

• Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S010 ; S011 S012 S013