Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.

• Trade Name: SPIRATION VALVE SYSTEM (INCLUDING AIRWAY SIZING KIT)
• 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
• Supplement Number: S007
• Date Received: 02/06/2015
• Decision Date: 08/17/2015
• Product Code: OAZ [ Registered Establishments with OAZ ]
• Advisory Committee: Anesthesiology
• Supplement Type: normal 75 day track
• Supplement Reason: change design/components/specifications/material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a modified version of the reloadable catheter and to introduce a 9mm valve. The device, as modified, will be marketed under the trade name spiration valve system and is indicated for 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. Spiration valve system use is limited to 6 weeks per prolonged air leak.