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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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.
Classification Nameone-way air-leak valve
Generic Nameone-way air-leak valve
Gyrus ACMI, Inc.
6675 185th avenue ne
redmond, WA 98052
HDE NumberH060002
Supplement NumberS005
Date Received04/11/2013
Decision Date01/29/2014
Product Code
OAZ[ Registered Establishments with OAZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for change in the configuration to a reloadable deployment catheter system, to include two component changes, the polytetrafluoroethylene (ptfe) coated plunger pin and new shipping lock. Also to change to the airway sizing kit and name change for the device from ibv valve system to spiration®valve system. The device, as modified, will be marketed under the trade name spiration® valve system and 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.