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U.S. Department of Health and Human Services

Product Classification

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Device one-way air-leak valve
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
Product CodeOAZ
Premarket Review Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible