FDA BRIEF: Week of July 11, 2016

class

 

Neurological Devices: Classification of Thermal System for Insomnia

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Product : Cereve Sleep System

Classification: Class II special controls.

Codification: 21 CFR 882.5700

Risks and Mitigations: 

Table 1--Thermal System for Insomnia Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation method
------------------------------------------------------------------------
Adverse skin reaction..................  Biocompatibility Assessment.
                                         Labeling.
Electromagnetic Interference with Other  Electromagnetic Compatibility
 Devices.                                 Testing.
                                         Labeling.
Electrical Safety (e.g., shock)........  Electrical Safety Testing.
                                         Labeling.
Thermal Injury.........................  Non-clinical Performance
                                          Testing.
                                         Software Verification,
                                          Validation, and Hazard
                                          Analysis.
                                         Labeling.
------------------------------------------------------------------------

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Gastroenterology-Urology Devices: Metallic Biliary Stent System for Benign Strictures

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Product :  WallFlex Biliary Rx Fully Covered Stent System

Classification: Class II special controls.

Codification: 21 CFR 876.5011

Risks and Mitigations: 

Table 1--Metallic Biliary Stent System for Benign Strictures Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risk                     Mitigation measure
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility Evaluation.
                                         Labeling.
Infection..............................  Sterilization Validation.
                                         Shelf Life Validation.
                                         Labeling.
Bile duct obstruction..................  Clinical Performance Testing.
  Stent migration......................  Non-clinical Performance
                                          Testing.
  Stent does not resolve obstruction...  Shelf Life Validation.
  Stent cannot be placed...............  Labeling.
  Expansion/compression forces.
  Foreshortening.......................
Trauma to bile ducts...................  Clinical Performance Testing.

[[Page 45231]]

 
  During stent deployment..............  Non-clinical Performance
                                          Testing.
  During removal.......................  Shelf Life Validation.
  Due to stent migration...............  Labeling.
  During stent indwell.
  Inability to safely remove stent.....
  Expansion/compression forces.........
------------------------------------------------------------------------

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