This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.

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510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments

9/19/94
       510(k) Checklist for Sterile Lubricating Jelly Used
             With Transurethral Surgical Instruments

     Note:  general guidance for the preparation of a 510(k) submission is 
     provided in the DRAERD "Draft Guidance for the Content of Premarket 
     Notifications."  Additional guidance on device modifications is provided 
     in the draft document "Deciding When to Submit a 510(k) for Change to an 
     Existing Device."  Both documents are available from the Center for 
     Devices and Radiological Health's Division of Small Manufacturers 
     Assistance at (800) 638-2041 or (301) 443-6597.

1.   Administrative information:

     a.   Classification name - Accessory to Endoscope
          (Transurethral Surgical Instrument)                    

     b.   Device trade name                                      

     c.   Sponsor/manufacturer name and address                  

     d.   Procode/Classification - FHX 78, Class II
          (21 CFR 876.1500)                                      

2.   Reason for the 510(k) submission (new device or a
     modification to an existing device)                         

3.   Intended use of the device:

     Sterile lubricating jelly is intended to facilitate
     the passage of transurethral surgical instruments           

4.   Device description:

     a.   List of device ingredients                             

          1.   Quantity of each ingredient (%)                   

          2.   Identification of active/inactive
               ingredients                                       

          3.   Function of each ingredient (e.g., 
               preservative, thickener, neutralizer,
               humectant, antibacterial)                         

          4.   Statement as to whether the device has
               any drug components and identification
               of these drug components                          

     b.   Explanation of the mode of action                      

5.   Proposed labeling, instructions for use,
     advertisements:

     a.   Instructions for use                                   

     b.   Intended use statement
          (See #3 above for example)                             

     c.   Prescription device statement
          (21 CFR 801.109)                                       

     d.   Labeled for single use                                 

     e.   Sterile                                                

     f.   Statement describing solubility
          (water-soluble or petroleum based)                     

     g.   Quantity of jelly provided                             

6.   Physical and Other testing:

     a.   Preservative effectiveness                             

     b.   Stability analysis (pH, viscosity, H2O
          solubility, lubricity)                                 

     c.   Antimicrobial effectiveness (if applicable)            

     d.   Other tests identified
          (provide protocol and results)                         

7.   Biocompatibility:

     a.   Evidence that the same formulation (i.e.,
          ingredients and concentration) of lubricating
          jelly is used in another, similar legally
          marketed device (provide the device name,
          manufacturer, and (if possible) 510(k) number);        

          OR

     b.   The results of the following biocompatibility
          tests on the final formulation (this is the
          minimum level of required testing):

          (1)  Mucosal irritation test,                          
          (2)  Sensitization test,                               
          (3)  Cytotoxicity test,                                          
          (4)  Acute systemic toxicity test, and                 
          (5)  Short-term implantation test                      

8.   Sterility information:

     a.   The method of sterilization                            

     b.   The method used to validate the sterilization
          cycle                                                  

     c.   The sterility assurance level (i.e., SAL)
          achieved by the sterilization cycle                    

     d.   The levels of the ethylene oxide, ethylene
          chlorhydrin, and ethylene glycol residuals on
          the device (if applicable)                             

     e.   The radiation level (in megarads) used (if
          applicable)                                            

     f.   A description of the packaging material used
          to ensure the sterility of the device                  

     g.   The method used to determine that the device
          is pyrogen free, if this will be claimed in
          the labeling                                           

9.   Comparison to legally marketed sterile lubricating
     jellies:

     a.   Name/manufacturer of predicate device                  

     b.   Labeling of predicate device                           

     c.   Intended use of predicate device                       

     d.   Description of predicate device                        

     e.   Description and/or diagrams/photographs
          of predicate device package and quantity
          provided                                               

     f.   510(k) number (if known) of the predicate
          device (or statement that the predicate device
          is preamendments)                                      

     g.   A detailed comparison of the similarities/
          differences (including all ingredients and
          relative concentrations) between the 510(k)
          device and the predicate device (in tabular
          format)                                                

10.  510(k) summary/statement                                    


     For further information contact:

     Urology and Lithotripsy Devices Branch
     Division of Reproductive, Abdominal, Ear,
       Nose and Throat, and Radiological Devices
     Office of Device Evaluation
     Center for Devices and Radiological Health
     (301) 594-2194.

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