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.
November 1, 1994
510(k) Checklist for Mechanical Lithotripters and Stone Dislodgers used
in Gastroenterology and Urology
Note:  General guidance for the preparation of a 510(k) submission
is provided in the DRAERD  "Draft Guidance for the Content of
Premarket Notifications."  This document is 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:        Adequate
                 
a. Sponsor/manufacturer name and address    
b. Establishment registration number    
c. Device trade name      
           
d. Procodes and Classification Names
Stone Dislodgers
Ureteral Stone Dislodger: 78 FFL, Class II, 
   21 CFR 876.4680      
Flexible Stone Dislodger (Urological): 78 FGO,
   Class II, 21 CFR 876.4680     
Biliary Stone Dislodger: 78 LQR, Class II, 
             21 CFR 876.5010     
Mechanical Lithotripters
  
Mechanical Biliary Lithotripter: 78 LQC,
Class II, 21 CFR 876.4500      
     
Bladder Stone Tripsor: 78 FGK, Class II,
          21 CFR 876.4500       Page 2  510(k) Checklist for Mechanical Lithotripters and Stone
Dislodgers used in Gastroenterology and Urology
2. Reason for the 510(k) submission: (new device or a      
          modification to an existing device)
3. Intended use of the device:                                
Stone dislodgers are intended to be used during
     urological and/or gastroenterological procedures
to endoscopically grasp, manipulate and remove calculi
and other foreign objects.  Mechanical Lithotriptors are
intended to grasp, crush and remove urinary and/or
biliary stones.
4. Device Description: 
a. List of device's component parts                      
b. Diagrams, drawings, photographs of the device      
c. Description of operation     
d. List of the ranges of sizes/models proposed             
for marketing          
e. Explanation of whether the device or any of its
parts are intended to be reused     
          If the device can be reused, evidence that                  
      it can withstand multiple cleanings and
          sterilizations, and certification that
the reprocessing instructions have been
scientifically validated     
5. Proposed Labeling, instructions for use, advertisements:
a. Intended use statement (see section 3 above for
acceptable wording)     
b. Instructions for use      
  Page 3  510(k) Checklist for Mechanical Lithotripters and Stone
Dislodgers used in Gastroenterology and Urology
c. Prescription device statement (Caution: Federal
(USA) Law restricts this device to sale by or
on the order of a physician)     
d. Labeled for single use only (if applicable)            
               
e. Labeled as sterile     
f. Reprocessing (cleaning, disinfection and
  sterilization) instructions (if applicable)       
     
6. Mechanical/physical testing of an appropriate number of final
sterilized devices:
a. Stone capture testing to validate that the stone
dislodger can successfully entrap and hold a
stone when pulled through a clear plastic tube
which simulates the size and geometry of the urethra, 
ureter, and/or common bile duct.  The sponsor should
provide the diameter of the tube used and describe the 
rationale used for determining the appropriate tube
diameter and geometry in this test.       
b. Pull testing to determine the minimum amount of tensile
load that the device can withstand without failing. 
The location and type of failure should be reported. 
This test should also be performed on a legally
marketed predicate to demonstrate equivalence.      
   
c. Flexibility testing to document that the distal portion
of the device is able to withstand the 90(cid:176)  deflection 
necessary to pass through the working channels of some 
endoscopes.        
d. For mechanical lithotripters, calculi crush testing to
validate that the device can crush actual stones.  If
actual stones are not available, a substitute material
may be used if the similarity of the fracture properties
of the substitute and the actual stones is demonstrated.  
Stones should be crushed until device failure, with the 
fracture strength and type of failure recorded.  If the  Page 4  510(k) Checklist for Mechanical Lithotripters and Stone
Dislodgers used in Gastroenterology and Urology
sponsor wishes to claim that more than one stone (or 
fragments of the same stone) can be crushed by one
device, data to support this claim are needed.  This
crush testing should also be performed on a legally
marketed predicate device to demonstrate equivalence.      
 7. Biocompatibility:
a. List of all device materials                              
b. For materials that contact either the
          mucosal tissue or infusion fluids (including adhesives      
       or color additives), provide either:
i. Evidence that the same formulations of these       
materials are used in another, similar legally
marketed device (provide the device name,           
manufacturer, and (if possible) 510(k) number);
or        
 
ii. The results of the following biocompatibility
tests (minimum required) conducted on the final 
sterilized product
         
(1) mucosal irritation test      
         
(2) sensitization assay      
(3) cytotoxicity test      
(4) acute systemic toxicity      
(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. For EtO sterilization, the residuals of ethylene
oxide (EtO), ethylene glycol (EtG), and ethylene
          chlorohydrin (EtCh)      
e. For gamma radiation sterilization, the radiation
level (in megarads) used       Page 5  510(k) Checklist for Mechanical Lithotripters and Stone
Dislodgers used in Gastroenterology and Urology
f. A description of the packaging material used to
          ensure the sterility of the device      
9. Comparison to legally marketed mechanical lithotripters
and stone dislodgers:
a. Name/manufacturer of predicate device(s)      
  b. Labeling of the predicate device      
c. Intended use of the predicate device      
   d. Description of the predicate device      
e. Diagrams/ photographs of the predicate device      
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 and            
differences between the 510(k) device and the
predicate device (in tabular format).  Note that a
comparison of the mechanical properties
identified in Section 6 above should also be
included.      
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