Guidance for the Content of Premarket Notifications for Ureteral Stents February 1993

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-0957
• Issued by: Center for Devices and Radiological Health

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.

A ureteral stent is described in the FDA regulation, 21 CFR 876.4620 (a), 
as a "tube-like implanted device that is inserted into the ureter to 
provide ureteral rigidity and allow the passage of urine.  The device may 
have finger-like protrusions or hooked ends to keep the tube in place.  It 
is used in the treatment of ureteral injuries and ureteral obstructions."  
The classification for this device is Class II as stated in 21 CFR 876.4620 
(b) and its procode is 78 FAD - splint, ureteral.  Examples of accessories 
for this device include a guidewire and a pusher (push catheter).

The primary reference for the information required to be in a premarket 
notification (510(k)) for a medical device is set forth in 21 CFR 807.87.  
The purpose of this regulation is to provide adequate documented 
information to determine substantial equivalence to a device in commercial 
distribution.  Substantial equivalence is to be established with respect 
to, but not limited to, intended use, design, materials, performance, 
safety, effectiveness, labeling, and other applicable characteristics.

FDA recommends that each premarket notification for a ureteral stent 
include the following information in order to ensure that the submission is 
complete and will permit a determination of substantial equivalence:

I.   The device name, including both the trade or proprietary name and the 
classification name (Ureteral Stent) of the device as described in 21 CFR 
807.87 (a).

II.  The establishment registration number, if applicable, of the owner or 
operator submitting the premarket notification as described in 21 CFR 
807.87 (b).

III. The class (Class II) in which the device has been placed under section 
513 of the act and the appropriate panel (78 Gastroenterology/Urology) as 
described in 21 CFR 807.87 (c).

IV.  Action taken by the person required to register to comply with the 
requirements of the act under section 513 for Special Controls.  Note that 
Special Controls are not currently required for ureteral stents under 
section 513 of the act.

V.   The Safe Medical Devices Act of 1990 (SMDA) requires all persons 
submitting a premarket notification submission to include either (1) a 
summary of the safety and effectiveness information in the premarket 
notification submission upon which an equivalence determination could be 
based (510(k) summary), OR (2) a statement that safety and effectiveness 
information will be made available to interested persons upon request 
(510(k) statement).  Safety and effectiveness information refers to 
information in the premarket notification submission, including adverse 
safety and effectiveness information, that is relevant to an assessment of 
substantial equivalence.  The information could be descriptive information 
about the new and predicate device(s), or performance or clinical testing 
information.

VI.  Proposed labels, labeling, and advertisements sufficient to describe 
the ureteral stent and its accessories, its intended use, and the 
directions for use should be provided with a specific intended use 
statement and any warnings, contraindications, or limitations clearly 
displayed as described in 21 CFR 807.87 (e).  The label of the device must 
bear the caution statement as outlined in 21 CFR 801.109 (b) (1):  
"CAUTION:  Federal law restricts this device to sale by or on the order of 
a physician."

     A.  A label includes any identification on the ureteral stent and on 
the package in which it is stored and shipped.  The package device label 
should include the device name, U.S. point of contact, corporation name, 
address, and phone number.  The package label should include all of the 
above, as well as sterility status, expiration date, disposable/single use, 
quantity enclosed, size (diameter and length), maximum implant duration, 
etc.

     B.  Device labeling for the ureteral stent and its accessories 
includes the intended use, a description of the device, and directions for 
use.

     	 1.  The intended use statement should include specific indications 
and the target population should be defined.

     	 2.  The directions for use should contain comprehensive 
instructions to include, but not necessarily be limited to, how to prepare 
the ureteral stent for use, how to place and remove the stent, maximum 
implant duration, visualization techniques, which parts of the set (i.e. 
stent, guidewire, and pusher) are single use/disposable or reusable, and 
functional test procedures for the ureteral stent prior to use.  
Troubleshooting procedures should be outlined and a corporation contact 
point should be identified if troubleshooting procedures fail.

     	 3.  Contraindications, precautions, and warnings should be 
included in the labeling of the device.

     C.  Advertisements or promotional literature for the ureteral stent 
that will accompany the device should be provided.  Literature or labeling 
may not imply approval by FDA in any manner.  Guidance on labeling issues 
is described in Bluebook Memo G91-1 "Device Labeling Guidance (3/8/91)" and 
a copy may be obtained from the Center for Devices and Radiological 
Health's Division of Small Manufacturers Assistance at (800) 638-3041 or 
(301) 443-6597.

VII. A Summary of Equivalence comparing similar devices legally in 
commercial distribution in the United States must be provided.  This 
includes devices in commercial distribution prior to May 28, 1976, the 
enactment date of the Medical Devices Amendments, and any new devices 
introduced subsequently.  A Summary of Equivalence includes similarities 
and differences between the device and the device to which it is compared.  
The ureteral stent should be compared to a legally marketed ureteral stent, 
including, but not limited to, the following:  intended use, design (stent 
diameter, stent length, type of curls, curl diameter, drainage holes (size 
and distance between), trailing suture, etc., other applicable 
specifications), materials (e.g. catheter shaft, curls, guidewire, pusher, 
trailing suture, etc.), performance, and patient population justifying any 
new population cited.

State whether the substantially equivalent device is a pre-amendment device 
or a device which has been through the 510(k) process, providing the 510(k) 
document control number if known.  The summary of equivalence information 
should be provided in a manner that is clear and comprehensible, e.g. 
tabular form.

VIII. For a device that has undergone a change or modification that could 
significantly affect the safety or effectiveness of the device, or the 
device is to be marketed for a new or different indication for use (e.g. 
injection stent with adaptor and injection/release catheter), the 510(k) 
must include appropriate supporting data to show that the manufacturer has 
considered what consequences and effects the change or modification or new 
use might have on the safety and effectiveness of the device, as described 
in 21 CFR 807.87 (g).

Significant modifications should be supported by a rationale for the 
modification with supporting documentation, including clinical or other 
valid scientific studies which demonstrate that these differences do not 
affect safety and effectiveness, as described in 21 CFR 807.87 (f).

The description of all ureteral stents and accessories should include any 
significant changes or modifications from the predicate device that could 
affect safety, effectiveness, or intended use.  Provide any functional, 
animal, clinical, and/or any other testing data to support your claims.  
Provide certification regarding any compliance with voluntary standards, if 
applicable.

IX.  The physical description of each ureteral stent to be marketed should 
be provided in the form of a labeled diagram, photograph/picture, 
schematic, etc., which includes all internal, external, etc. parts of the 
device.  The physical description should include the specifications (length 
and diameter) of the ureteral stent and identifies any components which are 
disposable.  The labeled diagram, photograph/picture, schematic, etc., 
should address the name and function of all parts of the ureteral stent 
(main shaft of stent, curls, drainage holes, markings, etc.).

If the ureteral stent is sold in a set that includes accessories, these 
accessories need to be identified and reviewed along with the ureteral 
stent and require the same types of information as stated above.  These 
accessories might include a guidewire, pusher, etc.  Labeling must state 
whether the accessory is intended for single use and whether it is reusable 
or disposable. 

X.   An exact identification of all materials used to fabricate the 
ureteral stent and its accessories should be provided and a statement 
regarding any material differences from the pre-amendment or substantially 
equivalent ureteral stent should be explicitly stated.  If the materials 
are identical to the pre-amendment or substantially equivalent device and 
are identically processed and sterilized, then this should be explicitly 
stated.  The sponsor will need to provide biocompatibility testing data on 
any material changes that have been implemented.  Ureteral stents are 
considered to be a long-term mucosal contacting implant and testing should 
include, but is not limited to, mucosal irritation, sensitization, 
cytotoxicity, chronic systemic toxicity, and implantation.  Implantation 
testing should reflect the recommended implant duration in labeling.  
Guidance for the testing is provided in the document entitled "Tripartite 
Biocompatibility Guidance for Medical Devices" and a copy may be obtained 
from the Center for Devices and Radiological Health's Division of Small 
Manufacturers Assistance at (800) 638-2041 or (301) 443-6597.

An exact identification of all colors (ink, dyes, markings, radiopaque 
material, etc.) used to fabricate the ureteral stent and its accessories 
should be provided and a statement regarding any colorant changes from the 
pre-amendment or substantially equivalent ureteral stent should be 
included.  If the colors are identical to the pre-amendment or 
substantially equivalent device then this should be explicitly stated.  The 
sponsor will need to provide biocompatibility testing data on any colorant 
changes that have been implemented; state how the markings are processed 
(etched, bands, in material, etc.) and whether the color contacts skin, 
mucosa, etc.

XI.  The following data should be provided to demonstrate substantial 
equivalence of your ureteral stents with respect to functional performance.  
These tests should be conducted on all sizes and in a manner as similar as 
possible to how the ureteral stent will be used in a medical/surgical 
procedure (i.e. at body temperature and in a simulated body fluid).  In 
addition, the ureteral stents to be tested must have been sterilized 
according to the validated sterilization process that is to be used for the 
marketed device, because sterilization may affect the device properties.

     A.  Flow Rate:  The flow rate in a stent at a given head pressure is 
dependent upon the inside diameter of the stent and the properties of the 
fluid passing through it.  This test should demonstrate the rate at which 
urine will flow through the stent.  A statistically valid number of stents 
should be tested to establish the flow rate of each stent size.  A sampling 
of stents representative of the product line, e.g. largest, smallest, 
longest, and shortest, should be tested.  Testing should be conducted in 
accordance with accepted industry standards, e.g. ASTM F-623-89 (modified 
as needed), and explicitly stated as such, or a description and analysis of 
the test procedures used should be provided justifying their validity.

     B.  Elongation/Yield and Tensile Strength:  These tests should 
demonstrate the percent elongation of the stent before deformation, i.e. 
cracking or stretching, and the point at which the stent tears or breaks, 
i.e. tensile strength.  A statistically valid number of stents should be 
tested to establish the elongation and tensile strengths.  Again, a 
sampling of stents representative of the product line should be tested.  
Testing should be conducted in accordance with accepted industry standards, 
e.g. ASTM D412, and explicitly stated as such, or a description and 
analysis of the test procedures used should be provided justifying their 
validity.

     C.  Curl Strength:  Curl strength is the measure of force required to 
straighten a curl of the stent and this test should demonstrate the point 
at which the curl straightens.  In addition, curl strength is considered to 
be directly related to a stent's resistance to migration.  A statistically 
valid number of stents should be tested to establish the curl strength of 
each curl size.  Again, a sampling of stents representative of the product 
line should be used.  Testing should be conducted in accordance with 
accepted industry standards and explicitly stated as such, or a description 
and analysis of the test procedures used should be provided justifying 
their validity.

     D.  Coefficient of Friction:  This test is optional for uncoated 
catheters.  This test is used to establish the effect of a lubricious or 
other type of coating on a stent where it is claimed that the coating is to 
reduce friction and promote ease of placement.  Again, a statistically 
valid number of stents should be tested to establish the coefficient of 
friction.  Testing should be conducted in accordance with accepted industry 
standards, e.g. ASTM D1894, and explicitly stated as such, or a description 
and analysis of the test procedures used should be provided justifying 
their validity.

     E.  Data that demonstrates whether the coating(s), if applicable, 
cause some change in the make-up of the underlying stent materials.

     F.  Shelf Life/Expiration Date:  Testing demonstrating that long 
periods of storage and adverse shipping conditions do not result in 
alterations of the coating(s) or its properties.

XII. Complete information regarding ureteral stents and its accessories 
that are sold sterile must be provided and must include sterilization 
method; validation method; packaging materials and a description of the 
packaging to ensure sterility is maintained; sterility assurance level 
(SAL), and radiation dose or the maximum levels of residuals of ethylene 
oxide, ethylene chlorohydrin, and ethylene glycol which remain on the 
device, whichever applicable.  If the device will be labeled as pyrogen 
free, or non-pyrogenic, provide a description of the method used to make 
that determination (LAL or Rabbit test).  Guidance on sterility issues is 
described in ODE Bluebook Memo K90-1 510(k) "Sterility Review Guidance 
(2/12/90)" and a copy may be obtained from the Center for Devices and 
Radiological Health's Division of Small Manufacturers Assistance at (800) 
638-2041 or (301) 443-6597.

If the ureteral stent and its accessories are sold and labeled as 
nonsterile or can be reprocessed, instructions on cleaning, disinfection, 
and/or sterilization should be provided.  Accessories that are disposable 
should be labeled as single use.

XIII. If this device is to be marketed as a kit, identify all components 
and provide the certification stated below:

     I certify that the following components of my kit are either (1) 
legally marketed pre-amendments devices, (2) exempt from premarket 
notification (consistent with the exemption criteria described in the 
classification regulation(s) and the limitations of exemptions from Section 
510(k) of the act (e.g., 862.9), or (3) have been found to be substantially 
equivalent through the premarket notification process for the use(s) for 
which the kit is to be intended (i.e., I am not claiming or causing a new 
use for the component(s)).  

     I further certify that these components are not purchased in "bulk", 
but are purchased in finished form, i.e., they are packaged, labeled, etc., 
consistent with their pre-amendments, exemption, or premarket notification 
criteria and status.

If you cannot make the above referenced certification statement (first 
paragraph) for each component of your kit, you must itemize the components 
without a pre-amendments, exemption, or premarket notification status.  In 
this case we will continue our premarket notification review of these 
components of your kit.

If you cannot make the above referenced certification statement (second 
paragraph) for each component of your kit, you must itemize these 
components, state whether they are pre-amendments, exempt, or have been 
found substantially equivalent through the premarket notification process, 
and describe how you further process them (e.g., sterile, 
package/repackage, label/relabel, etc.).

If the device kit contains components which are subject to regulation as 
drugs, a substantially equivalent determination will not apply to the drug 
component(s) of the device.  For information on applicable Agency 
requirements for marketing the drug component(s) in the kit, it is 
suggested that you contact the Center for Drug evaluation and Research's 
Division of Drug Labeling Compliance at (301) 295-8063.

 

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