Guidance For The Content Of Premarket Notifications For Urodynamic/Uroflowmetry Systems (Text Only)

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 urodynamic system is described in the FDA regulation, 21 CFR 876.1620 
(a), as a "device used to measure volume and pressure in the urinary 
bladder when it is filled through a catheter with carbon dioxide or water.  
The device controls the supply of carbon dioxide or water and may also 
record the electrical activity of the muscles associated with urination.  
The device system may include transducers, electronic signal conditioning 
and display equipment, a catheter withdrawal device to enable a urethral 
pressure profile to be obtained, and special catheters for urethral 
profilometry and electrodes for electromyography.  This generic type of 
device includes the cystometric gas (carbon dioxide) device, the 
cystometric hydraulic device, and the electrical recording cystometer, but 
excludes any device that uses air to fill the bladder."  The classification 
for this device is Class II as stated in 21 CFR 876.1620 (b) and its 
procodes are:  78 EXQ - cystometer, electrical recording; 78 FAP - 
cystometric gas (carbon dioxide) or hydraulic device; and 78 FEN - device, 
cystometric, hydraulic.

A uroflowmetry system is described in the FDA regulation, 21 CFR 876.1800 
(a), as a urine flow or volume measuring system "that measures directly or 
indirectly the volume or flow of urine from a patient, either during the 
course of normal urination or while the patient is catheterized.  The 
device may include a drip chamber to reduce the risk of retrograde 
bacterial contamination of the bladder and a transducer and electrical 
signal conditioning and display equipment.  This generic type of device 
includes the electrical urinometer, mechanical urinometer, nonelectric 
urinometer, disposable nonelectric urine flow rate measuring device, and 
uroflowmeter.  The classification for this device is Class II as stated in 
21 CFR 876.1800 (b) and its procodes are:  78 FFG - device, urine flow rate 
measuring, non-electrical, disposable; 78 EXS - urinometer, electrical; 78 
EXR - urinometer, mechanical; 78 EXT - urinometer, non-electrical; and 78 
EXY - uroflowmeter.

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, energy used/delivered, 
materials, performance, safety, effectiveness, labeling, and other 
applicable characteristics.

FDA recommends that each premarket notification for a 
urodynamic/uroflowmetry system 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 (Urodynamics Measurements System or Urine Flow or 
Volume Measuring System) 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 urodynamic/uroflowmetry 
systems 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 urodynamic/uroflowmetry system, 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 urodynamic/ 
uroflowmetry system 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 items, quantity enclosed, size, energy used, 
etc.

     B.  Device labeling for the urodynamic/uroflowmetry system 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 set up 
and prepare the urodynamic/ uroflowmetry system for use, how to operate the 
urodynamic/uroflowmetry system, how to stop operation, which parts are 
single use/disposable or reusable, functional test procedures for the 
urodynamic/ uroflowmetry system prior to use.  Maintenance and 
troubleshooting procedures should be outlined with instructions on how to 
perform the maintenance, frequency, and a corporation contact point if 
troubleshooting procedures fail.

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

     	 4.  Patient labeling must also be provided for devices (e.g., 
ambulatory urodynamic monitors) intended to be used by patients outside the 
health care setting.  This labeling should provide the patient with 
realistic expectations of device performance and potential complications 
and include instructions for use with appropriate warning and precautionary 
information.

     C.  Advertisements or promotional literature for the 
urodynamic/uroflowmetry system 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 urodynamic/uroflowmetry system should be compared to a legally marketed 
urodynamic/uroflowmetry system, including, but not limited to the 
following:  intended use, design (hardware, software, detection parameters 
and accuracy, safety features, and other applicable characteristics), 
energy used/delivered, materials of all components identifying those that 
come into patient contact, performance, target population justifying any 
new population cited, and any other related information.

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, 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 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 the urodynamic/uroflowmetry system should include any 
significant changes or modifications from the predicate device that could 
affect safety, effectiveness, or intended use.  Provide any bench, animal, 
clinical, functional, in vitro, and/or any other appropriate testing data 
to support your claims.  Provide certification regarding any compliance 
with voluntary standards, if applicable.

IX.  The physical description of each urodynamic/uroflowmetry system to be 
marketed should be provided in the form of a labeled diagram, 
photograph/picture, schematic, etc., which includes all internal/external, 
assembled/unassembled, etc. parts of the urodynamic/uroflowmetry system.  
The physical description should include the specifications (length, width, 
height, diameter, weight, power requirements, and other applicable 
information) of the urodynamic/uroflowmetry system.  The physical 
description should also identify  any parts which are disposable (i.e., 
catheters, collection cups, and transducers).  The labeled diagram, 
photograph/picture, schematic, etc., should address the name and function 
of all components of the urodynamic/ uroflowmetry system.  Examples of 
these components include the micturition seat/stand, weight/load cell 
transducer, funnel, collection cups, EMG transducers, data collection unit, 
power supply, electrical adapters/outlets (e.g. for transducer connection), 
etc.

If the urodynamic/uroflowmetry system is sold in a set that includes 
accessories, these accessories need to be identified and reviewed along 
with the urodynamic/uroflowmetry system and require the same types of 
information as stated above.  These accessories might include catheters, 
EMG transducers, and cavernosometry pump and accessories.  (Note:  
cavernosometry devices are not yet covered by a classification regulation, 
but they have a procode of 78 LST - erectile dysfunction device).  Labeling 
must state if the accessory is intended for single use and whether it is 
reusable or disposable.  If any of the accessories have been previously 
marketed for the same intended use, provide certification of pre-amendment 
status or the 510(k) number, if known.

X.   An exact identification of all materials used to fabricate the 
urodynamic/uroflowmetry system should be provided and a statement regarding 
any material differences from the pre-amendment or substantially equivalent 
urodynamic/uroflowmetry system should be explicitly stated.  If the 
materials are identical to the pre-amendment or substantially equivalent 
device and are 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 or justify why this data is 
not needed, i.e. the material does not come into patient contact.  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 urodynamic/uroflowmetry system should 
be provided and a statement regarding any colorant changes from the 
pre-amendment or substantially equivalent urodynamic/uroflowmetry system 
should be included.  If the colorants 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.  Data should be provided to demonstrate substantial equivalence of your 
urodynamic/uroflowmetry system with respect to functional performance.  
Testing should be conducted in a manner as similar as possible to how the 
urodynamic/uroflowmetry system will be used in a medical procedure.  A 
statistically valid number of urodynamic/uroflowmetry systems should be 
tested to establish the performance.  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.

Testing data validating stated accuracy, and functional tests that verify 
all features operate in accordance with specifications must be provided.  
System calibration should be explicitly addressed.  Electromagnetic 
compatibility should be addressed, including the effects of voltage spikes 
or power fluctuations on system performance.  For ambulatory systems, 
clinical or simulated use performance data that demonstrates accuracy and 
performance to specifications during a variety of patient activities must 
also be provided.

XII. Guidance for the information required in a premarket notification of a 
software controlled device is provided in the document entitled "Reviewer 
Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review 
(Draft 2/1/91)" 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.

XIII. Complete information regarding urodynamic/uroflowmetry systems and 
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 level 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).  Note that devices or tubing 
that enter the blood stream (e.g. cavernosometry) must be provided pyrogen 
free.  If the entire urodynamic/uroflowmetry system is not sold sterile and 
non-pyrogenic, labeling must clearly identify which parts are sterile 
and/or non-pyrogenic.  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 urodynamic/uroflowmetry system is sold and labeled nonsterile or can 
be reprocessed, instructions on disassembly, cleaning, disinfection, and/or 
sterilization should be provided. If appropriate, a statement that the 
urodynamic/uroflowmetry system requires high level disinfection should be 
provided and compatible solutions and/or procedures for high level 
disinfection and/or sterilization need to be identified. Accessories that 
are disposable should be labeled as single use.

XIV.  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.