DRAFT 510(k) CHECKLIST FOR ENDOSCOPIC ELECTROSURGICAL UNIT
(ESU) AND ACCESSORIES USED IN GASTROENTEROLOGY AND UROLOGY
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
AUGUST 16, 1995
8/16/95
510(k) Checklist for Endoscopic Electrosurgical Unit (ESU) and Accessories used in
Gastroenterology and Urology
The purpose of this 510(k) checklist is to identify the type of information to be
provided in a premarket notification (510(k)) to support a determination of substantial
equivalence for electrosurgical units (ESU) and accessories used in gastroenterology
and urology. The criteria listed within this 510(k) checklist are consistent with the
requirements that the Urology and Lithotripsy Devices Branch has utilized for these
devices for some time.
General guidance for the preparation of a 510(k) submission is provided in the
DRAERD "Draft Guidance for the Content of Premarket Notifications." Additionally,
guidance on the preparation of a 510(k) is available in our "Center for Devices and
Radiological Health Premarket Submissions Cover Sheet," which we are requesting that
manufacturers use in the preparation of any type of premarket submission, as part of a
pilot program. Additional guidance on device modifications is provided in the draft
document "Deciding When to Submit a 510(k) for Change to an Existing Device."
These 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.
Adequate?
1. Administrative information:
a. Classification name - Endoscopic ESU Unit
and Accessories
b. Device trade name
c. Sponsor/manufacturer name and address
d. Panel/Classification - 78, Class II,
21 CFR 876.4300
e. Procodes (Electrosurgical Unit):
KNS (Unit, ESU, Endoscopic
with or without accessories)
Procodes (Accessories):
FAS Electrode, Electrosurgical, Active,
Urological
FDI Snare, Flexible*
FDJ Snare, Rigid Self-Opening*
KGE Forceps, Biopsy, Electric*
* Covered under the "Draft Guidance for the
Content of Premarket Notifications for
Biopsy Devices used in Gastroenterology
and Urology (2/10/93)"
f. Establishment registration number
g. Special controls - None established
2. Reason for the 510(k) submission (new device or a
modification to an existing device)
3. Intended use of the device:
Electrosurgical units are intended to provide
electrical power to accessories (i.e., electrodes
biopsy forceps, snares, etc.) via the use of a high
frequency electrical current waveform passing into
the tissue during endoscopic gastroenterological
or urological procedures
4. Device description:
Electrosurgical Unit:
a. List of the device's components/parts, controls,
and attachments (e.g., line cord, dispersive
electrode, endoscope connector, footswitch,
indicator lamps, mode and power selector, etc.)
b. Diagrams, drawings, photographs of the device
c. Electrical specifications (i.e., circuitry,
line voltage/frequency, output frequency,
operating modes, maximum output power for
all modes, open circuitry voltage, crest
factor, etc.)
d. Dimensional characteristics (size, weight)
e. Safety features
f. Description of the ergonomic features of the
device (e.g., can the device be easily
operated, visual/audible alarms)
g. Explanation of whether or not the device is
software controlled (if so, this aspect of the
device must be described according to the draft
FDA guidance document "Reviewer Guidance for
Computer Controlled Medical Devices Undergoing
510(k) Review"). If the device does not contain
software, please explicitly state that there is
no software.
Accessories:
a. List of the device's components/parts, and
attachments (e.g., handle, sheath, cutting
loop/jaw/wire, etc.)
b. Diagrams, drawings, photographs of the device
c. Description of operation (e.g. cutting,
coagulation, biopsy, tissue removal,
transection of tissue, etc.)
d. Identify compatible ESU device/adapters/activation
cord and operation mode
e. List of all device materials
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) cytotoxicity test
(2) sensitization assay
(3) irritation or intracutaneous reactivity
f. Electrical/thermal specifications (e.g. maximum
power setting, output, etc for each mode of
operation)
g. Description of the ergonomic features of the
device (e.g., can the device be easily
operated)
h. List of the ranges of sizes/models proposed
for marketing (e.g., length, diameter,
tip configurations, etc.)
i. Explanation of whether the device or any of its
parts are intended to be reused including
assembly/disassembly instructions
5. Electrical safety/Performance testing
a. Data from testing that addresses electrical
safety (leakage current, grounding, isolation,
etc.) or certification that the finished product
meets all applicable requirements specified in
the latest version of a recognized electrical
standard for medical devices (e.g., ANSI/AAMI
American National Standard for Electrosurgical
Devices HF-18/1993).
b. Electromagnetic compatibility and interference
(EMC/EMI) should be addressed. To address this
item, immunity and emissions testing should be
performed to evaluate the potential of the
device to be affected by, as well as to cause,
electromagnetic interference in the intended
use environment. Additionally, if applicable,
the device's labeling should inform the user
of the potential of the device to interfere
with surrounding equipment. Appropriate
justification for why such testing is not needed
will be considered.
c. Other tests identified (provide protocol and
results)
6. Proposed labeling, instructions for use, advertisements:
(per the "Device Labeling Guidance," Blue Book Memo
G91-1)
a. Intended use statement (see section 3 above for
acceptable wording)
b. Instructions for use
c. Applicable contraindications, precautions, warnings
(i.e., keep the voltage power
as low as possible to achieve the desired effect,
do not activate ESU and laser simultaneously, do
not activate ESU and irrigation/suction
simultaneously, do not activate ESU when not in
contact with target tissue or positioned to
deliver energy to target tissue)
d. Troubleshooting procedures and solutions
e. Prescription device statement (Caution: Federal
(USA) Law restricts this device to sale by or
on the order of a physician)
Labeling for Accessories:
f. Reprocessing (cleaning, rinsing, disinfection or
sterilization) instructions (if applicable)
For additional important information on reprocessing,
please refer to the draft "Labeling Reusable Medical
Devices for Reprocessing in Health Care Facilities:FDA
Reviewer Guidance (March 1995)." A copy of this guidance
may be obtained from DSMA.
g. Labeled for single use only (if applicable)
h. Labeled as sterile (if applicable)
7. Sterility Information (if the device/accessories are labeled or
otherwise represented to be sterile
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
f. A description of the packaging material used to
ensure the sterility of the device
8. Comparison to legally marketed endoscopic
electrosurgical unit or accessory (electrode,
coagulator, or treatment electrode, etc.)
a. Name/manufacturer of predicate device
b. Labeling of predicate device
c. Intended use of predicate device
d. Description of predicate device
e. Diagrams/photographs of predicate device
f. 510(k) number (if known) of the predicate
device (or statement that the predicate device
is Pre-Amendments)
g. A detailed comparison of the similarities/
differences (including all the information
contained in section 4 above) between the 510(k)
device and the predicate device (in tabular format)
9. 510(k) summary/statement (21 CFR 807.92 and 807.93)
10. Truthful and accurate statement
(signed and in accordance with 21 CFR 807.87(j))
--------------------------
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.
(This document was still considered current as of July 1997. It will be reviewed again in July 1998.)