Premarket Notification (510(k)) 
Submissions for Bipolar 
Electrosurgical Vessel Sealers for 
General Surgery 
Guidance for Industry and Food and 
Drug Administration Staff 
 
Document issued on August 15, 2016. 
The draft of this document was issued on March 24, 2014. 
 
For questions regarding this document, contact the General Surgery Devices Branch 2, 301-796-
6970. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Office of Device Evaluation 
Division of Surgical Devices 
General Surgery Devices Branch 2  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov . Submit written comments to the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852. Identify all comments with the docket number FDA-2014-D-0218. Comments may not be 
acted upon by the Agency until the document is next revised or updated. 
Additional Copies 
Additional copies are available from the Internet. You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number 1300048 to identify the guidance you are requesting. 
    ii  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ............................................................................................................................. 2 
II.  Scope ....................................................................................................................................... 2 
III.  Device Description............................................................................................................... 3 
A.  Indications for Use ........................................................................................................... 3 
B.  Device Design .................................................................................................................. 4 
IV.  Substantial Equivalence Comparison .................................................................................. 5 
V.  Performance Data.................................................................................................................... 7 
A.  ESU .................................................................................................................................. 7 
B.  Active Components/Accessories ...................................................................................... 8 
C.  Miscellaneous Components/Accessories ......................................................................... 8 
D.  System Testing ................................................................................................................. 8 
E.  Chronic Animal Study ...................................................................................................... 9 
VI.  Clinical Testing .................................................................................................................. 11 
VII.  Labeling ............................................................................................................................. 11 
A.  Instructions for Use (User Manual) ................................................................................ 12 
B.  Device Labels ................................................................................................................. 14 
C.  Package Labels ............................................................................................................... 14 
D.  Labeling for Specific Components ................................................................................. 14 
Appendix A:  Glossary of Terms .................................................................................................. 16 
 
    iii  Contains Nonbinding Recommendations 
Premarket Notification (510(k)) Submissions 
for Bipolar Electrosurgical Vessel Sealers for 
General Surgery
 
Guidance for Industry and  
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff or Office responsible for this guidance as listed on the title page.  
I.  Introduction  
FDA has developed this guidance document to assist industry in preparing premarket notification 
(510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general 
surgery. These devices are designed to seal isolated blood and lymphatic vessels for hemostasis 
(as an alternative to ties) through the use of high-frequency electrical current between two 
electrodes in close proximity.  
For the current edition of the FDA-recognized standard(s) referenced in this document, see the 
FDA Recognized Consensus Standards Database Web site at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.  
II.  Scope 
The scope of this guidance document is limited to the Class II electrosurgical devices and 
accessories classified under the following regulation number: 
Section 878.4400 Electrosurgical cutting and coagulation device and accessories.  
An electrosurgical cutting and coagulation device and accessories is a device intended to 
remove tissue and control bleeding by use of high-frequency electrical current. 
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This generic type of device includes bipolar vessel sealing instruments, associated electrosurgical 
generators, and accessories for use in open and minimally invasive general surgical procedures. 
This guidance is intended only to address bipolar electrosurgical vessel sealers that have general 
indications for use in general surgery. If your device has specific indications, it may require 
additional information (e.g., additional bench and/or clinical data) or may be found to have a new 
intended use. For more information on this topic, please refer to FDAs Guidance for Industry: 
General/Specific Intended Use.  
This guidance is not intended to address the following devices: 
  devices that do not deliver radiofrequency electrical current (e.g., electrocautery, 
microwave ablation and ultrasonic surgical devices); 
  monopolar electrosurgical devices; 
  devices that are not indicated for sealing of isolated blood or lymphatic vessels (e.g., 
devices indicated only for general cutting and coagulation/hemostasis in bulk tissue); 
  devices intended for specific surgical procedures or procedures within a given 
specialty (e.g., ophthalmic use), i.e., anything other than general surgery; and 
  reprocessed single-use devices. 
In addition, please be aware that this guidance is a supplement to the guidance Premarket 
Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. This 
supplemental guidance provides additional recommendations or supersedes the electrosurgical 
devices guidance.  The following sections of the electrosurgical devices guidance are considered 
applicable to bipolar vessel sealers: 
  Software 
  Biocompatibility 
  Sterility 
  Reprocessing 
  Pyrogenicity 
  Shelf Life 
  Electrical Safety and Electromagnetic Compatibility 
III.  Device Description  
We recommend that you identify your device by the applicable regulation number described in 
Section II and include the following information:  
A. Indications for Use 
You should provide a clear statement of your devices Indications for Use. The 
Indications for Use as stated on the Indications for Use Statement page should be 
identical to that in the 510(k) Summary (if provided in lieu of a 510(k) Statement) and the 
device labeling.  You should also state that the device is a prescription use device, and 
indicate this accordingly on the Indications for Use Statement page. 
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Your 510(k) submission should include a comparison of the indications for use of your 
subject device and all cited predicate devices. The indications for bipolar electrosurgical 
vessel sealers should clearly state a maximum vessel size measured in the rounded, 
perfused state in a normotensive subject. If either the subject or predicate devices consist 
of multiple components with different indications, please specify these differences in 
your comparison. If you can demonstrate that the intended use of your device in 
comparison to the predicate is the same, and that there are no new technological 
characteristics that raise different questions of safety or effectiveness, then you should 
provide a rationale, including performance data when applicable, for any differences in 
indications between the subject and predicate device(s).  
B. Device Design 
You should provide a brief description of the devices operating principle(s) and 
mechanism of action for achieving the intended effects.  If the device will be labeled for 
use with multiple components or accessories, and the components/accessories are part of 
the submission, you should provide a list of all components/accessories with 
accompanying model numbers and/or part numbers. For the purpose of this guidance, 
components/accessories of vessel sealers refer to the electrosurgical unit (ESU), active 
components/active accessories, and miscellaneous components/accessories. If there are 
components/accessories that have received prior 510(k) clearance or are exempted from 
the 510(k) requirement, please provide the 510(k) numbers or indicate their exemption 
status, respectively.   
At a minimum, you should provide the following information regarding device design: 
1.  Device Components 
We recommend you provide a brief description of all major components or 
accessories where applicable to your submission: 
  ESU (i.e., the generator and control console) major functions, performance 
specifications, and physical specifications.  If the submission is for a vessel 
sealing accessory that will be utilized exclusively with a previously cleared 
generator you may provide the 510(k) number of the generator with a summary of 
the generators performance specifications (output power, waveform, peak voltage, 
etc.) in lieu of the major functions, full performance specifications and, physical 
specifications. 
  Active components/accessories (generally comprised of one or more active 
electrodes, active connector or cables, and active handle or hand piece) design, 
physical specifications, and patient contacting materials 
  Miscellaneous accessories such as foot pedal, electrode monitors, etc. 
2.  Submission for Specific Component(s)/Accessories 
If your submission is requesting clearance for a specific component or accessory but 
not the entire vessel sealer, you should describe the component/accessory. You 
should discuss how you intend or expect this component/accessory to be used.  For 
example, if the submission is for an active electrode(s) and will only be labeled for 
use with your own legally marketed devices, you should provide performance testing 
(see Section V, Performance Data) to demonstrate compatibility with your own 
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legally marketed devices.  Also, you should address the potential that this active 
electrode could be used with other manufacturers ESU and identify the associated 
risk(s). In your risk assessment, please identify whether you have incorporated into 
your device design a way to prevent using your active electrode with other 
manufacturers devices for which compatibility has not been established. Based on 
your risk assessment, you may need to provide additional performance testing to 
demonstrate this component will be safe and effective when used with other 
manufacturers devices. 
3.  Photograph and/or Drawing of the Device 
We recommend you provide high-level drawings, diagrams, and/or photographs of 
the device that can help explain the functions and features. We also recommend you 
provide an exploded or assembly view diagram or connection diagram, including all 
components clearly labeled. 
IV.  Substantial Equivalence Comparison 
We recommend that you compare your device with a legally marketed predicate device(s) that 
you believe is (are) substantially equivalent to your device with respect to indications for use and 
technology characteristics per 21 CFR 807.87(f). Side-by-side comparisons for each major 
component using a tabular format such as shown in Table 1 are desirable whenever possible. For 
each identified difference, please provide further discussion of the difference compared to the 
predicate and why this difference will not significantly affect safety or effectiveness. You may 
need to provide performance data to support that, even with significant differences, the device is 
as safe and effective as the predicate.   
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Table 1.  Example Comparison Table 
Description  Your Device  Predicate Device 
Indications for Use 
ESU 
  Major functions (e.g., monopolar 
and/or bipolar, temperature or 
impedance feedback system, 
electrodes monitoring, automatic 
detection of complete seal, method 
of activation, alarm functions). 
[Please note:  Power generators for 
vessel sealers should be bipolar; 
however, if the generator has 
additional monopolar functions for 
cutting or coagulation, these 
functions should be described 
accordingly.]  
  Performance specifications (e.g., 
output frequency, waveform, power 
output, voltage output, crest factor) 
  Physical specifications 
Active Components/Accessories 
  Physical dimensions and design 
(e.g., size, length, connector type) 
  Tip design/shape 
  Mechanism of cutting (e.g., 
mechanical and/or electrical) 
  Rated voltage 
  Materials (electrode, insulation, 
coating, etc.) 
Miscellaneous Accessories 
  Functions 
  Performance specifications 
  Physical specifications 
  Materials 
Vessels  
  Type 
  Maximum diameter 
  Size range 
When more than one predicate device is identified to establish substantial equivalence of your 
device, you should provide justification for the use of each predicate. You should address why 
the combination of features and/or functions into one device does not raise different types of 
safety and effectiveness questions for each predicate identified. An example of where multiple 
predicates could be used is if the device includes different technologies that can stand alone  but 
  6  Contains Nonbinding Recommendations 
can also be used together for the intended use of sealing vessels.  If there is a predicate device for 
each of the technologies, then the combination of these technologies, assuming that the use of 
one of the functions does not interfere with the others, could be found substantially equivalent. In 
such an instance, you may need to provide performance data to support your justification. 
V.  Performance Data 
We recommend that nonclinical testing be performed to demonstrate that each individual 
component of the vessel sealing system (or a representative from each family of closely related 
components) as well as the overall vessel sealing system with all the components connected 
(system) meets all the design and performance specifications. In the case where the 510(k) 
submission is for one or more components of the vessel sealing device, but not the entire vessel 
sealer (e.g., ESU only or active electrodes only), nonclinical testing as a system should be 
provided using legally marketed components with which your device is labeled as compatible. In 
the case where the 510(k) submission is for a vessel sealer and other active components of an 
electrosurgical device, recommendations for the necessary performance data for other active 
components/accessories of the electrosurgical device may apply.  Please refer to the FDA 
guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General 
Surgery.  
Depending on the substantial equivalence comparison to the predicate(s) above, nonclinical 
testing may be accomplished with bench testing alone, or it may necessitate testing in an in vivo 
or ex vivo animal model. The following are recommended nonclinical tests for each major 
component and for the system. 
You should provide full test reports for each test conducted.  A full test report includes: objective 
of the test, description of the test methods and procedures, study endpoint(s), pre-defined 
pass/fail criteria, results summary, and conclusions.  You should also provide an explanation of 
how the data generated from the test supports a finding of substantial equivalence. For any tests 
involving tissue effects, you should describe the clinical relevance of the acceptance criteria for 
each test and explain why the test results demonstrate acceptable clinical performance of your 
device. Nonclinical test conditions should simulate the worst-case conditions that your device is 
likely to encounter during clinical use. For those nonclinical tests that do not rely on FDA 
recognized consensus standards, the results of the testing on the proposed device should be 
compared to those of your predicate device(s). 
A. ESU 
You should provide a graphical display of the output waveform at the rated load, 
identifying the associated mode, amplitude, frequency, duty cycle, load used, and crest 
factor. 
You should provide a graph displaying the power output at maximum and half-of-
maximum intensity over the range of expected loads (e.g., 50  to 500  for bipolar).  
This information should be derived from experimental test data and not theoretical 
values, and it should include a comparison of these curves to the corresponding mode of 
the predicate device(s). 
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If the vessel sealer ESU possesses additional functions such that it can also perform as a 
high frequency surgical generator for other procedures besides vessel sealing, you should 
provide information for each mode of the ESU. Please refer to FDAs guidance, 
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General 
Surgery.  
B. Active Components/Accessories 
Mechanical testing of the active electrodes and instruments of the vessel sealer is 
important to minimize the risks associated with mechanical failure and short circuiting. 
Although the methods will vary based on the device design, you should assess the 
potential for damage to the device both before use (e.g., drop tests of the instrument in its 
packaging) and during use (e.g., bending force). Different considerations will also be 
necessary for single-use instruments versus reusable instruments. For reusable 
instruments, testing should demonstrate both adequate mechanical strength and electrical 
performance (e.g., insulation integrity) after multiple reuse and reprocessing cycles. For 
instruments with actuating parts, we recommend simulated repeated-use testing of the 
actuating part, including grasping force and force to jaw failure. Force to jaw failure is 
defined as the force required to cause the actuating component to no longer be able to 
grasp or close on the target tissue. This testing is important to ensure that the device can 
appropriately grasp the target tissue under worst case scenarios. For reusable instruments, 
this testing should be conducted after the maximum number of simulated use and 
reprocessing cycles. 
C. Miscellaneous Components/Accessories 
When your vessel sealing device also includes accessories such as a foot pedal, you 
should provide test results to show that each miscellaneous device meets all of the design 
specification and performance requirements. 
If a component/accessory has been previously cleared by FDA, you may provide the 
original 510(k) as a reference, rather than conducting additional tests for the referenced 
component/accessory. However, compatibility between the component/accessory and the 
proposed device should still be addressed.   
D. System Testing 
We recommend the following system testing to demonstrate bipolar electrosurgical vessel 
sealer performance when the 510(k) is for a new vessel sealing system or modifications 
that can reasonably be expected to modify the tissue effect of the system (i.e., change in 
jaw geometry or materials, jaw surface characteristics, clamping force, output power, or 
the generator control algorithm). Where the 510(k) includes a family of closely related 
devices that share the same jaw geometry or materials, jaw surface characteristics, 
clamping force, output power, and generator control algorithm, it is not necessary to 
repeat the system testing for all members of the family. The justification for relying on a 
family representative, or otherwise pooling data, should be provided in the protocol 
and/or report. This information should include testing on both the subject device and the 
predicate device(s) for comparison. 
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1.  Burst Pressure 
For each mode and representative instrument, you should provide burst pressure 
testing data to evaluate the seal strength of vessels sealed with your device when 
compared to vessels sealed with the predicate device. In this testing, vessels are 
sealed with the subject device and the predicate device. These vessels are then 
pressurized with liquid until failure. The maximum recorded pressure immediately 
prior to failure is recorded as the burst pressure.  
You should select a range of vessel sizes consistent with your indications for use and 
provide a rationale for the specific vessel types (veins, arteries, or both) selected. You 
should provide a thorough test report that includes a table listing each vessel sealed 
with information on burst pressure, vessel type, diameter, device sample number, 
physical observations (e.g., sticking, charring), and any errors or notes (e.g., the first 
seal attempt gave an alarm and the device was reapplied).  You should use the data 
from the burst pressure testing to determine the worst-case scenario for your chronic 
animal study by focusing on vessel sizes that present the most difficulty sealing or 
exhibit failures during the burst pressure testing.   
2.  Thermal Spread on Vessels 
For each mode and representative instrument, you should provide comparative data to 
evaluate the spread of thermal damage along the vessels. These data should include a 
quantitative measurement (under magnification) of the size (length, width, and depth) 
of the thermal damage zone. Two-dimensional histological assessments (e.g., length 
and width) are considered to be minimally acceptable measurements for assessing 
thermal spread. Three-dimensional histological assessments (e.g., length, width, and 
depth) should be performed as necessary to quantify thermal spread in seals that 
generate special growth characteristics (e.g., asymmetrical growth of the thermal 
spread). 
In this testing, vessels are sealed with either the subject or predicate device and the 
thermal damage (i.e., coagulation necrosis) is then assessed histologically to 
determine the distance from the edge of the seal.  
We recommend that you seal the vessels in vivo or provide a rationale for why ex vivo 
use does not impact the results. You should provide a thorough test report that 
includes representative high-quality, color images of several histology samples from 
each group that clearly indicate the edge of the seal and how the measurements were 
made. 
E. Chronic Animal Study 
We recommend chronic animal studies to demonstrate bipolar vessel sealing performance 
when the 510(k) is for a new vessel sealing system or modifications that can reasonably 
be expected to modify the tissue effect of the system (i.e., change in jaw geometry or 
materials, jaw surface characteristics, clamping force, power, or the generator control 
algorithm).  
Where the 510(k) submission includes a family of closely related devices that share the 
same jaw geometry or materials, jaw surface characteristics, clamping force, power, or 
the generator control algorithm, it is not necessary to repeat the system testing for all 
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members of the family. The justification for relying on a family representative, or 
otherwise pooling data, should be provided in the protocol and/or report.   
In order to assess the long-term seal quality and potential for injury to adjacent structures, 
you should perform a chronic animal study to evaluate your device performance at a 
minimum of 3 weeks post-procedure in at least 5 animals. Multiple vessels per animal 
should be sealed for an adequate study sample size.  This study may be done with only 
the proposed device, provided success criteria are pre-defined and clinically justified 
(e.g., no vessel leaks, normal vessel healing, and no adjacent tissue damage) and similarly 
produced data from the predicate device are available for comparison. You should 
provide a thorough test report that includes the following information at a minimum: 
  justification of the animal model and vessels chosen with respect to vessel type 
(e.g., artery and vein) and diameter; 
  a description of the surgical procedure, including if and how the vessels were 
transected after sealing and how the seals will be located at necropsy; 
  a description of the intra-operative evaluation of vessel leakage prior to closing 
the animal; 
  if intensity (i.e., power setting) is adjustable, a rationale for the output intensities 
used (in this case, we recommend testing a range of values that includes the 
worst-case setting); 
  a table that lists each vessel sealed with information on vessel type, diameter, 
device sample/identification number, seal appearance, gross findings at necropsy 
(e.g., unforeseen injury, large hematoma over the sealed site, adjacent tissue 
damage), and any comments related to failure or success of the sealing; 
  an animal husbandry/veterinary clinical observations report of how the animals 
fared from the time of operation to necropsy, with explanations of any clinical 
symptoms;  
  the post-surgical activity level of the animals, which should not be restricted, and 
a description of any stress placed on the animals (i.e., to elevate blood pressure); 
and 
  a histopathology report that describes the extent of vessel healing, evidence of 
leakage (hemorrhage and/or edema), and any adjacent tissue damage. 
Acceptable methods of identifying how seals are to be located at necropsy should be 
documented in the original protocol and the final test report.  Accordingly, the protocol 
and report should confirm the anatomical location(s) where the seals are performed. 
Sutures and ink are acceptable means for marking the specific seals within the anatomical 
areas documented in the protocol and report. 
Since the nonclinical animal studies recommended above will be used to help establish 
the safety of the device, they  must be conducted according to Good Laboratory Practices 
(GLPs) established by 21 CFR part 58.      
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VI.  Clinical Testing 
Clinical data are generally not necessary to support 510(k) submissions for bipolar 
electrosurgical vessel sealers intended for use in general surgery. However, if your device 
indications for use or device technology and/or mechanism of action is significantly different 
when compared to the predicate device(s), and if nonclinical testing is insufficient to establish 
substantial equivalence, clinical testing may be necessary to establish substantial equivalence to 
a predicate device.  
If you believe that clinical data are necessary, or if you are uncertain, we highly recommend that 
you contact the Agency through the Pre-Submission process to obtain early feedback on study 
design considerations (see the FDA guidance, Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration 
Staff). 
VII. Labeling  
The premarket notification must include labeling in sufficient detail to satisfy the requirements 
of 21 CFR 807.87(e).  Proposed labels, labeling, and advertisements sufficient to describe the 
vessel sealing device, its intended use, and the directions for use must be provided with a specific 
intended use statement and any warnings, contraindications, or limitations clearly displayed as 
described in 21 CFR 807.87(e).  Please consider the following suggestions for assistance in 
preparing labeling that satisfies the requirements of 21 CFR 807.87(e).  The following 
suggestions are aimed at assisting you in preparing acceptable labeling.  
Although final labeling is not required for 510(k) clearance, final labeling must comply with the 
requirements of 21 CFR part 801 before a medical device is introduced into interstate commerce. 
In addition, final labeling for prescription medical devices must comply with 21 CFR 801.109. 
As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate 
directions for lay use. Labeling must, however, include adequate information for practitioner use 
of the device, including indications, effects, routes, methods, frequency and duration of 
administration and any relevant hazards, contraindications, side effects, and precautions (21 CFR 
801.109(d)). 
We recommend that all bipolar electrosurgical vessel sealer submissions demonstrate compliance 
with the labeling sections of the currently FDA-recognized versions of the 60601 series of 
standards, including AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and (when 
applicable) IEC 60601-2-18. We also recommend that you include the information below in your 
labeling. Please note that some of the recommended labeling content is already included in the 
standards but has been repeated for emphasis. Other recommended content has been modified 
from the standards. 
Vessel sealing systems generally consist of several different interchangeable components used 
together to create the desired effect, including the ESU, reusable instruments, disposable 
instruments, footswitches, etc. Some of the labeling recommendations below may apply to only a 
single component or to each component in a system. You should determine which labeling is 
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appropriate, depending on the indications for use, the individual components, and how the 
components may be packaged (together or separately).  
The list below is not intended to be exhaustive of all the labeling requirements under part 801.  
A. Instructions for Use (User Manual) 
1.  Indications for Use 
Your labeling should clearly state the indications for use of your device as specified 
in your Indications for Use Statement. This information should be prominently 
located in the beginning of your directions for use. If your device consists of multiple 
components with different indications, please specify this in your labeling.  
2.  Contraindications 
We recommend including the following contraindication for bipolar vessel sealers:  
This device has not been shown to be effective for tubal sterilization or tubal 
coagulation for sterilization procedures. Do not use this device for these procedures. 
3.  Warnings 
We recommend including the following warnings, as applicable, in the instructions 
for use. Sample language is provided in italics. If you believe any of these warnings 
are not applicable to your device, please provide a justification for each omission. 
a.  DO NOT USE in patients who have electronic implants such as cardiac 
pacemakers without first consulting a qualified professional (e.g., cardiologist). A 
possible hazard exists because interference with the action of the electronic 
implant may occur, or the implant may be damaged. 
b.  DO NOT USE this instrument on vessels larger than __mm in diameter. 
c.  DO NOT USE in the presence of flammable anesthetics or oxidizing gases (such 
as nitrous oxide (N O) and oxygen) or in close proximity to volatile solvents (such 
2
as methanol or alcohol), as explosion may occur. 
d.  DO NOT place instruments near or in contact with flammable materials (such as 
gauze or surgical drapes). Instruments that are activated or hot from use may 
cause a fire.  
e.  When not using instruments, place them in a clean, dry, highly visible area not in 
contact with the patient. Inadvertent contact with the patient may result in burns. 
f.  DO NOT place the vessel and/or tissue in the jaw hinge. Place the vessel and/or 
tissue in the center of the jaws. 
g.  PRIOR TO CUTTING, inspect the vessel or tissue to ensure proper sealing. (If 
the device uses a simultaneous seal-and-cut technology, this warning can be 
omitted.) 
h.  DO NOT USE energy based devices to transect seals, such as electrosurgical 
pencils or ultrasonic scalpels. 
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i.  DO NOT attempt to seal over clips or staples or contact metal objects (e.g., 
retractors). Contact between an active electrode and any metal objects may result 
in alternate site burns or incomplete seals. 
j.  INSPECT reusable instruments and cables for damage prior to each use, 
especially the insulation of laparoscopic/endoscopic instruments. This may be 
done visually under magnification or with a high voltage insulation testing device. 
Insulation failures may result in burns or other injuries to the patient or operator. 
k.  ASPIRATE fluid from the area before activating the instrument. Conductive fluids 
(e.g., blood or saline) in direct contact with or in close proximity to an active 
electrode may carry electrical current or heat away from target tissues, which 
may cause unintended burns to the patient.  
l.  The surface of the active electrode may remain hot enough to cause burns after 
the RF current is deactivated. 
m. Due to concerns about the carcinogenic and infectious potential of 
electrosurgical byproducts (such as tissue smoke plume and aerosols), protective 
eyewear, filtration masks, and effective smoke evacuation equipment should be 
used in both open and laparoscopic procedures. 
n.  Connect adaptors and accessories to the electrosurgical unit only when the 
energy is off. Failure to do so may result in an injury or electrical shock to the 
patient or operating room personnel. 
4.  Cautions 
We recommend including the following cautions, as applicable, in the instructions for 
use. Sample language is provided in italics. If you believe any of these cautions are 
not applicable to your device, please provide a justification for each omission. 
a.  The intensity should be set as low as is necessary to achieve the desired effect.  
b.  Do not overfill the jaws of the instrument with tissue, as this may reduce device 
performance. 
c.  Keep the active electrodes clean. Build-up of eschar may reduce the instruments 
effectiveness. Do not activate the instrument while cleaning. Injury to operating 
room personnel may result. 
d.  Use caution during surgical procedures in which patients exhibit certain types of 
vascular pathology (atherosclerosis, aneurysmal vessels, etc.). When possible, 
apply the seal to unaffected vasculature. 
5.  Summary of Animal Studies 
You should provide a summary of the data from your animal studies to demonstrate 
that your device worked in this animal model to achieve sealing in arteries and veins 
of the tested size. You should also include a statement to the effect that clearance was 
not based on human clinical testing, and that there is no animal model predictive of 
how the device functions when used to seal vessels containing atherosclerotic plaque.   
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6.  Operating Information 
Operating instructions should contain detailed information such that the practitioner 
can set up and use the device safely and for the purposes for which it is intended. In 
addition, we recommend that you include instructions concerning the proper selection 
and use of accessories in order to avoid incompatibility and unsafe operation. For any 
accessories that may need to be replaced (e.g., disposable electrodes), you should also 
provide instructions in your labeling for obtaining replacements (e.g., model number 
and contact information). 
B. Device Labels 
In your submission, we recommend that you provide illustrations to show how each 
component/accessory of your device is labeled to demonstrate that all controls, switches, 
and connections (including those for hand switched active electrodes and foot switches) 
are clearly, concisely, and permanently labeled to identify their function and other 
important information (e.g., Type BF Applied Part). In the submission and the labeling, 
you should also describe the color of any controls or connections (e.g., blue coag 
button) so that the function of each is apparent.  
C. Package Labels 
We recommend that you provide draft package labels, which should include the 
manufacturer, model number, and important information about device reuse, sterility, 
shelf life, etc. 
D. Labeling for Specific Components 
1.  ESU 
Your directions for use should include information on the output specifications of 
your device so that the user can easily understand the energy that is being delivered. 
We recommend including the following information for each output mode of your 
device: 
a.  Graphs or tables illustrating the actual power output (under a specified 
impedance). These graphs or tables should be provided for each intensity setting 
if multiple intensity settings are available. 
b.  Graphs displaying the power output at maximum and half-of-maximum intensity 
over the range of expected impedances. 
c.  The maximum output voltage and instructions regarding selecting accessories 
with appropriate voltage ratings. 
2.  Active components and active accessories 
Your directions for use should include information on the compatibility of your 
instrument with other components of the electrosurgical system. We recommend 
including the following information: 
a.  The rated accessory voltage. 
b.  The compatible generator model or adequate instructions and criteria for the 
user to identify an adequate generator. 
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c.  The limitations on generator output settings and duration of activation. 
d.  A statement referring users to the generator manual for additional instructions. 
e.  If the instrument is reusable, adequate instructions on the cleaning, inspection, 
and sterilization and how to track the number of uses. You should also include 
a warning that visual inspection alone may not be sufficient to ensure that the 
insulation is intact.  
3.  Components and Accessories 
Your directions for use should include information on the compatibility for each of 
your accessories with the vessel sealing device. For some accessories, such as 
suction/irrigation pumps and smoke evacuation devices, a separate standalone 
instructions for use should be considered. 
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Appendix A:  Glossary of Terms 
The following terms are defined for the purpose of this guidance only and may or may not 
correspond to their broader usage. 
Active accessory  The component of the electrosurgical device used by the operator to produce 
surgical effects at the intended site on the patient.  Generally comprised of an active handle, 
the cord or cable, and the active electrode (may be monopolar or bipolar for general 
electrosurgical units). 
Active electrode  The conductive portion of the electrosurgical instrument that delivers high 
density electrical current to the patient at the surgical site. This may or may not be 
removable from the instrument handle. 
Bipolar  An electrosurgical device in which the current flows between two active electrodes 
placed in close proximity. 
Coagulation  The change of a liquid, especially blood, to a solid. This is considered separate 
from coagulation necrosis. 
Coagulation necrosis  Necrosis in which the affected cells or tissue are converted into a dry, 
opaque, fairly homogenous eosinophilic mass as a result of the coagulation of protein. 
Continuity monitor  A component of a monopolar electrosurgical system that monitors the 
connection between the neutral electrode and the generator. The continuity monitor 
produces an alarm if the connection is lost, but it cannot detect if there may be a high 
current density through the neutral electrode. 
Electrocautery  The use of electric current to heat an instrument, which is applied to tissue to 
create an effect. The current passes through the instrument only and not through the 
patients tissue. 
NOTE: The term electrocautery is often used incorrectly to refer to electrosurgical devices. 
To prevent confusion, FDA recommends that you avoid misuse of this term. 
Electrosurgical device  A device that passes high-frequency electrical current through soft 
tissues for the purpose of removing tissue or controlling bleeding. 
ESU  Abbreviation for electrosurgical unit. This term refers to the generator and control 
console.  
Generator  The component of the electrosurgical system that produces the high-frequency 
current waveform that is delivered to tissues via the connecting cable(s), instrument(s), and 
electrode(s). 
Instrument  The component of the electrosurgical system that is manipulated by the operator 
and applied to the surgical site, generally consisting of the handle and active electrode. 
Radiofrequency (RF)  Generally refers to frequencies ranging from 100 kHz to 5 MHz. This is 
intended to exclude other frequencies (e.g., microwave ablation devices) that may 
technically fall within the radiofrequency portion of the electromagnetic spectrum but 
operate in a fundamentally different manner. 
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Vessel sealer  An electrosurgical device intended to seal isolated blood and lymphatic vessels 
for hemostasis, as an alternative to ties. Usually bipolar. 
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