On June 14, 2023, FDA issued a guidance titled Content of Premarket Submissions for Device 
Software Functions.1 This final guidance supersedes the Guidance for the Content of Premarket 
Submissions for Software Contained in Medical Devices, issued on May 11, 2005. The final 
guidance issued on June 14, 2023, provides information regarding the recommended 
documentation sponsors should include in premarket submissions for FDAs evaluation of the 
safety and effectiveness of device software functions. In particular, the final guidance includes 
information to help determine a devices Documentation Level (formerly known as Level of 
Concern). The purpose of the Documentation Level is to help identify the minimum amount of 
information that would support a premarket submission that includes device software functions. 
Within the framework of the superseded guidance, electrosurgical devices intended for use in 
general surgery were considered a device with a Major Level of Concern. Based on the devices 
risk in the context of the devices intended use, as discussed in the final guidance Content of 
Premarket Submissions for Device Software Functions, electrosurgical devices intended for use 
in general surgery should generally address the recommendations for an Enhanced 
Documentation Level. The actual Documentation Level for your device may vary based on the 
specifics of your device. For more information about the Documentation Level and 
recommended documentation for a premarket submission, sponsors are encouraged to review the 
guidance Content of Premarket Submissions for Device Software Functions. 
 
 
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-
submissions-device-software-functions. Contains Nonbinding Recommendations 
Premarket Notification (510(k)) 
Submissions for Electrosurgical 
Devices for General Surgery 
Guidance for Industry and Food and 
Drug Administration Staff  
 
Document issued on March 9, 2020.  
 
Document originally issued on August 15, 2016. 
The draft of this document was issued on March 24, 2014. 
 
 
For questions about this document, contact OHT4: Office of Surgical and Infection Control 
Devices/ DHT4A: Division of General Surgery Devices, 301-796-6970. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  
 
    1  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-0217. 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 include the document 
   
number 19029 and complete title of the guidance in the request.
    2  Contains Nonbinding Recommendations 
Table of Contents 
 
I.  Introduction ...................................................................................................................... 4 
II.  Scope ................................................................................................................................ 5 
III.  Device Description........................................................................................................... 6 
A.  Indications for Use ..................................................................................................... 6 
B.  Device Design ............................................................................................................ 6 
IV.  Predicate Comparison ...................................................................................................... 7 
V.  Software ........................................................................................................................... 9 
VI.  Biocompatibility ............................................................................................................ 10 
VII.  Sterility ........................................................................................................................... 11 
VIII. Reprocessing .................................................................................................................. 12 
IX.  Pyrogenicity ................................................................................................................... 12 
X.  Shelf Life ....................................................................................................................... 13 
XI.  Performance Data........................................................................................................... 14 
A.  ESU .......................................................................................................................... 14 
B.  Active Components/Accessories .............................................................................. 14 
C.  Neutral Electrodes .................................................................................................... 15 
D.  Miscellaneous Components/Accessories ................................................................. 15 
E.  System Testing ......................................................................................................... 15 
XII.  Electrical Safety and Electromagnetic Compatibility .................................................... 18 
XIII. Clinical Testing .............................................................................................................. 19 
XIV. Labeling ......................................................................................................................... 20 
A.  Instructions for Use (User Manual) .......................................................................... 21 
B.  Device Labels ........................................................................................................... 23 
C.  Package Labels ......................................................................................................... 23 
D.  Labeling for Specific Components ........................................................................... 23 
Appendix A.  Glossary of Terms ............................................................................................ 26 
    3  Contains Nonbinding Recommendations 
Premarket Notification (510(k)) 
Submissions for Electrosurgical 
Devices 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 electrosurgical devices intended for use in general surgery. These 
devices are designed to cut and/or remove tissue and control bleeding through the use of high-
frequency electrical current. For the purpose of this guidance, electrosurgical devices may also 
be called radiofrequency (RF) devices or high-frequency (HF) devices. 
For the current edition of the FDA-recognized standard(s) referenced in this document, see the 
FDA Recognized Consensus Standards Database.1 For more information regarding use of 
consensus standards in regulatory submissions, refer to the FDA guidance titled Appropriate 
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.2   
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 guidance means that something is suggested or 
recommended, but not required. 
                                                 
1 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  
2 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices. 
  4  Contains Nonbinding Recommendations 
II.  Scope 
The scope of this 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. 
Electrosurgical devices under this regulation are indicated for general tissue cutting and/or 
coagulation. 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, refer to FDAs Guidance for Industry: General/Specific Intended 
Use.3 
There are electrosurgical devices that have been classified under other medical panels (e.g., 21 
CFR part 872 for dental devices). This guidance is not applicable to devices classified under the 
following regulations: 
  Section 872.4920 Dental electrosurgical unit and accessories 
  Section 876.4300 Endoscopic electrosurgical unit and accessories 
  Section 882.4400 Radiofrequency lesion generator 
  Section 882.4725 Radiofrequency lesion probe 
  Section 884.4150 Bipolar endoscopic coagulator-cutter and accessories 
  Section 884.4160 Unipolar endoscopic coagulator-cutter and accessories 
  Section 886.4100 Radiofrequency electrosurgical cautery apparatus  
  Section 886.4115 Thermal cautery unit 
This guidance is applicable to electrosurgical devices that may have multiple uses or indications, 
if one of those indications includes tissue cutting and/or coagulation. In addition, some 
electrosurgical devices may include both open and minimally invasive uses; in those cases, this 
guidance document would apply. This guidance also applies to devices that may include an 
arthroscopic indication. In addition, please be aware that there is supplemental guidance for 
electrosurgical devices for other specific indications (e.g., RF vessel sealers). In such instances, 
the supplemental guidance may provide additional recommendations or supersede this guidance. 
We recommend that you search FDAs guidance database4 for any device specific supplemental 
guidance or contact the Division of General Surgery Devices for more information. 
For a new device that combines an electrosurgical device with another device(s) (e.g., 
mechanical massager or low level light source) into a single system, and is designed to operate 
simultaneously or in sequence to achieve a desired clinical effect in tissue, additional data are 
                                                 
3 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-
guidance-industry. 
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents.  
 
  5  Contains Nonbinding Recommendations 
usually necessary to demonstrate that the new device is substantially equivalent to the predicate 
devices working independently. We recommend that you contact the Agency through the Q-
submission process to obtain further guidance for data recommendations in such cases. For 
information on the Q-submission process, see FDAs guidance, Requests for Feedback and 
Meetings for Medical Device Submissions: The Q-Submission Program.5   
III.  Device Description 
We recommend that you identify your device by the applicable regulation number described in 
Section II and include the following information:  
  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 if the device is a prescription (including home use) 
or over-the-counter (OTC) device, and indicate this accordingly on the Indications for 
Use Statement page. 
  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 electrosurgical devices refer to the electrosurgical unit (ESU), 
active component/active accessory, neutral electrode, and miscellaneous 
components/accessories. If there are components/accessories that have received prior 
510(k) clearance or are exempted from the 510(k) requirement, you should provide the 
510(k) numbers or indicate their exemption status, respectively.   
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 
                                                 
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program.  
  6  Contains Nonbinding Recommendations 
  Active components/active accessories (generally comprised of one or more 
active electrode(s), active connector or cables, and active handle or hand 
piece) design, physical specifications, and patient contacting materials 
  Neutral electrodes (also commonly called dispersive electrodes, grounding 
pads, patient return electrodes, or passive/plate electrode) design, physical 
specifications, and patient contacting materials 
  Miscellaneous accessories such as foot pedal, irrigation pumps, suction or 
smoke evacuation, etc. 
2.  Submission for Specific Components/Accessories 
If your submission is requesting clearance for a specific component or accessory, but 
not the entire electrosurgical device, 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 and will only be labeled for 
use with your own legally marketed devices, you should provide performance testing 
(see Section XI, Performance Data) to demonstrate compatibility with your own 
legally marketed devices. Also, you should address the potential that this active 
electrode could be used with other manufacturers electrosurgical devices and identify 
the associated risk(s). In your risk assessment, you should 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.  Predicate Comparison 
For devices reviewed under the 510(k) process, manufacturers must compare their new device to 
a similar legally marketed predicate device to support its substantial equivalence (section 513(i) 
(21 U.S.C. 360c(i)) of the FD&C Act; 21 CFR 807.87(f)). This comparison should provide 
information to show how your device is similar to and different from the predicate. Side-by-side 
comparisons for each major component using a tabular format such as shown in Table 1, 
whenever possible, are desirable. See below for an example of how this information may be 
organized. For each identified difference, you should 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. 
  7  Contains Nonbinding Recommendations 
Table 1. Example Comparison Table 
Description  Your Device  Predicate Device 
Indications for Use     
Prescription or OTC     
ESU     
  Major functions (e.g., bipolar, 
monopolar, temperature sensors, 
impedance monitor, continuity 
monitor) 
  Performance specifications (e.g., 
output frequency, waveform, 
power output, voltage output, 
crest factor) 
  Physical specifications 
Active accessory     
  Monopolar or bipolar 
  Physical dimensions and design 
(e.g., size, length, connector 
type) 
  Rated voltage 
  Materials (electrode, insulation, 
coating, etc.) 
Neutral electrodes     
  Conductive or capacitive 
  Physical specifications 
  Materials 
Miscellaneous accessories     
  Functions 
  Performance specifications 
  Physical specifications 
  Materials 
 
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 
can also be used together for the intended use of cutting and coagulating tissue. 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. For more information on the appropriate use of multiple predicates, 
  8  Contains Nonbinding Recommendations 
see FDAs guidance The 510(k) Program: Evaluating Substantial Equivalence in Premarket 
Notifications [510(k)].6 
V.  Software 
Significance:  Software in electrosurgical generators ensures that appropriate energy is delivered 
to the patient. Adequate software performance testing provides assurance that the device is 
operating within safe parameters. 
Recommendation:  Refer to the FDA guidance, Guidance for the Content of Premarket 
Submissions for Software Contained in Medical Devices7 for a discussion of the software 
documentation that you should provide in your submission. The software guidance outlines the 
type of documentation to be provided based on the level of concern associated with the device. 
FDA generally considers the software for electrosurgical device generators that are intended for 
general surgery indications to present a major level of concern. If you believe that the software 
in your device presents a lower level of concern (e.g., moderate or minor) as defined in the 
software guidance, you should provide a scientific justification that supports your rationale of the 
level of concern based on the possible consequences of software failure. 
We recommend that you provide a full description of the software/firmware supporting the 
operation of the subject device following the software guidance, commensurate with the 
appropriate level of concern. This recommendation applies to original device/systems as well as 
to any software/firmware changes made to already-marketed devices. Changes to software must 
be re-validated and re-verified in accordance with Design Controls, 21 CFR 820.30(i), and 
documented in the Design History File (see 21 CFR 820.30(j)). Some software changes may 
warrant the submission of a new 510(k). In such cases, it is recommended that you consult the 
FDA guidance, Deciding When to Submit a 510(k) for a Software Change to an Existing 
Device.8  
As appropriate, you should also provide information on the cybersecurity aspects of your device, 
including, but not limited to, the following facets of information security with respect to 
communications features of your device and associated software:  confidentiality, integrity, 
availability and accountability.   
Confidentiality assures that no unauthorized users have access to the information. 
Integrity is the assurance that the information is correctthat is, it has not been improperly 
modified. 
                                                 
6 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-
equivalence-premarket-notifications-510k.  
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-
submissions-software-contained-medical-devices.  
8 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
software-change-existing-device.  
 
  9  Contains Nonbinding Recommendations 
Availability suggests that the information will be available when needed. 
Accountability is the application of identification and authentication to assure that the 
prescribed access process is being done by an authorized user. 
The FDA guidance, Content of Premarket Submissions for Management of Cybersecurity in 
Medical Devices,9 provides additional information regarding cybersecurity and medical 
devices. 
If the device includes off-the-shelf software, you should provide the additional information as 
recommended in the FDA guidance titled Off-The-Shelf Software Use in Medical Devices10 
and Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) 
Software.11   
Overall, the documentation related to the software contained in the medical device should 
provide sufficient evidence to describe the role of the software included in the device, and 
performance testing to demonstrate that the software functions as designed. 
VI.  Biocompatibility 
Significance:  Electrosurgical devices contain patient-contacting materials that, when used as 
intended, i.e., given the contact type and duration, may induce a harmful biological response. 
Recommendation:  You should determine the biocompatibility of all patient-contacting materials 
present in your device. For polymeric materials, you should identify each material by trade name 
and manufacturer. If your materials are identical in composition and processing methods to 
materials used in a predicate device or another device with the same contact type and duration 
(e.g., tissue contacting, less than 24 hours) for electrosurgical applications, you may reference 
previous testing experience in lieu of new testing. 
We recommend that you follow the FDA guidance, Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk 
management process,12 which identifies the types of biocompatibility assessments that should 
be considered and recommendations regarding how to conduct related tests. 
Differences in formulation, processing, sterilization, or device surface properties that could affect 
biocompatibility of the final product may warrant additional biocompatibility testing. 
                                                 
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-
management-cybersecurity-medical-devices-0.  
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-medical-devices.  
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-healthcare-
organizations-about-fdas-guidance-industry-cybersecurity-networked-medical.  
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and.  
  10  Contains Nonbinding Recommendations 
Most active electrodes should be considered external devices that contact tissue/bone/dentin for a 
limited contact duration (less than 24 hours). As a result, we recommend evaluation for: 
  Cytotoxicity (see ISO 10993-5, Biological evaluation of medical devices  Part 5: Tests 
for in vitro cytotoxicity); 
  Intracutaneous reactivity (see ISO 10993-10, Biological evaluation of medical devices  
Part 10: Tests for irritation and skin sensitization);  
  Delayed type sensitivity (see ISO 10993-10, Biological evaluation of medical devices  
Part 10: Tests for irritation and skin sensitization); and 
  Consideration of acute systemic toxicity testing, either by inclusion of the testing or a 
rationale for its omission (see ISO 10993-11, Biological evaluation of medical devices  
Part 11: Tests for systemic toxicity). 
Most neutral electrodes should be considered surface devices that contact only intact skin for a 
limited contact duration (less than 24 hours). As a result, we recommend evaluation for: 
  Cytotoxicity (see ISO 10993-5, Biological evaluation of medical devices  Part 5: Tests 
for in vitro cytotoxicity); 
  Dermal irritation (see ISO 10993-10, Biological evaluation of medical devices  Part 10: 
Tests for irritation and skin sensitization); and 
  Delayed type sensitivity (see ISO 10993-10, Biological evaluation of medical devices  
Part 10: Tests for irritation and skin sensitization). 
For biocompatibility testing conducted using extraction samples, we recommend that you: 
  Determine the appropriate amount of test material as outlined in ISO 10993-12, 
Biological evaluation of medical devices  Part 12: Sample preparation and reference 
materials, or an equivalent method, using surface area to extractant volume ratios (mass 
to extractant volume ratios should only be used if surface area cannot be calculated); 
  Use both polar and nonpolar extractants;  
  Describe the condition of the extraction vehicle (e.g., color, presence of any particles);  
  Explain any changes in the post-extraction vehicle (compared to pre-extraction); and 
  Describe the details of storage conditions, if applicable.  
VII. Sterility 
Significance:  Electrosurgical devices for general surgery indications come in contact with blood 
and body tissue and should be adequately sterilized to minimize infections and related 
complications. 
  11  Contains Nonbinding Recommendations 
Recommendation:  For electrosurgical devices labeled as sterile, we recommend that you provide 
sterility information for the finished device. For information on sterility information in 510(k) 
submissions for devices labeled as sterile, see the FDA guidance, Submission and Review of 
Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as 
Sterile.13 You should sterilize the device to a sterility assurance level (SAL) of 1x10-6. Please 
note that your sterilization process must be validated in accordance with the Quality System 
Regulation (21 CFR part 820). 
VIII.  Reprocessing 
Significance: The patient contacting components of electrosurgical devices that are reused 
should be adequately cleaned, disinfected, and sterilized between uses to minimize infections and 
prevent device degradation. 
Recommendation: Under FDA labeling regulations (21 CFR part 801), a device must have 
adequate directions for use, which include instructions on preparing a device for use. Instructions 
on how to reprocess a reusable device or a single-use device that is provided non-sterile to the 
user are critical to ensure that a device is appropriately prepared for its initial and/or subsequent 
uses. For information on the development and validation of reprocessing instructions in your 
proposed device labeling, see FDAs guidance, Reprocessing Medical Devices in Health Care 
Settings: Validation Methods and Labeling.14 
IX.  Pyrogenicity 
Significance:  Pyrogenicity testing is used to help protect patients from the risk of febrile 
reaction due to gram-negative bacterial endotoxins and/or chemicals that can leach from a 
medical device (e.g., material-mediated pyrogens). 
Recommendation:  To address the risks associated with the presence of bacterial endotoxins, 
electrosurgical devices labeled as non-pyrogenic should follow the recommendation in Section 
VII, Sterility. Recommended pyrogen limit specifications have been identified in FDAs 
guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) 
Submissions for Devices Labeled as Sterile.15 
To address the risks associated with material-mediated endotoxins, it is recommended that you 
follow the recommendations in the FDA guidance, Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices  Part 1: Evaluation and testing within a risk 
management process.16 
                                                 
13 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled.  
14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-
health-care-settings-validation-methods-and-labeling.  
15 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled.  
16 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
  12  Contains Nonbinding Recommendations 
For devices intended to be labeled as non-pyrogenic, we recommend that both the bacterial 
endotoxin and rabbit material-mediated pyrogen testing be conducted. 
X.  Shelf Life 
Significance:  Shelf life testing is conducted to support the proposed expiration date through 
evaluation of the package integrity for maintaining device sterility and/or evaluation of any 
changes to device performance or functionality. 
Recommendation:  With respect to package integrity for maintaining device sterility, you should 
provide a description of the packaging, including how it will maintain the devices sterility, a 
description of the package integrity test methods, and a summary of the package integrity test 
results. FDA recommends that package integrity test methods include simulated distribution and 
associated package integrity, as well as simulated (and/or real-time) aging and associated seal 
strength testing, to validate package integrity and shelf life claims. We recommend you follow 
the methods described in the FDA-recognized series of consensus standards AAMI/ANSI/ISO 
11607-1: Packaging for terminally sterilized medical devices  Part 1: Requirements for 
materials, sterile barrier systems and packaging systems and AAMI/ANSI/ISO 11607-2: 
Packaging for terminally sterilized medical devices  Part 2: Validation requirements for 
forming, sealing and assembly processes. 
With respect to evaluating the effects of aging on device performance or functionality, shelf life 
studies should evaluate the critical physical and mechanical properties of the device that are 
necessary to ensure it will perform adequately and consistently during the entire proposed shelf 
life. To evaluate device functionality, we recommend that you assess each of the bench tests 
described in Section XI, Performance Data, and repeat all tests that evaluate design components 
or characteristics that are potentially affected by aging. For example, aging can affect the 
performance of most polymeric materials used; therefore, tests that evaluate the integrity and 
performance of the insulation should be repeated after aging. For those bench tests that you do 
not repeat, you should provide a rationale explaining why the performance characteristics 
assessed by the tests are not expected to be affected by aging. 
We recommend that you provide a summary of the test methods used for your shelf life testing, 
results and the conclusions drawn from your results. If you use devices subject to accelerated 
aging for shelf life testing, we recommend that you specify the way in which the device was aged 
and provide a rationale to explain how the results of shelf life testing based on accelerated aging 
are representative of the results if the device were aged in real time. We recommend that you age 
your devices as per the currently FDA-recognized version of ASTM F1980: Standard Guide for 
Accelerated Aging of Sterile Barrier Systems for Medical Devices and specify the environmental 
parameters established to attain the expiration date. For devices or components containing 
polymeric materials, you should conduct testing on real-time aged samples to confirm the results 
of the accelerated aging study. This testing should be conducted in parallel with 510(k) review 
and clearance, with results documented to file in the design history file (i.e., the test reports do 
not need to be submitted to FDA). 
  13  Contains Nonbinding Recommendations 
XI.  Performance Data 
We recommend that nonclinical testing be performed to demonstrate that each individual 
component of the device, as well as the electrosurgical device 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 electrosurgical device but not the entire 
electrosurgical device (e.g., electrosurgical generator 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. Depending on the substantial equivalence comparison to the 
predicate(s) above, nonclinical testing may be accomplished with bench testing alone, or an in 
vivo or ex vivo animal model may be necessary.17 The following are recommended nonclinical 
tests for each major component and for the system. 
  ESU 
For each mode, 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. 
For each mode, you should provide a graph displaying the power output at maximum and 
half-of-maximum intensity over the range of expected loads (e.g., 100  to 2000  for 
monopolar). 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). 
  Active Components/Accessories 
Mechanical testing of electrosurgical instruments 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 
articulating 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. Testing of the cutting performance of any instrument that 
includes a mechanical cutting function should also be performed, where applicable. For 
                                                 
17 FDA supports the principles of the 3Rs, to reduce, refine, and replace animal use in testing when feasible. We 
encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, 
adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency 
to an animal test method. 
  14  Contains Nonbinding Recommendations 
reusable instruments, this testing should be conducted after the maximum number of 
simulated use and reprocessing cycles.   
  Neutral Electrodes 
Neutral electrode thermal performance, contact impedance, and adhesion testing should 
be performed in accordance with the currently FDA-recognized version of IEC 60601-2-
2, Medical electrical equipment  Part 2-2: Particular requirements for the basic safety 
and essential performance of high frequency surgical equipment and high frequency 
surgical accessories. If alternative test methods and test procedures are developed, a 
detailed description of the testing and test results should be provided. In addition, you 
should provide a discussion regarding why the testing and test results are comparable to 
the currently FDA-recognized version of the IEC 60601-2-2 standard.  
For reusable neutral electrodes, the above testing should be performed following 
simulated reuse and reprocessing cycles according to the instructions for use. 
  Miscellaneous Components/Accessories 
When your electrosurgical device also includes accessories such as a foot pedal, 
irrigation pump, suction device, or smoke evacuation device, you should provide test 
results to show that each of those accessories meets all of the design and performance 
specifications.  
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.   
  System Testing 
In addition to the component testing, testing of the electrosurgical device with all the 
components and accessories working together as a system may be necessary. The 
following are examples of system testing that may be needed for electrosurgical devices:  
1.  Thermal Effects on Tissue 
For each mode and each representative active component or electrode, you should 
provide a measurement (under magnification) of the size (length, width, and depth) of 
the thermal damage zone, i.e., coagulation necrosis. This testing may be performed on 
ex vivo animal tissue.  
To support a specific soft tissue indications for use, testing should be performed in 
tissues relevant to the specific indications for use. The target and surrounding tissues 
should be used to provide the most clinically applicable thermal data. In some cases, 
other tissue type(s) with comparable thermo-physiological properties may be 
considered for testing if accompanied by a scientific justification. 
  15  Contains Nonbinding Recommendations 
To support a general soft tissue indication, testing should include at least three tissue 
types. FDA recommends testing liver, kidney, and muscle tissue to cover a range of 
tissue densities, but other tissue types may be appropriate based on the proposed 
indicated treatment location. We recommend measuring thermal damage under 
magnification using histology; however, if another method is used, a rationale for that 
measurement method should be provided. 
If active components or electrodes are grouped into a device family for test purposes, 
you should provide the rationale for identifying a family representative or otherwise 
pooling data from multiple active components in the test protocol. At a minimum, 
each test should be performed in triplicate at the minimum, default, and maximum 
power settings. We recommend providing the results in a chart and/or graph that 
indicates the width and depth of thermally damaged zone in relation to the power 
setting, and duration of activation for different tissue types.  
Thermal damage is a function of spatial temperature distribution over time (i.e., 
temperature-time history), which involves heating as well as cooling. Therefore, 
testing should be performed such that the tissue is exposed to relevant (best-case, 
realistic-case, and worst-case) temperature-time history as expected in vivo. The 
tissue should be maintained at the baseline temperature relevant for the indications for 
use (e.g., core body temperature for internal tissues) prior to application of the active 
component or electrode. After application of the device, the tissue should be allowed 
to cool back down to baseline temperature as it would under clinical conditions of use 
in order for the energy to flow and the thermal damage to develop.  
The tissue under test should be such that the flow of energy and thus, the 
development of thermal damage, is not impeded by the boundary conditions. For 
example, during testing in ex vivo tissue, if the tissue sample is too small or too thin, 
then the tissue would not be large enough for the thermal damage to fully develop. 
Also, during ex vivo tissue testing if the tissue is kept at baseline temperature using a 
water bath, but the flow rate in the water bath is set too high, the flow may impede the 
development of thermal damage by removing the energy reaching the tissue 
boundaries faster than what is typically permissible physiologically.   
We recommend providing graphs of temperature versus time at relevant locations in 
the tissue of interest to show that the thermal damage was produced in response to the 
temperature-time history relevant for the clinical conditions of use. The temperature-
time history should be measured using temperature probes that are calibrated and that 
have appropriate response time to be able to accurately measure the temperatures. 
Data and/or justification should be provided regarding the appropriateness of the 
temperature probes in measuring temperatures with sufficient spatial and temporal 
resolution. 
Thermal damage should be assessed using histological stains, such as Hematoxylin-
Eosin (H&E), lactate dehydrogenase (LDH), or triphenyl tetrazolium chloride (TTC). 
Your choice of stain should be appropriate to fully assess the extent (depth, thickness, 
width, and volume) of the adversely affected tissue region. You should provide data 
  16  Contains Nonbinding Recommendations 
and/or a scientific justification to show that your choice of stain(s) enables you to 
accurately quantify the full extent of the adversely affected tissue region.  
Note that for specific tissue and/or anatomic location type indications (e.g., lung, 
colorectal tissue, skin, mucosa, neural tissue), additional testing may be necessary in a 
chronic animal study. If you believe a chronic animal study is necessary, we highly 
recommend that you contact the Agency through the Q-Submission process to obtain 
early feedback on your study design considerations (see FDA guidance, Requests for 
Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program).18 
2.  Temperature Monitoring 
For electrosurgical devices that include temperature sensing, you should provide 
testing to demonstrate that this feature works as intended. Although the methods will 
vary based on the device design, your testing should demonstrate that the temperature 
sensing under simulated conditions meets your design specification and performance 
requirements. 
3.  Contact Quality Monitoring (CQM) and/or Continuity Monitoring 
For electrosurgical generators and neutral electrodes with contact quality and/or 
continuity monitoring capabilities, you should provide testing to demonstrate that 
these features work as intended. Although the methods will vary based on the 
monitoring design, your testing should provide data on conditions where the 
monitoring is effective in order to write adequate instructions for use.  
4.  Capacitive Coupling 
If the proposed device design includes monopolar electrosurgical electrodes for use in 
minimally invasive surgery, we recommend you test for active coupling resistance 
between the subject device and a conductive cannula/trocar device under simulated 
normal use conditions. This testing should be performed as recommended by the 
currently FDA-recognized versions of IEC 60601-2-18, Medical electrical equipment 
 Part 2-18: Particular requirements for the basic safety and essential performance 
of endoscopic equipment and IEC 60601-2-2. For electrosurgical electrodes and 
accessories, we also recommend you address the risks of leakage currents through 
insulation as well as capacitive coupling with other surgical equipment (e.g., pulse 
oximeter probes, invasive blood pressure transducers, temperature probes camera 
systems) as a part of your risk management process (e.g., cross-coupling between 
different HF patient circuits). 
You should provide complete test reports for each test conducted. For information on 
recommended content and format of test reports for non-clinical bench performance testing in 
                                                 
18 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program.  
 
  17  Contains Nonbinding Recommendations 
premarket submissions, refer to FDAs guidance, Recommended Content and Format of Non-
Clinical Bench Performance Testing Information in Premarket Submissions.19  
FDA recommends that complete test reports be provided for all tests performed because the IEC 
60601-2-2 and IEC 60601-2-18 series of standards include general methods with multiple 
options, and in some cases they do not include acceptance criteria or address assessment of 
results. Therefore, when a declaration of conformity (DOC) is submitted with respect to IEC 
60601-2-2 and IEC 60601-2-18, a copy of the supplemental information used to support the 
declaration (e.g., a copy of the study test report) should be provided. For additional information 
regarding the use of consensus standards and a DOC, refer to the FDA guidance, Appropriate 
Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.20 
You should also provide an explanation of how the data generated from the test support 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). 
XII. Electrical Safety and Electromagnetic Compatibility 
Significance:  Electrical safety is the ability of a device to operate properly in its intended use 
environment without operating unexpectedly due to electrical fluctuations from either battery or 
mains power. Electromagnetic compatibility (EMC) is the ability of a device to operate properly 
in its intended use environment without operating unexpectedly due to electromagnetic 
disturbances or introducing excessive electromagnetic disturbance into that environment. 
Recommendation:  All electrosurgical devices should undergo basic electrical, thermal, and 
EMC testing to evaluate the potential for insufficient electrical safety and EMC. We recommend 
that you conduct your testing and comply with the labeling provisions outlined in the currently 
FDA-recognized versions of the 60601 series of standards listed below. Given the potential 
variability in the test setup due to different designs and multiple components, you should submit 
the complete test reports for your device in reference to these standards. 
  AAMI/ANSI ES60601-1, Medical electrical equipment  Part 1: General requirements 
for basic safety and essential performance 
                                                 
19 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket. 
20 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices.  
  18  Contains Nonbinding Recommendations 
  IEC 60601-1-2, Medical electrical equipment  Part 1-2: General requirements for basic 
safety and essential performance  Collateral Standard: Electromagnetic disturbances  
Requirements and tests 
  IEC 60601-2-2, Medical electrical equipment  Part 2-2: Particular requirements for the 
basic safety and essential performance of high frequency surgical equipment and high 
frequency surgical accessories 
Additionally, endoscopic/laparoscopic electrosurgical instruments should demonstrate 
compliance with IEC 60601-2-18, Medical electrical equipment  Part 2-18: Particular 
requirements for the basic safety and essential performance of endoscopic equipment.
 
For additional information on providing EMC information in a premarket review, please see the 
FDA guidance, Information to Support a Claim of Electromagnetic Compatibility (EMC) of 
Electrically-Powered Medical Devices.21 
In addressing EMC, please be aware that according to IEC 60601-2-2, high frequency surgical 
instruments are intentional emitters of electromagnetic energy and, therefore, emissions testing 
to IEC 60601-1-2 is only needed for power generators in the idle state (i.e., powered on but 
surgical energy not activated). However, even during idle testing, particular attention should be 
paid to the effects of connected accessories and instruments, such as cord length (for resonant 
frequency) and instruments that contain electronics. For instruments with different cord lengths, 
connection types, or electronic components, it may not be appropriate to use a single 
representative instrument model for testing purposes. 
If your submission is for a specific component of the electrosurgical device, you are still 
expected to evaluate your component while connected to other components of the electrosurgical 
device system. This should be performed consistent with how you intend or expect your 
component to be used and the intended environment of use. 
If your electrosurgical device incorporates wireless technology including RFID (radio frequency 
identification) technology, meeting the IEC 60601 standards is insufficient to demonstrate that 
your device will not be susceptible to electromagnetic interferences and that your wireless 
technology will perform reliably. Review FDAs guidance, Radio Frequency Wireless 
Technology in Medical Devices,22 for a discussion on risks associated with wireless technology 
and suggestions regarding how to address these risks. 
XIII.  Clinical Testing 
Clinical data are generally not necessary to support 510(k) submissions for electrosurgical 
devices that are intended for general surgery indications. However, if your device indications for 
use or device technology and/or mechanism of action is significantly different when compared to 
                                                 
21 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/information-support-claim-
electromagnetic-compatibility-emc-electrically-powered-medical-devices.  
22 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/radio-frequency-wireless-
technology-medical-devices-guidance-industry-and-fda-staff.  
  19  Contains Nonbinding Recommendations 
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. For example, many electrosurgical devices for aesthetic use have utilized clinical data to 
demonstrate that the devices are as safe and effective as the predicate. For additional information 
regarding this topic, refer to Section F of the FDA guidance document, The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications [510(k)].23  
If you believe that clinical data are necessary, or if you are uncertain, we highly recommend that 
you contact the Agency through the Q-Submission process to obtain early feedback on study 
design considerations (see the FDA guidance, Requests for Feedback and Meetings for Medical 
Device Submissions: The Q-Submission Program).24 
XIV.  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 
electrosurgical 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)). 
As stated above in Section XII, Electrical Safety and Electromagnetic Compatibility, we 
recommend that all electrosurgical device 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. 
Electrosurgical systems generally consist of several different interchangeable components used 
together to create the desired effect, including the ESU, active accessory, neutral electrodes, 
                                                 
23 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-
substantial-equivalence-premarket-notifications-510k.  
24 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program.  
  20  Contains Nonbinding Recommendations 
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 
appropriate, depending on the indications for use, the individual component, and how the 
components may be packaged (together or separately). If your submission is for a specific 
component, your labeling should describe compatibility recommendations and results from your 
risk assessment, as it relates to device compatibility. 
The list below is not intended to be exhaustive of all the labeling requirements under part 801.  
  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.  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, you should 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 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 ether or alcohol), as explosion may occur. 
c.  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.  
d.  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. 
e.  INSPECT 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. 
f.  The surface of the active electrode may remain hot enough to cause burns after 
the RF current is deactivated. 
  21  Contains Nonbinding Recommendations 
g.  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. 
h.  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. 
i.  If the device is argon enhanced, you should include warnings and 
recommendations regarding gas embolisms. 
j.  If the instrument is reusable, you should also include a warning that visual 
inspection alone may not be sufficient to ensure that the insulation is intact. 
k.  DO NOT activate the instrument when not in contact with target tissue, as this 
may cause injuries due to capacitive coupling with other surgical equipment. 
The following additional warnings should be included for monopolar instruments: 
l.  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.  
m. DO NOT USE with hybrid trocar systems, i.e., a combination of metal and plastic, 
when using monopolar active components. This may result in alternate site burns 
due to capacitive coupling. Use only all-metal or all-plastic trocar systems. 
n.  Prior to increasing the intensity, check the adherence of the neutral electrode and 
its connections. Apparent low output or failure of the device to function correctly 
at the normal operating settings may indicate faulty application of the neutral 
electrode or poor contact in its connections.  
o.  If the device uses a neutral electrode and does not have a CQM, you should 
include a warning that loss of safe contact between the neutral electrode and the 
patient will not result in an alarm.  
p.  If the device uses a neutral electrode and does have a CQM, you should include a 
warning that loss of safe contact between the neutral electrode and the patient will 
not result in an alarm unless a compatible monitoring neutral electrode is used. 
3.  Cautions 
We recommend including the following cautions in the instructions for use. Sample 
language is provided in italics. 
  22  Contains Nonbinding Recommendations 
a.  The intensity should be set as low as is necessary to achieve the desired effect. 
[unless there is a risk associated with low settings, e.g., argon coagulation] 
b.  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. 
4.  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. In 
particular, you should include advice concerning the compatibility between CQMs 
and neutral electrodes and direct the user to verify that the generators output voltage 
does not exceed the rated accessory voltage. 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). 
  Device Labels 
In your submission, we recommend that you provide illustrations to show how each 
component 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.  
  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.  
  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. 
  23  Contains Nonbinding Recommendations 
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 active 
electrodes with other components of the electrosurgical device. 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. 
c.  The limitations on generator output settings and duration of activation. 
d.  A statement referring users to the generator and neutral electrode user manuals for 
additional instructions. 
e.  If the instrument is monopolar, clearly communicate to the user that the hand 
piece is a monopolar device, and that a neutral electrode should be used with the 
generator to prevent burns/injury to the patient. 
f.  For ablation of tissue, the labeling should include a recommended ablation time 
per lesion size, a lesion size and shape range for which the device is effective, 
directions on how to perform multiple ablations on a single lesion including how 
you relocate the probe in a lesion, a time versus temperature versus lesion size 
created chart to inform users of the expected performance, and directions on how 
the user knows when an ablation is complete. 
3.  Neutral Electrodes 
For monopolar devices, your directions for use should include information on the 
compatibility of your neutral electrodes with other components of the electrosurgical 
device. We recommend including the following information: 
a.  The surface area and size. 
b.  Adequate instructions for the user to identify a compatible CQM or a warning that 
it is not compatible with CQMs. 
c.  The compatible generator model or adequate instructions and criteria for the user 
to identify an adequate generator. 
d.  The limitations of generator output settings and typical, tested, or demonstrated 
times.  
  24  Contains Nonbinding Recommendations 
e.  The appropriate patient population (e.g., size, weight). 
f.  Detailed instructions on how to apply the electrode to the patient, including 
recommendations for application site selection and preparation, warnings and 
precautions, and pre-application tests. 
4.  Components and Accessories 
Your directions for use should include information on the compatibility for each of 
your accessories with the electrosurgical device. For some accessories, such as 
suction/irrigation pumps and smoke evacuation devices, separate instructions for use 
should be considered. 
5.  Reusable Devices 
For any reusable components and accessories, you should provide adequate 
reprocessing instructions and information, as recommended in Section VIII.  
  25  Contains Nonbinding Recommendations 
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 (monopolar or bipolar). 
Active electrode  The conductive portion of the electrosurgical device that delivers high 
density electrical current to the patient at the surgical site. This may or may not be 
removable from the active handle. 
Argon beam coagulator  An electrosurgical device that combines the uses of argon gas with 
RF current to form a plasma at the surgical site to effect hemostasis in bleeding tissue. 
Besides argon gas, other gases (e.g., nitrogen) have been used. 
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. 
Contact quality monitor (CQM)  A component of a monopolar electrosurgical system that 
monitors the contact between the neutral electrode and the patient. The CQM produces an 
alarm if the contact becomes insufficient and the patient is at risk for burns. 
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. 
Electrosurgical system  A complete electrosurgical system includes the ESU, active 
accessories, neutral electrodes (if applicable), and miscellaneous accessories. 
  26  Contains Nonbinding Recommendations 
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). 
Hyfrecator  A type of monopolar electrosurgical device in which the current flows from a 
single active electrode at the surgical site and returns to earth (ground) through the patients 
own body capacitance. 
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. 
Monopolar  An electrosurgical technique in which the current flows from a single active 
electrode at the surgical site, through the patient, to a relatively distant neutral electrode. 
Neutral electrode  An electrode connected to the patient, in an anatomical location away from 
the surgical site, to provide a return path for the high-frequency current. The neutral 
electrode has a large area relative to the active electrode in order to provide a low current 
density. Also known as: patient plate, ground pad, return electrode, dispersive electrode, 
inactive electrode, passive electrode, indifferent electrode, etc. 
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. 
Vessel sealer  An electrosurgical device intended to seal isolated blood and lymphatic vessels 
for hemostasis, as an alternative to ties. Usually bipolar. 
 
  27