Contains Nonbinding Recommendations 
Coronary, Peripheral, and 
Neurovascular Guidewires  
Performance Tests and 
Recommended Labeling 
Guidance for Industry and 
Food and Drug Administration Staff 
Document issued on October 10, 2019. 
For questions about this document, contact: 
  OHT2:  Office of Cardiovascular Devices/DHT2C:  Division of Health Technology 2C 
at (301) 796-2520 
  OHT5:  Office of Neurological and Physical Medicine Devices/DHT5A:  Division of 
Health Technology 5A at (301) 796-2823 
This guidance supersedes Coronary and Cerebrovascular Guidewire 
Guidance issued January 1995. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health  Contains Nonbinding Recommendations 
Preface 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration 
to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 
20852. Identify all comments with the docket number FDA-2018-D-1775. 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 16007 and complete title of the guidance in the request .  Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction ....................................................................................................................... 1 
II.  Background ....................................................................................................................... 2 
III.  Scope ................................................................................................................................. 2 
IV.  Premarket Submission Recommendations ........................................................................ 2 
A.  Device Description ............................................................................................. 2 
B.  Predicate Comparison ......................................................................................... 3 
C.  Biocompatibility ................................................................................................. 4 
D.  Sterility ............................................................................................................... 5 
E.  Pyrogenicity ........................................................................................................ 5 
F.  Shelf Life and Packaging ................................................................................... 6 
G.  Non-Clinical Bench Testing ............................................................................... 7 
A.  Clinical Performance Testing ........................................................................... 13 
B.  Labeling ............................................................................................................ 14 
V.  Modifications .................................................................................................... 16  Contains Nonbinding Recommendations 
Coronary, Peripheral, and 
Neurovascular Guidewires -
Performance Tests and 
Recommended Labeling 
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 
This guidance document provides recommendations for premarket notification (510(k)) 
submissions for guidewires intended for use in the coronary vasculature, peripheral 
vasculature, and neurovasculature.  The recommendations reflect current review practices 
and are intended to promote consistency and facilitate efficient review of these submissions. 
For the purposes of this guidance, the coronary vasculature includes blood vessels within the 
heart, including the ostium of the left main coronary artery; the neurovasculature includes 
blood vessels within the cranium, typically considered the vasculature distal to the cervical 
segment of the internal carotid artery; the peripheral vasculature includes all other 
cardiovascular vasculature. This document is intended to assist industry in designing and 
executing appropriate performance testing to support a 510(k) submission and provides 
recommendations for content and labeling to include in the submission. 
For the current edition of the FDA-recognized standards referenced in this document, see the 
FDA Recognized Consensus Standards Database web site at https://www.accessdata.fda.gov/ 
scripts/cdrh/cfdocs/cfStandards/search.cfm. For more information regarding use of consensus 
standards in regulatory submissions, please refer to FDA guidance titled Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices.1
                                                
1 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-
consensus-standards-premarket-submissions-medical-devices 
1  Contains Nonbinding Recommendations 
FDA's 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. 
II.  Background 
Guidewires are used to facilitate the placement of therapeutic devices during percutaneous 
interventional procedures. In the context of this guidance, the guidewires being discussed are 
intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature. 
There have been many technological advancements since the initial regulation of these 
devices. Therefore, updated information and additional clarity is needed regarding FDAs 
recommendations for performance testing and labeling for a 510(k) submission for new or 
modified guidewires. 
This document supplements other FDA documents regarding the specific content 
requirements and recommendations of a 510(k) submission. You should also refer to 21 CFR 
807.87 and FDAs guidance, Format for Traditional and Abbreviated 510(k)s.2
III.  Scope 
The scope of this document is limited to guidewires indicated for use in the coronary 
vasculature, peripheral vasculature, and neurovasculature, regulated under 21 CFR 870.1330 
and with product codes listed in the table below. 
Product Code  Regulation Number  Name 
Wire, Guide, Catheter, Cardiovascular 
DQX  21 CFR 870.1330 
(Coronary and Peripheral) 
Guide, Wire, Catheter, 
MOF  21 CFR 870.1330 
Neurovasculature 
IV.  Premarket Submission Recommendations 
A. Device Description 
We recommend that you identify your device by the applicable regulation and product code 
described in Section III above and include the information described below. 
                                                
2 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-
abbreviated-510ks-guidance-industry-and-fda-staff
2 Contains Nonbinding Recommendations 
  Device components: FDA recommends that you identify and explain the function of 
all components and accessories, including packaging. You should include a clear 
description of the basic operation of the device and identify any unique features (e.g. 
steerable tip), when applicable. You should also identify all sizes, configurations and 
models included within the scope of the submission. If your device contains any 
joints (i.e., locations where adhesives, thermal fusion, or other joining methods are 
used for bonding components of the guidewire), we recommend that you identify the 
joint location and bonding method used. 
  Engineering drawing(s) of the device: FDA recommends that you provide 
engineering drawing(s) with all dimensions, tolerances, and components clearly 
labeled (e.g., tip configuration, tip performance, and dynamic material interactions 
(e.g., mechanism to control tip deflection)). In addition to the engineering drawing(s), 
a photograph of the device can also be provided. FDA recommends that you include 
this for each device, accessory, and/or component included within the scope of the 
submission. 
  Technological characteristics: FDA recommends that you describe the technical and 
performance specifications and include a brief description of the device design in the 
device description section of the submission. The specifications may include 
performance-related product measurement tolerances, operating limitations, and any 
other functional, physical, and environmental specifications of the device. We also 
recommend that you describe ranges and/or accuracy of the specifications. 
  Materials: FDA recommends that each material(s) be clearly identified along with its 
corresponding contact duration. We recommend identifying both the generic 
material(s) of construction and the unique material identifier(s). If your device 
includes coating(s), we recommend that you identify the coating name, chemical 
formulation, coating purpose, whether the coating is hydrophobic or hydrophilic, 
thickness, length, location and details of how the coating is applied to the guidewire 
substrate. For some device materials, it may be appropriate to provide a reference to 
either a recognized consensus standard, or to a Letter of Authorization (LOA) for a 
device Master File (MAF) for this information. 
B.  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 
(21 U.S.C. 360c(i); 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, 
whenever possible, are desirable. See below for an example of how this information may be 
organized. This table is not intended to represent an exhaustive list of comparative 
parameters; ensure you provide all relevant device descriptive characteristics, as outlined in 
Section IV.A. Device Description, above. 
3 Contains Nonbinding Recommendations 
Description  Subject Device  Predicate Device (Kxxxxxx) 
Indications for Use 
Intended Use 
Wire Diameter 
Device Length 
Tip Length 
Tip Type and Shape 
Tip Flexibility 
Wire Material 
Coating(s) Material, Length 
and Location 
Tip Material 
Accessories 
Packaging Configuration 
Sterilization Method 
Shelf Life 
As part of your comparison, we recommend that you clearly explain the intended clinical 
environment and intended use of your device. The indications for use statement should 
identify whether the device is intended to navigate into the coronary vasculature, peripheral 
vasculature, and/or neurovasculature. If your device contains any feature(s) that is unique to 
your device compared to the predicate, we recommend that you clearly describe the 
feature(s), the location(s), and the operational characteristics and provide an explanation as to 
why the differences do not raise different questions of safety and effectiveness. 
C. Biocompatibility 
Significance: Guidewires contain patient-contacting materials, which, when used as intended 
(i.e., limited direct contact with circulating blood), may induce a harmful biological response. 
Recommendation: You should determine the biocompatibility of all patient-contacting 
materials present in your device. If your device is identical in composition and processing 
methods to guidewires with a history of successful use, you may reference previous testing 
experience or the literature, if appropriate. For some device materials, it may be appropriate 
to provide a reference to either a recognized consensus standard, or to a LOA for a device 
MAF. 
If you are unable to identify a legally marketed predicate device with similar 
location/duration of contact and intended use that uses the same materials as used in your 
device, we recommend you conduct and provide a biocompatibility risk assessment. The 
assessment should explain the relationship between the identified biocompatibility risks, the 
information available to mitigate the identified risks, and identify any knowledge gaps that 
remain. You should then identify any biocompatibility testing or other evaluations that were 
conducted to mitigate any remaining risks. We recommend that you follow FDAs guidance 
Use of International Standard ISO-10993-1, Biological evaluation of medical devices - Part 
4 Contains Nonbinding Recommendations 
1: Evaluation and testing within a risk management process3 which identifies the types of 
biocompatibility assessments that should be considered and recommendations regarding how 
to conduct related tests. 
Per ISO 10993-1: Biological evaluation of medical devices  Part 1: Evaluation and testing 
within a risk management process and Attachment A of FDAs guidance on ISO-10993-1, 
guidewires are externally communicating devices with limited (<24 hour) duration direct 
contact with the circulating blood. Therefore, the following endpoints should be addressed in 
your biocompatibility evaluation: 
  cytotoxicity; 
  sensitization; 
  irritation/intracutaneous reactivity; 
  acute systemic toxicity; 
  material-mediated pyrogenicity; 
  complement activation (SC5b-9 pathway is recommended and C3a pathway 
optional); 
  in vivo thrombogenicity; and 
  direct and indirect hemolysis. 
The following additional considerations are recommended for guidewires. If novel materials 
are used, then genotoxicity testing may also be needed. Testing should be conducted with the 
largest surface area device model and worst-case exposure. Test samples should represent the 
final, sterilized device. 
D. Sterility 
Significance: Depending on the intended use, guidewires will contact blood and possibly 
cerebrospinal fluid and therefore should be adequately sterilized to minimize infections and 
related complications. 
Recommendation: For guidewires labeled as sterile, we recommend that you provide 
information for the final, sterilized device in accordance with FDAs guidance Submission 
and Review of Sterility Information in Premarket Notification (510(k)) Submissions for 
Devices Labeled as Sterile.4
E.  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). 
                                                
3 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and 
4 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled 
5 Contains Nonbinding Recommendations 
Recommendation: To address the risks associated with the presence of bacterial endotoxins, 
guidewires should meet pyrogen limit specifications by following the recommendations 
outlined in FDAs guidance Submission and Review of Sterility Information in Premarket 
Notification (510(k)) Submissions for Devices Labeled as Sterile.5 You should also follow 
the recommendations in Guidance for Industry Pyrogen and Endotoxins Testing: Questions 
and Answers.6 To address the risks associated with material-mediated endotoxins, follow 
the recommendations in FDAs guidance Use of International Standard ISO-10993, 
'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.7
For devices intended to be labeled as non-pyrogenic, we recommend that both the bacterial 
endotoxin and rabbit material-mediated pyrogen testing be conducted. 
F.  Shelf Life and Packaging 
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, and a description of the package integrity test methods, but not the package test data. 
We recommend that package integrity test methods include simulated distribution and 
associated package integrity testing, 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 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 device properties 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 IV.G. Non-Clinical 
Performance Testing and repeat all tests that evaluate design components or characteristics 
that are potentially 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 
                                                
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled 
6https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-pyrogen-and-
endotoxins-testing-questions-and-answers 
7 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-
10993-1-biological-evaluation-medical-devices-part-1-evaluation-and 
6 Contains Nonbinding Recommendations 
devices were aged. 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 used to attain 
the expiration date. For devices or components containing polymeric materials or coatings, 
you should conduct testing on real-time aged samples to confirm the results of the 
accelerated aging study(ies). This testing can be conducted in parallel with 510(k) review and 
clearance, with results documented to file in the design history file (i.e., complete test reports 
do not need to be submitted to FDA). 
G. Non-Clinical Bench Testing 
The purpose of the non-clinical bench testing is to ensure that the device performs as 
intended under the specified conditions of use and supports a demonstration of substantial 
equivalence to the predicate device. The non-clinical performance testing recommended for 
each devices intended use may vary based on its respective risk profile associated with the 
intended target vasculature. FDA recommends that you provide the information below to 
evaluate the material and performance characteristics of your final, sterilized device that 
represents the worst-case design for each performance test. Where appropriate, the 
performance of the proposed device should be compared to that of the predicate device.8 If a 
test listed in Section IV.G. Non-Clinical Performance Testing is excluded from your 
submission, we recommend that you provide a clinical and risk-based justification for its 
omission. 
For information on recommended content and format of test reports for the testing described 
in this section, refer to FDAs guidance, Recommended Content and Format Non-Clinical 
Bench Performance Testing Information in Premarket Submissions.9
1.  Pre-Conditioning 
Pre-conditioning can include a variety of test sample preparations and may depend on the test 
being conducted. Prior to conducting the non-clinical performance testing, we recommend 
that you prepare the device per the instructions for use. For certain device characteristics 
being evaluated (e.g., coating integrity, particulate generation), you should also subject the 
device to additional pre-conditioning (e.g., extended soaking in physiologically relevant 
solution at 37 C), and tracking through a simulated use model as discussed in Section 
IV.G.2. Simulated Use Model) to present worst-case clinical use. We recommend that you 
clinically justify pre-conditioning parameters used for each test, where applicable. 
                                                
8 See FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 
[510(k)] - Guidance for Industry and Food and Drug Administration Staff (https://www.fda.gov/regulatory-
information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-
notifications-510k), for more information on comparing to a primary predicate or reference device. 
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-
format-non-clinical-bench-performance-testing-information-premarket 
7 Contains Nonbinding Recommendations 
2.  Simulated Use Model 
The simulated use model may be used when pre-conditioning or when testing in simulated 
anatomy is recommended. Your anatomical model should be appropriately tortuous to 
represent a challenging vasculature for the patient population intended to be treated. When 
designing your anatomical model, you should consider lumen diameter, bend radii, bend 
reversals, number of bends, tracking length, and coefficient of friction of tracking materials 
(e.g., polyurethane, silicone, Teflon, glass latex, native vessel). We recommend that your 
anatomical model include all relevant pathway attributes to represent the human anatomy. 
Should a two-dimensional anatomical model be chosen rather than a three-dimensional 
model, all native pathway attributes should be maintained and represented within the model. 
Furthermore, the anatomical model should appropriately model the various anticipated 
curvatures and disease states, if applicable, the device will encounter from all proposed 
access sites. While there are currently no standardized models of the coronary vasculature, 
peripheral vasculature and/or neurovasculature, an example of a tracking fixture that FDA 
has previously accepted in premarket submissions is described in Figure X2.4 of ASTM 
F2394-07: Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent 
Mounted on Delivery System. 
When describing your simulated use model(s), we recommend that you identify the materials 
of construction of the model and include images and engineering diagrams with dimensions 
(e.g., lengths, tubing diameters, radii of bend). We also recommend that a clinical rationale 
supporting the selection of the anatomical model parameters include a review of available 
imaging data or literature regarding the anatomy of the intended population. In addition, for 
devices intended to be used in the neurovasculature, your simulated use model should be as 
tortuous as the relevant vasculature included in your instructions for use. Specifically, we 
recommend that you use a full three-dimensional anatomical model including the intended 
access site (e.g., femoral, radial) to the intended target location in the neurovasculature. To 
simulate a clinically challenging tortuosity, your full neurovascular anatomical model should 
include, at a minimum, the Internal Carotid Artery (ICA) siphon, two (2) 180-degree turns 
and two (2) 360-degree turns, at the distal portion of the anatomical model. Alternative 
neurovasculature anatomical models should be justified with respect to clinically challenging 
neurovasculature tortuosity based on the intended use of the device and/or specific 
performance test being evaluated. 
3.  Dimensional Verification 
Significance: Accurate device dimensions help the physician to select appropriate product 
sizes. They can also affect the functional behavior of the device. 
Recommendation: We recommend providing dimensional specifications and tolerances for 
the device as manufactured. The tolerances chosen should be based on risk and should have 
an appropriate clinically or scientifically relevant justification. We recommend using a 
calibrated tool to verify each dimension. At a minimum, the length and outer diameter should 
be measured and reported. If applicable, tip length, coating length, or other guidewire 
features should also be reported. 
8 Contains Nonbinding Recommendations 
4.  Visual Inspection 
Significance: Guidewire defects, including kinks, cracks, deformations or debris, can 
contribute to clinical complications, affecting the safety and performance of the device. 
Recommendation: We recommend testing to ensure that the devices are free of extraneous 
matter and surface defects due to processing that could cause trauma to the vessels during 
use. If the device is coated, the coating should appear uniform. We recommend examining 
the devices with a minimum 2.5X magnification. This test may be conducted independently 
or in conjunction with another performance test if performed prior to performance testing to 
represent the as-manufactured product. Please note that for coated devices, visual inspection 
alone at 2.5X magnification is likely insufficient to adequately evaluate the coating integrity 
and additional test considerations should be followed (see Section IV.G.10. Coating 
Integrity). 
5.  Simulated Use 
Significance: Use of the device in a simulated use model, in combination with other 
interventional devices, as appropriate, can provide more clinically relevant information about 
its performance than isolated bench top performance testing. 
Recommendation: We recommend that you use your device in combination with ancillary 
devices (e.g., introducer, guiding catheter) according to the instructions for use and track the 
device through the simulated use model multiple times. Please see Section IV.G.2 Simulated 
Use Model for recommendations in developing your anatomical model. You should report 
observations regarding compatibility with ancillary devices, appropriate preparation, and the 
maneuverability of the device through the simulated use model. You should also report the 
integrity of the device prior to, during (e.g., kinking, compromised push ability), and after 
use. This test may be conducted in conjunction with other tests when appropriately justified. 
6.  Tensile Strength 
Significance: Joint failure could lead to device failure and/or vessel damage. 
Recommendation: We recommend testing the strength of each unique joint to failure. If there 
are multiple joints composed of the same material and adhesion method, then the worst-case 
joint may be used to represent all joints. Prior to testing we recommend that the samples are 
prepared per the instructions for use and then pre-conditioned as needed to simulate worst-
case conditions and tracked through a simulated use model. Tensile strength testing should 
demonstrate that your device is capable of withstanding tensile forces greater than those 
expected in clinical use. When setting your acceptance criteria, we recommend that you 
consider testing the predicate device concurrently or determine the theoretical force based on 
clinical information. When the acceptance criteria are established, a clinical basis for their 
appropriateness should be included in your protocol. Because the strain rate used may affect 
the resulting data, and thus, the acceptability of the acceptance criteria and results, we also 
recommend that you report the strain rate used to test each sample and justify this rate. 
9 Contains Nonbinding Recommendations 
7.  Tip Pull 
Significance: Tip detachment may adversely impact clinical performance (e.g., result in distal 
embolization). 
Recommendation: For guidewires that contain one or more joints at the distal tip (e.g., spring 
or coil tips), we recommend evaluating the tensile force to separate the distal tip from the 
guidewire. Prior to testing, we recommend that the samples are prepared per the instructions 
for use and then pre-conditioned as needed to simulate worst-case conditions and tracked 
through a simulated use model. This test may be performed as part of the tensile strength 
assessment (see Section IV.G.6 Tensile Strength above), if applicable. 
8.  Torque Strength 
Significance: Inability to withstand torsional forces typical of clinical use (i.e., 
torqueing/rotating the device to navigate to the target vasculature) may lead to device failure 
and/or vessel damage. 
Recommendation: We recommend that you prepare the samples per the instructions for use, 
pre-condition as needed to simulate worst-case conditions and track each device through a 
simulated use model. We recommend the distal end of the device be constrained from 
movement and the proximal end of the guidewire be rotated until failure. We recommend 
that you report the number of rotations to failure and the failure mode for each device tested. 
9.  Torqueability 
Significance: An inability of the distal tip to respond to manipulations made at the proximal 
end may adversely impact clinical performance (e.g., whipping effects may cause vessel 
damage and/or inability to navigate vessels). 
Recommendation: We recommend that you prepare the samples per the instructions for use, 
pre-condition as needed to simulate worst-case conditions and track each device through a 
simulated use model. With the sample in the simulated use model and the distal end 
unconstrained, we recommend that you rotate the proximal end of the guidewire. You should 
report the rotational input to the resulting distal rotation at 90-degree intervals (with your 
applied rotation angle determined with reference to the device risk and intended use) and 
calculate a proximal-to-distal rotational ratio for each sample. 
10. Coating Integrity 
Significance: Coating separation (i.e., peeling, flaking, shedding delamination and/or 
sloughing off) or degradation may adversely impact clinical performance (e.g., result in 
inflammation at access site, pulmonary embolization, pulmonary infarct, myocardial 
embolization, myocardial infarct, embolic stroke, cerebral infarct, tissue necrosis, or death).10
                                                
10 See FDA Safety Communication on Lubricious Coating Separation from Intravascular Medical Devices, at 
http://wayback.archive-
it.org/7993/20170722215712/https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm473794.htm. 
10 Contains Nonbinding Recommendations 
Recommendation: Coating integrity testing should include an interpretation of the data 
collected (including a discussion of why any observed defects are acceptable given the 
intended use and potential risk associated with the intended use) before and after subjecting 
the device to simulated use testing in a representative tortuous model. We recommend 
assessing the device for any coating delamination or degradation during simulated use. You 
should provide representative images (using scanning electron microscopy and/or optical 
microscopy) of the coated surface pre- and post-simulated use testing. Images should be 
taken using 40X magnifications in order to detail any coating defect. Multiple 
magnifications (up to 500X) may be needed to properly visualize any observed defects. If 
your coating is clear, it may be beneficial to dye the coating prior to assessing the device 
surface in order to allow for proper visualization. It may be helpful to include baseline (i.e., 
before simulated use) reference samples for comparative purposes if the guidewire is dyed. 
We recommend that you conduct the coating integrity testing simultaneously with the 
particulate evaluation as described in Section IV.G.11. Particulate Evaluation to assess the 
origin, quantity, and size of particulates that may be removed from your device during 
simulated use. If your device contains coating defects, you should provide a scientific 
rationale explaining why the coating anomalies do not pose a safety risk. 
11. Particulate Evaluation 
Significance: Particulate generation during clinical use may result in serious adverse events 
including pulmonary embolism, pulmonary infarction, myocardial embolism, myocardial 
infarction, embolic stroke, tissue necrosis and death; therefore, guidewires intended to 
navigate the coronary vasculature or neurovasculature pose the greatest clinical risk and 
should be evaluated for particle generation along with coating integrity assessment in a 
representative simulated use model. If your device is intended to only navigate the peripheral 
vasculature and the coating integrity evaluation identified coating defects (e.g., along the 
length of the guidewire) that may raise additional clinical concerns, particulate evaluation 
may be needed to address potential safety concerns. 
Recommendation: To accurately account for particulates generated during the use of your 
device, the particles should be characterized after simulated use. We recommend that the 
number of particulates generated at each evaluation be quantified and characterized by size 
and count using a validated method (e.g., light obscuration, light refraction) under continuous 
flow conditions to simulate blood flow. Specifically, we recommend that the total number of 
particulates be reported in the following size ranges:  10m,  25m, and at the largest size 
for which validation yields  75% recovery. At a minimum, the largest size should be 
 50m. For particulates that are greater than 50 m, we recommend that you distinguish, by 
percentage, the amount that are  200 m,  500 m and  1000 m, if those measurement 
methods are available, as these larger sized particulates pose a greater embolic risk. 
Appropriate precautions should also be implemented to ensure that the particles are 
suspended during particle counting and sizing to minimize aggregation and other artifacts 
from the test system. For further guidance on particulate evaluation, please refer to Section 
VIII.A.13. of FDA Guidance for Industry and FDA Staff, Class II Special Controls 
Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) 
Catheters (https://www.fda.gov/regulatory-information/search-fda-guidance-
11 Contains Nonbinding Recommendations 
documents/class-ii-special-controls-guidance-document-certain-percutaneous-transluminal-
coronary-angioplasty). 
You should provide a clinical discussion explaining why the results of the particulate 
evaluation and the associated coating integrity assessments do not raise a safety concern. If 
the particulate evaluation raises safety concerns, then chemical characterization may be 
needed to identify the particulate source(s). 
12. Lubricityy 
Significance: Lubricious coatings may be incorporated to decrease frictional forces 
experienced when navigating the target vasculature, and the functionality and performance of 
these coatings should be demonstrated. 
Recommendation: We recommend that you characterize the drag force of the coating (e.g., 
pinch test) after the samples are prepared per the instructions for use and then pre-
conditioned as needed to simulate worst-case conditions. In addition to coating integrity 
testing (Section IV.G.10), you should consider assessing the coating durability by performing 
the lubricity test multiple times (i.e., a clinically relevant number of passes). The mechanism 
of lubrication (e.g., hydrodynamic) should be identified. Any observations (e.g. the changes 
in the drag forces with cycling, coating defects using high resolution imaging) and 
conclusions should be reported. 
13. Corrosion Resistance 
Significance: Guidewire corrosion can cause or contribute to premature device failure. In 
addition, corrosion byproducts may be toxic or cause other adverse biological and tissue 
responses. 
Recommendation: We recommend that any metallic component of the device be examined 
for signs of corrosion after an immersion test (e.g., exposure of the device to a series of saline 
baths at room temperature, boiling, and 37 C beyond the maximum expected clinical use 
duration). For more information regarding recommendations of methodology for this testing, 
please refer to the currently recognized version of ISO 10555-1: Intravascular catheters  
Sterile and single-use catheters  Part 1: General requirements, Annex A. Although this 
standard has been written for intravascular catheters, the method used to evaluate corrosion 
resistance is applicable to guidewires. 
14. Kink Resistance 
Significance: Guidewires may be subjected to bending forces during use, and an inability to 
withstand forces that are typical of clinical use could lead to device failure and/or vessel 
damage. 
Recommendation: Your device should demonstrate resistance to kinking (and other failure 
modes) when bent around anatomically relevant radii. The samples should be prepared per 
the instructions for use and then pre-conditioned as needed to simulate worst-case conditions. 
To evaluate the resistance to kinking, you should bend the guidewire around mandrels of 
12 Contains Nonbinding Recommendations 
decreasing radii until kink, plastic deformation, and/or fracture occurs or to the smallest bend 
radii expected during clinical use, whichever comes first. This evaluation should account for 
all joints. When reporting the results, you should identify the mandrel sizes tested, which 
mandrel caused device failure, the location of failure and the type of failure observed. 
15. Tip Flexibility 
Significance: Safe and successful navigation through tortuous vessels relies on the 
mechanical properties of the guidewire tip. Inappropriately designed guidewire tips may 
result in vessel perforation, dissection and/or other vessel damage. 
Recommendation: After the samples are prepared per the instructions for use and then pre-
conditioned as needed to simulate worst-case conditions, we recommend that you identify the 
force that induces buckling deformation when the device is held at 5, 10 and 20 mm from the 
distal tip. 
16. Radiopacity 
Significance: Insufficient radiopacity could impede safe and appropriate usage of the device 
as it will not be clearly visible during use. 
Recommendation: We recommend choosing a sample size up to 5 devices to ensure that the 
radiopaque markers or radiopaque portions of the device are visible using clinical imaging 
techniques. We recommend a qualitative or quantitative measure of radiopacity, wherein the 
guidewire is compared to a standard material or predicate device as a control via real-time or 
plain film x-ray. It is acceptable to use data acquired as part of animal studies, in vitro 
phantoms, or equivalent models.11 For additional information regarding recommendations of 
methodology for this testing, please refer to the currently recognized version of ASTM F640: 
Standard Test Method for Determining Radiopacity for Medical Use.We recommend 
 
including high-quality images of the guidewires and the control(s) in your submission. 
A. Clinical Performance Testing 
Significance: In some cases, pre-clinical evaluation does not fully characterize all clinical 
experience, outcomes, and risks. In such cases, we recommend that you conduct in vivo (i.e., 
clinical) studies to evaluate device safety and effectiveness for new and modified guidewires. 
Recommendation: Clinical evidence is generally unnecessary for most guidewires; however, 
such testing may be requested in situations such as the following: 
  indications for use in complex clinical scenarios (e.g., crossing chronic total 
occlusions (CTOs)) of the coronary and peripheral arteries; 
                                                
11 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. 
13 Contains Nonbinding Recommendations 
  cases where engineering and/or animal testing raise issues that warrant further 
evaluation with clinical evidence; 
  indications for use dissimilar from legally marketed devices of the same type; or 
  new technology, i.e., technology different from that used in legally marketed devices 
of the same type yet does not raise different questions of safety or effectiveness. 
We will consider alternatives to clinical testing (such as animal testing) when the proposed 
alternatives are supported by an adequate scientific rationale. If a clinical study is needed to 
demonstrate substantial equivalence, i.e., conducted prior to obtaining 510(k) clearance of 
the device, the study must be conducted under the Investigational Device Exemptions (IDE) 
regulation, 21 CFR Part 812. Generally, FDA believes guidewires addressed by this guidance 
document are significant risk devices subject to all requirements of 21 CFR 812. See the 
FDA Guidance titled, Significant Risk and Nonsignificant Risk Medical Device Studies.12
In addition to the requirements of Section 21 CFR 812, sponsors of such trials must comply 
with the regulations governing institutional review boards (21 CFR Part 56) and informed 
consent (21 CFR Part 50). 
In some cases, real-world data (RWD) may be used to support expansion of the indication 
for a device for which 510(k) clearance has already been obtained. Whether the collection of 
RWD for a legally-marketed device requires an IDE depends on the particular facts of the 
situation. Specifically, if a cleared device is being used in the normal course of medical 
practice, an IDE would likely not be required. For additional information regarding this topic, 
please refer to the FDA Guidance entitled Use of Real-World Evidence to Support 
Regulatory Decision-Making for Medical Devices.13
B.  Labeling 
The premarket notification must include proposed labeling in sufficient detail to satisfy the 
requirements of 21 CFR 807.87(e). Proposed labels and labeling, sufficient to describe 
guidewires, their intended use, and the directions for use must be provided. 
As a prescription device, guidewires are exempt from having adequate directions for lay use 
required under section 502(f)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act) 
(21 U.S.C.  352(f)(1))) as long as the conditions in 21 CFR 801.109 are met. For instance, 
labeling must include adequate information for the intended user 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)). 
For additional recommendations regarding coated devices, please see FDAs guidance 
Labeling Considerations for Intravascular Catheters, Wires, and Delivery Systems with 
                                                
12 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-
nonsignificant-risk-medical-device-studies 
13 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-
support-regulatory-decision-making-medical-devices 
14 Contains Nonbinding Recommendations 
Lubricious Coating14, which includes specific labeling recommendations for this subset of 
guidewires. The instructions for use or package insert should include the following 
information. The list below is not intended to be exhaustive of all the labeling requirements 
under part 801. 
1.  Device Description 
We recommend that you include a description of the guidewire identifying the important 
components and the functions of each such as the length, outer diameter along the length 
including transition zones, tip shape, coating location(s) and characteristics (e.g., 
hydrophobic or hydrophilic), if applicable. 
2.  Indications for Use Statement 
The indications for use statement described in the labeling should be supported by 
information in the 510(k) submission and clearly identify any specific regions of the 
vasculature. 
3.  Contraindications 
We recommend including contraindications to describe situations in which there are known 
hazards or risks, as applicable, in the instructions for use. If you believe there are no known 
contraindications, please state none known. 
4.  Warnings/Precautions 
We recommend including the following warnings/precautions, as applicable, in the 
instructions for use. Sample language is provided in italics. If you believe any of these 
warnings/precautions are not applicable to your device, please provide a justification for each 
omission. 
  A warning statement regarding the indications for which the device has been 
confirmed to perform as intended, such as the following: The safety and 
effectiveness of the device has not been established or is unknown in vascular regions 
other than those specifically indicated. For example, if a specific guidewire is only 
indicated for peripheral vascular use based on the information provided in the 510(k) 
submission, the device should include a warning that the safety and effectiveness of 
the device has not been established in the coronary vasculature or neurovasculature. 
  A warning against reuse or re-sterilization of the device, which could affect medical 
device materials and components, such as This device is intended for single use. Do 
not reuse or re-sterilize. 
  A warning statement about the unestablished safety and effectiveness of a 
reprocessed device intended for multiple uses. For example, The device is intended 
for single-patient use and should not be reprocessed or used after reprocessing. 
                                                
14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/intravascular-catheters-wires-
and-delivery-systems-lubricious-coatings-labeling-considerations 
15 Contains Nonbinding Recommendations 
  Guidewires should be used under fluoroscopic guidance. We recommend that you 
consider the inclusion of important precautions and/or warnings to ensure the safety 
of device use associated with fluoroscopy for both patients and clinical operators. 
5.  Potential Adverse Events 
We recommend that you include information on the potential adverse events that may result 
from use of your device. FDA acknowledges that the specific adverse events may depend on 
the specific design and intended use of the device. Such adverse event may include, but are 
not limited to: 
  Access site complications 
  Allergic reaction (to contrast, device or other) 
  Aneurysm 
  Angina or unstable angina 
  Bleeding/hemorrhage 
  Cardiac tamponade/pericardial effusion 
  Death 
  Embolization (plaque, thrombus, device, tissue, or other) 
  Infection 
  Myocardial infarction or ischemia 
  Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA) 
  Thrombosis/Thrombus 
  Vasospasm 
  Vessel trauma, perforation, dissection 
  X-Ray radiation exposure complications (e.g., alopecia, burns ranging in severity 
from skin reddening to ulcers, cataracts, and delayed neoplasia) 
6.  Directions for Use 
We recommend that you provide specific directions for use of the guidewire. If your device 
contains a coating(s), then the directions for use should clearly explain how to properly 
prepare the device prior to clinical use. 
V.  Modifications 
In accordance with 21 CFR 807.81(a)(3), a device modification that could significantly 
affect the safety or effectiveness of the device or represents a major change or modification 
in the intended use of the device requires a new 510(k). The changes or modifications listed 
below would likely require submission of a new 510(k). Note that this list is not exhaustive 
but provides examples of modifications that will generally require submission of a new 
510(k). For additional details, please see FDA guidance Deciding When to Submit a 510(k) 
for a Change to an Existing Device.15
Such changes or modifications include: 
                                                
15 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-
change-existing-device 
16 Contains Nonbinding Recommendations 
  Guidewire Material  A change in core guidewire material could significantly affect 
both safety and effectiveness of the device by altering the biocompatibility risk 
profile or device performance. 
  Coating(s) Location, Material, Amount, or Processing  A change in the coating 
composition, location, and the processes used to apply the coating could significantly 
affect both safety and effectiveness of the device by altering the biocompatibility risk 
profile and/or device performance. 
  Dimensions Not Previously Cleared  A change to a critical dimensional 
characteristic of the guidewire that is beyond the previously cleared range for your 
device could significantly affect both safety and effectiveness by significantly 
affecting the performance risk profile. 
  Tip Configuration  A change to the tip shape, material, or adhesion process could 
significantly affect both the safety and effectiveness of the device because of a 
change to the known risk of tip detachment and the ability of the guidewire to 
properly navigate the intended vasculature. 
  Additional Vasculature  A change in the target vasculature could significantly affect 
both safety and effectiveness due to new or altered risks associated with different 
clinical conditions than those previously addressed in prior submissions. 
FDA believes that the following changes or modifications would likely not require 
submission of a new 510(k): 
  minor changes to the device packaging (e.g., hard copy of the Instructions for Use is 
replaced by an electronically available copy); 
  an extension of shelf life implemented according to the test protocols previously 
reviewed under the cleared submission; or 
  a dimensional change within the existing specification tolerance or a critical 
dimensional characteristic that is within the range of the previously cleared device. 
17