Contains Nonbinding Recommendations
Peripheral Percutaneous Transluminal 
Angioplasty (PTA) and Specialty 
Catheters - Premarket Notification 
(510(k)) Submissions
Guidance for Industry and Food and 
Drug Administration Staff
Document issued on April 14, 2023.
The draft of this document was issued on January 13, 2020.
For questions regarding this document, contact the Plaque Modification Devices Team in OHT2: 
Office of Cardiovascular Devices/DHT2C: Division of Health Technology 2C at (301) 796-
6075.
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-2019-D-5422. 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 GUI00016018 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
I.  Introduction ..............................................................................................................................1
II.  Scope ........................................................................................................................................2
III.  Premarket Submission Recommendations ...............................................................................2
A.  Device Description...............................................................................................................2
B.  Predicate Comparison ..........................................................................................................3
C.  Biocompatibility ..................................................................................................................4
D.  Sterility .................................................................................................................................6
E.  Pyrogenicity .........................................................................................................................6
F.  Shelf-Life and Packaging .....................................................................................................7
G.  Non-Clinical Performance Testing ......................................................................................8
(1)  Standard Performance Testing for PTA and Specialty Catheters ................................8
(2)  Additional Tests for Catheters Intended for Infusion of Contrast Media or Other 
Fluids ..........................................................................................................................20
(3)  Additional Tests for Catheters Intended for In-Stent Restenosis (ISR) Use or for 
Stent Expansion following Stent Deployment ...........................................................21
(4)  Additional Tests for Scoring/Cutting Balloons ..........................................................21
H.  Animal Safety and Performance Testing ...........................................................................22
I.  Clinical Performance Testing ............................................................................................23
J.  Labeling .............................................................................................................................24
K.  Modifications .....................................................................................................................24 Contains Nonbinding Recommendations
Peripheral Percutaneous Transluminal 
Angioplasty (PTA) and Specialty 
Catheters  Premarket Notification 
(510(k)) Submissions
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, including bench testing and coating 
characterizations for 510(k) submissions for peripheral percutaneous transluminal angioplasty 
(PTA) balloon and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent 
restenosis (ISR), scoring/cutting balloons). These devices are catheter-based devices intended to 
treat lesions in the peripheral vasculature. This document provides anatomy-specific testing 
recommendations and expands on FDAs current thinking for testing of these devices. FDA is 
issuing this guidance to clarify FDAs premarket submission recommendations for PTA 
catheters and specialty catheters and to promote consistency across submissions.  
For the current edition of the FDA-recognized consensus standards referenced in this document, 
see the FDA Recognized Consensus Standards database 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 the 
FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket 
Submissions for Medical Devices.1
1https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-
standards-premarket-submissions-medical-devices
1 Contains Nonbinding Recommendations
This document supplements other FDA documents regarding the specific content requirements 
of premarket submissions.You should also refer to 21 CFR 807.87 and FDAs guidance, 
Format for Traditional and Abbreviated 510(k)s.2
In general, FDA's guidance documents 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. Scope 
Thescope of this document is limited to class II PTA balloon catheters regulated under 21 CFR 
870.1250 and class II specialty catheters regulated under 21 CFR 870.1210 and 21 CFR 
870.1250 with product codes listed in the table below. 
Table 1: Device Types within the Scope of This Guidance.
Regulation Number Product Code Device
870.1210 KRA Continuous Flush Catheter
870.1250 DQY Percutaneous Catheter
870.1250 LIT Peripheral Transluminal Angioplasty Catheter
870.1250 PNO Percutaneous Cutting/Scoring Catheter
In this guidance, PTA balloon catheters refer to standard peripheral angioplasty balloon 
catheters. Specialty catheters can include but are not limited to the following 510(k) devices: 
infusion catheters, balloon catheters with unique design characteristics (e.g., cutting/scoring), 
and balloon catheters intended for specific indications (e.g., ISR, post-dilatation of stents). Class 
III drug-coated balloons have additional risks and considerations and are not addressed in this 
guidance document. 
III. Premarket Submission Recommendations 
A.  Device Description 
We recommend you identify your device by the applicable regulation number and product code 
indicated in Section IIabove and include the information described below.
 Device components and mode of operation: FDA recommends that you identify all 
components and accessories included in the premarket submission, including packaging, 
with a clear description of how the device is utilized to achieve the intended use in the 
intended anatomy.
2https://www.fda.gov/regulatory-information/search-fda-guidance-documents/format-traditional-and-abbreviated-
510ks
2 Contains Nonbinding Recommendations
 Photograph and engineering drawing(s) of the device: FDA recommends that you 
provide a photograph, as well as an engineering drawing with relevant dimensions, 
tolerances, and components labeled, of the device. FDA recommends that you include 
this for each device, accessory, or component included in the premarket submission.
 Technological characteristics: FDA recommends that you describe the technical and 
performance specifications and include a brief description of the device design 
requirements in the device description section of the premarket 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 you provide a list of all components, their respective 
material(s) of composition, and their patient-contacting classification (e.g., non-
contacting, indirect-contacting, or direct-contacting). For each component, you should 
identify the generic material of construction and the unique material identifier (e.g., 
Chemical Abstract Services (CAS) number).
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 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 the Device Description section, above.
Table 2: Sample predicate comparison table to outline differences and similarities between 
the subject and predicate devices.
Description Subject Device Predicate Device (Kxxxxxx)
Intended Use
Indications for Use
Guidewire Compatibility
Sheath Compatibility 
Catheter length
Catheter Shaft Outer 
Diameter
Balloon Lengths (if 
applicable)
Balloon Diameters (if 
applicable)
Nominal Pressure (if 
applicable)
3 Contains Nonbinding Recommendations
Description Subject Device Predicate Device (Kxxxxxx)
Rated Burst Pressure (if 
applicable)
Component Materials (list 
individually)
Coating Material (if 
applicable)
Coating Length (if 
applicable)
Packaging Configuration 
Sterilization Method
C. Biocompatibility 
Significance: PTA balloon catheters and specialty catheters contain patient-contacting materials, 
which, when used for their intended purpose (i.e., 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. If your device is identical in composition, manufacturing, and processing 
methods to any PTA balloon catheters or specialty catheters with a history of safe use, you may 
reference previous testing experience or the literature, if appropriate. For some device materials, 
it may be appropriate to provide either a reference to an FDA-recognized consensus standard or a 
letter of authorization (LOA) for a device master file (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 and potential mitigation strategies as 
well as identify knowledge gaps that remain. You should then identify any biocompatibility 
testing or other evaluations that have been conducted to mitigate remaining risks.
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 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, PTA 
balloon catheters and specialty catheters are external-communicating devices in contact with 
circulating blood for a limited contact duration. Therefore, the following endpoints should be 
addressed in your biocompatibility evaluation, either through testing or scientific rationale for 
why additional testing is not needed:
3https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-
1-biological-evaluation-medical-devices-part-1-evaluation-and
4 Contains Nonbinding Recommendations
 cytotoxicity;
 sensitization;
 irritation or intracutaneous reactivity;
 acute systemic toxicity;
 material-mediated pyrogenicity;
 hemocompatibility;
o direct and indirect hemolysis;
o SC5b-9 complement activation; and
o thrombogenicity.
Please note that a genotoxicity assessment may be requested if PTA balloon catheters or 
specialty catheters contain novel patient-contacting materials that have not been previously 
evaluated for use in contact with circulating blood in legally marketed medical devices.
For biocompatibility testing, we recommend that your subject device test article be the final 
finished device, including exposure to all manufacturing processes, such as packaging and 
sterilization. If differences exist between the final subject device and the biocompatibility test 
article, additional information describing all differences and why they do not impact 
leveragability of the testing should be provided for each relevant biocompatibility endpoint as 
identified above. FDA recommends including only and all applicable patient contacting 
components in the test articles.
If an animal study is being conducted in order to evaluate the safety and/or performance of your 
device, you can consider evaluating your device for thrombogenicity in this study in lieu of a 
separate thrombogenicity study (e.g., the 4-hour non-anticoagulated venous implant (NAVI) 
model described in ISO 10993-4 Biological evaluation of medical devices  Part 4: Selection of 
tests for interactions with blood). If assessing thrombogenicity in a large animal study, you 
should consider incorporating relevant thrombogenicity-related attributes into your study design 
(e.g., clinically relevant anticoagulation regimen and activated clotting time (ACT), worst-case 
device dwell time, providing high-resolution images of the device post-removal from the animal 
to assess for thrombus, and downstream thromboembolism assessment). In addition, a dynamic 
in vitro flow loop or material-mediated thrombogenicity approach with surface assessment (e.g., 
SEM or optical imaging with a 40X magnification) may be appropriate for some device 
types/designs based on device geometry, materials, patient blood contact duration, and 
anticoagulation status. To determine the thrombogenicity test strategy for your specific device, 
FDA recommends discussing your approach with the Agency using the Q-Submission Program 
prior to test initiation. For details on the Q-Submission Program, please refer to the guidance 
5 Contains Nonbinding Recommendations
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 
Program.4
D. Sterility 
Significance: PTA balloon catheters and specialty catheters come in contact with blood and 
should be adequately sterilized to minimize infections and related complications.
Recommendation: For PTA balloon catheters and specialty catheters labeled as sterile, we 
recommend that you provide information for the finished device in accordance with the FDA 
guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) 
Submissions for Devices Labeled as Sterile.5
E. Pyrogenicity 
Significance: Pyrogenicity testing is used to assess 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, PTA 
balloon catheters and specialty catheters should meet pyrogen limit specifications by following 
the recommendations outlined in the FDAs guidance, Submission and Review of Sterility 
Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile6
(510(k) Sterility Guidance). You should also follow the recommendations in Guidance for 
Industry Pyrogen and Endotoxins Testing: Questions and Answers.7
To address the risks associated with material-mediated endotoxins, you should 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. 8
Devices in contact with the cardiovascular system should meet pyrogen limit specifications 
discussed in the 510(k) Sterility Guidance and should be labeled non-pyrogenic. For devices 
intended to be labeled as non-pyrogenic, we recommend that both bacterial endotoxin and 
material-mediated pyrogens be addressed.
4https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program
5https://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/submission-and-review-sterility-
information-premarket-notification-510k-submissions-devices-labeled
7https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-pyrogen-and-
endotoxins-testing-questions-and-answers
8https://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
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 the 
device performance to ensure adequate functionality.
Recommendation: With respect to package integrity for maintaining device sterility for PTA 
balloon catheters and specialty catheters, 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 data, including the test, acceptance criteria, 
results, and any deviations noted. The following conditioning and testing should be conducted:
Simulated Shipping and Climatic Conditioning: The full packaging configuration should be 
subjected to simulated shipping (per ASTM D4169: Standard Practice for Performance Testing 
of Shipping Containers and Systems) and climatic conditioning (per ASTM D4332: Standard 
Practice for Conditioning Containers, Packages, or Packaging Components for Testing) prior to 
packaging testing. 
Aging: 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 required to ensure it will perform adequately and consistently during the entire proposed 
shelf life. To evaluate device functionality after aging, we recommend that you assess each of the 
bench tests described in Section III.G and repeat all tests that evaluate design components or 
characteristics that may be affected by aging. A rationale should be provided for changes in the 
methods used for the aged testing as compared to the methods used for the baseline testing (e.g., 
smaller sample size, different device sizes assessed, omitted testing). 
For PTA balloon catheters and specialty catheters that are provided sterile and/or have a 
proposed expiration date, 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 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 (i.e., test 
temperature, humidity, cycle, ambient temperature) established to attain the expiration date. For 
devices or components containing polymeric materials, you should plan to conduct testing on 
real-time aged samples to confirm that the accelerated aging is reflective of real-time aging. This 
testing should be conducted in parallel with 510(k) review and clearance with results 
documented to file in the devices design history file in accordance with the provisions of 21 
CFR 820.30 (i.e., the test reports do not need to be submitted to FDA).
Packaging Testing: We recommend that you assess the packaging integrity and strength of both 
the materials and seal of the sterile barrier. The integrity of the packaging materials can be 
assessed using test methods such as the bubble leak test (per ASTM F2096: Standard Test 
Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)) and/or 
burst testing (per ASTM F2054/F2054M: Standard Test Method for Burst Testing of Flexible 
Package Seals Using Internal Air Pressurization Within Restraining Plates). The integrity of the 
7 Contains Nonbinding Recommendations
seals can also be assessed using numerous test methods, including a visual assessment (per 
ASTM F1886/F1886M: Standard Test Method for Determining Integrity of Seals for Flexible 
Packaging by Visual Inspection), the bubble leak test (per ASTM F2096: Standard Test Method 
for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)), and/or the 
dye penetration test (per ASTM F1929: Standard Test Method for Detecting Seal Leaks in 
Porous Medical Packaging by Dye Penetration). A seal strength assessment (per ASTM 
F88/F88M: Standard Test Method for Seal Strength of Flexible Barrier Materials) should also 
be conducted at baseline and after aging (accelerated with real-time confirmatory testing) in 
order to ensure that the seals will not be compromised due to any force exerted on the seal. 
G. Non-Clinical Performance Testing 
(1) Standard Performance Testing for PTA and Specialty 
Catheters 
Non-clinical performance testing is recommended for PTA and specialty catheters in order to 
fully characterize the device and also ensure that the devices can perform as intended under 
clinically-relevant conditions. The testing recommended below should be conducted on the 
finished product that was subjected to all manufacturing processes, including sterilization. 
Otherwise, a discussion of the differences between the test article and finished product should be 
discussed and justified. 
 
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 of Non-Clinical 
Bench Performance Testing Information in Premarket Submissions.9 As noted in this document, 
FDA recommends that you provide a scientific or statistical justification for the sample sizes 
used for each test.
Please note that the recommendations provided in ISO 10555-1: Intravascular Catheters  
Sterile and Single-Use Intravascular Catheters  Part 1: General Requirements and ISO 10555-
4: Sterile and Single-Use Intravascular Catheters  Part 4: Balloon Dilatation Catheters are 
directly applicable to PTA catheters and many specialty catheters. Therefore, the testing and 
methods recommended in these standards should be followed, or a rationale for deviating from 
these methods should be provided. However, these standards may not include all testing 
recommended by FDA or may not be specific enough regarding the methods or criteria for 
recommended testing. Therefore, the recommendations described below, which augment these 
consensus standards, should also be followed.
Before conducting the testing described below, FDA recommends that you precondition 
catheters by tracking through a tortuous path fixture (as described in Section III.G(1)bbelow). 
This is recommended for all testing, as clinically-relevant tracking, using physiological 
conditions, may impact testing outcomes. If preconditioning is not performed prior to a certain 
test, a scientific rationale should be provided indicating why the attribute would not be affected 
by this conditioning.
9https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-and-format-
non-clinical-bench-performance-testing-information-premarket
8 Contains Nonbinding Recommendations
a. Dimensional Verification 
Significance: Accurate device dimensions help the physician to select the proper product and 
accessory device sizes. They may also affect the operators ability to track the catheter to and 
across lesions.
Recommendation: We recommend that you provide dimensional specifications and tolerances as 
well as data to verify that these specifications are met for your device as manufactured. At a 
minimum, we recommend that you measure and report catheter effective length, shaft inner and 
outer diameter, and crossing profile. For balloon catheters, the balloon outer diameter and length 
should also be characterized, as described in ISO 10555-4.
The crossing profile, typically defined as the maximum diameter found between the proximal 
end of the balloon (if applicable) and the distal tip of the catheter, should be quantitatively 
measured. This can include the proximal balloon bond and, in some cases, other parts of the 
catheter for unique devices where the maximum outer diameter may not be related to a balloon. 
The measurement should address potential differences in crossing profile that may exist in the 
circumferential direction. For these situations, we recommend that you evaluate the crossing 
profile of your catheter along different longitudinal paths (e.g., rotating the test sample 90 for 
measurements). We recommend that you report the crossing profile in either the instructions for 
use, the outside package labeling, or both. Various methods can be utilized, such as contact and 
non-contact methods, as deemed appropriate. If pass/fail testing is employed, (e.g., go/no go 
gauges), a rationale should be provided to support the methods and the sizes of these aids, along 
with details regarding the methods.
The quantitative crossing profile data should be used to support the labeled introducer sheath 
compatibility. Since the size of commercially-available introducer sheaths vary, pass/fail 
introducer sheath compatibility testing alone is not sufficient to support a labeled sheath 
compatibility. If you are labeling your device with an introducer sheath compatibility that is 
smaller than your measured crossing profile, a scientific rationale should be provided. 
Shaft inner diameter measurement, or pass/fail guidewire compatibility testing, should be 
provided to support the labeled guide wire compatibility. 
b. Simulated Use 
Significance: The recommended instructions for use and techniques for preparation, insertion, 
tracking, deployment (if applicable), retraction, and removal, if properly followed, should safely 
and reliably deliver the catheter to the intended location without adversely affecting the device.
Recommendation: We recommend that you conduct testing to demonstrate that the catheter can 
be safely and reliably prepared, inserted, tracked, deployed (if applicable), retracted, and 
removed using the recommended techniques, accessory devices, and instructions for use, without 
damage to the device. We recommend that this simulated use testing be performed by tracking 
the device through an in vitro fixture that mimics typical in vivo physiologic conditions and 
appropriately challenging anatomic characteristics (e.g., a tortuous path in a 37 ?C aqueous 
9 Contains Nonbinding Recommendations
environment) to the length that would enter a patient in clinical use. The fluid used in the 
simulated use model should closely mimic the properties of human blood (e.g., water, saline) and 
should not include components to reduce frictional forces (e.g., lubricants, soap). The clinical 
basis and rationale for the model used should be provided. In general, FDA recommends a three-
dimensional model, including a clinically-relevant access site (e.g., appropriately challenging 
entry angle and entry path curves), with a sufficient number of curves. The length, diameters, 
number of curves, and radii of curvatures should be sufficient to appropriately challenge the 
device to simulate clinical use in anatomy for which the device is intended. An engineering 
drawing, with relevant dimensions labeled (e.g., lengths, diameters, angles), and images of the 
model should be provided.
We recommend that you conduct testing with accessory devices that would be used in a typical 
clinical procedure (e.g., introducer, guidewire) using worst-case sizes (e.g., smallest inner-
diameter introducer sheath per labeled compatibility). You should report any abnormality or 
difficulty observed during the simulated procedure as well as any damage observed to the 
catheter or any of the accessory devices.
For PTA catheters, it may be informative to measure and report the diameter and axial location 
of the largest deflated balloon profile, including the inner member or wire. This information may 
assist in determining the extreme dimensions of compatible accessory devices (i.e., minimum 
internal diameter). Determining the insertion/retraction forces may also be informative as this 
may assist in supporting the specifications used for device tensile testing.
It may be possible to combine the simulated use testing with coating integrity testing (see 
Section III.G(1)l) and/or particulate evaluation (see Section III.G(1)m), but you should take care 
to ensure that only minimal additional handling of the sample is required for the coating integrity 
evaluation such that particulates are neither lost nor generated. 
 
c. Balloon Rated Burst Pressure 
Significance: The rated burst pressure (RBP) is the pressure at which 99.9% of balloons can 
survive with 95% confidence. Failure of a balloon to maintain integrity at the RBP could result 
in device failure or vessel damage.
Recommendation: We recommend that you follow ISO 10555-4, Annex A, when conducting this 
testing. In addition to what is described in this standard, the following should be taken into 
consideration.
We recommend that you conduct testing on the longest length of every balloon diameter and the 
shortest length of both the smallest diameter and largest diameter. Table 3 illustrates the 
recommended test matrix.
10 Contains Nonbinding Recommendations
Table 3: Balloon Sizes Recommended for RBP Testing (Example).
Balloon Length (mm)
Balloon Diameter (mm)
40 60 80 100 120
4.0 X X
4.5 X
5.0 X
5.5 X
6.0 X X
We recommend that you test balloons that are not constrained by any test fixture, such as tubing, 
and that you inflate the balloons, at a rate similar to clinical use, until failure. We recommend 
that you record as test failures any loss of:
 integrity of the balloon, such as a rupture or leak; or
 pressure due to failure of the balloon, shaft, or seals.
We recommend that you record the pressure at which the device failed and the failure mode 
(e.g., longitudinal tear, circumferential tear, pinhole). A discussion and rationale should be 
provided for the failure mode observed. We also recommend that you calculate RBP as the 
pressure at which 99.9% of the balloons will survive with 95% confidence based on statistical 
analysis of the test data. The lower tolerance limit determined from this analysis should be 
reported and be used to support the RBP specified in the device labeling.
d. Balloon Fatigue (Repeat Balloon Inflations) 
Significance: Balloons on PTA catheters are often inflated multiple times during clinical use. 
Failure of the balloon to withstand multiple inflations could lead to device failure or vessel 
damage.
Recommendation: We recommend that you follow ISO 10555-4, Annex B, when conducting this 
testing, unless otherwise specified below. In addition to what is described in this standard, the 
following should be taken into consideration.
We recommend that you determine the repeatability, to 10 inflations, of successful balloon 
inflation to the RBP. We recommend that you test device sizes according to the four corners 
paradigm:
 largest diameter/longest length;
 largest diameter/shortest length;
 smallest diameter/longest length; and
 smallest diameter/shortest length.
11 Contains Nonbinding Recommendations
Table 4 illustrates the recommended test matrix.
Table 4: Example of Four Corners Test Matrix.
Balloon Length (mm)
Balloon Diameter (mm)
40 60 80 100 120
4.0 X X
4.5
5.0
5.5
6.0 X X
We recommend that you test balloons that are not constrained by any test fixture, such as tubing, 
and that you inflate the balloons incrementally until they reach the RBP. For each sample, we 
recommend that you hold the RBP for a typical clinical inflation time (e.g., 30 seconds), or the 
time specified in the instructions for use, deflate the balloon, and inflate it again to the RBP, for a 
total of 10 cycles. We recommend that you report loss of pressure, whether due to failure of the 
balloon, shaft, or proximal or distal seals, as a test failure. We recommend that you record all 
failure modes and that your results demonstrate that 90% of the balloons will survive the test 
with at least 95% confidence.
e. Balloon Compliance (Diameter vs. Pressure) 
Significance: The diameter of a deployed PTA balloon varies with inflation pressure. A 
compliance chart in the labeling that relates balloon diameter to balloon pressure guides proper 
selection of catheter size to fit the target vasculature site. Incorrect selection of catheter size may 
lead to device failure or vessel damage.
Recommendation: We recommend that you follow ISO 10555-4, Annex D, when conducting this 
testing. In addition to what is described in this standard, the following should be taken into 
consideration.
We recommend that you test balloon sizes, as illustrated previously in Table 3, and that you test 
multiple product lots. We recommend that you include data showing inflation pressure versus 
balloon diameter over the full range of recommended inflation diameters and report the results in 
either the instructions for use, the outside package labeling, or both. A graphical or tabular 
presentation (i.e., a compliance chart) should be included in the labeling. We recommend that 
you identify the nominal inflation pressure and RBP. The compliance chart can include pressures 
up to (but not exceeding) 25% above the RBP, if you provide data and statistics demonstrating 
that 99% of the balloons will not fail at the listed pressure with 95% confidence. We also 
recommend that you describe if and how you performed any data rounding and show all 
instances, if applicable. Compliance charts should not be normalized (i.e., modified in any way 
in order to ensure that the nominal diameter is exactly achieved at the labeled nominal pressure) 
or calculated based on limited testing. Table 5 shows an example of compliance chart for a 
balloon with 4.0 mm to 6.0 mm diameters, with a nominal pressure of 9 atm and varying RBPs. 
12 Contains Nonbinding Recommendations
Table 5: Balloon Compliance Chart Example.
Balloon Nominal Diameter (mm)
Pressure  (X = balloon diameter at the given pressure)
(atm)
4.0 4.5 5.0 5.5 6.0
9.0* X X X X X
10.0 X X X X X
11.0 X X X X X
12.0 X X X X X
13.0 X X X X X
14.0 X X X X** X**
15.0 X X X** X X
16.0 X** X** X X X
*Nominal; **RBP
f. Balloon Inflation and Deflation Time 
Significance: Balloons occlude the target vessel and obstruct blood flow while inflated. Inflation 
and deflation times affect occlusion time. Excessively slow inflation or deflation of a balloon 
could lead to prolonged lack of blood flow and damage to downstream tissues. Both inflation and 
deflation time are pertinent to evaluate, as both of these attributes may affect device performance 
and may result in prolonged lack of blood flow and damage to downstream tissues.
Recommendation: We recommend that you follow ISO 10555-4, Annex C, for deflation time 
testing. In addition to what is described in this standard, the following should be taken into 
consideration when conducting balloon inflation and deflation time testing.
We recommend that you demonstrate, using techniques recommended in your instruction 
manual, that the balloon inflates and deflates within acceptable times and provide the clinical 
basis for your acceptance criteria. We recommend that you test the largest diameter at the longest 
balloon length and evaluate which other sizes may warrant testing based on your risk analysis. 
g. Catheter Bond Strength 
Significance: Failure of bonds in the catheter could lead to device failure, vessel damage, and/or 
embolic risk due to device remnants within the vasculature.
Recommendation: We recommend that you test the bond strength at all locations where 
adhesives, thermal fusion, or other joining methods are used for bonding components of the 
catheter. Multiple bonds/joints that are located in close proximity should be tested separately, if 
possible. We recommend that the testing demonstrate that all joints/bonds can withstand tensile 
forces greater than those that may be experienced during clinical use. As such, we also 
recommend that you provide the clinical basis (e.g., literature, retraction forces) for your bond 
strength acceptance criteria. As discussed above, insertion and retraction force assessments 
during simulated use testing may also be used to support your bond strength acceptance criteria. 
Comparative testing involving a legally marketed predicate device that has a history of safe use 
13 Contains Nonbinding Recommendations
is also appropriate. Please note that the values identified in ISO 10555-1: Intravascular 
Catheters  Sterile and Single-Use Intravascular Catheters  Part 1: General Requirements 
alone should not be used to rationalize your acceptance criteria, as the clinical relevance of these 
criteria have not been established for peripheral interventional applications. The test 
method/protocol for this testing should clearly describe the methods utilized, including the 
portions of the device that were fixed into each clamp and the pull rate.
h. Tip Pull Test 
Significance: Failure of bonds in the distal tip could lead to device failure, vessel damage, and/or 
embolic risk due to device remnants within the vasculature.
Recommendation: For devices with one or more joints in the distal tip (e.g., spring or nose-cone 
tips), we recommend evaluating the tensile force that will separate the distal tip from the 
catheter. We recommend that the testing demonstrate that the joints/bonds can withstand tensile 
forces greater than those that may be experienced during clinical use. 
Please note that this testing should be conducted on all tips that are joined or bonded to the 
catheter by any means, regardless of tip length. If the tip is not long enough to be gripped for 
tensile testing, modifications to the test methods (e.g., longer tip joined by same method for the 
test article, alternate or modified grip) should be employed. Tips that are not separate 
components (e.g., extension of inner tubing) do not need to be tested as they are not bonded. 
i. Flexibility and Kink Test 
Significance: Catheters may be subjected to tight angulations in tortuous vasculature during use. 
Inability to withstand flexural forces that are typical of clinical use could lead to device failure or 
vessel damage.
Recommendation: We recommend that you conduct testing which demonstrates that the catheter 
will not kink at a bend radius that is appropriate for the intended anatomy. For example, we 
recommend that you consider wrapping the catheter around a series of mandrels with 
successively smaller radii until the catheter kinks, the lumen collapses, or the device shows no 
kinking at a radius smaller than what could be considered appropriately challenging for the 
intended anatomy. This testing should be conducted along the full length, or representative 
portions, of the catheter without the use of a guidewire as this would indicate a worst-case 
scenario (or a rationale should be provided if a guidewire is used). We also recommend you 
provide the clinical basis for your acceptance criterion. This could include literature or testing 
demonstrating the proposed criterion is appropriate in representative angulations for the intended 
anatomy. Assessment of the kink resistance of your device during simulated use alone is not 
considered an appropriately challenging assessment as it does not challenge the device to failure. 
This should be considered supporting information.
j. Torque Strength  
Significance: Catheters may be subjected to torsional forces during use. Even non-fixed wire 
catheters could be subject to torsional forces if the tip is inadvertently caught on a stent, calcified 
14 Contains Nonbinding Recommendations
lesion, etc. Inability to withstand torsional forces that are typical of clinical use could lead to 
device failure or vessel damage.
Recommendation: We recommend that you assess the ability of the catheter to withstand 
torsional forces when the distal tip is not free to rotate by rotating the proximal end of the 
catheter until failure. We also recommend that you test the torque strength of the catheter in the 
simulated-use fixture by tracking through the fixture and then clamping the distal end and 
rotating the proximal end. We recommend that you report the number of rotations to failure and 
the failure mode for each sample tested. Alternatively, it may be possible to test the device to a 
specific number of turns (i.e., not to failure) if the pre-determined acceptance criterion is 
established as appropriately challenging compared to clinical use.
k. Radiopacity 
Significance: Insufficient radiopacity may impede safe and reliable delivery of the balloon to the 
intended location as it will not be clearly visible during use.
Recommendation: We recommend that you demonstrate that the radiopaque markers/materials 
on the balloon catheter can be seen under typical fluoroscopic methods. We recommend that you 
provide a qualitative or quantitative measure of radiopacity, wherein the balloon catheter is 
visible using real-time and plain film x-ray. It is acceptable to provide images from animal 
studies, in vitro phantoms, or equivalent models in order to support the visibility/radiopacity of 
your device. If these data are leveraged from animal or bench testing, please provide a reference 
in the submission to where the images can be located. The methods described in ASTM F640: 
Standard Test Methods for Determining Radiopacity for Medical Use are generally considered 
acceptable.
l. Coating Integrity  
Significance: Coatings are intended to improve the performance of the device. Delamination or 
degradation of a coating may lessen its benefit or otherwise negatively impact its clinical 
performance and patient safety (e.g., causing embolization downstream).
Recommendation: Coating integrity testing should be conducted if your device has any coating 
along the length of the catheter and/or on the balloon portion of the device. We recommend that 
you address the aspects described below for any coatings applied to the surfaces of your product.
Coating Description
We recommend that you describe the clinical purpose and intended function of the coating, such 
as enhanced radiopacity, thromboresistance, or lubricity. We also recommend that you describe 
the physical structure of the coating, such as coating thickness, and indicate its chemical 
identification.
Test Samples
You should conduct testing on the finished product that was subjected to all manufacturing 
processes, including sterilization. Otherwise, discussion of, and justification for, the differences 
15 Contains Nonbinding Recommendations
between the test article and finished product should be provided. You should provide a scientific 
or statistical justification for the sample size for each test. We recommend that you implement a 
sampling plan to examine multiple lots of product (3) to assess both inter- and intra-lot 
variability. Because coating integrity may be impacted by balloon size, you should perform 
testing on the extremes (i.e., four corners) and an appropriate intermediate size for the entire 
product matrix proposed, as depicted in Table 6.
Table 6: Example of Four Corners Plus Intermediate Test Matrix.
Balloon Length (mm)
Balloon Diameter (mm)
40 60 80 100 120
4.0 X X
4.5
5.0 X
5.5
6.0 X X
It may be possible to combine coating integrity testing and particulate evaluation (Section 
III.G(1)m) with simulated use testing (Section III.G(1)b), but you should take care to ensure that 
only minimal additional handling of the sample is required for the coating integrity evaluation 
such that particulates are neither lost nor generated.
Interpretation of Data
Coating integrity is considered a characterization test. While acceptance criteria do not need to 
be included in the premarket submission, descriptions of visualization criteria for the assessment 
(e.g., no voids, no cracks) should be provided. Furthermore, you should provide an interpretation 
of the analysis.
Test reports should include a detailed discussion of the morphology of the coated surfaces. If 
numerous defects are observed, quantifying defects using microscopy may be helpful. This may 
include counting the number of total defects per unit area or measuring the total representative 
defect area. You should support your discussion with representative color images, including any 
areas with observed defects, at a sufficient magnification to characterize the defects. Multiple 
magnifications may be warranted to visualize and adequately characterize the product. If the 
coating is difficult to visualize (e.g., clear hydrophilic coating), measures should be taken in 
order to ensure proper visualization (e.g., dyeing). The discussion of acceptable coating integrity 
should include a justification that the number, size, and/or total area of defects observed will not 
impact clinical performance or safety. Side-by-side testing with a predicate device may be 
helpful to support substantial equivalence for 510(k) devices.
We recommend that you address the aspects described below for any coatings applied to the 
surfaces of your product.
16 Contains Nonbinding Recommendations
Baseline Coating Integrity
We recommend that you conduct a visual assessment of the coating integrity on all appropriate 
surfaces of the final catheter to establish a baseline for comparison to coating characteristics after 
testing performed after simulated use. If the coating is present on the balloon surface, unfolding 
or partially inflating the device may be necessary to characterize coating at different locations. 
We recommend that you appropriately quantify characteristics such as continuity and voids in 
the coating, as described above.
Simulated Use Coating Integrity
We recommend that you evaluate the coating integrity via visual assessment after simulated use. 
Catheters should be tracked through an aqueous, tortuous path fixture (as described in Section 
III.G(1)b) and then expanded in the aqueous medium to the maximum labeled diameter 
described in the instructions for use prior to visual inspection.
We recommend you test coating integrity under appropriately challenging conditions of use. For 
example, for balloons intended for ISR or post-deployment stent expansion, we recommend that 
you evaluate the coating integrity after tracking the device through a tortuous path fixture and 
inflating to the largest labeled diameter within a stent which has been deployed in the mock 
vessel.
Functional Testing
We recommend you demonstrate that the coating can achieve its intended function. For example, 
if a coating is intended to provide lubricity to the catheter, it may be helpful to demonstrate that 
the frictional forces are decreased or at least equivalent to similar products with similar coatings. 
For this type of assessment, we recommend that you characterize the drag force of the coating 
(e.g., pinch test, force characterization during simulated use) after the samples are prepared per 
the instructions for use.
m. Particulate Evaluation (Coated Devices Only) 
Significance: Particulate matter can be generated by the manufacturing process, environment, or 
from the breakdown of any coating (e.g., hydrophilic coating) on the catheter or from the device 
packaging. If particles are introduced in the bloodstream during an angioplasty procedure, they 
may present an embolic risk to the patient. Measurement of the total quantity and size of 
particulates a device may generate is an indication of embolic risk. Due to lower embolic risks of 
peripheral devices as compared to other vasculatures, if the coating and substrate are not novel 
and coating integrity testing has been conducted with acceptable results, a particulate evaluation 
may not be needed. However, this testing should be conducted if these factors have not been met, 
or to further support the coating integrity of your device.
Recommendation: We recommend that you measure the total quantity and size of the particulates 
generated during the simulated use of your device, addressing the aspects described below.
17 Contains Nonbinding Recommendations
Test Samples
We recommend conducting testing on the finished product that was subjected to all 
manufacturing processes, including sterilization. Otherwise, discussion of, and justification for, 
the differences between the test article and finished product should be provided. A scientific or 
statistical justification for the sample size should be provided. We recommend that you 
implement a sampling plan to examine multiple lots of product (3) to assess both inter- and 
intra-lot variability. You should perform testing on the extremes and an appropriate intermediate 
size for the entire product matrix proposed (i.e., four corners and intermediate size matrix; see 
Table 6.)
It may be possible to combine the particulate evaluation and simulated use coating integrity 
testing (Section III.G(1)l) with simulated use testing (Section III.G(1)b), but you should take care 
to ensure that only minimal additional handling of the sample is required for the coating integrity 
evaluation such that particulates are neither lost nor generated.
Interpretation of Data
Particulate testing, if warranted, should be conducted as part of your design verification testing 
and should include acceptance criteria (i.e., not be for characterization only). A rationale for the 
criteria used as well as a discussion of the results should also be provided. The discussion of 
acceptable particulate evaluation and limits should include a justification that the number and 
size of particulates is not expected to impact safety or clinical performance. This may include a 
reference to any applicable standards, the use of side-by-side testing with a legally marketed 
device (e.g., predicate device) demonstrating equivalent results, or references to animal testing or 
other available safety information. Because acceptable number and size of particulates for 
devices such as catheters have not been standardized, a clinically relevant scientific rationale for 
the particulate acceptance criteria, which should consider the device indication, the procedure in 
which the device is used, and the tissues or organs that may be affected, should be provided.
Test Methods
We recommend that you evaluate particulate generated by the entire PTA system, including 
accessory devices expected to be used during a clinical procedure. Catheters should be tracked 
through an aqueous, tortuous path fixture (as described in Section III.G(1)b) and then expanded 
in an aqueous medium to the maximum labeled diameter described in the instructions for use 
prior to visual inspection. When deployed, the balloon should be in direct contact with the 
simulated vessel without the use of other coatings, lubricants, sheaths, or protective wraps 
between the balloon and the simulated vessel. To ensure measurement of the total number of 
particulates that could be potentially introduced into the bloodstream, the catheter should be 
inserted into the test fixture to the extent at which it would be inserted in clinical use. The total 
number of particulates, including those from the catheter and accessory devices, should be 
reported in each of three size ranges: 10m, 25m, and at the largest size for which validation 
yields 75% recovery. At a minimum, the largest size should be 50m. Appropriate precautions 
should be taken to ensure that the particles are suspended during sampling for particle counting 
and sizing to minimize artifacts from the test system.
18 Contains Nonbinding Recommendations
We recommend that you perform particulate evaluation under appropriately challenging 
conditions of use. For example, for balloons intended for ISR or post-deployment stent 
expansion, we recommend that you evaluate the quantity and sizes of particulates generated from 
tracking the device through the tortuous path fixture (as described in Section III.G(1)b) and 
inflating to the largest labeled diameter within a stent which has been deployed in the mock 
vessel.
Method Validation
You should describe and validate particle counting and sizing methods. Validation should be 
conducted using particulate standards of known quantity and size. Particles should be introduced 
into your model and counting apparatus in a similar manner as the device would be introduced 
clinically. The percent recovery, or accuracy, should be determined and meet the criteria 
described above. For a system to be considered validated, 90% recovery should be 
demonstrated for the 10m and 25m size ranges. Please note that recovery rates well above 
100% would not be considered valid.
Acceptance Criteria
Particulate testing should include acceptance criteria (i.e., not be for characterization only). 
Specific criteria should be established, justified, and met. If large amounts of particulates are 
shed, it may be important to demonstrate comparability to a legally-marketed predicate device 
used in the same target vasculature or provide evidence of safety through your animal studies 
(with appropriate downstream assessments). A scientific rationale should be provided to support 
the particulate acceptance criteria that are used. Note that safety issues related to particulates 
may go undetected in patients or may be attributed to the disease or other comorbidities and, 
therefore, a rationale based only on history of safe clinical use of the device, or other similar 
catheters, is often not sufficient to justify particulate acceptance criteria.
Particulate Chemical Identification 
Particulate matter can be generated from numerous sources, including the manufacturing process 
and/or environment contamination, from the breakdown of any coating on the catheter, or from 
the device packaging. It is important to establish that a significant number of particulates are not 
being introduced from other unintended sources, as described above, which may present an 
embolic risk. Therefore, if a large amount of particulates are shed from your device, it may be 
pertinent to conduct additional analysis, such as a chemical characterization of the particulates, 
in order to determine their source. For this testing, FDA recommends that you perform chemical 
identification of representative particulate populations and report the results in relative amounts 
(percentages). Chemical characterization of captured particulates for identity can be 
accomplished through a variety of methods including energy-dispersive x-ray spectroscopy 
(EDX), Fourier transform infrared (FTIR) spectroscopy, Raman spectroscopy, mass 
spectroscopy, or diffraction techniques.
Chemical identification of representative particulate material should be performed with 
justification for the methods used and samples analyzed. The sample should be sufficiently large 
in order to ensure that the particulates assessed are representative of the particulates that would 
19 Contains Nonbinding Recommendations
be generated during the deployment of the device. The method used should be capable and 
sufficient for chemical identification. Specific details regarding the capture and analysis (e.g., 
how the samples were filtered, color images of the filters, how the samples were chosen, details 
regarding the number of particulates analyzed as compared to the total particulates filtered) of 
the particulates should be provided. Regarding sizes to be assessed, the four corners testing 
paradigm may not be needed if adequate justification is provided for why the device sizes used 
for testing are representative of their entire product matrix (e.g., same materials, manufacturing 
processes).
There are certain instances when providing additional supporting analyses may allow for reduced 
(e.g., smaller sample size, fewer particulates analyzed) or omitted chemical identification testing. 
Supporting analyses could include any or all of the following:
 particulate quantitation studies with the uncoated balloon catheter manufactured in the 
identical way as the coated device but including potential inclusion of a dummy 
coating process, demonstrating sufficiently low amounts of particulates;
 a discussion regarding the potential interactions of your coating, including all 
components, with the catheter materials and their potential to introduce some of the 
catheter extractables/leachables into the particulates;
 representative color images of the particulates captured on the entire filter demonstrating 
no concerning information (e.g., unexpected appearance);
 a risk assessment regarding potential contaminants and the coating chemical 
compositions;
 a discussion of the animal studies data indicating no concerning downstream or embolic 
events; and
 a discussion and references to any historical clinical data indicating no concerning 
embolic events.
(2) Additional Tests for Catheters Intended for Infusion of 
Contrast Media or Other Fluids 
a.  Catheter Body Burst Pressure 
Significance: The catheter body should be designed to withstand pressures typically needed to 
achieve contrast media flow rates used in clinical practice. Inability to withstand pressures that 
are typical of clinical use could lead to device failure or vessel damage.
Recommendation: We recommend that you follow ISO 10555-1, Annex F, for burst pressure 
testing. In addition to what is described in this standard, the following should be taken into 
consideration when conducting balloon inflation and deflation time testing.
We recommend that you determine the maximum pressure that the catheter body can withstand 
during injection. We recommend you conduct the testing under clinical use conditions (i.e., 
20 Contains Nonbinding Recommendations
including use of a syringe, automatic injector). The contrast medium or fluid should be 
representative of worst-case clinical conditions. We also recommend you provide the clinical 
basis for your acceptance criteria.
b. Infusion Flow Rate 
Significance: The catheter should be designed to achieve clinically acceptable contrast media 
flow rates. Inability to achieve acceptable flow rates could lead to user error and adverse clinical 
consequences.
Recommendation: We recommend that you follow ISO 10555-1, Annex E, for flowrate testing. 
In addition to what is described in this standard, the following should be taken into consideration 
when conducting balloon inflation and deflation time testing.
We recommend that you conduct testing that demonstrates that the catheter is capable of 
achieving clinically acceptable contrast media flow rates. We recommend that testing be 
conducted at maximum catheter burst pressures (as identified in Section III.G(2)a) as well as 
pressures typical of clinical use. We recommend that you report the maximum flow rate in the 
device labeling. We also recommend you provide the clinical basis for your acceptance criteria. 
 
(3) Additional Tests for Catheters Intended for In-Stent 
Restenosis (ISR) Use or for Stent Expansion following Stent 
Deployment 
If you label a PTA catheter for ISR use or for stent expansion immediately following stent 
deployment (for purposes of securing the stent to the vessel wall and ensuring that the stent is 
completely deployed), we recommend you conduct balloon rated burst pressure and fatigue 
testing within an expanded stent (see Sections III.G(1)c and III.G(1)d). If the balloon has a 
coating on it, we also recommend conducting coating integrity and particulates testing in a 
simulated use model that includes an expanded stent (see Sections III.G(1)l and III.G(1)m). 
 
(4) Additional Tests for Scoring/Cutting Balloons 
Scoring and cutting balloons concentrate the dilating forces along the scoring elements or 
atherotomes. Due to the additional design features, scoring and cutting balloons have additional 
considerations beyond a standard PTA catheter.
a. Scoring/Cutting Mechanism Securement 
Significance: Detachment of the scoring/cutting mechanism(s), such as wire or atherotomes, 
could result in device failure, vessel damage, and/or embolic risk due to device remnants within 
the vasculature.
Recommendations: We recommend that you determine the force (e.g., tensile, shear) at which 
the bonding of the scoring/cutting mechanism fails. We recommend you provide the clinical 
basis for your test method and acceptance criteria based on the type and level of risk.
21 Contains Nonbinding Recommendations
b. Scoring/Cutting Performance  
Significance: The scoring/cutting mechanism of the device introduces additional risks, such as 
vascular damage, as compared to a standard PTA catheter. Failure to achieve adequate scoring or 
cutting could lead to the device not performing as intended. 
Recommendations: We recommend that you demonstrate that the device can score a lesion, as 
intended. Performance of your device should be evaluated in a calcified bench model, animal 
model with calcified lesions, cadaveric model, and/or clinical study and compared to a legally 
marketed predicate device. We encourage you to contact the FDA early to discuss the proposed 
model to evaluate the scoring/cutting performance (see FDA guidance Requests for Feedback 
and Meetings for Medical Device Submissions: The Q-Submission Program10).
c. Substantially-Equivalent Safety Outcomes (Demonstration of 
No Added Risks)  
Significance: If a scoring/cutting balloon catheter has novel technological characteristics (i.e., 
scoring/cutting mechanism that is different from the standard scoring wire or cutting atherotomes 
of the predicate device), additional safety questions may arise, such as added risk of vessel 
dissection or perforation.
Recommendations: If different technological characteristics as compared to the predicate are 
used to achieve the intended function, we recommend that you assess whether the safety 
outcomes (i.e., scoring depth, perforation/dissection rate) of your device are substantially 
equivalent to those of the identified predicate, using the predicate device as the control in an 
animal model and/or clinical study.
H. Animal Safety and Performance Testing 
Significance:  Animal testing is generally recommended to evaluate the in vivo safety and 
performance of some specialty catheters and potentially some PTA balloon catheters, particularly 
for new designs, significant device modifications, and new indications for use. An example of 
this is for a scoring balloon with a new cutting mechanism.
Recommendation:  Animal testing of PTA balloon catheters and specialty catheters should 
address factors that cannot be evaluated through bench tests or in a clinical study. The study 
design and endpoints should be based upon the mechanism of action of the device and mitigation 
of risk. 
FDA supports the principles of the 3Rs, to replace, reduce, and/or refine animal testing when 
feasible. You should consider the best practices for the development, conduct and presentation of 
these animal studies while incorporating modern animal care and use strategies.
We encourage manufacturers to take advantage of the Q-Submission Program to ensure that the 
animal study protocol addresses safety concerns and contains elements which are appropriate for 
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program
22 Contains Nonbinding Recommendations
a regulatory submission (e.g., the study should be performed under Good Laboratory Practice 
(GLP) regulations as stated in 21 CFR 58 at an animal study facility with appropriate licensure 
and accreditations).11 In addition, if you are proposing to use a non-animal testing method that 
you believe is suitable, adequate, validated, and feasible, we recommend that you discuss the 
proposal using the Q-Submission Program. We will consider if such an alternative method could 
be assessed for equivalency to an animal test method.  For details on the Q-Submission Program, 
please refer to the guidance Requests for Feedback and Meetings for Medical Device 
Submissions: The Q-Submission Program.12
For devices with notable dissimilarity from legally-marketed PTA devices (e.g., new indications, 
designs, technology), we recommend that you conduct animal testing to confirm safety of the 
device and procedure and to evaluate the performance, including functional characteristics, of the 
PTA or specialty catheter.
For scoring balloons, we strongly recommend animal testing to demonstrate equivalent safety 
outcomes for all scoring/cutting devices, as compared to their predicate, especially when the 
technological characteristics differ. We recommend that you evaluate these devices in an 
appropriate animal model and that you provide a supporting rationale for the chosen animal 
model in your submission. The predicate device should be used as a control in these studies. We 
strongly recommend that these studies be conducted in accordance with 21 CFR part 58 or 
explain why the noncompliance would not impact the validity of the study data provided to 
support a substantial equivalence determination.
I. Clinical Performance Testing 
Clinical evidence is generally unnecessary for most PTA balloon and specialty catheters; 
however, such testing may be requested in situations such as the following:
 indications for use dissimilar from legally marketed devices of the same type (e.g., 
treatment of specific diseases or lesion types);
 new technology (i.e., technology different from that used in legally marketed devices of 
the same type); and
 cases where engineering and/or animal testing raise issues that warrant further evaluation 
with clinical evidence.
If a clinical study is needed to demonstrate substantial equivalence, i.e., conducted prior to 
obtaining 510(k) clearance of the device, the study should generally be conducted under the 
Investigational Device Exemptions (IDE) regulation, 21 CFR 812. Generally, we believe PTA 
balloon catheters and specialty catheters addressed by this guidance document are significant risk 
11 See also FDA Guidance General Considerations for Animal Studies Intended to Evaluate Medical Devices 
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-animal-
studies-medical-devices).
12https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-
medical-device-submissions-q-submission-program
23 Contains Nonbinding Recommendations
devices subject to all requirements of 21 CFR part 812. Please see the FDA guidance, 
Significant Risk and Nonsignificant Risk Medical Device Studies.13 In addition to the 
requirements of 21 CFR part 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).  
When data from clinical investigations conducted outside the United States are submitted to 
FDA for PTA and specialty catheters, the requirements of 21 CFR 812.28 may apply.14  21 CFR 
812.28 outlines the conditions for FDA acceptance of clinical data from investigations conducted 
outside the US when submitted to support premarket submissions. For more information, see the 
FDA guidance, Acceptance of Clinical Data to Support Medical Device Applications and 
Submissions: Frequently Asked Questions.15
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.16
J. Labeling 
The regulatory submission must include proposed labeling in sufficient detail to satisfy the 
requirements of 21 CFR 807.87(e) for premarket notifications. Labeling for PTA balloon 
catheters and specialty balloons should include all applicable information, including indications, 
contraindications, warnings, product information, a summary of the clinical data (if applicable), 
and directions for use.
As prescription devices, PTA balloon and specialty catheters are exempt from having adequate 
directions for lay use under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) as long as the conditions in 21 CFR 801.109 are met. For instance, labeling must 
include adequate information for practitioner use of the device, including indications, effects, 
routes, methods, frequency and duration of administration (e.g., infusion time, inflation 
duration), and any relevant hazards, contraindications, side effects and precautions (21 CFR 
801.109(d)).
K. Modifications 
In accordance with 21 CFR 807.81(a)(3), a device change or modification that could 
significantly affect the safety or effectiveness of the device or represents a major change or 
13 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/significant-risk-and-nonsignificant-
risk-medical-device-studies
14 Applies to data from clinical investigations that began on or after February 21, 2019 and are submitted to support 
a premarket submission, including IDEs, PMAs, and 510(k)s.
15 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-clinical-data-support-
medical-device-applications-and-submissions-frequently-asked
16https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-
regulatory-decision-making-medical-devices
24 Contains Nonbinding Recommendations
modification in the intended use of the device requires a new 510(k).17 The changes or 
modifications listed below are examples of changes that may require submission of a new 
510(k). Note that this list is not exhaustive but provides examples of modifications that are likely 
to 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.18
Such changes or modifications include:
 Change in device dimensions: FDA considers dimensional changes to be modifications in 
design. This type of change could significantly affect safety and effectiveness of the 
device as it may alter the device performance. Thus, if dimensional changes are not 
within the range that was previously cleared, testing may be needed to support the 
change. The magnitude and criticality of the modified dimension should be considered 
when determining if a new 510(k) is needed.  
 Change to indirect or direct blood contacting components: FDA considers these changes 
to be modifications in material, which could significantly affect safety and effectiveness 
of the device by altering engineering attributes and/or introducing different types or 
quantities of residual chemicals, which could result in a toxic response. Therefore, a change 
in the material could impact device performance and biocompatibility, which could 
impact patient safety.
 Change in sterilization technique: Depending on the type of change, a change in 
sterilization method can be significant as it could significantly affect safety and 
effectiveness of the device (e.g., impact device sterility and biocompatibility). For 
example, changes to an ethylene oxide sterilization process may leave increased ethylene 
oxide residuals. Additionally, changes in sterilization may unintentionally affect device 
materials, which could consequently affect the safety and/or performance of the device. 
The potential impact of the sterilization change on material performance and 
characteristics should be considered when determining the need for a new 510(k).
17Section 3308 of the Food and Drug Omnibus Reform Act of 2022, Title III of Division FF of the Consolidated 
Appropriations Act, 2023, Pub. L. No. 117-328 (FDORA), enacted on December 29, 2022, added section 515C 
Predetermined Change Control Plans for Devices to the FD&C Act (section 515C). Under section 515C, FDA can 
approve or clear a predetermined change control plan (PCCP) for a device that describes planned changes that may 
be made to the device and that would otherwise require a supplemental premarket approval application or premarket 
notification. For example, section 515C provides that a supplemental premarket approval application (section 
515C(a)) or a premarket notification (section 515C(b)) is not required for a change to a device if the change is 
consistent with a PCCP that is approved or cleared by FDA. Section 515C also provides that FDA may require that a 
PCCP include labeling for safe and effective use of a device as such device changes pursuant to such plan, 
notification requirements if the device does not function as intended pursuant to such plan, and performance 
requirements for changes made under the plan. If you are interested in proposing a PCCP in your marketing 
submission, we encourage you to submit a Pre-Submission to engage in further discussion with CDRH. See FDAs 
guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program 
available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program.
18https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device
25 Contains Nonbinding Recommendations
Examples of changes or modifications in the indications for use of the device that would likely 
require a new 510(k) are:
 A change in specific lesion characteristics (e.g., chronic total occlusion, ISR).
 Claims in improvement of outcomes in other technologies (e.g., pre-treatment with 
scoring balloons improves outcomes of drug-coated balloons).
We believe that the following modifications will likely not require submission of a new 510(k):
 Minor changes in packaging: A minor change in packaging (e.g., replacing hardcopy 
instructions for use with an electronic version, update to the expiration date) is not 
expected to impact device safety and performance.
 Increase in shelf-life: An increase in device shelf-life is not expected to impact device 
safety and performance as long as the testing protocol has been previously reviewed and 
accepted in a prior submission. Additionally, the test results should fall within the 
acceptance criteria previously found to be acceptable.
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