A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use.
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X It may be possible to combine the simulated use Coating Integrity see below and Particulate Evaluation see Section 13 below with Balloon Preparation, Deployment and Retraction testing see Section 2 above , 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. Acceptance criteria are not required; however, you should provide an interpretation of the data. In your coating integrity test reports you should include a detailed discussion of the surfaces using any practical methods to quantify defects. This may include counting the number of total defects per unit area, measuring representative defect areas, and measuring worst-case defect areas.
You should support your discussion with representative images including worst-case at a sufficient magnification to characterize the defects. Multiple magnifications may be needed to visualize and adequately characterize the product. The discussion of acceptable coating integrity should include a justification that the number and size of defects observed will not impact clinical performance. FDA recommends that you address the aspects described below for any coatings applied to the surfaces of your product.
Baseline Coating Integrity FDA recommends that you conduct a visual assessment of the coating integrity on all appropriate surfaces of the catheter before expansion to establish a baseline for comparison to coating characteristics after testing performed under other conditions.
We recommend that you appropriately quantify characteristics such as continuity and voids in the coating, as described above. Simulated Use Coating Integrity FDA also recommends that you evaluate the coating integrity after simulated use, via visual assessment. Catheters should be tracked through a tortuous path fixture as described above in Section 2.
Balloon Preparation, Deployment and Retraction and then expanded in air or an aqueous medium to the maximum labeled diameter described in the Instructions for Use prior to visual inspection. We recommend you test coating integrity under the worst-case 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 as described above in Section 2.
Balloon Preparation, Deployment and Retraction and inflating to the largest labeled diameter within a stent which has been deployed in the mock vessel. Particulate Evaluation Significance Particulate matter can be generated by the manufacturing process or from the breakdown of any coating e. 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. Recommendation We recommend that you measure the total quantity and size of the particulates generated during the simulated use of your device. Test Samples You should conduct all testing on the finished product subject to all manufacturing processes including sterilization.
You should provide a scientific or statistical justification for the sample size you plan to test. You should perform testing on the extremes and an appropriate intermediate size for the entire product matrix proposed four corners and intermediate size matrix — see Table 5 above.
It may be possible to combine the Particulate Evaluation see below and simulated use Coating Integrity testing see Section 12 above with Balloon Preparation, Deployment and Retraction testing see Section 2 above , 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 generation is considered a characterization test. Test Methods We recommend that you evaluate particulate generated by the entire PTCA system, including accessory devices expected to be used during a clinical procedure.
Balloon Preparation, Deployment and Retraction 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 particles that could be potentially introduced into the bloodstream, the catheter should be inserted into the text fixture to the extent at which it would be inserted in clinical use.
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.
We recommend you perform particulate evaluation under the worst-case 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 particulate generated from tracking the device through the tortuous path fixture as described above in Section 2.
Method Validation You should describe and validate particle counting and sizing methods. We recommend that you introduce a known amount of various particle sizes into the test setup and quantify the amount of particles recovered. The number of particles recovered should closely approximate the number you artificially introduced into the system. 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 FDA recommends 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. 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.
Contrast Media 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 FDA recommends that you conduct testing that demonstrates that the catheter is capable of achieving clinically acceptable contrast media flow rates.
We recommend that testing be done at maximum catheter burst pressures as identified in the test described above , as well as pressures typical of clinical use. We recommend that you report the maximum flow rate in the device labeling. Back to the top C. Additional Tests for Catheters Intended for In-Stent Restenosis or for Stent Expansion following Stent Deployment If you label a PTCA catheter for in-stent restenosis, 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 the following tests within an expanded stent.
Failure of a balloon to maintain integrity at the RBP could result in device failure or vessel damage. Recommendation We recommend that you conduct this testing on complete catheters or subassemblies in which the balloon is mounted on the catheter shaft. We recommend that you conduct testing on representative sizes as shown in the example in Table 3, for each labeled RBP. We recommend that you inflate the balloons incrementally until failure.
We recommend that you record as test failures any loss of: integrity of the balloon, such as a rupture or leak 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. We also recommend that you calculate RBP as the pressure at which We recommend that you specify RBP in the device labeling. Use of a PTCA catheter inside a stent may affect balloon fatigue strength. Failure of the balloon to withstand multiple inflations could lead to device failure or vessel damage.
Recommendation FDA recommends that you determine the repeatability, to 10 inflations, of successful balloon inflation to the RBP. We recommend that you inflate the balloons incrementally until they reach the RBP. For each sample we recommend that you hold the RBP for 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 any loss of pressure, whether due to failure of the balloon, shaft, or proximal or distal seals, as a test failure. Back to the top IX.
We recommend that you evaluate PTCA devices in an appropriate animal model that closely approximates the intended use of the device in humans, and that you provide this information in your submission. We encourage you to contact the review branch early in the product development process to discuss your study design. General provisions for animal testing of PTCA devices are discussed below.
Device We recommend that you use the finished, sterilized devices including the delivery catheters in your studies. Studies should include a reasonable representation of all device sizes. Control We recommend that you consider the inclusion of a control device to facilitate evaluation of the histopathology results. Acute Observations We recommend that preclinical animal testing address: damage to vessel wall potential to cause thrombosis or hemolysis over the course of the procedure angiographic assessment during procedures, including evaluation of flow rate, thrombus formation and vessel injury.
Follow-Up Observations We recommend the animal studies include follow up observations with detailed pathology at 24 to 48 hours post-treatment as described below. Pathology We recommend that the evaluations performed on necropsied animals include gross assessment of the device as well as careful histological examination of the vessel segment where the device was deployed.
The vessel segment should be examined for vessel injury and inflammation. The animal study report should include the full pathology report, providing line listings and clear copies of photographs and photomicrographs. Back to the top X. While, in general, clinical studies will not be needed for most PTCA devices, FDA may recommend that you collect clinical data for a PTCA device with any one of the following: indications for use dissimilar from legally marketed PTCA device of the same type designs dissimilar from designs previously cleared under a premarket notification new technology; i.
FDA will always consider alternatives to clinical testing when the proposed alternatives are supported by an adequate scientific rationale. If you conduct a clinical study, your study design should address the concerns described below. We recommend you contact the review branch early in your device development process to discuss the study design appropriate to your device.
Study Design We recommend that you conduct a multi-center, prospective single-arm study designed to collect data to support the safety and effectiveness of your device. For devices that will be indicated for use for in-stent restenosis, your study should include a sufficient number of in-stent restenosis patients. Primary Safety Endpoint s We recommend that your study include a primary safety endpoint such as acceptable rates for in-hospital and out-of-hospital complications.
Complications are typically defined as clinically significant major adverse cardiac events MACE including death, myocardial infarction MI, Q-wave and non-Q-wave , coronary artery bypass graft CABG surgery, and repeat target vessel revascularization.
Primary Efficacy Endpoint s We recommend that your study include a primary efficacy endpoint such as a clinically meaningful decrease in post-procedure percent diameter stenosis. This endpoint is typically assessed by collecting and analyzing qualitative and quantitative angiographic data recorded both by the physician during the procedure and by post-procedure independent core lab analysis.
If a clinical study is needed to demonstrate substantial equivalence, i. Sterilization and Shelf Life A. PTCA catheters are devices in contact with circulating blood; therefore we recommend you test the devices for pyrogenicity.
We recommend that your specifications include the test procedure and acceptance criteria for endotoxins. All blood-contacting cardiovascular devices and combination products should be pyrogen-free. Pyrogenicity testing is used to help define limits to protect patients from the risk of febrile reaction. We also recommend you provide a: description of the method used to make the determination, e. Shelf Life FDA recommends that shelf life testing address package integrity to ensure sterility, as well as stable device functionality over the expected life cycle.
To evaluate device functionality, we recommend that you assess each of the bench tests described in Section IX. For example, aging can potentially affect the performance of polymer materials used for PTCA balloons, catheters, and coatings; therefore, all tests other than radiopacity should be repeated after aging.
We also recommend that you provide the protocol used for your shelf life testing, the results of the testing, and the conclusions drawn from your results. If you use devices subjected to accelerated aging for shelf life testing, we recommend that you specify the way in which the device was aged. Since PTCA catheters generally contain polymeric materials, you should plan to conduct real-time testing to confirm that accelerated aging is reflective of real-time aging.
CFR - Code of Federal Regulations Title 21
Malakree This document corrects that error. Summary The Food and Drug Administration FDA is issuing a proposed administrative order to reclassify nonroller-type cardiopulmonary bypass guudance pump devices, when used for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II special controls and subject to premarket notification ghidance on new information. The Food and Drug Administration FDA is issuing a final rule to require the filing of a premarket approval application PMA or a notice of completion of a product development protocol PDP for implantable pacemaker pulse generators. Submit either electronic or written comments on this proposed order by April 7, FDA is also proposing to require the filing of a premarket approval application PMA or a notice of completion guidane a product development protocol PDP for ECP devices for other intended uses specified in this proposed order.
FDA PTCA GUIDANCE PDF
U.S. Food and Drug Administration