Class II Special Controls-Certain Percutaneous Transluminal Coronary Angioplasty.docx

Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) CathetersDocument issued on: September 8, 2010The draft of this document was issuedMay 30, 2008.For questions regarding this draft guidance document, contact Kathryn OCallaghan at 301-796-6349 or by email:.U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological HealthInterventional Cardiology Devices BranchDivision of Cardiovascular DevicesOffice of Device EvaluationPrefacePublic CommentWritten comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Divisions of Management Systems and Policy, Office of Human Resources and Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852.Alternatively, electronic comments may be submitted to.When submitting comments, please refer to docket number 2008D-0275.Comments may not be acted upon by the Agency until the document is next revised or updated.Additional CopiesAdditional copies are available from the Internet. You may also send an e-mail request to receive an electronic copy of the guidance or send a fax request to 301-847-8149 to receive a hard copy.Please use the document number (1608) to identify the guidance you are requesting. Table of ContentsI.IntroductionII.BackgroundIII.ScopeIV.Device DescriptionV.Risks to HealthVI.Biocompatibility TestingVII.Content and Format of Test DataA.Summary ReportsB.Test ReportsC.Test ProtocolsVIII.Performance TestingA.Dimensional and Functional AttributesB.Additional Tests for Catheters Intended for Infusion of Contrast Media or Other FluidsC.Additional Tests for Catheters Intended for In-Stent Restenosis or for Stent Expansion following Stent DeploymentIX.Animal TestingX.Clinical InformationXI.Sterilization and Shelf LifeA.SterilizationB.Shelf LifeXII.LabelingAppendix A:Test SummaryAppendix B:Applicable StandardsGuidance for Industry and FDA StaffClass II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Guidance for Industry and FDAI.IntroductionThis guidance document was developed as a special control to support the reclassification of certain Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters into class II (special controls).The device is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion; treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.This guidance does not apply to cutting/scoring PTCA catheters.On December 4, 2000, the Circulatory System Devices Panel recommended that certain PTCA catheters be reclassified from class III to class II with special controls.This guidance is issued in conjunction with aFederal Registernotice announcing the issuance of an order reclassifying this device type.Following the effective date of an order reclassifying the device, any firm submitting a 510(k) for a PTCA catheter will need to address the issues covered in the special control guidance.However, the firm need only show that its device meets the provisions of the guidance or in some other way provides equivalent assurances of safety and effectiveness.II.BackgroundFDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of PTCA catheters, other than cutting/scoring PTCA catheters.Thus, a manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the act), including the premarket notification requirements described in 21 CFR 807, Subpart E, (2) address the specific risks to health associated with PTCA devices identified in this guidance, and (3) obtain a substantial equivalence determination from FDA prior to marketing the device.This special controls guidance document identifies the classification regulation and product code for PTCA catheters (Please refer toSection III.Scope).In addition, other sections of this special controls guidance list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with these PTCA catheters and lead to a timely 510(k) review and clearance.This document supplements other FDA documents regarding the specific content requirements of a premarket notification submission.You should also refer to 21 CFR 807.87,Format for Traditional and Abbreviated 510(k)s1and the section of CDRHs Device Advice,How to Prepare a 510(k) Submission.2III. ScopeThe scope of this document is limited to percutaneous transluminal coronary angioplasty (PTCA) catheters as described below in 21 CFR 870.5100 (a).The product code associated with this device is LOX percutaneous transluminal coronary angioplasty (PTCA) catheter.Section 870.5100. Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.(a)Standard PTCA catheter(1)Identification.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.A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)Classification.Class II (special controls).The special control for this device is FDAs “Class II Special Controls Guidance Document: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See 870.1(e) for the availability of this guidance document.(b)Cutting/scoring PTCA Catheter(1)Identification.A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered.A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion.A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)Classification. Class III (premarket approval).As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See 870.3.Cutting/scoring PTCA catheters (procode NWX) remain in class III and continue to require premarket approval.IV. Device DescriptionWe recommend that you identify your device by regulation and product code described inSection III.Scope,and include the following information:Device components and theory of operationWe recommend that you identify all components and accessories included in the submission.Photograph or drawing of the deviceWe recommend that you provide a photograph or drawing of the device, as well as a functional block diagram (including all accessories). If additional diagrams, dimensions, tolerances, and/or schematics are useful to fully describe and characterize the device, we recommend that you include them for each device, accessory or component included in the 510(k) submission.Technological characteristicsWe recommend that you describe the technical and performance specifications and include a brief description of the device design requirements in this section.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.Patient-contacting materialsWe also recommend that you provide a list of all patient contacting components and their respective materials.For each component, you should identify the generic material of construction and the unique material identifier.V.Risks to HealthInTable 1below, FDA has identified the risks to health generally associated with the use of the PTCA devices addressed in this document.The measures recommended to mitigate these identified risks are given in this guidance document, as shown inTable 1below.We recommend that you conduct a risk analysis to identify any other risks specific to your device and include the results of this analysis.If you elect to use an alternative approach to address a particular risk identified in this document, or have identified risks additional to those in this document, you should provide sufficient detail to support the approach you have used to address that risk.Table 1: Risk / Mitigation Recommendations for PTCA DevicesIdentified RiskRecommended Mitigation MeasuresAdverse Tissue ReactionSection VI.Biocompatibility TestingDevice FailureSection VIII.Performance TestingSection XI.Sterilization and Shelf LifeAdverse Interaction with Other DevicesSection VIII.Performance TestingSection IX.Animal TestingUser ErrorSection IX.Animal TestingSection X.Clinical InformationSection XII.LabelingVessel DamageSection IX.Animal TestingSection X.Clinical InformationInfectionSection XI.Sterilization and Shelf LifeVI. Biocompatibility TestingFDA recommends that you conduct biocompatibility testing as described in the FDA guidance,Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing, for external devices in contact with the circulating blood for a limited duration (i.e., less than 24 hours).3We recommend that you select biocompatibility tests appropriate for the duration and level of contact with your device.If identical materials and identical material processing are used in a predicate device with the same type and duration of patient contact, you may identify the predicate device in lieu of providing biocompatibility testing.Sample PreparationIt is important to understand how the test samples compare to the final sterilized product.For biocompatibility testing conducted using extraction samples, we recommend that you: determine the appropriate amount of test material as outlined inISO 10993-12or an equivalent method, using surface area to extractant volume ratios (mass to extractant volume ratios should only be used if surface area cannot be calculated) use both polar and nonpolar extractants describe the condition of the extraction vehicle (e.g., color, presence of any particles) explain any changes in the post-extraction vehicle (compared to pre-extraction) describe the details of storage conditions, if applicable.If extraction samples are not used immediately, we recommend that you follow the storage conditions described inISO 10993-12or an equivalent method.We also recommend that you explain how storage does not affect your test results.You should also consider the following additional recommendations when conducting your biocompatibility assessment:CytotoxicityWe recommend that extractions be conducted at 37C for 24 hours using a vehicle with both mammalian cell culture media (MEM) and 5% serum, as these materials will allow for extraction of both polar and nonpolar constituents from the test sample.Sensitization (Guinea Pig Maximization Method)We recommend that test reports confirm that all female animals used in the testing are not pregnant, as pregnancy can reduce the ability of a female animal to detect a sensitization response.We recommend either that you run concurrent controls, or that the test laboratory run controls within 3 months of the test samples.We also recommend you provide protocols and results from positive control testing to confirm that you used the same methods for both the positive control testing and the test samples.HemocompatibilityFor blood-contacting devices (regardless of contact duration), we recommend that you consider hemolysis, immunology (complement activation), andin vivothromboresistance.Immunology testing should appropriately address the various complement activation pathways.We recommend that you assessin vitroC3a and SC5b-9 fragment activation using standard testing methods, such as those outlined inASTM F2065-00e14andASTM F1984-99 (2003)5,or an equivalent method.Alternatively, you may provide a rationale for omitting this testing, if all the materials used in the formulation and processing of the device have a history of previous use in blood-contacting devices with similar contact duration.In addition, you may assessin vivothrombogenicity during preclinical animal testing in lieu of a separate caninein vivothrombogenicity test.If a 4 hour caninein vivothrombogenicity study is needed (e.g., due to the use of novel materials never before used in a medical devices or questionable findings from the vascular animal studies), we recommend the study be conducted in a venous, unheparinized model.GenotoxicityGenotoxicity testing should be performed if new materials are included that have never been used in blood-contacting devices or implants in order to evaluate the genotoxic response to any particulates and leachables which still may be present after the catheter is removed from the body.6Material-mediated PyrogenicityWe recommend that you assess pyrogenic responses to chemical leachants over the duration of device contact with the patient.We recommend that you assess material-mediated pyrogenicity using traditional biocompatibility extraction methods, such as those outlined in theUSP 28 Rabbit Pyrogen Test(e.g., 50C for 72 hours; 70C for 24 hours; or 120C for 2 hours) or an equivalent method.You should consider that temperatures above 37C may result in toxicities not representative of the final product.VII.Content and Format of Test DataA.Summary ReportsFor traditional 510(k) submissions, we recommend that you present test data in a summary that includes the elements described below.Table of ContentsYou should place a table of contents at the front of the document.Each line listing in the table of contents should refer to major section titles and the page numbers where each section can be found.Test SummariesWe recommend that you briefly describe all tests performed.If you follow an FDA- recognized standard without deviation, you may choose to reference that standard instead of describing the test methods.Test Data SummariesYou should include test data summaries for all tests.The summaries should contain: minimum measured value (min) maximum measured value (max) mean standard deviation of the test data (std. dev.).Summary of ConclusionsYou should summarize your conclusions regarding whether the results support the safety and effectiveness of your device for each test.You should include full test reports for all tests performed, as described below.B.Test ReportsYou should include full test reports for all tests performed.Your test reports should include the sections described below.Test Specimen InformationYour test specimen description should include: number of test specimens size (diameter, length, or other relevant dimensions) of all test specimens rationale for the number of test specimens and sizes tested whether the specimens are representative of the finished product sterilization parameters and number of sterilization cycles applied to the test specimens.Test ProtocolYou should submit your test method or protocol.It should contain enough detail that an individual familiar with intravascular catheter testing will be able to interpret the test results.See Section C below.Protocol DeviationsYou should describe any protocol deviations and their impact on the conclusions you draw from the test.Test Parameters and Acceptance CriteriaYou should report the test parameters and acceptance criteria that you use, including: an explanation of and rationale for critical test parameters specifications or acceptance and rejection criteria a rationale for the specification or acceptance and rejection criteria based on the clinical requirements of the device.Raw DataWe recommend that you include all raw data in appendices, or make the raw data available for our review upon request.Test ResultsYou should summarize your test results and include statistical analysis when it is appropriate.Data AnalysisYou should analyze the data, including any outlying points and anomalous results, and explain whether the data meet the given acceptance criteria.ConclusionsWe recommend that you describe the