Class II Special Controls Guidance Document for Certain PTCA Catheters

Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters Document issued on: September 8, 2010 The draft of this document was issued May 30, 2008.   For questions regarding this draft guidance document, contact Kathryn O’Callaghan at 301-796-6349 or by email: kathryn.ocallaghan@fda.hhs.gov. U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health Interventional Cardiology Devices BranchDivision of Cardiovascular DevicesOffice of Device Evaluation     Preface Public Comment Written 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 Copies Additional copies are available from the Internet. You may also send an e-mail request todsmica@fda.hhs.gov 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 Contents I.    Introduction II.   Background III.  Scope IV.   Device Description V.    Risks to Health VI.   Biocompatibility Testing VII.  Content and Format of Test Data A. Summary Reports B. Test Reports C. Test Protocols VIII.  Performance Testing A. Dimensional and Functional Attributes B. Additional Tests for Catheters Intended for Infusion of Contrast Media or Other Fluids C. Additional Tests for Catheters Intended for In-Stent Restenosis or for Stent Expansion following Stent Deployment IX.    Animal Testing X.     Clinical Information XI.    Sterilization and Shelf Life A. Sterilization B. Shelf Life XII.   Labeling Appendix A:Test Summary Appendix B: Applicable Standards Guidance for Industry and FDA Staff Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Guidance for Industry and FDA I. Introduction This 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 Register notice 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. Background FDA 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 to Section 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)s[1] and the section of CDRH’s Device Advice, How to Prepare a 510(k) Submission.[2]