FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1

{0}------------------------------------------------ Ostial Corporation 5 10(k) Notification: Flash-C PTCA Balloon Dilatation Catheter # OCT 1 1 #### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 5.0: - A. Submitter Information Submitter's Name: Address: Telephone: Fax: Contact Person: Date of Preparation: ## B. Subject Device Trade Name: Common/Usual Name: Classification Name: Ostial Corporation 510 Clyde Avenue Mountain View, CA 94043 650-903-9100 x 232 650-903-0119 Kaitlin von Hoffmann Clinical and Regulatory Associate July 20, 2012 Flash-C PTCA Balloon Dilatation Catheter Balloon Catheter Catheters, Transluminal Coronary Angioplasty, Percutaneous (21 CFR 870.5100, Product Code LOX) K122178 Pa ## C. Predicate Device Name(s) Primary Predicate: Trade Name(s): Classification Name: Secondary Predicate: Classification Name: Maverick XL Monorail PTCA Dilatation Catheter, P860019/S183 Catheters, Transluminal Coronary Angioplasty, Percutaneous (21 CFR 870.5100, Product Code LOX) Flash-C PTCA Balloon Dilatation Catheter, K113775 Catheters, Transluminal Coronary Angioplasty, Percutaneous (21 CFR 870.5100, Product Code LOX) #### D. Device Description: Trade Name(s): The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature. The Flash-C PTCA Balloon Dilatation Catheter is a .014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring and a working length of 135cm. The Flash-C PTCA Balloon Dilatation Catheter uses a dual balloon design that features a compliant anchoring balloon, which prevents distal migration of the balloon during angioplasty. The second semi-compliant higherpressure balloon allows for luminal dilatation of de novo lesions and post deployment stent expansion. ### E. Intended Use: The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature. {1}------------------------------------------------ Ostial Corporation 510(k) Notification: Flash-C PTCA Balloon Dilatation Catheter ## F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use: The purpose of this Traditional 510(k) is to seek an expanded indication for six of the Flash-C PTCA Balloon Dilatation Catheter models cleared by 510(k) #K113775 on June 29, 2012. In accordance with the current thinking of the FDA as reflected by The 510k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Draft Guidance dated December 27, 2011, Ostial Corporation is claiming two predicates for the subject device. The expanded indication for the subject Flash-C PTCA Balloon Dilatation Catheter is consistent with the overall intended use of the predicate devices, namely balloon dilatation of a coronary artery, bypass graft or stent. Substantial equivalence was established between the first iteration of the Flash-C PTCA Balloon Dilatation Catheter and the primary predicate Maverick XL Monorail PTCA Balloon Dilatation Catheter via the original Traditional 510(k) for the device product line, #K111284 cleared on August 17, 2011. The expanded indications for use for the Flash-C PTCA Balloon Dilatation Catheter is identical to the Maverick XL Monorail PTCA Balloon Dilatation Catheter. The Maverick XL device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Maverick XL balloon catheter is also indicated for the post delivery expansion of balloon expandable stents. With respect to the subject device, the Maverick catheter features equivalent indications for use, design, packaging, fundamental technology, manufacturing and sterilization. The secondary predicate Flash-C PTCA Balloon Dilatation Catheter was cleared with an indication that is a subset of the proposed expanded indications for use are being modified to add an indication for the post delivery expansion of balloon expandable stents within the coronary vasculature. The predicate and subject Flash-C PTCA Balloon Dilatation Catheters are the same device. No design modifications or changes to packaging, manufacturing or sterilization have been made since the clearance of the predicate Flash-C device. The subject device and predicate devices are substantially equivalent in terms of intended use, fundamental scientific technology, target population, and operating principles. #### G. Performance Data: Biocompatibility testing has previously been completed on the Flash-C PTCA Balloon Dilatation Catheter. Requirements for biological evaluation of the proposed device were based on the Blue Book Memorandum issued on May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed: - ISO MEM Elution Assay - ASTM Hemolysis Assay - Complement Activation C3a and SC5b-9 Assay - Thromboresistance Evaluation - Materials Mediated Rabbit Pyrogen - ISO Guinea Pig Maximization Sensitization K122178 Page 2 of 3 - ISO Acute Systemic Injection Test - ISO Intracutaneous Reactivity Test - Pyrogen (LAL) Chromogenic {2}------------------------------------------------ Ostial Corporation 510(k) Notification: Flash-C PTCA Balloon Dilatation Catheter > The Flash-C PTCA Balloon Dilatation Catheter was evaluated using the following in-vitro performance bench testing to confirm the performance characteristics as compared to the predicate device: - . Balloon Crossing Profile - Catheter Shaft Diameter - Catheter Working Length . - Catheter Inner Diameter . - Angioplasty Balloon Rated Burst Pressure . - Anchoring Balloon Burst Volume t - . Angioplasty Balloon Compliance - . Balloon Inflation Time - Balloon Deflation Time - Angioplasty Balloon Rated Burst Pressure (in Stent) - Anchoring Balloon Burst Volume (in Stent) - Angioplasty Balloon Fatigue - Anchoring Balloon Fatigue - Catheter Bond Strength - Catheter Tip Pull Strength - Catheter Torque Strength - Simulated Use - Flexibility and Kink Resistance - Radiopacity - Angioplasty Balloon Fatigue (in Stent) - Anchoring Balloon Fatigue (in Stent) All test results demonstrate that the device materials, the manufacturing process, and the design for the Flash-C PTCA Balloon Dilatation Catheter met the established specifications necessary for consistent performance according to its intended use. ### H. Conclusions: The Flash-C PTCA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, test protocols, and/or customer inputs. The Flash-C PTCA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate devices and does not raise any new safety or effectiveness questions. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 1 2012 Ostial Corporation c/o Ms. Kaitlin von Hoffmann 510 Clyde Avenue Mountain View, CA 94043 Re: K122178 Trade/Device Name: Flash-C PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Standard Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: July 20, 2012 Received: July 23, 2012 Dear Ms. von Hoffmann: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must {4}------------------------------------------------ ## Page 2 - Ms. von Hoffman comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. .g. billah Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Ostial Corporation S 10(k) Notification: Flash-C PTCA Balloon Dilatation Catheter ## SECTION 4.0: INDICATIONS FOR USE STATEMENT K122178 510(k) Number: Flash-C PTCA Balloon Dilatation Catheter Indication For Use: Device Name: The Flash-C PTCA Balloon Dilatation Catheter is indicated for balloon The I last Of TOT Banconting of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Flash-C PTCA Balloon Dilatation Catheter is also indicated for the post delivery expansion of balloon expandable stents within the coronary vasculature. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) MAST (Division Sign-Off) Division of Cardiovascular Devices 122178 510(k) Number_