Arrow FiberOptix Intra-Aortic Balloon Catheter Kit

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. April 9, 2020 Arrow International Inc. Apurva Gokhale Senior Regulatory Affairs Specialist 16 Elizabeth Drive Chelmsford, Massachusetts 01824 Re: K200634 Trade/Device Name: FiberOptix Intra-Aortic Balloon Catheter Kit Regulation Number: 21 CFR 870.3535 Regulation Name: Intra-Aortic Balloon And Control System Regulatory Class: Class II Product Code: DSP Dated: March 6, 2020 Received: March 10, 2020 Dear Apurva Gokhale: 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). 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200634 #### Device Name FiberOptix® Intra-Aortic Balloon Catheter Kit Indications for Use (Describe) The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically indicated for use in any of the following conditions: 1. Acute Coronary Syndrome 2. Cardiac and Non-Cardiac Surgery 3. Complications of Heart Failure Type of Use (Select one or both, as applicable)| | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 2. 510(k) Summary [As required by 21 CFR 807.92] Date Prepared: 6 March 2020 | Submitter | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>16 Elizabeth Drive<br>Chelmsford, MA 01824<br>Establishment Registration: 3010532612 | |-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------| | | Arrow International, Inc. (Subsidiary of Teleflex, Inc.)<br>Reading, PA 19605<br>Owner/ Operator: 2518433 | | Company Contact | Apurva N. Gokhale<br>Sr. Regulatory Affairs Specialist<br>Arrow International, Inc.<br>16 Elizabeth Drive<br>Chelmsford, MA 01824 | Apurva.gokhale@teleflex.com | Regulatory Information | | |------------------------|--------------------------------------------------| | Proprietary Name: | FiberOptix® Intra-Aortic Balloon Catheter Kit | | Common Name: | System, Balloon, Intra-Aortic and Control System | | Product Code: | DSP | | Regulation #: | 870.3535 | | Description: | Intra-aortic balloon & control system | | Regulatory Class: | Class II | Phone: 978-250-5100 extension 722202 - Leqally Marketed ● K190117 Arrow FiberOptix IAB (Arrow International, Inc. - Cleared June 13, Predicate Device 2019)- Primary Predicate The FiberOptix® Intra-Aortic Balloon (IAB) Catheter consists of an inflatable balloon, Device Description which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon. > The FiberOptix® IAB Catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB catheter tip inner surface. > The FiberOptix® IAB Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip. {4}------------------------------------------------ The FiberOptix® IAB Catheter is utilized for intra-aortic balloon counterpulsation Intended Use therapy in the aorta, whereby balloon inflation, during diastole and deflation during systole increases blood supply to the heart muscle and decreases work of the left ventricle. The FiberOptix® IAB Catheter with the Intra-Aortic Balloon Pump as a control Indications for Use system is clinically indicated for use in any of the following conditions: - 1. Acute Coronary Syndrome - 2. Cardiac and Non-Cardiac Surgery - 3. Complications of Heart Failure The subject FiberOptix® IAB catheter is similar in design and identical in Technological indications for use to the predicate devices. Arrow Intra-Aortic Balloon Fiber Optic Characteristics Comparison Sensor/ Fiber Optic Measurement System and Arrow FiberOptix IAB Catheter. Compared to the predicate devices, the subject FiberOptix® IAB has a modified configuration of the fiber optic sensor along the distal length of the IAB catheter to improve its robustness. > The technological differences between the subject and the predicate devices have been evaluated through bench tests to provide evidence that the FiberOptix® IAB Catheter is substantially equivalent to the predicate devices. The modified design of the FiberOptix® IAB Catheter has been verified through the following tests: - Insertion, Durability Test & (FOS) Static Pressure Test ● - . Simulated Misuse Test & (FOS) Static Pressure Test The results of the verification test met the specified acceptance criteria and performed similar to the predicate device. The testing demonstrates that the subject FiberOptix® IAB catheter is substantially equivalent to the predicate device. The subject FiberOptix® IAB Catheter is substantially equivalent to the Substantial specified predicate device, FiberOptix® IAB Catheter (K021462 and K190117) Equivalence Conclusion based on a comparison of the device functionality, materials, technological characteristics, and indications for use. The device modifications and results of design verification tests do not raise new or different questions of safety or effectiveness; therefore, the subject device is substantially equivalent to the predicate device.