Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. April 19, 2023 Medtronic Inc. Anna Wetherille Sr. Regulatory Affairs Specialist 8200 Coral Sea St. NE Mounds View, Minnesota 55112 Re: K223168 Trade/Device Name: Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Code: QWF Dated: March 15, 2023 Received: March 16, 2023 Dear Anna Wetherille: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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The background is white. for Nicole Gillette 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) K223168 Device Name Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface Indications for Use (Describe) The Medtronic tubing and accessories sets for extracorporeal membrane oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent. Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> 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}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness | Date Prepared: April 18, 2023 | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establish Registration Number: 2184009 | | Contact Person: Anna Wetherille<br>Senior Regulatory Affairs Specialist<br>Phone: (763) 514-9842<br>Fax: (763) 367-8361<br>E-mail: anna.wetherille@medtronic.com<br><br>Juli Rubin (Alternate)<br>Senior Regulatory Affairs Program Manager<br>Phone: (763) 526-2357<br>Email: juli.c.rubin@medtronic.com | | Trade Name: Tubing and Accessories Sets for Extracorporeal Membrane<br>Oxygenation (ECMO) Balance™ Biosurface | | Common Name: Extracorporeal Life Support Circuit and Accessories | | Classification Name: Extracorporeal circuit and accessories for long-term<br>respiratory/cardiopulmonary failure | | Classification: Class II (with special controls) | | Regulation Number: 21 CFR 870.4100 | | Product Code: QWF | | Name of Predicate Device: FDA Final Order 81 FR 7451, February 12, 2016 | | Name of Reference Device: Tubing Pack (K171979) | {4}------------------------------------------------ ### Device Description: The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface ("eSets") contain components used to prepare an extracorporeal circuit for extracorporeal membrane oxygenation (ECMO) and extracorporeal life support (ECLS) procedures. The Base eSet Model BB22LSB contains a preassembled drainage and return loop, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The Accessory eSet Model BB22LSA contains nonstandard components to supplement the basic extracorporeal circuit, as needed per case and hospital protocols. This product is nonpyrogenic, is intended for single use, and has been sterilized using ethylene oxide. Maximum transit temperature: 50°C (122°F). Standard storage conditions are sufficient to safeguard the device. Store the device in the original packaging at room temperature in a dry place. Bench studies were performed after device preconditioning including exposure (up to 21 days) to simulated in vivo use conditions to demonstrate safety and reliability. #### Indication for Use: The Medtronic tubing and accessories sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance biosurface are indicated for use in ECMO and extracorporeal life support (ECLS) procedures for adult patients with acute respiratory failure or acute cardiopulmonary failure, when other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent. ### Comparison to Predicate (Special Controls): Substantial equivalence evaluation includes a comparison to requirements in the FDA Final Order 81 FR 7451, February 12, 2016, as well as a comparison to the Reference Device. Per FDA Final Order (81 FR 7451) membrane lung devices for long-term pulmonary support, a preamendment class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, were redesignated and reclassified to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. The Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface device meets all special controls identified in 21 CFR 870.4100, as follows: - Technological Characteristics: The geometry and design parameters of the subject ● device are consistent with the device's intended use in extracorporeal support procedures, and the device is compatible with the other devices and accessories in the extracorporeal circuit. - Biocompatibility: The subject device is demonstrated to be biocompatible in ● accordance with ISO 10993-1:2018 and with FDA guidance document Use of {5}------------------------------------------------ International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (4 September 2020). - Sterility and Shelf-life: Sterilization adoption evaluation and shelf-life testing ● demonstrate that the subject device maintains its sterility, integrity, durability, and reliability over the stated shelf life of the device. - Non-clinical Performance: Substantial equivalence of the performance characteristics ● is demonstrated on bench, mechanical integrity, durability, and reliability testing. - Labeling: The Instructions for Use include a detailed summary of the non-clinical ● evaluations pertinent to use of the device in an extracorporeal circuit and adequate instructions with respect to anticoagulation, circuit setup, performance characteristics with respect to compatibility among different devices and accessories in the circuit, and maintenance during a procedure. ### Comparison to Reference Device: A comparison of the Medtronic Tubing and Accessories Sets for ECMO with Balance™ Biosurface to the reference device indicates the following similarities: - Similar intended use, the only exception is the extended duration of extracorporeal support. - Same technological characteristics ● - Same operating principle - Same design features ● - Similar materials, the only exception is the new TOTM plasticizer used for the ● prolonged use components - Same shelf life, the subject device has a 2-year shelf life ### Summary of Performance Data In vivo pre-clinical and clinical studies involving patients or animals were not necessary to demonstrate the safety and performance of the subject device. Pre-clinical bench testing was used to verify the performance characteristics of this device. The following preclinical bench studies were conducted: - 21-day Simulated use durability testing ● - Tensile strength after life conditioning (long term use) - Pressure test after life conditioning (long term use) ● - Functional testing - Kink testing ● - Blood trauma testing ● - Coating coverage ● {6}------------------------------------------------ ## Conclusion: The data included in this submission are sufficient to demonstrate that the Medtronic Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface meets the special controls in FDA's Final Order (81 FR 7451, Redesignation as Extracorporeal Circuit and Accessories For Long- term Respiratory/cardiopulmonary Failure (ECMO), February 12, 2016), to connect perfusion devices and circulate blood as part of an extracorporeal circuit for use in Extracorporeal Membrane Oxygenation (ECMO) and Extracorporeal Life Support (ECLS) procedures.