MC3 Crescent Jugular Dual Lumen Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 3, 2021 MC3, Inc. Martha Rumford VP Regulatory 2555 Bishop Circle West Dexter, Michigan 48130 Re: K203409 Trade/Device Name: MC3 Crescent™ Jugular Dual Lumen Catheter Regulation Number: 21 CFR 870.4100 Regulation Name: Extracorporeal Circuit And Accessories For Long-Term Respiratory/Cardiopulmonary Failure Regulatory Class: Class II Product Code: PZS Dated: March 26, 2021 Received: March 29, 2021 Dear Martha Rumford: 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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Sincerely, Nicole Gillette for Assistant Director (Acting) 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) K203409 #### Device Name MC3 Crescent™ Jugular Dual Lumen Catheter #### Indications for Use (Describe) The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use, dual lumen catheter that provides both venous drainage and reinfusion of blood via the jugular vein and is indicated for use in adult and pediatric patients with acute respiratory failure requiring Veno-Venous Extracorporeal Membrane Oxygenation, where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is simple and modern, with a focus on the company's name and area of expertise. ### 510(k) Summary MC3 Jugular Dual Lumen Catheter | Date Prepared: | May 3, 2021 | |------------------------------|----------------------------------------------------------------------------------------------------------------------| | Sponsor Information: | | | Owner/Applicant/Submitter: | MC3 Incorporated<br>2555 Bishop Circle West<br>Dexter, MI 48130<br>1-734-995-9089<br>Registration number: 3011468686 | | Contact Person: | Martha Rumford<br>VP Regulatory<br>2555 Bishop Circle West<br>Dexter, MI 48130<br>734.995.9089 | | Device Names/Classification: | | | Device Trade Name: | MC3 Crescent™ Jugular Dual Lumen Catheter | | Device Common Name: | Dual Lumen ECMO Cannula | | Regulation Name: | Extracorporeal circuit and accessories for long-term<br>respiratory/cardiopulmonary failure | | Regulation Number: | 21 CFR 870.4100 | | Product Code: | PZS | | Predicate Device: | Jugular Dual Lumen Catheter (K180151) | | Reference Devices: | Origen Reinforced Dual Lumen Cannula (K113869) | | | Avalon Elite Bi-Caval Dual Lumen Catheter (K081820) | # Indications for Use: The MC3 Crescent™ Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring Venous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent. Indications for use of the dual lumen catheters remains the same as the predicate device. ### Device Description: The MC3 Jugular Dual Lumen Catheters are dual lumen catheters supplied with an introducer to facilitate wire guided placement into the vasculature via percutaneous (Seldinger type) vascular access methods. The introducer is designed to follow a prepositioned standard guide wire (not included) or obturator (blunt end closed tip introducer) when following a surgical placement. The catheter is wire reinforced {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for MC3 Cardiopulmonary. The logo consists of a red abstract symbol on the left, followed by the text "MC3" in dark blue. Below "MC3" is the word "Cardiopulmonary" in a smaller font, also in dark blue. The logo appears to be for a medical or healthcare-related organization specializing in cardiopulmonary services. for flexibility and kink-resistance and includes depth marks. Both the introducer and catheter are made of radiopaque materials and the catheter also includes tantalum radiopaque markers at the infusion port, proximal and distal drainage holes, and the catheter tip. The catheter body contains an integrated suture site for use during securement. An optional suture collar is provided and can be used for supplemental securement only. A dilator is also included. The dilators are the same diameter of the catheter and are designed to be used for dilation of the vessel. These catheters are provided in a variety of sizes ranging from 13Fr (8.9 cm insertable length) to 32Fr (34 cm insertable length). # Comparison of Technological Characteristics to Predicate Device: The MC3 Dual Lumen Catheter product line is extended by scaling the design to include additional sizes. An optional blunt tipped introducer (obturator) and assembly stylet are added to the smallest diameter catheters. All materials and methods of manufacture are identical. # Class II Special Controls The subject MC3 Crescent™ Jugular Dual Lumen Catheter has demonstrated conformance to the Special Controls outlined in 21 CFR 870.4100 in a manner equivalent to the Predicate Device. The following information outlines how we conform. Because this product is a line-extension, a risk assessment determined when previous testing is applicable to the new design. Special Controls met are: - . Technological Characteristics: Geometry and design parameters are consistent with the devices intended use in extracorporeal life support procedures. The subject device is designed to be compatible with other extracorporeal circuit devices and accessories. - . Biocompatibility: The subject device is demonstrated to be biocompatible as a prolonged use device in accordance with ISO 10993-1:2009 and GLP (21 CFR 58), and pursuant to FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."" - . Sterility and Shelf-life: Testing demonstrates the sterility of the subject device as provided and that it maintains its sterility, integrity, durability, and reliability over the stated Shelf-life of the device. - . Non-clinical Performance: Substantial equivalence is demonstrated by performance characteristics on the bench, mechanical integrity, 30-day durability, and reliability for a longterm duration of use. - . In vivo Evaluation: 7-day in vivo thrombogenicity evaluation demonstrates the subject device's performance over a long-term duration of use in a biologic test system. - . Labeling: The instructions for use includes a detailed summary of the non-clinical and in vivo evaluations pertinent to the device's use in an extracorporeal circuit. Adequate instructions are also included with respect to anticoagulation, circuit setup, maintenance during a procedure, and performance characteristics relevant to compatibility among different devices and accessories in the circuit. Conclusion: The information and data included in this 510(k) Notification demonstrate that the subject MC3 Crescent™ Jugular Dual Lumen Catheter is substantially equivalent to the Predicate Device for both venous drainage and reinfusion of blood via the jugular vein during extracorporeal life support procedures in patients with acute respiratory or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent.