← Product Code [DTN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN) · K011864 # TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B (K011864) _Medtronic Vascular · DTN · Jul 9, 2001 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K011864 ## Device Facts - **Applicant:** Medtronic Vascular - **Product Code:** [DTN](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN.md) - **Decision Date:** Jul 9, 2001 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 870.4400 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular - **Attributes:** Therapeutic ## Intended Use The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump. ## Device Story The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is a perfusion device used in clinical settings to manage cardioplegia delivery during surgery. It accepts arterial blood from an oxygenator and asanguineous cardioplegia solution as inputs. The device mixes these fluids in a predetermined ratio and passes them through a heat exchanger to warm or cool the mixture. The final output is delivered to the patient via a cannula, driven by a single occlusive roller pump. The system incorporates a Trillium™ biopassive surface coating on blood-contacting pathways to improve hemocompatibility. It is operated by perfusionists or surgical staff in an operating room environment. The device assists in myocardial protection by providing temperature-controlled cardioplegic solutions, directly impacting the patient's cardiac status during bypass procedures. ## Clinical Evidence No clinical data. Substantial equivalence is supported by in vitro bench testing, including evaluation of coating characteristics (leaching), physical characteristics (pressure integrity, priming volume), and performance characteristics (ease of prime, heat exchanger performance, pressure drop, and blood trauma). ## Technological Characteristics The device is a cardioplegia delivery system featuring a Trillium™ biopassive surface coating on blood-contacting surfaces. It utilizes a heat exchanger for thermal regulation and is designed for use with a single occlusive roller pump. The device is a modification of an existing system, maintaining the same materials and manufacturing processes, with the coating being the sole technological change. ## Regulatory Identification A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation. ## Special Controls *Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. ## Predicate Devices - MYOtherm™ XP Cardioplegia System ([K971105](/device/K971105.md)) - AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface ([K973760](/device/K973760.md)) ## Related Devices - [K971105](/device/K971105.md) — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM · Avecor Cardiovascular, Inc. · Jul 11, 1997 - [K012898](/device/K012898.md) — MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM · Cobe Cardiovascular, Inc. · Sep 17, 2001 - [K162958](/device/K162958.md) — MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge · Medtronic, Inc. · Feb 1, 2017 - [K964571](/device/K964571.md) — VISION CARDIOPLEGIA DELIVERY SYSTEM · Lifestream Int'L, Inc. · Aug 8, 1997 - [K973475](/device/K973475.md) — CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) · Medtronic Vascular · Nov 20, 1997 ## Submission Summary (Full Text) {0}------------------------------------------------ # JUL = 9 2001 ## SUMMARY OF SAFETY AND EFFECTIVENESS ## COMPANY AND CONTACT PERSON Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: ... (763) 391-9136 FAX: (763) 391-9603 Stephani K. Ayala, Regulatory Affairs Specialist, Regulatory Affairs #### DEVICE NAME Trillium™ MYOtherm™ XP Cardioplegia Delivery System ## NAME OF PREDICATED OR LEGALLY MARKETED DEVICE MYOtherm™ XP Cardioplegia Delivery System (K971105) AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760) ## DESCRIPTION OF DEVICE The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is designed to mix arterial blood from oxygenators with asanguineous cardioplegja solution. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. #### STATEMENT OF INTENDED USE The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump. ## STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE The MYOtherm" XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump. ## STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence". Special 510 (k) Notification Medtronic, Inc. Medtronic Perfusion Systems Trillium™ MYOtherm™ XP Cardioplegt Delivery System June 8, 2001 .. Confidential {1}------------------------------------------------ ## DETERMINATION OF SUBSTANTIAL EQUIVALENCE This "SPECIAL 510(k)" is being submitted for a modification to the MYOtherm" XP Cardioplegia System. The modification to the current MYOtherm " XP Cardioplegia System is to coat the blood contact surfaces with Trillium". The Trillium™ MYOtherm" XP Cardioplegia Delivery System is being compared to the following Marketed Devices: - MYOtherm™ XP Cardioplegia System (K971105) . - AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760) The Trillium™ MYOtherm" XP Cardioplegia Delivery System has the same indications statement and intended uses as the: - MYOtherm™ XP Cardioplegia System (K971105) . The Trillium™ MYOtherm™ XP Cardioplegia Delivery System has "no new technological characteristics (e.g., materials and manufacturing processes)" from the MYOtherm Cardioplegia System. The technological characteristic is solely the coating material of the blood pathway: - Trillium™ . The technological characteristic of the Trillium™ Biopassive Surface is common to other hollow fiber oxygenators currently in commercial distribution as follows: - AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760) This technological characteristic "could affect the safety and effectiveness of the device". However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics". "Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the Trillium" MYOtherm XP Cardioplegia Delivery System is substantially equivalent to other marketed cardioplegia delivery systems. Special 510 (k) Notification Medtronic, Inc. Medtronic Perfusion Systems Trillium " MYOtherm" XP Cardioplegla Delivery System June 8, 2001 Confidential {2}------------------------------------------------ K011864 p3 of 3 The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium™ MYOtherm™ XP Cardioplegia Delivery System does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed cardioplegia delivery system. The in vitro bench testing included analysis of: Coating Characteristics - Coating . - Leaching . Physical Characteristics - Pressure integrity . - Priming volume ● Performance Characteristics - Ease of prime . - Heat exchanger performance . - Pressure drop 4 - Blood trauma 대 Special 510 (k) Notification Medtronic, Inc. Medtronic Perfusion Systems Trillium™ MYOtherm™ XP Cardioplegia Delivery System June 8, 2001 Confidential {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three figures representing health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 9 2001 Medtronic Perfusion Systems c/o Ms Marie Holm Associate Product Regulations Manager 7611 Northland Drive N Minneapolis, MN 55428.1088 Re: K011864 Trade Name: Trillium™ MYOtherm™ XP Cardioplegia Delivery System (Models: XP41T and XP41BT) Regulation Number: 870.4400 Regulatory Class: II (Two) Product Code: DTN Dated: July 5, 2001 Received: July 5, 2001 Dear Ms. Holm: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might {4}------------------------------------------------ Page 2 - Ms Marie Holm have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, (301) 59 reter the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, [signature] James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ ## Indications for Use ### K011864 Device Name: Trillium™ MYOtherm™ XP Cardioplegia Delivery System Indications for Use: The Trillium™ MYOtherm™ XP Cardioplegia Delivery System is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Per 21 CFR 801.109 OR Over-The-Counter-Use pöller Division of Cardiovascular & Respiratory Devices 510(k) Number K011864 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K011864](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTN/K011864) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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