CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS

{0} MAY 23 1996 K960755 # SUMMARY OF SAFETY AND EFFECTIVENESS ## COMPANY AND CONTACT PERSON Medtronic, Inc. Cardiopulmonary Division 4633 E. La Palma Avenue Anaheim, CA 92807 714-779-3700 Debra J. Kridner, Manager Regulatory Affairs ## DEVICE NAME CardioTherm™ Blood Cardioplegia Delivery Systems (CTXXX Series and CTXXXBR Series) ## NAME OF PREDICATE OR LEGALLY MARKETED DEVICE - Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems (K934355) - Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219) - Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171) - Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369) ## DESCRIPTION OF DEVICE Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios depending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery. The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow 510(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary February 22, 1996 Confidential Page 144 {1} fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water. The flow of solution through the Medtronic CardioTherm™ Blood Cardioplegia Heat Exchanger is as follows: ## Blood/Cardioplegia The blood and/or cardioplegia solution enters the bottom of the device, flows up through the polypropylene hollow fibers, flows back down a center collecting tube, and exits the from the bottom of the device. ## Water The cooling/warming water enters a side port, passes around the outside walls of the polypropylene fibers, then exits through a parallel side port. Heat exchange occurs as the blood/cardioplegia solution passes through the hollow fibers, while the temperature regulated cooling/warming water passes around the outside walls of the same fibers. The blood/cardioplegia solution is cooled/ warmed as it flows through the heat exchanger. By connecting tubing of specific inner diameters to the heat exchanger, a predetermined approximate ratio of blood to cardioplegia solution may be delivered to the patient. The tubing sets are manufactured with polyvinyl chloride tubing and polycarbonate/polyvinyl chloride connectors which are currently used as components in the commercially distributed Medtronic Extracorporeal InterSept™ Custom Tubing Packs (K800178) and Medtronic InterSept™ Crystalloid Cardioplegia Delivery System (K885154). Four of the various delivery ratios available are: 1. a tubing set for 1:1 ratio of blood to asanguineous cardioplegia. 2. a tubing set for 2:1 ratio of blood to asanguineous cardioplegia. 3. a tubing set for 4:1 ratio of blood to asanguineous cardioplegia. 4. a tubing set for 9:1 ratio of blood to asanguineous cardioplegia. These tubing ratios are common to commercially available blood cardioplegia systems; including the Medtronic Electromedics, Inc. Blood Cardioplegia Delivery Systems, the Gish Biomedical, Inc. Single Pass Blood Cardioplegia (SPBC) Systems, the Avecor Cardiovascular MYOtherm™ Cardioplegia Delivery Systems and the Sorin Biomedical BCD ADVANCED Blood Cardioplegia System. Tubing inner diameters for commercially available tubing sets generally range from 3/32" (2.4 mm) to 17/64" (6.7mm). 510(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary February 22, 1996 Confidential Page 145 {2} # STATEMENT OF INTENDED USE The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution. # STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES The Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems are intended to mix, cool, and deliver oxygenated blood/cardioplegia solution in a predetermined ratio. The Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems are intended to mix, cool/warm, and deliver oxygenated blood/cardioplegia solution. The Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems are intended to mix, cool, and deliver oxygenated blood/cardioplegia solution in a predetermined ratio. The Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System are intended to mix, cool/warm, and deliver oxygenated blood/cardioplegia solution. # STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON A table comparing the intended use and technological characteristics of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems with the four noted substantially equivalent devices is provided in Attachment I. # DETERMINATION OF SUBSTANTIAL EQUIVALENCE This premarket notification submission provides substantial equivalence information and rationale which addresses the introduction to commercial distribution of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia System. The Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are substantially equivalent to other Blood Cardioplegia Systems currently in commercial distribution. These predicate/marketed devices include: - Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems (K934355) - Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/K944219) - Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171) - Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369) The Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems have an intended use which is substantially equivalent to other Blood Cardioplegia Systems currently in commercial distribution. These predicate/marketed devices include: 510(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary February 22, 1996 Confidential Page 146 {3} - Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems (K934355) - Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/K944219) - Avecor Cardiovascular - MYOther™ Cardioplegia Delivery Systems (K904171) - Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369) The Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems have technological characteristics which are substantially equivalent to other Blood Cardioplegia Systems currently in commercial distribution. These predicate/marketed devices include: - Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems (K934355) - Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K89680/K944219) - Avecor Cardiovascular - MYOther™ Cardioplegia Delivery Systems (K904171) - Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369) The design, construction, materials and nominal specifications of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are either identical or substantially equivalent to other Blood Cardioplegia Systems currently in commercial distribution. These predicate/marketed devices include: - Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems (K934355) - Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/K944219) - Avecor Cardiovascular - MYOther™ Cardioplegia Delivery Systems (K904171) - Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369) 510(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary February 22, 1996 Confidential Page 147 {4} DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS | | Medtronic, Inc. CardioTherm™ Blood Cardioplegia System | Medtronic, Inc./Electromedics Inc. Blood Cardioplegia. Delivery Systems | Gish Biomedical, Inc. SPBC Blood Cardioplegia Systems | Avecor Cardiovascular MYOtherm™ Cardioplegia Delivery Systems | Sorin Biomedical BCD ADVANCED Blood Cardioplegia System | | --- | --- | --- | --- | --- | --- | | 510(k) Number: | This submission | K934355 | K896807 | K904171 | K925369 | | Catalog Number(s): | CT-XXX Series CT-XXXBR Series | D1081A, D1080A, D1082A | SPBC-XX Series SPBC-XXBR Series | MYOtherm™ XX Series MYOtherm™ XX BR Series | BCD ADV X Series (includes bridge/shunt system) | | Intended Use: | To mix, cool, warm and deliver oxygenated blood/cardioplegia solution. | To mix, cool, and deliver oxygenated blood/cardioplegia solution in a predetermined ratio. | To mix, cool/warm, and deliver oxygenated blood/cardioplegia solution. | To mix, cool, and deliver oxygenated blood/cardioplegia solution in a predetermined ratio. | To mix, cool/warm, and deliver oxygenated blood/cardioplegia solution. | | Performance Characteristics: | | | | | | | Heat Exchanger | | | | | | | Priming Volume (mL) | 46 | 55 | 83 | 68 | 55 | | Maximum Flow Rate (LPM) | 1 | 3 | not rated | not rated | .5 | | Fluid Path Pressure (maximum) | 500 mmHg | not rated | 300 mmHg | 500 mmHg | not rated | | Water Path Pressure (maximum) | 45 psi | 45 psi | 65psi | 40 psi | 80 psi | | Technological Characteristics: | | | | | | | Configuration | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger | | Heat Exchanger | | | | | | | Vent Port | Yes | Yes | Yes | Yes | Yes | | Bubble Chamber | Yes | Yes | Yes | Yes | Yes | | Temperature Well | Yes | Yes | Yes | Yes | Yes | | Pressure Monitoring Line | Yes | Yes | Yes | Yes | Yes | | Patient Delivery Line | Yes | Yes | Yes | Yes | Yes | | | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | 510(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary February 22, 1996 Confidential Page 148 {5} DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS | | Medtronic, Inc. CardioTherm™ Blood Cardioplegia System | Medtronic, Inc./Electromedics Inc. Blood Cardioplegia. Delivery Systems | Gish Biomedical, Inc. SPBC Blood Cardioplegia Systems | Avecor Cardiovascular MYOTherm™ Cardioplegia Delivery Systems | Sorin Biomedical BCD ADVANCED Blood Cardioplegia System | | --- | --- | --- | --- | --- | --- | | Materials | | | | | | | Heat Exchanger Housing Heat Exchanger | Polycarbonate Polypropylene | Polycarbonate Stainless steel | Polycarbonate Aluminum | Polycarbonate Stainless steel | Polycarbonate Aluminum | | Tubing Sets | Polyvinyl chloride Polycarbonate | Polyvinyl chloride Polycarbonate | Polyvinyl chloride Polycarbonate | Polyvinyl chloride Polycarbonate | Polyvinyl chloride Polycarbonate | | Specifications | | | | | | | Tubing Set Ratios | Separate sets (1:1, 2:1, 4:1 and 9:1) | Separate sets (1:1, 2:1 and 4:1) | Separate sets (1:1, 2:1, 4:1 and 9:1) | Separate sets (1:1, 2:1, 4:1 and 9:1) | Separate sets (1:1, 2:1, 4:1 and 8:1) | | Tubing Inner Diameter | 1/12 inch to 1/4 inch | 1/8 inch to 1/4 inch | 3/32 inch to 17/64 inch | 1/8 inch to 1/4 inch | 3/32 inch to 17/64 inch | | Ratio Capability | Variable (w/bridge clamps) (all blood, 1:1, 2:1, 4:1, 9:1 and all crystalloid with various tubing sets) | Variable (1:1, 2:1 and 4:1) | Variable (w/bridge clamps) (all blood, 1:1, 2:1, 4:1, 9:1, and all crystalloid with various tubing sets) | Variable (w/bridge clamps) (all blood, 1:1, 2:1, 4:1, 9:1, and all crystalloid with various tubing sets) | Variable (w/bridge clamps) (all blood, 1:1, 2:1, 4:1, 8:1, and all crystalloid with various tubing sets) | | Mode of Operation | This blood/cardioplegia system is used in the extracorporeal circuit for mixing, cooling, warming and delivery of oxygenated blood and/or cardioplegia solution. The multiple configurations allow the clinician the capability of providing varying ratios of blood to cardioplegia solution based on the patients’ clinical need. | This blood/cardioplegia system is used in the extracorporeal circuit for mixing, cooling, warming and delivery of oxygenated blood and/or cardioplegia solution. The multiple configurations allow the clinician the capability of providing varying ratios of blood to cardioplegia solution based on the patients’ clinical need. | This blood/cardioplegia system is used in the extracorporeal circuit for mixing, cooling, warming and delivery of oxygenated blood and/or cardioplegia solution. The multiple configurations allow the clinician the capability of providing varying ratios of blood to cardioplegia solution based on the patients’ clinical need. | This blood/cardioplegia system is used in the extracorporeal circuit for mixing, cooling, warming and delivery of oxygenated blood and/or cardioplegia solution. The multiple configurations allow the clinician the capability of providing varying ratios of blood to cardioplegia solution based on the patients’ clinical need. | This blood/cardioplegia system is used in the extracorporeal circuit for mixing, cooling, warming and delivery of oxygenated blood and/or cardioplegia solution. The multiple configurations allow the clinician the capability of providing varying ratios of blood to cardioplegia solution based on the patients’ clinical need. | 10(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary February 22, 1996 Confidential Page 149