AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF

{0}------------------------------------------------ # 111912 JUL 2 7 2011 # 2 510(k) Summary The following page contains the 510(k) Summary. {1}------------------------------------------------ K III 972 Image /page/1/Picture/1 description: The image shows the Medtronic logo. On the left is a circular emblem with a figure in motion, possibly representing a person exercising or undergoing rehabilitation. To the right of the emblem is the word "Medtronic" in a bold, stylized font. The logo appears to be a representation of the company's focus on medical technology and improving health outcomes. # 510(k) Summary | Date Prepared: | July 6, 2011 | |-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Medtronic<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establish Registration Number: 2184009 | | Contact Person: | Jessica Sixberry<br>Senior Regulatory Affairs Specialist<br>Phone: (763) 514-9849<br>Fax: (651) 367-1893<br>Email: jessica.m.sixberry@medtronic.com | ### Device Name and Classification: | Product Family: | Centrifugal Blood Pumps | |----------------------|------------------------------------------------------| | Trade Name: | Affinity Blood Pumps, Bio-Pumps | | Common Name: | Centrifugal Blood Pump | | Regulation Number: | 870.4360 | | Product Code: | KFM | | Classification: | Class III | | Classification Name: | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | | Product Family: | MYOtherm Cardioplegia Delivery Systems | |----------------------|----------------------------------------| | Trade Name: | MYOtherm Cardioplegia Delivery Systems | | Common Name: | Cardioplegia Delivery | | Regulation Number: | 870.4240 | | Product Code: | DTR | | Classification: | Class II | | Classification Name: | Heat-Exchanger, Cardiopulmonary Bypass | | Product Family: | Arterial Blood Filters | |----------------------|------------------------------------------------------| | Trade Name: | Affinity Arterial Filters | | Common Name: | Arterial Blood Filters | | Regulation Number: | 870.4260 | | Product Code: | DTM | | Classification: | Class II | | Classification Name: | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | Product Family: Oxygenators Alleviating Pain · Restoring Health · Extending Life {2}------------------------------------------------ のお気になる。 | Product Family: | Oxygenators | |----------------------|---------------------------------------------------------------------------------------------| | Trade Name: | Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber,<br>Minimax Plus Oxygenator | | Common Name: | Hollow Fiber Oxygenators | | Regulation Number: | 870.4350 | | Product Code: | DTZ | | Classification: | Class II | | Classification Name: | Oxygenator, Cardiopulmonary Bypass | .. . . . - ・ September 1998 - 1999 - 1999 *** - | Product Family: | Cardiotomy/Venous Reservoirs | |----------------------|------------------------------------------| | Trade Name: | Affinity Cardiotomy/Venous Reservoirs | | Common Name: | Cardiotomy/Venous Reservoir | | Regulation Number: | 870.4400 | | Product Code: | DTN | | Classification: | Class II | | Classification Name: | Reservoir, Blood, Cardiopulmonary Bypass | | Product Family: | Venous Reservoir Bags | |----------------------|------------------------------------------| | Trade Name: | MVR Collapsible Venous Reservoir Bag | | Common Name: | Venous Reservoir Bag | | Regulation Number: | 870.4400 | | Product Code: | DTN | | Classification: | Class II | | Classification Name: | Reservoir, Blood, Cardiopulmonary Bypass | | Product Family: | Flow Probes | |----------------------|----------------------------------| | Trade Name: | Bio-Probe Flow Probe | | Common Name: | Flow Probe | | Regulation Number: | 870.2120 | | Product Code: | DPT | | Classification: | Class II | | Classification Name: | Probe, Blood-Flow, Extravascular | | Product Family: | Tri-Optic Measurement Cells | |----------------------|-----------------------------------------------------| | Trade Name: | Tri-Optic Measurement Cells | | Common Name: | Tri-Optic Measurement Cells | | Regulation Number: | 870.4330 | | Product Code: | DRY | | Classification: | Class II | | Classification Name: | Monitor, Blood-Gas, On-line, Cardiopulmonary Bypass | | Product Family: | Tubing and Connectors | |-----------------|-----------------------| |-----------------|-----------------------| {3}------------------------------------------------ # K111912 . | Product Family: | Tubing and Connectors | |----------------------|----------------------------------------------------------------| | Trade Name: | Extracorporeal Circuit Tubing and Connectors | | Common Name: | Tubing and Connectors | | Regulation Number: | 870.4210 | | Product Code: | DWF | | Classification: | Class II | | Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass | | Product Family: | Resting Heart System | |----------------------|----------------------------------------------------------------------------------------------------------| | Trade Name: | Resting Heart System | | Common Name: | Low Prime Extracorporeal Circuit | | Regulation Number: | 870.4400<br>870.4290 | | Product Code: | DTN<br>DTL | | Classification: | Class II | | Classification Name: | Reservoir, blood, Cardiopulmonary Bypass<br>Adapter, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | | Product Family: | Cardioplegia Adapters | |----------------------|----------------------------------------------------------------| | Trade Name: | DLP Cardioplegia Adapters | | Common Name: | Cardioplegia Adapters | | Regulation Number: | 870.7290 | | Product Code: | DTL | | Classification: | Class II | | Classification Name: | Adapter, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | | Product Family: | Aortic Root Cannula | | Trade Name: | DLP Aortic Root Cannula | | Common Name: | Aortic Root Cannula | | Regulation Number: | 870.4210 | | Product Code: | DWF | | Classification: | Class II | | Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass | | Product Family: | Arterial Cannula | |----------------------|----------------------------------------------------------------| | Trade Name: | DLP, Select, EOPA Arterial Cannula | | Common Name: | Arterial Return Cannula | | Regulation Number: | 870.4210 | | Product Code: | DWF | | Classification: | Class II | | Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass | . · {4}------------------------------------------------ .. . . . . : | Product Family: | Venous Cannula | |----------------------|----------------------------------------------------------------| | Trade Name: | DLP, MC2, MC2X, Single Stage, Two Stage, Three Stage Cannula | | Common Name: | Venous Cannula | | Regulation Number: | 870.4210 | | Product Code: | DWF | | Classification: | Class II | | Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass | | Product Family: | Femoral Cannula | |----------------------|------------------------------------------------------------------| | Trade Name: | DLP and Bio-Medicus, Femoral Arterial and Femoral Venous Cannula | | Common Name: | Femoral Cannula | | Regulation Number: | 870.4210 | | Product Code: | DWF | | Classification: | Class II | | Classification Name: | Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass | : ### Predicate Devices | Product Family: | Associated 510(k)s | |----------------------------------------------|------------------------------------------------------------------| | Centrifugal Blood<br>Pumps | K852807, K973011, K050109, K111658 | | | | | MYOtherm<br>Cardioplegia<br>Delivery Systems | K003724, K011864 | | | | | | | | Arterial Blood Filters | K000379, K013084, K033468, K071253 | | Oxygenators | K933586, K973760, K000430 | | Cardiotomy/Venous<br>Reservoirs | K926226, K936003, K021287 | | | | | Venous Reservoir<br>Bags | K920774 | | | | | Flow Probes | K830858, K012747 | | Tri-Optic<br>Measurement Cells | K910421, K012743 | | | | | Tubing and<br>Connectors | K891687, K902845, K012538 | | | | | Resting Heart<br>System | K031700 | | | | | Cardioplegia<br>Adapters | K790563, K790564, K791498, K841482, K850385 | | | | | Aortic Root Cannula | K790565, K810548, K834039, K865079 | | Arterial Cannula | K840001, K840002, K031037, K031518, K033416, K043179,<br>K061254 | {5}------------------------------------------------ | <strong>Product Family:</strong> | Associated 510(k)s | |----------------------------------|------------------------------------------------------| | Venous Cannula | K841275, K845045, K031776, K031827, K033264, K052372 | | Femoral Cannula | K872033, K875353, K884129, K915268, K924642, K052524 | ### Device Description No changes to the devices are being made. An additional source of the raw material used to make USP heparin used in Carmeda and Trillium coatings is being added. #### Indications for Use In general, these devices are intended for use during cardiopulmonary bypass surgery for up to 6 hours. No changes were made to the intended use of the individual devices. #### Comparison to Predicate Devices - Intended Use: All devices have the same intended use as their predicate devices. . - Principles of Operation and Technology: All devices have the same principle of . operation and technology as their predicate devices - Performance: Testing demonstrates that there is no coating performance difference . between the two sources of raw material for heparin. - Suppliers: The supplier of USP heparin remains the same. A new source of raw material . is being added. #### Summary of Performance Data Bench testing was used to establish the interchangability of the two sources of raw material for USP heparin used in Carmeda and Trillium coating. Animal and human clinical testing was not required to establish substantial equivalence. The following performance tests were conducted: - . Coating testing - Potency of Heparin . - . Chemistry testing #### Conclusion Medtronic has demonstrated that the new source of raw material for heparin is interchangeable with the current source of raw material for heparin based upon testing results. Therefore, the Carmeda and Trillium coated devices are substantially equivalent to the existing, predicate devices. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Medtronic Perfusion System c/o Ms. Jessica Sixberry Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428 JUL 2 7 2011 Re: K111972 Affinity Blood Pumps, Bio-Pumps Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller type cardiopulmonary blood pump Regulatory Class: Class III (three) Product Code: KFM, DTR, DTM, DTZ, DTN, DPT, DRY, DWF, DTL Dated: July 7, 2011 Received: July 11, 2011 Dear Ms. Sixberry: 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. 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. {7}------------------------------------------------ ### Page 2 - Ms. Jessica Sixberry If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, K Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### 1 Statement of Indications for Use The following page contains a representative 'indications for use' statement from each of the associated families that are included in this change. The following is a list of the associated families of Medtronic devices: - . Centrifugal Blood Pumps - MYOtherm Cardioplegia Delivery Systems . - Arterial Blood Filters . - . Oxygenators : - . Cardiotomy/Venous Reservoirs - Venous Reservoir Bags . - Flow Probes . - . Tri-Optic Measurement Cells - . Tubing and Connectors - . Resting Heart System - . Cardioplegia Adapters - . Aortic Root Cannula - . Arterial Cannula - Venous Cannula . - Femoral Cannula ● {9}------------------------------------------------ KIJ1972 510(k) Number (if known): _ Device Name: Affinity CP Centrifugal Blood Pump Indications for Use: The Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring completecardiopulmonary bypass (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). Prescription Use X OR Per 21 CFR 801.109 Over-The-Counter Use ... ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) K (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K111972 {10}------------------------------------------------ ### Device Name: Medtronic MYOtherm XP, Cardioplegia Delivery System Indications for Use: The MYOtherm XP® is a device intended for the mixing, warming/ cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. #### Device Name: Affinity Arterial Filter Indications for Use: The Affinity Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli. #### Device Name: Affinity Hollow Fiber Oxygenator with Plasma Resistant Fiber Indications for Use: The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. #### Device Name: Affinity NT Integrated CVR Membrane Oxygenator Indications for Use: The AFFINITY® NT Integrated CVR Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. #### Device Name: MVR Collapsible Venous Reservoir Bag Indications for Use: This product, is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator. The MVR® Holder (Model MVR-SH) is indicated for use with the MVR® Collapsible Venous Reservoir Bag. #### Device Name: Medtronic Coated Accessories (Flow Probes) Indications for Use: This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery. Device Name: Medtronic Coated Accessories (Tri-Optic Measurement Cells) Indications for Use: This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery. {11}------------------------------------------------ Device Name: Medtronic Packs and Accessories (Tubing and Connectors) Indications for Use: This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery. #### Device Name: Medtronic Resting Heart System Indications for Use: The Medtronic® Resting Heart™ Module is indicated for use in surgical procedures requiring extracorporeal circulatory support, gas exchange, and thermal regulation. The device is indicated for use in procedures requiring blood flow rate of 1-6 lpm and lasting up to six hours. The system is indicated for use only with the Bio-Console®. The VARD is indicated for use only with the AAR1000. The Bio-Pump+® Blood Pump in the Medtronic® Resting Heart™ Module is indicated for use only with the Bio-Console®. The Carmeda® AFFINITY® NT Oxygenator and Carmeda® AFFINITY® Arterial Filter in the Medtronic® Resting Heart™ Module have the same indications for use as a Carmeda® AFFINITY® NT Oxygenator and Carmeda® AFFINITY® Arterial Filter used in other extracorporeal circuits. Device Name: Medtronic DLP "Y" Adapter - Coronary Perfusion Indications for Use: This adapter is intended for use in conjunction with the delivery of cardioplegia solution. #### Device Name: Medtronic DLP Aortic Root Cannula Indications for Use: This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The #23009 cannula may also be used to monitor pressure in the aorta. #### Device Name: Medtronic EOPA 3D Arterial Cannula Indications for Use: These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. Device Name: Medtronic DLP Single Stage Venous Cannula Indications for Use: These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. {12}------------------------------------------------ Device Name: Medtronic DLP Femoral Arterial and Venous Cannula Indications for Use: This cannula is intended for rapid femoral venous and arterial access for short term cardiopulmonary bypass. : · 公司