MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC

{0}------------------------------------------------ Kb82965 ## JAN ] 2 2009 ### 510(K) SUMMARY OFFICIAL CONTACT: Fortunato (Tito) Aldape Director of Regulatory Affairs, CT SBU MEDRAD, Inc. One MEDRAD Drive Indianola, PA 15051 (412) 767-2400 ext. 4013 CLASSIFICATION NAME: Injector with Syringe, Angiographic Powered Injector with Syringe COMMON NAME(S): PROPRIETARY NAME: MEDRAD Stellant CT Injector System with P3TTM Cardiac PREDICATE DEVICES: MEDRAD Stellant CT Injector System with P3T™ CardiacFlow (K072886) ### Stellant Injector System INTENDED USE: P3T™ Cardiac is intended for use with CT Angiography. P3T™ Cardiac computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection. ### P3TTM Cardiac Software Accessory INTENDED USE: P3T™ Cardiac is intended for use with CT Angiography. P3T™ Cardiac computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection. INDICATIONS FOR USE: P3T™ Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE: The MEDRAD Stellant CT Injector System with P3T™ Cardiac is a syringe-based fluid delivery system indicated for delivery of contrast media during computed tomography procedures. The MEDRAD Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. {1}------------------------------------------------ MEDRAD Stellant CT Injector System operating software includes P3T™ Cardiac, an optional, password-enabled software accessory. The injector system, when used with P3T™ Cardiac, maintains the same intended use, same operational parameters, and same labeling (with the addition of the P3T™ Cardiac operation manual), and is used in the same manner as the injector system without the software accessory. The P3T™ Cardiac software accessory provides the convenience of generating patientspecific contrast injection protocols, and increases the consistency of individualized injection protocols among technologists. The purpose of this submission is to obtain FDA clearance of the expansion of the indications of MEDRAD's previously cleared device, Stellant CT Injector System with P3T™ CardiacFlow. A comparison of features and principles of operation between the proposed device and predicate device is provided in Table 1 on the following page. {2}------------------------------------------------ Table 1: Comparison of Stellant Injector System with P3T™ CardiacFlow (K072886) to Stellant Injector System with P3T™ Cardiac. | Feature | Proposed Device:<br>Stellant CT Injector System<br>with P3T™ Cardiac | Predicate Device:<br>Stellant CT Injector System<br>with P3T™ CardiacFlow<br>(K072886) | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The MEDRAD Stellant CT<br>Injector System is intended for<br>the specific purpose of injecting<br>intravenous contrast media into<br>humans for diagnostic studies in<br>computed tomography (CT)<br>applications.<br><br>The P3T™ Cardiac software<br>accessory computes individual<br>contrast injection protocols and<br>scan timing, based on patient<br>characteristics, scanner<br>parameters and contrast<br>concentration. | The MEDRAD Stellant CT<br>Injector System is intended for<br>the specific purpose of injecting<br>intravenous contrast media into<br>humans for diagnostic studies in<br>computed tomography (CT)<br>applications.<br><br>The P3T™ CardiacFlow software<br>accessory computes individual<br>contrast injection protocols and<br>scan timing, based on patient<br>characteristics, scanner<br>parameters and contrast<br>concentration. | | Indications | P3T™ Cardiac is indicated for<br>use with CT Angiography of the<br>cardiac structures, coronary<br>arteries, chambers of the heart,<br>pulmonary vasculature, thoracic<br>and abdominal aorta. | The P3T™ CardiacFlow software<br>accessory is intended for use in<br>CT angiography of cardiac<br>structures, including coronary<br>arteries, chambers of the heart,<br>and thoracic and abdominal<br>aorta during gated ECG<br>acquisition. | | User Interface | The P3T™ software accessory<br>can be turned on or off by the<br>user for any given injection The<br>user will be required to<br>confirm/change the suggested<br>protocol before beginning an<br>injection. | The P3T™ software accessory<br>can be turned on or off by the<br>user for any given injection The<br>user will be required to<br>confirm/change the suggested<br>protocol before beginning an<br>injection. | | Single or Dual Syringe<br>System | Dual syringe model | Dual syringe model | | Information Display | Color LCD | Color LCD | | Programming Keys | Non-dedicated keys - software<br>determined | Non-dedicated keys - software<br>determined | | Feature | Proposed Device:<br>Stellant CT Injector System<br>with P3T TM Cardiac | Predicate Device:<br>Stellant CT Injector System<br>with P3TTM CardiacFlow<br>(K072886) | | Multi-Phase | Up to 6 phases per P3TTM<br>injection protocol | Up to 6 phases per P3TTM<br>injection protocol | | Arming Modes | Single | Single | | Protocol<br>Storage/Recall<br>Capability | 32 protocols | 32 protocols | | Hold Capability | 20 minutes max. | 20 minutes max. | | Safety Stop<br>Mechanism | Multi-layered software stops<br>with backup monitoring | Multi-layered software stops<br>with backup monitoring | | Syringe System | Single syringe model: 200 ml<br>syringe<br>Dual syringe model: two 200 ml<br>syringes | Single syringe model: 200 ml<br>syringe<br>Dual syringe model: two 200 ml<br>syringes | | Programmed Volume | 1 to 200 ml | 1 to 200 ml | | Volume Remaining<br>Readout | LED on injector head; graphical<br>and numeric on LCD | LED on injector head; graphical<br>and numeric on LCD | | Fill Rate | Variable up to 10 mL/sec | Variable up to 10 mL/sec | | Flow Rate | 0.1mL/sec to 10.0 mL/sec | 0.1mL/sec to 10.0 mL/sec | | Programmable<br>Pressure Limit | 325 psi default, user settable 50 to<br>325 psi | 325 psi default, user settable 50 to<br>325 psi | | Pause | Programmable - 1 sec to 900 sec in<br>1 sec increments | Programmable – 1 sec to 900 sec in<br>1 sec increments | | Autofill | Fill rate 4 mL/sec | Fill rate 4 mL/sec | | Retract Control | Yes (Automatic) | Yes (Automatic) | | Remote Start Switch | Yes | Yes | | Pressure Graph | Yes | Yes | | Syringe Sensing | Yes | Yes | | Autoload | Yes | Yes | | Auto<br>Dock/Retract/Advance | Yes; user-selectable autodock and<br>advance; user-selectable auto-<br>retract | Yes; user-selectable autodock and<br>advance; user-selectable auto-<br>retract | | Protocol Lock /<br>Remote Arming | Yes | Yes | | Check for Air | Yes | Yes | | Scan Delay | 1 sec to 300 sec in 1 sec<br>increments | 1 sec to 300 sec in 1 sec<br>increments | | Test Inject | Yes | Yes | | Feature | Proposed Device:<br>Stellant CT Injector System<br>with P3TTM Cardiac | Predicate Device:<br>Stellant CT Injector System<br>with P3TTM CardiacFlow<br>(K072886) | | Maintainer | | | | Flow Profile Display | Yes | Yes | | Imaging System<br>Interface (ISI) | Yes | Yes | | Functionality | | | {3}------------------------------------------------ and the comments of the comments of the comments of {4}------------------------------------------------ : : {5}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MEDRAD, Inc. c/o Mr. Fortunato (Tito) Aldape Director of Regulatory Affairs, CT SBU One MEDRAD Drive Indianola, PA 15051 JAN ] 2 2009 Re: K082905 > Trade/Device Name: P3TTM Cardiac Common Name: Angiographic injector and syringe Regulation Number: 21 CFR 870.1650 Regulatory Class: II Product Code: DXT Dated: December 21, 2008 Received: December 30, 2008 Dear Mr. Fortunato: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Mr. Fortunato (Tito) Aldape 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Duna R. Vuchiner A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ### Indications for Use ## 510(k) Number (if known): K082905 # Device Name: P3TTM Cardiac Indications for Use: INTENDED USE: P3TTM Cardiac is intended for use with CT Angiography. P3TTM Cardiac computes individual contrast injection protocols and scan timing, based on patient characteristics, scanner parameters and contrast concentration. The user will be required to confirm/change the suggested protocol before beginning an injection. INDICATIONS FOR USE: P3T™ Cardiac is indicated for use with CT Angiography of the cardiac structures, coronary arteries, chambers of the heart, pulmonary vasculature, and thoracic and abdominal aorta. ## Contraindications (if applicable): None Prescription Use ✔ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dunna D (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K082905