EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle head with three lines representing its feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle head. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # JUN 1 9 2003 Mr. Steven Hartman Senior Project Engineer, CT Products E-Z-EM, Inc. 717 Main Street WESTBURY NY 11590 Re: K031571 Trade/Device Name: E-Z-EM EmpowerCTA Injector System with Optional EDA Regulation Number: 21 CFR 870.1650 Regulation Name: Automatic contrast medium injector Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 74 IZQ and 90 JAK Dated: May 19, 2003 Received: May 22, 2003 Dear Mr. Hartman: 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 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 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. {1}------------------------------------------------ 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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. Nancy C. Brogdon Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### هاء سه سه سه مسه # INDICATIONS FOR USE | 510(k) Application: | Special 510(k) Device Modification | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | E-Z-EM EmpowerCTA Injector System with optional EDA | | Indications for Use: | | | | CT Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body. | | | EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector. | Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |---------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | KC31571 | | Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use | |---------------------------------------|----|----------------------| |---------------------------------------|----|----------------------| . {3}------------------------------------------------ JUN 1 9 2003 K031571 ECEMI Visualize a healthier world ## EmpowerCTA Injector System 510(k) Summary #### Submitter's Information: Telephone Number: Fax Number: Contact: Date Prepared: Trade Name: Common Name: Classification Name: Predicate Device: E-Z-EM, Inc. 717 Main Street Westbury, NY 11590 (516) 333-8230, ext. 2345 (516) 333-8278 Steven Hartman, Senior Project Engineer, CT Injectors May 19, 2003 EmpowerCTA Injector System (Trademark Pending) CT Iniector Injector, Syringe, Extra-Luminal Plethysmograph, Impedance EmpowerCT Injector System, K011160 (Internal Project Name, and Name Used in the 510(k) Application: E-Z-EM PercuPump 2001 CT Injector) ### Indications for Use: CT Injector: Administration of nonionic and ionic compounds and flushing media in conjunction with computed tomography (CT) scanning of the body. The EDA is intended to detect extravasations of ionic and non-ionic contrast media during powered CT contrast injections. #### Device Description: The EmpowerCTA Injector System is an injection system that uses one or two consumable syringe(s) to displace contrast media and flushing media to the patient. A motor driven linear actuator controls displacement of the syringe piston. This method of contrast injection is consistent with predicate devices from E-Z-EM for over 12 years. This new version of the EmpowerCT Injector family addresses the addition of a second syringe for the device for purposes of displacing flushing media. A summary of the device as compared to the predicate device is as follows: E-Z-EM EmpowerCTA 510(k) Submission Summary Page 1 of 9 {4}------------------------------------------------ ### Comparative Summary Tables | | Proposed Device | Predicate Device | |--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | | EmpowerCTA Injector | EmpowerCT Injector<br>(PercuPump 2001) | | Indication for Use | Administration of nonionic<br>and ionic compounds and<br>flushing media in conjunction<br>with computed tomography<br>(CT) scanning of the body | Administration of<br>nonionic and ionic<br>compounds in<br>conjunction with<br>computed tomography<br>(CT) scanning of the<br>body | | Design | Syringe type injector,<br>software controlled, venous<br>side, low pressure injector. | Same | | Anatomical Sites | Inject contrast and flushing<br>media into a peripheral vein | Inject contrast media into<br>a peripheral vein | | Radiation | No ionizing radiation emitted | Same | | Thermal | No thermal energy introduced<br>into patient | Same | . : : : E-Z-EM EmpowerCTA 510(k) Submission Summary Page 2 of 9 {5}------------------------------------------------ | | Proposed Device<br>EmpowerCTA Injector | Predicate Device<br>EmpowerCT Injector<br>(Percupump 2001) | |--------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Injector Head | Located Adjacent to CT Scanner<br>Gantry via Floor or Overhead<br>Mounting | Same | | Power Supply | Switching Power Supply in<br>Dedicated Enclosure | Switching Power Supply<br>in Dedicated Enclosure | | Remote Control | Located Adjacent to CT Scanner<br>Console via Table or Wall<br>Mounting | Same | | EDA (Extravasation<br>Detection Accessory) | Located in Dedicated Enclosure<br>mounted to same Floor or<br>Overhead Mounting as Injector<br>Head | Same | | Pendant | Dedicated Single Button,<br>Start/Pause connected to Injector<br>Head and/or Remote | Same | | | Proposed Device<br>EmpowerCTA Injector | Predicate Device<br>EmpowerCT Injector<br>(Percupump 2001) | |----------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------| | Syringe | Existing 200 ml, Proprietary E-Z-EM<br>Interface (Catalog No. 6720) | Same | | EDA Electrode Patch | Existing Proprietary E-Z-EM<br>Electrode Patch (Catalog No. 7881) | Same | | EDA Patient Cable<br>(Semi-Disposable) | Existing Patient Cable (Catalog No.<br>9871) | Same | E-Z-EM EmpowerCTA 510(k) Submission Summary Page 3 of 9 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {6}------------------------------------------------ | | Proposed Device | Predicate Device | |---------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Performance<br>(Injector) | EmpowerCTA Injector | EmpowerCT Injector<br>(Percupump 2001) | | Flow Rate | 0.1 to 10 ml/sec in user specified<br>increments of 0.1 ml/sec<br>Accuracy: ±5% of programmed<br>rate +0.1 ml/sec | 0.1 to 10 ml/sec in user<br>specified increments of<br>0.1 ml/sec<br>Accuracy: ±5% of<br>programmed rate +0.1<br>ml/sec) | | Delivery Volume | 1 to 200 ml in user specified<br>increments of 1 ml<br>Accuracy: ±2% of programmed<br>volume +1ml) | 1 to 200 ml in user<br>specified increments of 1<br>ml<br>Accuracy: ±2% of<br>programmed volume<br>+1ml | | Maximum Pressure | 50 to 300 psi in user specified<br>increments of 1 psi<br>Accuracy: ±10% of programmed<br>pressure limit + 10 psi) | 20 to 300 psi in user<br>specified increments of 1<br>psi<br>Accuracy: ±10% of<br>programmed pressure<br>limit + 10 psi) | | Pressure Limiting | Yes | Yes | 100 - 100 - E-Z-EM EmpowerCTA 510(k) Submission Summary Page 4 of 9 . {7}------------------------------------------------ | | Proposed Device | Predicate Device | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Performance (EDA) | EmpowerCTA Injector | EmpowerCT Injector<br>(Percupump 2001) | | Bio-Impedance Sensing | Range: 10 to 250<br>Resolution: 1/3 Ohm<br>Accuracy: +/-10%<br>Endpoints calibrated to 10 Ohm<br>+10% -0% and<br>250 Ohm -10% +0% | Same | | Indicated Extravasation<br>Detection Threshold | 20 ml | Same | E-Z-EM EmpowerCTA 510(k) Submission Summary Page 5 of 9 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {8}------------------------------------------------ | | Proposed Device | Predicate Device | |---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Environmental<br>Requirements | EmpowerCTA Injector | EmpowerCT Injector<br>(Percupump 2001) | | Operating Temperature<br>Operating Humidity,<br>Operating Altitude &<br>Storage Temperature | Meets Requirements set forth in<br>IEC/EN60601-1, Medical<br>Electrical Equipment Part 1:<br>General Requirements for Safety | Same | | Electromagnetic<br>Compatibility (EMC) | Meets Requirements set forth in<br>IEC/EN 60601-1-2, Medical Electrical<br>Equipment Part 1: Collateral Standard,<br>Electromagnetic Compatibility<br>CISPR 11 (EN55011: 1998/1999)<br>IEC 60601-1-2: 1993/2001<br>EN61000-4-2: 1995<br>EN61000-4-3: 1996<br>EN61000-4-4: 1995<br>EN61000-4-5: 1995<br>EN61000-4-6: 1996<br>EN61000-4-8: 1993<br>EN61000-4-11: 1994 | Meets Requirements set forth in IEC/EN<br>60601-1-2, Medical Electrical Equipment<br>Part 1: Collateral Standard,<br>Electromagnetic Compatibility<br>CISPR 11<br>IEC 801-2<br>IEC 801-3<br>IEC 801-4<br>IEC 801-5 | | UL/CSA | Medical Device Listing to UL<br>2601-1 / CSA C22.2 No. 601.1,<br>Electrical Class II, Type B Isolation<br>rating, Injector, Type CF, Isolation<br>rating, EDA | Same | | Energy Requirements | 100/240 VAC 50/60 Hz<br>Auto Seeking | Same | | Shock and Vibration | International Safe Transit Authority<br>(ISTA), Project 3C | Same | : 60 E-Z-EM EmpowerCTA 510(k) Submission Summary Page 6 of 9 ・・・・・・・・・ {9}------------------------------------------------ | Injector Head<br>Displays and<br>Controls | Proposed Device<br>EmpowerCTA Injector | Predicate Device<br>EmpowerCT Injector<br>(PercuPump 2001) | |-------------------------------------------------------|-----------------------------------------------|------------------------------------------------------------| | Display | 240 x 180 Pixel<br>Electrolumenescent Display | Same | | Syringe Advance<br>Slow | Membrane Key | Same | | Syringe Advance<br>Fast | Membrane Key | Same | | Syringe Retract<br>Slow | Membrane Key | Same | | Syringe Retract Fast | Membrane Key | Same | | Auto Initialize | Membrane Key | Same | | Replace Syringe | Membrane Key | Same | | Test Injection | Membrane Key | Same | | Auto-Fill | Membrane Key | Same | | Begin Fill | Membrane Key | Same | | | Proposed Device | Predicate Device | | Injector Head<br>Displays and Controls<br>"Continued" | EmpowerCTA Injector | EmpowerCT Injector<br>(PercuPump 2001) | | Increase Flow Rate | Membrane Key | Membrane Key | | Decrease Flow Rate | Membrane Key | Membrane Key | | Hand Knob | Direct Connection to Drive<br>Mechanism | Same | | Syringe Warmer | Snap On | Same | | Illuminated<br>Stop/Arm/Run/Pause Status<br>Indicator | LED | LED | E-Z-EM EmpowerCTA 510(k) Submission Summary Page 7 of 9 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 61 {10}------------------------------------------------ E-Z-EM EmpowerCTA 510(k) Submission Summary Page 8 of 9 - : 62 : : {11}------------------------------------------------ | | Proposed Device | Predicate Device | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Remote Control<br>Display and<br>Controls | EmpowerCTA Injector | EmpowerCT Injector<br>(PercuPump 2001) | | Display | 800 x 600 Color TFT LCD<br>with Touchscreen Overlay | 800 x 600 Color TFT<br>LCD<br>with Touchscreen<br>Overlay | | Maximum Number of<br>Injection Phases per<br>Protocol | 8 (Contrast Only)<br>or<br>2 (1 Contrast followed by 1<br>Saline)<br>or<br>3 (2 Contrast followed by 1<br>Saline) | 8 | | Maximum Number of<br>Stored Injection<br>Protocols | 50 | 50 | | Programmed Pause | Yes | Yes | | External CT Trigger<br>Port | Yes | Yes | | Audio Speaker | Yes | Yes | | EDA Display and<br>Controls | Proposed Device | Predicate Device | |-----------------------------|----------------------------------------------------------------------------------|----------------------------------------| | EDA Display and<br>Controls | EmpowerCTA Injector | EmpowerCT Injector<br>(PercuPump 2001) | | Display | EDA Function Supported<br>within Remote Control Display<br>and Touchscreen Field | Same | and the comments of the country of E-Z-EM EmpowerCTA 510(k) Submission Summary Page 9 of 9