REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS

{0}------------------------------------------------ **NEMOTO KYORINDO CO., LTD.** 20 Hongo Bunkvo-ku. Toky +81- 3-584 EDHONE +81- 3-5842-8589 K092896 OCT 29 2010 ## REMPRESS Contrast Delivery System 510(k) Summary | Contact Name: | Jim Knipfer | |-------------------|--------------------------------------| | | Executive Director, Technical Center | | | Nemoto Kyorindo Co., Ltd. | | | 2-12-4 Aoki, Kawaguchi | | | Saitama, Japan 332-0031 | | | Phone: +81-48-250-3255 | | | FAX: +81-48-250-3256 | | Proprietary Name: | REMPRESS | Common Name: Classification Name: Predicate Device(s): Injector System Injector and Syringe, Angiographic Angiomat Illumena Injector, K963071 Angiomat 6000 Injector, K860204 #### Intended Use: Intended USE. The contrast delivery system REMPRESS is an intravascular injection system intended for the administration r fie contrast delivery of over in conjunction with angiographic imaging procedures. Of contrast media or normal saline used in conjunction with angiographic imaging procedu #### Description: Description: The main components of the REMPRESS are the Console, Powerhead and Main Control Unities parfiguration The main components of the REM RED are a pedestal or table mount configuration the partiguration the parayimity contigurations of the KENI NESS are a possible in the angiographic suite and normally in close proximity. three main components of the injection, such as volume, flow rate and pressure are programmed by to the patient. The parameters of the injection) and the Console is powered via 24 volts DC the operator via the graphical user interface with touchscreen inputers) and the operatur via the gruption assi. Includes which is derived from a remote AC to DC converter (similar to that integrine protocol has which is defived from a remote AC to DG connections interface cable. After the injection protocol has been communicates with Main Control Unit communications interface van p communicates with Man Control ont Contribution of the lead screw ram. The ram pushes the push-rood of set, the Powernead performs the life. the syringe which expels fluid from the barrel of the syringe. The following paragraphs provide more details for each of these main components. POWERHEAD: The Powerhead provides a means for accepting and identifying a given syringe and then POWERHEAD: The Powernead provides a means to and which will eject the contrast or normal applying a force to the plunger of the syringe via its screw driven ram which will {1}------------------------------------------------ # Bunkvo-ku To PHONE POWERHEAD: The Powerhead provides a means for accepting and identifying a given syringe and then applying a force to the plunger of the syringe via its screw driven ram which will eject the contrast or normal saline from the barrel of the syringe. The Powerhead is in constant communications with the Main Control Unit for determining injection protocol and to monitor all Powerhead functions and injection sequences. The injection information is communicated to the user Console to provide immediate feedback of injection operation. CONSOLE: The Console is the main user interface for the REMPRESS. It provides a color graphical user interface with an overlying touchscreen for easy injection monitoring and injection setup. At the completion of an injection the injection results are clearly displayed to the user. The Console provides a connection for a remote Handswitch that can be used to start or stop an injection. The Console resides normally in the angiographic suite and is typically located near the patient. MAIN CONTROL UNIT: The Main Control Unit is the interface between the Console and the Powerhead. The Main Control Unit receives the user input data from the Console and converts.to the necessary control information then relays to the Powerhead. The Main Control unit also provides the power necessary to operate the Powerhead. The Main Control Unit is located inside the angiographic suite and communicates with the Console via a communications link. The system is designed to deliver a variety of injection protocols. The REMPRESS injection system is also provided with a variety of consumables products for connecting the syringes to the patient. #### SUBSTANTIAL EQUIVALENCE A comparison chart shown in Table 1 compares the technological characteristics of the REMPRESS contrast delivery system to the predicate devices the Liebel-Flarseim's Angiomat Illumena and Angiomat 6000. The REMPRESS is substantially equivalent to the predicate devices. The REMPRESS injector system safely and effectively injects contrast or saline solutions as desired by the user. {2}------------------------------------------------ # Nemoto # NEMOTO KYORINDO CO., LTD.yo 113-0033 Japan 2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan TELEFHONE +81-3-5842-8571 FACSIMILE 2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan TELEPHONE +81-3-5842-8571 FACSIMILE +81-3-5842-8589 | Characteristic/<br>Feature | Angiomat 6000<br>(Predicate device) | Angiomat Illumena<br>(Predicate Device) | REMPRESS<br>(New Device) | |----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Multi-phasic Contrast<br>Injections | 9 phases per protocol | 4 phases per protocol | 1 phase per protocol | | Protocol Storage | 99 protocols | 99 protocols | 20 protocols | | X-ray/Scan Delay | 0 - 255 secs. | 0 - 300 secs. | 0 - 99 secs | | Inject Delay | 0 - 255 secs. | 0 - 300 secs. | 0 - 99 secs | | Inter-phase Delay | None | 0 - 300 secs. | None | | Inject Interval | None | 0 - 300 secs. | None | | Syringe System | 260ml, 150ml, or 125ml | 150ml or 125ml | 150ml | | Volume Remaining | Mechanical Scale on<br>Powerhead | LED display on<br>Powerhead | LED Display on<br>Powerhead | | Display | 3 to 25ml/sec | 3 to 25ml/sec | 0.5 - 2.5ml/sec | | Filling Rate | 0.01 to 40ml/sec for<br>125/150ml syringe | 0.01 to 40ml/sec for<br>125/150ml syringe | 0.1 to 25ml/sec with<br>150ml syringe | | Flow Rate | 0.01 to 59ml/sec for<br>260ml syringe | | | | Pressure Limit | 100 to 1200 PSI | 75 to 1200 PSI | 50 - 1200 PSI | | Remote Start Switch | Yes | Yes | Yes | | Safety Stop Mechanism | Electrical stop when<br>Injection parameters are<br>out of specification | Electrical stop when<br>injection parameters are<br>out of specification | Electrical stop and<br>mechanical backup<br>stopper when injection<br>parameters are out of<br>specification | | User Interface Features<br>- Fill / Expel Control<br>- Air Detection | Push button on head<br>Operator visual<br>inspection | Push button on head<br>Operator visual<br>inspection | Push button on head<br>Operator visual<br>inspection | | - Programming Injection<br>- Status Display | Keypad<br>Powerhead lights | Touchscreen<br>Powerhead lights | Touchscreen<br>Powerhead lights | | Materials | Plastics and metals | Plastics and metals | Plastics and metals | | Anatomical Sites | Arterial and Venous<br>injections | Arterial and Venous<br>injections | Arterial and Venous<br>injections | | Intended Use Statement | The Angiomat 6000 is<br>designed to inject<br>radiopaque contrast<br>medium into the<br>vascular system for<br>Angiography procedures<br>as prescribed by<br>qualified health care<br>professionals. | The Angiomat Illumena<br>is designed to inject<br>radiopaque contrast<br>medium into the<br>vascular system for<br>Angiography and CT<br>procedures as prescribed<br>by qualified health care<br>professionals. | The contrast delivery<br>system REMPRESS is an<br>intravascular injection<br>system intended for the<br>administration of<br>contrast media or<br>flushing solutions used<br>in conjunction with<br>angiographic imaging<br>procedures. | | Target Population | Humans | Humans | Humans | | Sterility | Consumables are<br>provided sterile | Consumables are<br>provided sterile | Consumables are<br>provided sterile | {3}------------------------------------------------ 2-27-20 Hongo Bunkyo-ku, Tokyo TELEPHONE +81- 3-5842-857 +81- 3-5842-8589 FACSIMILE ## SUMMARY OF PERFORMANCE TESTING SUMMARY OF PEN ORFIANCE TEBRETS Performance testing was completed in order to verify the Many the Manager chart Penomiance testing was completed in the system as outlined in the substantial equivalence chart. For achieving the specification parameters for the system the substantial eq or actileving the specification parameble in these values validates the substantial equivalence, procure and verification of the system daily to accuracy of delivered flow rate, volume, pressure and manual control speeds. #### VOLUME VULUME Fluid delivery of an hijector is characenza - parameter in that is has the greatest effect on image quality. The volume delivered is the most critical parameter in that is v limit. The volune delivered is the ness and compared to the volume programmed. During testing, the volume delivered was accurately measured the volumes within During testing, the volume delivered with and and the REMPRESS system successfully delivered the volumes within the allowable specifications. #### FLOW RATE FLOW RATE The second most critical variable parameter in delivering fluid to a patient is the flow rate. In the event of a injections, the injection time and volume were recorded then the flow rate calculated. In the event of a injections, the injection the volume was were wowen not to accurately represent the flow rate pressure imit injection, the volune and and are and are and the internetions and more of the flow rate the data was officed from this Specification. NOTE: Pressure imit injections and only the operator measured within the allowable fanges of the e. reduce the flow rate from the user set flow rate to maintain a constant pressure, as desired by the operator. #### PRESSURE PRESSURE During all injections, the injector monitors the pressure in order in order to avoid failure of During all Injections, the injector moniters the p. During an Injections, the injector moniters the progetype used in the dignbyed your and pressure imited. An upper limit is section and measured and compared to the displayed values and the symnge. Bunny tostings were within the allowable specifications. ### MANUAL CONTROL SPEEDS MANUAL CONTROL SPEEDS The REMPRESS has two speeds for manually moving the forward or reverse key in The REMPRESS has two speeds for manadily moving the forward or reverse key in on the Powerhead, the rams can be moved at varying speeds. Dyring tresting, speeds on the Powerhead, the rams can be niver at harfying of combination with the accelerator key, the rams can be moved at maximum speed. During testing, speeds were confirmed to be within the allowable specification range. {4}------------------------------------------------ # Nemoto NEMOTO KYORINDO CO., LTD. INDINIO I O IS I OLDI (120 O Off 23-0033 Japan 2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan 2-27-20 Hongo Bunkyo-ku, Tokyo 113-0033 Japan FACSIMILE - - TELEFHONE - - 81-3-5 TELEPHONE +81-3-5842-8571 FACSIMILE +81-3-5842-8589 #### CONCLUSION CONCLUSION The REMPRESS contrast delivery system provided its ability to perform within its specificated as a The REMPRESS Contrast delivery by stant p result, its performance is deemed acceptable and substantially equivalent to the predicate devices. {5}------------------------------------------------ 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, and three human figures in profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Nemoto Kyorindo Co, Ltd. c/o Mr. Jim Knipfer Executive Director, Technical Center 2-12-4 Aoki, Kawaguchi Saitama, JAPAN 332-0031 OCT 2 9 2010 Re: K092896 Trade/Device Name: REMPRESS Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II (two) Product Code: DXT Dated: October 18, 2010 Received: October 25, 2010 Dear Mr. Knipfer: 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. {6}------------------------------------------------ #### Page 2 - Mr. Jim Knipfer 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Dma R. Viener Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## OCT 2 9 2010 # Indications for Use 510(k) Number (if known): K 09 28 9 6 Device Name: REMPRESS Indications for Use: The contrast delivery system REMPRESS is an intravascular injection system The ountrast believe of contrast media or normal saline used in conjunction with angiographic imaging procedures. 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Diana R. Jackson ision of Cardiovascular Devices Page 1 of 1 510(k) Number_ko92896