AUREFLO MONITORING SYSTEM

{0}------------------------------------------------ DEC 2 1 2011 KI 12657 pg lof 2 Image /page/0/Picture/1 description: The image shows the logo for Transonic Systems Inc. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "The Flow Measurement Specialists." ## 510(k) SUMMARY Summary of Safety & Effectiveness | Submitter's Name & Address: | Transonic Systems, Inc.<br>34 Dutch Mill Road<br>Ithaca, NY 14850 | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person & Telephone: | David Klementowski<br>607-257-5300 | | Date Summary Prepared: | September 9, 2011 | | Device Name: | Classification Name - Flowmeter, Blood, Cardiovascular<br>Common/Usual Name - Blood Flowmeter<br>Proprietary Name - AureFlo Monitoring System | | Predicate Device: | K040228 Medi-Stim VeriQ System | #### Device Description In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Systems AureFlo Monitoring System. The device is a versatile monitoring system to continuously measure, display, record and document absolute volume flow and other derived parameters. It is used during surgery with Transonic Flowprobes to measure and display blood flow in vessels. It can also be used with Sterile Tubing Flowsensors to measure and display flow of fluids through tubing circuits. AureFlo's flexible integrated system can be set up in a variety of configurations. A stand-alone HT300-Series flowmeter can be upgraded to work with Flow Trace® software. The system can also be set up on any operating room cart with an optional monitor stand: The display panel is an Intel® Pentium M® CPU touch-screen computer/monitor with Microsoft Windows XP®. The computer/monitor's manual can be accessed by selecting "Help" on the Windows Start Screen. FlowTrace® Software works exclusively with HT300-Series-FT Flowmeters to provide a real-time waveform display of volume flow, mean flow and Pulsatile Index (PI). During CABG surgery, connection with an ECG signal allows for an on-screen ECG display, diastolic/systolic shading of coronary graft waveforms and calculation of a D/S (diastolic/systolic) Ratio. {1}------------------------------------------------ K112657 pg 2 of 3 #### Intended Use The AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric patients for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts; where surgery is medically indicated; intraoperatively, rather than in chronic implant; at intraoperative sites which admit and retain ultrasonic couplant; with minimal vessel manipulation or constriction (to avoid vessel spasm); where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound. | Characteristic | Transonic Systems AureFlo Monitoring System | Medi-Stim VeriQ System | |------------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------------| | Flow measurements | | | | > Technology | Ultrasonic Transit-time | Ultrasonic Transit-time, PW Doppler | | > No. of channels | 1 or 2 | 1, 2 or 4 | | > Measured parameters | Mean and pulsatile flow values | | | > Simulated Doppler sound | Yes | | | > Type of probes | Perivascular, cardiac output and tubing measurements | Perivascular, cardiac output and tubing measurements | | User Interface | | | | > Flow line zero calibration | Automatic (EEPROM) | Automatic (EEPROM) | | > Controls | Touch screen | Touch screen | | > Read-out | 15" LCD display | 19" LCD display | | > Documentation | Patient database (hard disk), print-out or pdf output via external memory | Patient database (hard disk), print-out or HTML output via external memory | | Technology Platform | | | | > Hardware | Proprietary analog transit time front end with post-processing circuitry | Pentium microprocessor<br>Proprietary digital transit time front end | | > Software | Windows XP | Windows XP | ### Technological Characteristics Compared to Predicate Device ### Conclusions and Safe & Effectiveness The AureFlo Monitoring System is deemed to be safe and effective based on the safety testing completed by TUV Rheinland of North America, Inc., in accordance with the IEC 60601-1 Medical Electrical Equipment standard. This system also tested to and found to be in compliance for electromagnetic compatibility in accordance with the CISPR 11 standard. {2}------------------------------------------------ K112657 Pg 3 of 3 In addition, bench testing was conducted by Transonic Systems Inc. and the validation report can be found in Section 18 of this 510(k) submission. Prior to shipment, the finished product will be tested and must meet all required release specifications before distribution. The array of testing required for release includes, but are not limited to; physical testing and visual examination (in-process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the product's performance parameters conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed, and revised in accordance with document control cGMP's. {3}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DEC 2 1 2011 Transsonic Systems, Inc. c/o Mr. David Klementowski VP, Regulatory Affairs and Quality 34 Dutch Mill Road Ithaca, NY 14850 K112657 Re: Trade/Device Name: Transonic Systems AureFlo Monitoring System Regulation Number: 21 CFR 870.2100 Regulation Name: Flowmeter, Blood, Cardiovascular Regulatory Class: Class II Product Code: DPW Dated: December 7, 2011 Received: December 8, 2011 Dear Mr. Klementowski: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10. use stated in the encrosuly to regional date of the Medical Device Amendments, or to conimered province that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices mat have been results in assess and in a premarket approval application (PMA). and Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, dierelore, manes of the Act include requirements for annual registration, listing of general bontrols profices in the practice, labeling, and prohibitions against misbranding and actives, good manararianing proH does not evaluate information related to contract liability aduncialion. Thease note: "ODFF" as that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classified (boo are regulations affecting your device can be {4}------------------------------------------------ Page 2 - Mr. David Klementowski 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 r hat 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, Mark Fellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K112657 # Indications for Use 510(k) Number (if known): Device Name: Transonic Systems AureFlo Monitoring System Indications For Use: The AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts; where surgery is medically indicated; intraoperatively, rather than in chronic implant; at intraoperative sites which admit and retain ultrasonic couplant; with minimal vessel manipulation or constriction (to avoid vessel spasm); where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound. 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) | (Division Sigh-Off) | | |---------------------|--| |---------------------|--| Division of Cardiovascular Devices | 510(k) Number | 112657 | |---------------|--------| |---------------|--------| Page 1 of 1