SONOTT FLOWLAB(R)

{0}------------------------------------------------ KII1730 # JAN - 6 2012 ## 510(K) SUMMARY ## Submitter Information Contact Person : Phone: Fax: E-Mail: em-tec GmbH Lerchenberg 20 86923 Finning Germany www.em-tec.de Mr. B. Brand Regulatory Affairs Manager +49(0)8806 9236 21. +49(0)8806 9236 50, bernhard.brand@em-tec.de ### Date Prepared Device Name Trade/Proprietary Name: Common/Usual Name: Classification Name: June 6, 2011 SonoTT FlowLab® Blood Flow Meter Flowmeter, Blood, Cardiovascular CFR § 870.2100 Product Code DPW Classification: Class II ## Predicate Device Name MediStim VeriQ VQ1001- VQ4122 Trade name: SonoTT Ultrasonic Flowcomputer These devices are the same in terms of Intended use/Indication, clinical applications, type of construction, measurement technology, sensor types, energy source and emitted energy, anatomical sites and material/biocompatibility issues. ## Device Description The SonoTT FlowLab® is used for the volumetric measurement of liquid flowing through tubing systems (in combination with the SonoTT Clamp-On Transducer), to measure blood volume flow (in combination with the SonoTT Vascular Probe) and flow velocity in arteries and veins (in combination with the SonoTT Pulse Wave {1}------------------------------------------------ Doppler Probe). The measurement principle is the ultrasound transit-time and Doppler method. ، ## Substantial Equivalence . . がない。 『 | | Medi-Stim VeriQ | SonoTT Ultrasonic<br>Flowcomputer | SonoTT FlowLab® | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | VQ1001- VQ4122 | | | | Indications<br>for use | The Medi-Stim VeriQ<br>System is an<br>intraoperative<br>diagnostic system that<br>utilizes<br>ultrasonography to<br>guide surgeons to<br>successfully plan and<br>accomplish surgical<br>interventions. | The Sono TT Ultrasonic<br>Flowcomputer is<br>indicated for the<br>volumetric measurement<br>of liquid flowing through<br>tubing systems ( with<br>Clamp-On Transducer).<br>The measurement<br>principle is the<br>ultrasound transit-time<br>method. The<br>Flowcomputer is<br>designed for continuous<br>operation in intensive<br>care units<br>and operating rooms. For<br>the patient's safety the<br>device is to be operated<br>only by qualified<br>medically-trained<br>personnel. | The SonoTT FlowLab®<br>with the accessories is a<br>system to measure the<br>flow rate of liquids (e.g.<br>blood) with the ultrasonic<br>transit-time and velocity<br>patterns of blood with<br>Doppler method. It<br>supports the planning,<br>implementation, efficiency<br>control and documentation<br>of interventions carried out<br>in the area of<br>cardiovascular, vascular<br>and, transplantation, or the<br>monitoring of<br>extracorporeal circulatory<br>systems. | | | The clinical indications<br>for the device are: | The medical use of the<br>device is appropriate to<br>procedures such as the<br>following: | The following medical<br>applications are<br>supported: | | | 1) Accurate transit<br>time blood volume and<br>Doppler velocity flow<br>measurements during<br>cardiovascular-,<br>vascular-,<br>transplantation- and<br>neuro-surgery | 1) Extracorporeal flow<br>measurement on tubings<br>with Clamp-On<br>Transducer during<br>interventions like Cardio-<br>pulmonary bypass,<br>membrane-oxygenation,<br>hemodialysis;<br>hemofiltration,<br>plasmapheresis,<br>perfusion, infusion,<br>transfusion | 1) Intraoperative blood<br>flow measurement with the<br>SonoTT Vascular Probe to<br>assist surgeons at surgical<br>interventions<br>2) Measurement of flow<br>direction and velocities of<br>blood in vessels using the<br>SonoTT Pulse Wave<br>Doppler Probe to assist | | | 2) Simultaneous<br>measurements of<br>blood pressure,<br>vascular resistance,<br>interfaced<br>physiological signals<br>and other derived<br>parameters during<br>these procedures.<br>3) Detection of normal | | the surgeon in the non-<br>invasive assessment of<br>vascular changes.<br>3) Extracorporeal flow<br>measurement in<br>continuous operation on<br>tube systems in<br>combination with the<br>SonoTT Clamp-On<br>Transducer in intensive | | | and abnormal blood | | | | | volume and Doppler | | care units and operating | | | velocity flow patterns | | theatres | | | | | | | | during these | | The following actions can | | | procedures. | | be performed | | | | | simultaneously when | | | | | these measurements are | | | | | | | | 4) Provides guidance | | in progress: | | | to prepare surgical | | | | | plans at the initiation of | | 4) Pressure measurement | | | surgery and to support | | in combination with a | | | the successful | | standard blood pressure | | | accomplishment of | | transducer | | | surgery including | | | | | detection and location | | | | | of vessels during | | 5) Secondary displays of | | | | | additional physiological | | | surgical procedures. | | analogue signals and | | | | | corresponding derived | | | | | parameters | | | | | | | | 5) Detection and | | The SonoTT Vascular | | | quantification of the | | Probe is intended for | | | degree of stenosis in | | transient use only with | | | arteries by using the | | continuous contact with | | | Doppler velocity | | | | | profile. | | patient of less than 60 | | | | | minutes. | | | | | | | | | | For the patient's safety | | | | | they must be operated by | | | | | qualified medical | | | | | personnel. | | Patient | Adult and pediatric | No restrictions acc. | Aduit and pediatric | | group | | operator manual | | | | Not intended for any | | Not intended for | | | kind of fetal | | examination of foetuses | | | applications. acc. | | (prenatal) and neonates | | | operator manual | | (foetal) . | | | | | | | | | | | | Ultrasound | Transit-time, | Transit time, | Transit time, | | modalities | | | | | | PW Doppler | PW Doppler | PW Doppler | | | | | | | Measureme | Vessel transducer, | | | | nt Probes | Doppier Probe | Clamp-on Sensor | Vessel transducer, | | | | | Doppler Probe, | | | | | | | | | | Clamp-on Sensor | | Other<br>inputs | Blood pressure, ECG,<br>Auxiliary inputs | Blood pressure, Auxiliary<br>inputs | Blood pressure, ECG,<br>Auxiliary inputs | {2}------------------------------------------------ The proposed device is substantial equivalent to the predicate devices with respect to intended use, patient population, measurement and sensor technology and auxiliary channels. Therefore it meets the requirements for section 510(k) substantial equivalence and is as safe, as effective, and performs as well as the predicate devices {3}------------------------------------------------ ## Test Data The SonoTT FlowLab® and the accessories were subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of: - 1. Electrical Safety Testing - EMC Testina 2. - Ultrasonic acoustic output testing က - 4. Alarm testing - క్. Software Validation - 6. Mechanical Stability Testing - 7. Packaging Testing - 8. Biocompatibility evaluation of Vascular Probe and Pulse Wave Doppler Probe - တ် Sterility evaluation of Vascular Probe - 10. Usability Validation The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a Blood Flow Meter. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, a symbol often associated with medicine and healthcare. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JAN - 6 2012 em-tec GmbH c/o Mr. Olaf Teichert TÜV SÜD America, Inc. 1775 Old Highway 8 NW, Ste 104 New Brighton, MN 55112-1891 K11730 Re: Trade/Device Name: SonoTT FlowLab® Flowmeter Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Codes: DPW, ITX Dated: December 28, 2011 Received: December 30, 2011 Dear Mr. Teichert: We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) premainted is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for tegary manated to of the Medical Device Ameral Food Drug commerce prior to May 28, 1776, the enacintent with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance with and proval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval or of the Act and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, becjost to the group registration, listing of general controls provisions of the Act include requirements for annual registration, and general controls provisions of the trectine, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SC above) into extine major regulations affecting your device can be it may be subject to additional controls. Existing major regulation affect if may be subject to additional controls. Entroling major and on 898. In addition, FDA may lound in the Code of I cacial Regulations, Four device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated on a banded with other requirements of the Act that FDA has made a determination that your device complies - You must that FDA has made a decemmanon alla Jour access of by other Federal agencies. You must {5}------------------------------------------------ Page 2 – em-tec GmbH c/o Mr. Olaf Teichert 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/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, for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ | 510(k) Submission Section D | SonoTT FlowLab | | | |-----------------------------|-----------------|----------|---------------------------------------------------------------------------------------------------------------------| | Indications for Use | FL-FDIU-1.1.doc | 05/26/11 | <div style="text-align: right;"> -em-tec<br/> MEDICAL TECHNOLOGY </div> | # Indications for Use 510(k) Number (if known): _ K | | 7 30 Device Name: SonoTT FlowLab ### Indications for Use The SonoTT FlowLab® with the accessories is a system to measure the flow rate of liquids (e.g. blood) with the ultrasonic transit-time and velocity patterns of blood with Doppler method. It supports the planning, implementation, efficiency control and documentation of interventions carried out in the area of cardiovascular, vascular and, transplantation, or the monitoring of extracorporeal circulatory systems. The following medical applications are supported: - Intraoperative blood flow measurement with the SonoTT Vascular Probe to assist e surgeons at surgical interventions - Measurement of flow direction and velocities of blood in vessels using the SonoTT Pulse . Wave Doppler Probe to assist the surgeon in the non-invasive assessment of vascular changes. - Extracorporeal flow measurement in continuous operation on tube systems in . combination with the SonoTT Clamp-On Transducer in intensive care units and operating theatres The following actions can be performed simultaneously when these measurements are in progress: - Pressure measurement in combination with a standard blood pressure transducer t - Secondary displays of additional physiological analogue signals and corresponding . derived parameters The SonoTT Vascular Probe is intended for trans…