SONO TT ULTRASONIC FLOWCOMPUTER

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 0 2004 em-tec GmbH c/o Mr. Stefan Preiss Responsible Third Party Official TUV Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891 Re: K040909 Trade Name: Sono TT Ultrasonic Flowcomputer Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (two) Product Code: DPW Dated: April 6; 2004 Received: April 8, 2004 Dear Mr. Preiss: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases as stained the device is substantially equivalent (for the referenced above and we have determined the article predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interslate continered problem that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to Federal Food, Drug, and Cosmode Fros et. The general controls provisions of the Act include the general controls provisions of the Fiften of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This determination of substantial equivalence applies to the following transducers intended for I ms determination of substantial equiver, as described in your premarket notification: CT3/8x3/32"A {1}------------------------------------------------ ## Page 2 - Mr. Stefan Preiss If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (so above) into existing major regulations affecting your device can may be subject to such additional controls. Existing major regulations FRA may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachar Ing your 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 3 issuation of a succession of the requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cueral statutes and regularents ancluding, but not limited to: registration and listing (21 Comply with an the Hot 810 (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality bytichlo (Sections 531-542 of the Act); 21 CFR 1000-1050. This determination of substantial equivalence is granted on the condition that prior to shipping I ins detentination of Substaintal equirance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers If Appendix 07 (cherosou) of the Station tic Ultrasound Systems and Transducers." If the special Secking Marketing Creatures on Dacgeptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. The results in a classification for your device and thus permits your device to proceed to market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. 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" (21 CFR Part 807.97). 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html". {2}------------------------------------------------ Page 3 – Mr. Stefan Preiss If you have any questions regarding the content of this letter, please contact Kachi Enyinna at (301) 443-8262. Sincerely yours, Dma R. Vochmes \$\delta\$ Bram D. Zuckerman, M.D. Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known): | 640969 Device Name: Sono TT Ultrasonic Flowcomputer Indications for Use: The Sono TT Ultrasonic Flowcomputer in combination with an ultrasonic clamp-on Transducer is indicated for the contact less volumetric measurement of liquid flowing through tubing systems. The measurement principle is the ultrasound transit-time method. The medical use of the device is appropriate in the following extracorporeal procedures: - Cardio-pulmonary bypass, membrane-oxygenation, hemodialysis, hemofiltration, plasmapheresis - Perfusion, infusion, transfusion - Several shunt-applications The Flowcomputer can be used in intensive care units and operating rooms. For the patient's safety the device is to be operated only by qualified medically-trained personnel. ## Contraindication: This device has been built and sold only for the intended purpose mentioned above, The supplied measured values serve only to monitor the flow rate of the device in use (e.g. oxygenator, blood pump). These values are not to be used either for an evaluation of a patient's status or for the basis of medical actions without the confirmation of another approved medical measurement procedure. It is the operator's responsibility to use the device as described in the User's Manual and in any of its following revision releases. The use of clinical procedures and techniques lie in the physician's area of responsibility. Prescription Use Yes AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use No (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dena P. Archer Division Sign-Off) Trision of Cardiovascular Devices 310(K) Number_K040909 Applicant: em-tec GmbH, Lerchenberg 20, 86923 Finning, Germany, www.em-tec.de Phone: +49(0)8806 9236 0, Fax: +49(0)8806 9236 50, info@cm-tec.de Contact Parcon · Mr A Knahe Phone: +49(0)8806 9236 21, ak(@em-tec. de