TESLA NIBP

{0}------------------------------------------------ | KO62974 | |---------| | P1/2 | | 510(k) Number: | | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | | 100 - 1000000 - 100 - 1000 - 1000 - 1000 - 100 - 100 - 100 - 100 - 100 - 100 - 100<br>assessment assessment consistent and definite programs and the | Date: Date: Date: Date: Page 1 of 2 # 510(k) Summary AUG 1 3 2007 ## Introduction This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence. # 510(k) Applicant Mammendorfer Institut für Physik und Medizin GmbH Oskar-von-Miller-Strasse 6 82291 Mammendorf Germany ## 510(k) Correspondent Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors, Inc. 13605 West 7th Ave. Golden, CO 80401 USA ## Date Prepared September 26, 2006 #### Trade Name of Device Tesla NIBP ### Common Name of Device Patient Physiological Monitor (without arrhythmia detection) ### Classification Name Patient Physiological Monitor (without arrhythmia detection) ## 510(k) Classification Class II under regulation 21 CFR 870.1130 ## Device Description and Intended Use The Testa"(820) Blood Pressure Monitor is an automatic non-invasive blood pressure (NIBP) measurement system that is intended for use in an MR-environment at a maximum magnetic field strength of 20mT. The completed system meets the requirements of AAMI standard SP10:2003+A1:2003. The Testal Pro design makes it possible to position the system within an RF-shielded MRI-room. {1}------------------------------------------------ | 510(k) Number: | |----------------| |----------------| -2974 Date: Page 2 of 2 The device is intended to be used in the MRI-environment where patient care is provided by Healthcare Professionals, i.e. physicians, and nurses, trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition. The Testa VBP® measures and displays: - 1. Systolic Pressure - 2. Diastolic Pressure - 3. Heart Rate (BPM) - 4. Mean Arterial Pressure (MAP) MIPM will distribute pressure cuffs for use with the Testa" that are manufactured by other medical device manufacturing companies, and which are already cleared by FDA for sale in the USA. ### Predicate Devices Omega™ 1400 MRI monitoring system, as manufactured by Invivo Diagnostics Imaging. Omron HEM 711AC, as manufactured by Omron Healthcare, Inc., Vernon Hills, IL. ### Risk Management This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program. Mammendorfer Institut für Physik und Medizin GmbH believes that the Tesla NIBP is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 3 2007 Medical Device Regulatory Advisors c/o Mr. Robert N. Clark President and Senior Consultant 13605 West 7th Ave. Golden, Colorado 80401 Re: K062974 Tesla NIBP Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: July 19, 2007 Received: July 23, 2007 Dear Mr. Clark: 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 such 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. {3}------------------------------------------------ Page 2 - Mr. Robert N. Clark 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. 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 (240) 276-0120. 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 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/cdrh/industry/support/index.html. Sincerely vours. Bhimamor for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: ____ TeslaMIBP® Indications for Use: The Testa'"Be® monitor is an automatic oscillometric measuring system designed to take non-invasive blood pressure measurements. It measures systolic pressure, diastolic pressure, mean arterial pressure and heart rate. The Testa "BP® monitor is intended to be used on neonate, pediatric and adult populations during MR-examinations at a maximum magnetic field strength of 20mT. Prescription Use X (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) B.Brummer Tesla NIBP 510(k) Submission Page 15 of 382 l of l