MRI Patient Monitor TeslaDUO

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 28, 2016 MIPM Mammendorfer Institut Fur Physik Und Medizin GmbH % Andre Kindsvater Senior Consultant RA & OA Emergo Group 16 Congress Avenue Suite 1400 Austin, Texas 78701 Re: K153739 Trade/Device Name: MRI Patient Monitor TeslaDUO Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: May 22, 2016 Received: May 26, 2016 Dear Andre Kindsvater: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 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. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K153739 Device Name MRI Patient Monitor TeslaDUO Indications for Use (Describe) The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. The TeslaDUO is intended for use in the Adult and Pediatric populations for continuous monitoring of Pulse Oximetry (SpO2). The TeslaDUO is intended for use in the Adult, Pediatric and Neonatal populations for continuous monitoring of Non-Invasive Blood Pressure (NIBP). The TeslaDUO is intended for use by health care professionals. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # Section 5 – 510(k) Summary # MRI Patient Monitor TeslaDUO # K153739 #### 1. Submission Sponsor MIPM Mammendorfer Institut für Physik und Medizin GmbH Oskar-von-Miller-Str. 6 Mammendorf 82291 Germany Phone: (+49) 8145 9209-12 Fax: (+49) 8145 9209-13 Contact: Hans Schwaiger Title: General Manager #### 2. Submission Correspondent Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: +41 78 843 7077 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: André Kindsvater, Senior Consultant, RA/QA Email: project.management@emergogroup.com #### 3. Date Prepared April 28th, 2016 ### 4. Device Identification | Trade/Proprietary Name: | MRI Patient Monitor TeslaDUO | |-------------------------|--------------------------------------------------------------------------| | Common/Usual Name: | Physiological Patient Monitor | | Classification Name: | monitor, physiological, patient (without arrhythmia detection or alarms) | | Regulation Number: | 870.2300 | | Product Code: | MWI | | Device Class: | Class II | | Classification Panel: | Cardiovascular | {4}------------------------------------------------ ## 5. Legally Marketed Predicate Device(s) K142032, MRI Patient Monitoring System Tesla M3 MIPM Mammendorfer Institut für Physik und Medizin GmbH #### 6. Device Description The MRI Patient Monitor TeslaDUO ("TeslaDUO") is a magnetic resonance compatible patient monitoring device for use in MRI rooms (HF-proof, magnet-resistant) to monitor and display data from vital signs sensors during MRI examinations (MRI procedures) of patients. It is capable of continuously monitoring and displaying data in graphic and numeric form from the following sensors/measurement modules: - Pulse Oximetry (SpO2 and Pulse Rate) - Non-Invasive Blood Pressure (NIBP and PR) ### 7. Indication for Use Statement The MRI Patient Monitor TeslaDUO is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients. The TeslaDUO is intended for use in the Adult and Pediatric populations for continuous monitoring of Pulse Oximetry (SpO2). The TeslaDUO is intended for use in the Adult, Pediatric and Neonatal populations for continuous monitoring of Non-Invasive Blood Pressure (NIBP). The TeslaDUO is intended for use by health care professionals. ### 8. Substantial Equivalence Discussion The following table compares the MRI Patient Monitor TeslaDUO to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device. {5}------------------------------------------------ | Manufacturer | MIPM | MIPM | Significant<br>Differences | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Trade Name | MRI Patient Monitor<br>TeslaDUO | MRI Patient Monitoring<br>System Tesla M3 | | | 510(k) Number | TBD | K142032 | N/A | | Product Code | MWI | MWI | Equivalent | | Regulation Number | 870.2300 | 870.2300 | Equivalent | | Regulation Name | Monitor, Physiological, Patient<br>(without arrhythmia detector<br>or alarms) | Monitor, Physiological,<br>Patient (without arrhythmia<br>detector or alarms) | Equivalent | | Indications for Use | The MRI Patient Monitor<br>TeslaDUO is intended for<br>monitoring of vital signs<br>during MRI examinations (MRI<br>procedures) of patients.<br>The TeslaDUO is intended for<br>use in the Adult and Pediatric<br>populations for continuous<br>monitoring of Pulse Oximetry<br>(SpO2) | The MRI Patient Monitoring<br>System Tesla M3 is intended<br>for monitoring of vital signs<br>during MRI examinations (MRI<br>procedures) of patients.<br>The Tesla M3 is intended for<br>use in the Adult, Pediatric and<br>Neonatal populations for the<br>continuous monitoring of<br>Electrocardiogram (ECG),<br>Non-Invasive Blood Pressure<br>(NIBP), Invasive Blood<br>Pressure (IBP), Temperature,<br>Respiration, Capnography<br>(etCO2), Oxygen and<br>Anesthetic Agents.<br>The Tesla M3 is intended for<br>use in the Adult and Pediatric<br>populations for the<br>continuous monitoring of<br>Pulse Oximetry (SpO2). | Equivalent<br>TeslaDUO does not<br>have ECG, IBP, CO2,<br>Temperature,<br>Oxygen and<br>Anesthetic Agents<br>options | | | The TeslaDUO is intended for<br>use in the Adult, Pediatric and<br>Neonatal populations for<br>continuous monitoring of<br>Non-Invasive Blood Pressure<br>(NIBP).<br>The TeslaDUO is intended for<br>use by health care<br>professionals. | The Tesla M3 is intended for<br>use by health care<br>professionals. | | | Intended Population | Adult, Pediatric, Neonatal | Adult, Pediatric, Neonatal | Equivalent | | Mechanism of<br>Action | Data Acquisition | Data Acquisition | Equivalent | | Technology<br>Overview | PEMS and Software | PEMS and Software | Equivalent | | Pulse Oximetry | Waveform and Numeric | Waveform and Numeric | Equivalent | | NIBP | Numeric | Numeric | Equivalent | | Manufacturer | MIPM | MIPM | Significant<br>Differences | | Trade Name | MRI Patient Monitor<br>TeslaDUO | MRI Patient Monitoring<br>System Tesla M3 | | | Material | Housing mainly coated<br>aluminium,<br>antimagnetic stainless steel,<br>plastics | Housing mainly coated<br>aluminium,<br>antimagnetic stainless steel,<br>plastics | Equivalent | | Latex Free | Yes | Yes | Equivalent | | Sterile | No | No | Equivalent | | Single-Use | No | No | Equivalent | | Shelf Life | N/A | N/A | Equivalent | | MRI safe | Yes | Yes | Equivalent | | Mode of operation | Continuous | Continuous | Equivalent | | Energy Output | none | none | Equivalent | | Software | Yes | Yes | Equivalent | | Battery Operated | Li-lon | Li-lon | Equivalent | | AC Powered | 100 to 240 VAC, 50/60 Hz | 100 to 240 VAC, 50/60 Hz | Equivalent | | Complies with ISO<br>10993-1 | Yes | Yes | Equivalent | | Electrical Safety<br>Testing Passed | Yes | Yes | Equivalent | # Table 5A – Comparison of Characteristics {6}------------------------------------------------ ## 9. Non-Clinical Performance Data As part of demonstrating safety and effectiveness of TeslaDUO and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, MIPM completed a number of nonclinical performance tests against applicable standards. | | Test | Pass / fail criteria | Results | |---|----------------------------------|------------------------------------------------------------------------------|---------| | 1 | Electrical safety | Compliance to IEC 60601-1:2012 | Passed | | 2 | Electromagnetic<br>compatibility | Compliance to EN/IEC 60601-1-2: 2007<br>Compliance to EN/IEC 60601-1-2: 2014 | Passed | | 3 | Multifunction<br>Patient Monitor | Compliance to IEC 60601-2-49: 2011-02 | Passed | | 4 | Alarms | Compliance to IEC 60601-1-8:2006+A1:2012-<br>11 | Passed | | 5 | Biocompatibility | Compliance to ISO 10993-1 | Passed | | 6 | Risk<br>Management | Compliance to ISO 14971:2007 | Passed | | 7 | Software | Compliance to IEC 62304:2006 | Passed | | Table 5B – Performance Standards Testing Summary | | | |--------------------------------------------------|--|--| | | | | {7}------------------------------------------------ | | Test | Pass / fail criteria | Results | |----|----------------|----------------------------------------------------------------------|---------| | 8 | Pulse Oximeter | Compliance to ISO 80601-2-61: 2011 | Passed | | 9 | NIBP | Compliance to IEC 80601-2-30:2009-<br>01 (ed.1.0) | Passed | | 10 | Batteries | IEC 62133:2012 | Passed | | 11 | Usability | IEC 60601-1-6:2010-01 + A1:2013<br>IEC 62366:2007 (Ed. 1) + A1: 2014 | Passed | The TeslaDUO passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device: Extensive tests were performed to verify the proper functioning of the TeslaDUO and the accessories in the intended Magnetic Resonance (MR) environment. Both, the influence of the TeslaDUO on the functioning of the intended MRI Scanners and the influence of the intended MRI Scanners on the functioning of the TeslaDUO were tested. Further tests were undertaken to demonstrate the performance of the device and its accessories in the intended MRI environment, such as: - Measurement of Magnetostatic Forces, - Magnetic Immunity, - MRI Immunity, and - Radio Frequency field induced and Gradient field induced Heating All tests passed. #### 10. Clinical Performance Data There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device. ### 11. Statement of Substantial Equivalence lt has been shown in this 510(k) submission that the difference between the MRI Patient Monitor TeslaDUO and the predicate devices MRI Patient Monitoring System Tesla M3 do not raise any questions regarding its safety and performance. The TeslaDUO has the similar intended use and the same technological characteristics as the previously cleared predicate device Tesla M3. The TeslaDUO as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).