The Tesla M3 is intended for use in the Adult, Pediatric and Neonatal populations for the continuous monitoring of Electrocardiogram (ECG), Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Temperature, Respiration, Capnography (etCO₂), Oxygen and Anesthetic Agents.

The Tesla M3 is intended for use in the Adult and Pediatric populations for the continuous monitoring of Pulse Oximetry (SpO2).

The Tesla M3 is intended for use by health care professionals.

Device Description

The Tesla M3 is a MRI Patient Monitoring System that is intended to monitor and display vital signs during MRI examinations (MRI procedures) of patients. It is capable for continuous monitoring and displaying data from the following sensors/measurement modules in graphic and numeric form:

Electrocardiogram (ECG),
Pulse Oximetry (SpO2),
. Non-Invasive Blood Pressure (NIBP),
. Invasive Blood Pressure (IBP),
Temperature, Respiration,
Capnography (etCO2), and
. Oxygen and Anesthetic Agents

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MRI Patient Monitoring System Tesla M3, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Electrical safety	Compliance to IEC 60601-1:2012	Passed
Electromagnetic compatibility	Compliance to EN/IEC 60601-1-2: 2007	Passed
Multifunction Patient Monitor	Compliance to IEC 60601-2-49: 2011-02	Passed
Alarms	Compliance to IEC 60601-1-8:2006+A1:2012-11	Passed
Biocompatibility	Compliance to ISO 10993-1	Passed
Risk Management	Compliance to ISO 14971:2007	Passed
Software	Compliance to IEC 62304:2006	Passed
Pulse Oximeter	Compliance to ISO 80601-2-61: 2011	Passed
Respiratory Gas Monitor	Compliance to ISO 80601-2-55: 2011-12	Passed
IBP (Invasive Blood Pressure)	Compliance to IEC 60601-2-34:2011-05	Passed
NIBP (Non-Invasive Blood Pressure)	Compliance to IEC 80601-2-30:2009-01 (ed.1.0)	Passed
ECG (Electrocardiogram)	Compliance to IEC 60601-2-27:2011-03 (ed.3.0)	Passed
Thermometers	Compliance to ISO 80601-2-56: 2009 (ed. 1.0)	Passed

2. Sample Sizes Used for the Test Set and Data Provenance

The provided summary does not mention specific sample sizes for any clinical test sets. The testing conducted was primarily non-clinical compliance testing to established international standards. The provenance of data is not specified beyond being "non-clinical testing" conducted by the manufacturer, MIPM.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. Since the testing was non-clinical and focused on compliance to international standards, it's unlikely that "experts" in the sense of medical professionals establishing a ground truth for a test set were used in the same way they would be for an AI-driven diagnostic device. The ground truth would be defined by the specifications of the standards themselves (e.g., a known electrical signal for ECG accuracy, a calibrated pressure source for NIBP accuracy).

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of compliance testing against objective standards, a formal adjudication method like "2+1" or "3+1" used in clinical studies with subjective assessments would not be applicable. The results are typically "Pass" or "Fail" based on whether the device meets the quantitative requirements of the standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is a physiological patient monitor, not an AI-assisted diagnostic tool, and the submission explicitly states that "no clinical testing was required to support the medical device."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a physiological patient monitor; therefore, it's an "algorithm only" device in the sense that its measurements are generated by internal algorithms without human interpretation being part of its performance determination. However, it's important to differentiate this from AI-driven diagnostic algorithms. The "standalone" performance here refers to the device's ability to accurately measure vital signs against established standards, independent of human interpretation or intervention in the measurement process itself. The non-clinical performance testing summarized in the table above represents its standalone performance against these technical standards.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on the objective specifications and requirements outlined in the referenced international standards (e.g., IEC, ISO). For example:

For ECG: known electrical signals or waveforms.
For NIBP: calibrated pressure sources.
For Pulse Oximetry: simulated oxygen saturation levels.

It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Tesla M3 is a hardware-based physiological monitor with embedded software/firmware for data acquisition and processing, not a machine learning or AI device that requires a "training set" in the context of deep learning or similar algorithms. Its development and validation are based on engineering principles and compliance with medical device standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm being trained. The "ground truth" for the device's functioning, as mentioned above, is established by adherence to the specifications of recognized international medical device standards.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2015

MIPM Mammendorfer Institut fur Physik und Medizin GmbH % Andre Kindsvater Senior Consultant RA & QA Emergo Europe Consulting Prinsessegracht 20 The Hague, 2514AP NL

Re: K142032

Trade/Device Name: MRI Patient Monitoring System Tesla M3 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: March 26, 2015 Received: March 26, 2015

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

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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 of medical devicerelated 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 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.

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

510(k) Number (if known) K142032

K142032 Page 1 of 1

Device Name MRI Patient Monitoring System Tesla M3

Indications for Use (Describe)

The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.

The Tesla M3 is intended for use in the Adult, Pediations for the continuous monitoring of Electrocardiogram (ECG). Non-Invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Temperature, Respiration, Capnography (etCO2), Oxygen and Anesthetic Agents.

The Tesla M3 is intended for use in the Adult and Pediatric populations for the continuous monitoring of Pulse Oximetry (SpO2).

The Tesla M3 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 complete 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."

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510(k) Summary

for

MRI Patient Monitoring System Tesla M3

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, General Manager and QA Manager

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: PHONE Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: André Kindsvater, Senior Consultant, RA/QA Email: project.management@emergogroup.com

3. Date Prepared

May 7th, 2015

4. Device Identification

Trade/Proprietary Name:	MRI Patient Monitoring System Tesla M3
Common/Usual Name:	Physiological Patient Monitor
Classification Name:	monitor, physiological, patient (without arrhythmia detection oralarms)
Classification Regulation:	870.2300
Product Code:	MWI
Device Class:	Class II
Classification Panel:	Cardiovascular

5. Legally Marketed Predicate Device(s)

MRI Compatible Patient Monitor Tesla Guard, 510(k) number: K071802

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6. Device Description

Electrocardiogram (ECG),
Pulse Oximetry (SpO2),
. Non-Invasive Blood Pressure (NIBP),
. Invasive Blood Pressure (IBP),
Temperature, Respiration,
Capnography (etCO2), and
. Oxygen and Anesthetic Agents

7. Indication for Use Statement

The MRI Patient Monitoring System Tesla M3 is intended for monitoring of vital signs during MRI examinations (MRI procedures) of patients.

The Tesla M3 is intended for use in the Adult and Pediatric populations for the continuous monitoring of Pulse Oximetry (SpO2).

The Tesla M3 is intended for use by health care professionals.

8. Substantial Equivalence Discussion

The following table compares the MRI Patient Monitoring System Tesla M3 to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

In the 'Significant Differences' column of the table, list the differences between the device and the predicate and briefly justify why these differences do not raise safety and effectiveness concerns.

Manufacturer	MIPM	MIPM	SIGNIFICANTDIFFERENCES
Trade Name	MRI Patient MonitoringSystem Tesla M3	Tesla Guard
510(k) Number	K142032	K071802	N/A
Product Code	MWI	MWI	Equivalent
Manufacturer	MIPM	MIPM	SIGNIFICANTDIFFERENCES
Trade Name	MRI Patient MonitoringSystem Tesla M3	Tesla Guard
Regulation Number	870.2300	870.2300	Equivalent
Regulation Name	Monitor, Physiological,Patient (without arrhythmiadetector or alarms)	Monitor, Physiological,Patient (without arrhythmiadetector or alarms)	Equivalent
Indications for Use	The MRI Patient MonitoringSystem Tesla M3 is intendedfor monitoring of vital signsduring MRI examinations(MRI procedures) of patients.The Tesla M3 is intended foruse in the Adult, Pediatricand Neonatal populations forthe continuous monitoring ofElectrocardiogram (ECG),Non-Invasive Blood Pressure(NIBP), Invasive BloodPressure (IBP), Temperature,Respiration, Capnography(etCO2), Oxygen andAnesthetic Agents.The Tesla M3 is intended foruse in the Adult and Pediatricpopulations for thecontinuous monitoring ofPulse Oximetry (SpO2).The Tesla M3 is intended foruse by health careprofessionals.	The Tesla Guard ®Patient Monitor is capable ofmonitoring:• SpO2 (Arterial OxygenSaturation)• ECG (3-Lead)• IBP (Invasive BloodPressure)• NIBP (Non-invasive BloodPressure)• CO2 and Anesthetic Agents(with optional multi-gasmodule)This device will produce visualand audible alarms if any ofthese parameters varybeyond preset limits andproduce timed or alarmrecordings.With the optional multi-gasmodule installed, sampledbreathing gases from adultsand pediatrics can bedisplayed. The multi-gasmodule continuouslymeasures the content of CO2,N2O, O2 and one of theanesthetic agents, Halothane,Isoflurane, Enflurane,Sevoflurane and Desflurane inany mixture, andcommunicates realtime and derived gasinformation to the TeslaGuard ® Patient Monitor.The device is intended to beused in the environmentwhere patient care isprovided by HealthcareProfessionals, i.e. physicians,nurses, and technicians,trained on the use of thedevice, who will determinewhenuse of the device is indicatedbased upon their professional	Substantiallyequivalent.Tesla Guard does nothave a Temperatureoption
Manufacturer	MIPM	MIPM	SIGNIFICANTDIFFERENCES
Trade Name	MRI Patient MonitoringSystem Tesla M3	Tesla Guard
		assessment of the patient'smedical condition.The device is intended for usein the Adult, Pediatric andNeonatal populations.MRI Compatibility Statement:The Tesla Guard ® PatientMonitor is designed for use inan MRI-environment at amaximum magnetic fieldstrength of 20mT.
Material	Housing mainly coatedaluminium,antimagnetic stainless steel,plastics	Housing mainly coatedaluminium,antimagnetic stainless steel,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
Overall Design	PEMS and Software	PEMS and Software	Equivalent
ECG	Waveform and Numeric	Waveform and Numeric	Equivalent
Pulse Oximetry	Waveform and Numeric	Waveform and Numeric	Equivalent
NIBP	Numeric	Numeric	Equivalent
IBP (1 or 2)(optional)	Waveform and Numeric	Waveform and Numeric	Equivalent
Capnography(optional)	Waveform and Numeric	Waveform and Numeric	Equivalent
Gases:Capnography,Oxygen andAnesthetic Agents(Auto Detection)(optional)	Waveform and Numeric	Waveform and Numeric	Equivalent
Temperature(1 or 2)(optional)	Numeric	No (the Tesla Guard does notinclude optional temperaturemeasurements)	Different
Mode of operation	Continuous	Continuous	Equivalent
Battery Operated	Two batteries, Li-Ion	One battery, Pb	Equivalent
AC Powered	100 to 240 VAC, 50/60 Hz	100 to 240 VAC, 50/60 Hz	Equivalent
Complies with ISO10993-1	Yes	Yes	Equivalent
Electrical SafetyTesting Passed	Yes	Yes	Equivalent

Table 5A - Comparison of Characteristics

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9. Non-Clinical Performance Data

MIPM did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design against the company's

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Test	Pass / fail criteria	Results
1	Electrical safety	Compliance to IEC 60601-1:2012	Passed
2	Electromagneticcompatibility	Compliance to EN/IEC 60601-1-2: 2007	Passed
3	MultifunctionPatient Monitor	Compliance to IEC 60601-2-49: 2011-02	Passed
4	Alarms	Compliance to IEC 60601-1-8:2006+A1:2012-11	Passed
	Biocompatibility	Compliance to ISO 10993-1	Passed
	RiskManagement	Compliance to ISO 14971:2007	Passed
5	Software	Compliance to IEC 62304:2006	Passed
6	Pulse Oximeter	Compliance to ISO 80601-2-61: 2011	Passed
7	Respiratory GasMonitor	Compliance to ISO 80601-2-55: 2011-12	Passed
8	IBP	Compliance to IEC 60601-2-34:2011-05	Passed
9	NIBP	Compliance to IEC 80601-2-30:2009-01 (ed.1.0)	Passed
10	ECG	Compliance to IEC 60601-2-27:2011-03(ed.3.0)	Passed
11	Thermometers	Compliance to ISO 80601-2-56; 2009 (ed. 1.0)	Passed

Table 5B - Performance Testing Summary

For a complete listing of all applicable performance standards and their extent of compliance see Section 09 - Declarations of Conformity and the corresponding Summary Reports.

10. Clinical Performance Data

There was no 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 a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the difference between the Tesla M3 and the predicate devices do not raise any questions regarding its safety and effectiveness. The Tesla M3, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).