MRI PATIENT MONITORING SYSTEM TESLA M3

K142032 · Mipm Mammendorfer Institut Fur Physik Und Medizin · MWI · May 7, 2015 · Cardiovascular

Device Facts

• Record ID: K142032
• Device Name: MRI PATIENT MONITORING SYSTEM TESLA M3
• Applicant: Mipm Mammendorfer Institut Fur Physik Und Medizin
• Product Code: MWI · Cardiovascular
• Decision Date: May 7, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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, 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 Story

MRI Patient Monitoring System Tesla M3 monitors vital signs during MRI examinations. Inputs: ECG, SpO2, NIBP, IBP, temperature, respiration, capnography, oxygen, and anesthetic agents via patient-connected sensors. Device processes signals to display numeric and graphic data on an integrated monitor. Used in MRI suites by physicians, nurses, and technicians. Output allows real-time patient status assessment, enabling clinicians to monitor stability during imaging. Benefits: continuous patient surveillance in magnetic environments, facilitating timely clinical intervention.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (EN/IEC 60601-1-2), and performance testing for specific modules (ECG, SpO2, NIBP, IBP, Capnography, Temperature) against relevant IEC/ISO standards.

Technological Characteristics

Housing: coated aluminum, antimagnetic stainless steel, plastics. Power: 100-240 VAC or dual Li-Ion batteries. Connectivity: standalone monitor. Software: PEMS. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 10993-1, ISO 14971, IEC 62304, ISO 80601-2-61, ISO 80601-2-55, IEC 60601-2-34, IEC 80601-2-30, IEC 60601-2-27, ISO 80601-2-56.

Indications for Use

Indicated for continuous monitoring of vital signs during MRI procedures in adult, pediatric, and neonatal populations (ECG, NIBP, IBP, Temp, Resp, Capnography, O2, Anesthetic Agents) and adult/pediatric populations (SpO2). Intended for use by healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Tesla Guard (K071802)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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."

{3}------------------------------------------------

# 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: [phone] Fax: [phone] 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: [phone] Fax: [phone] Contact: André Kindsvater, Senior Consultant, RA/QA Email: [e-mail]

### 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 or<br>alarms) |
| 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

{4}------------------------------------------------

### 6. 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

## 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, 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.

### 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 | SIGNIFICANT<br>DIFFERENCES |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Trade Name | MRI Patient Monitoring<br>System Tesla M3 | Tesla Guard | |
| 510(k) Number | K142032 | K071802 | N/A |
| Product Code | MWI | MWI | Equivalent |
| Manufacturer | MIPM | MIPM | SIGNIFICANT<br>DIFFERENCES |
| Trade Name | MRI Patient Monitoring<br>System Tesla M3 | Tesla Guard | |
| Regulation Number | 870.2300 | 870.2300 | Equivalent |
| Regulation Name | Monitor, Physiological,<br>Patient (without arrhythmia<br>detector or alarms) | Monitor, Physiological,<br>Patient (without arrhythmia<br>detector or alarms) | Equivalent |
| Indications for Use | The MRI Patient Monitoring<br>System Tesla M3 is intended<br>for monitoring of vital signs<br>during MRI examinations<br>(MRI procedures) of patients.<br><br>The Tesla M3 is intended for<br>use in the Adult, Pediatric<br>and Neonatal populations for<br>the 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><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).<br><br>The Tesla M3 is intended for<br>use by health care<br>professionals. | The Tesla Guard ®<br>Patient Monitor is capable of<br>monitoring:<br>• SpO2 (Arterial Oxygen<br>Saturation)<br>• ECG (3-Lead)<br>• IBP (Invasive Blood<br>Pressure)<br>• NIBP (Non-invasive Blood<br>Pressure)<br>• CO2 and Anesthetic Agents<br>(with optional multi-gas<br>module)<br>This device will produce visual<br>and audible alarms if any of<br>these parameters vary<br>beyond preset limits and<br>produce timed or alarm<br>recordings.<br>With the optional multi-gas<br>module installed, sampled<br>breathing gases from adults<br>and pediatrics can be<br>displayed. The multi-gas<br>module continuously<br>measures the content of CO2,<br>N2O, O2 and one of the<br>anesthetic agents, Halothane,<br>Isoflurane, Enflurane,<br>Sevoflurane and Desflurane in<br>any mixture, and<br>communicates real<br>time and derived gas<br>information to the Tesla<br>Guard ® Patient Monitor.<br>The device is intended to be<br>used in the environment<br>where patient care is<br>provided by Healthcare<br>Professionals, i.e. physicians,<br>nurses, and technicians,<br>trained on the use of the<br>device, who will determine<br>when<br>use of the device is indicated<br>based upon their professional | Substantially<br>equivalent.<br>Tesla Guard does not<br>have a Temperature<br>option |
| Manufacturer | MIPM | MIPM | SIGNIFICANT<br>DIFFERENCES |
| Trade Name | MRI Patient Monitoring<br>System Tesla M3 | Tesla Guard | |
| | | assessment of the patient's<br>medical condition.<br>The device is intended for use<br>in the Adult, Pediatric and<br>Neonatal populations.<br>MRI Compatibility Statement:<br>The Tesla Guard ® Patient<br>Monitor is designed for use in<br>an MRI-environment at a<br>maximum magnetic field<br>strength of 20mT. | |
| 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 |
| 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)<br>(optional) | Waveform and Numeric | Waveform and Numeric | Equivalent |
| Capnography<br>(optional) | Waveform and Numeric | Waveform and Numeric | Equivalent |
| Gases:<br>Capnography,<br>Oxygen and<br>Anesthetic Agents<br>(Auto Detection)<br>(optional) | Waveform and Numeric | Waveform and Numeric | Equivalent |
| Temperature<br>(1 or 2)<br>(optional) | Numeric | No (the Tesla Guard does not<br>include optional temperature<br>measurements) | 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 ISO<br>10993-1 | Yes | Yes | Equivalent |
| Electrical Safety<br>Testing Passed | Yes | Yes | Equivalent |

#### Table 5A - Comparison of Characteristics

{5}------------------------------------------------

{6}------------------------------------------------

### 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

{7}------------------------------------------------

| 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 | 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 |
| | Biocompatibility | Compliance to ISO 10993-1 | Passed |
| | Risk<br>Management | 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 Gas<br>Monitor | 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-<br>01 (ed.1.0) | Passed |
| 10 | ECG | Compliance to IEC 60601-2-27:2011-03<br>(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.