(286 days)
Not Found
No
The summary describes a standard vital signs monitor for use during MRI procedures and does not mention any AI or ML capabilities.
No
The device is described as a "MRI Patient Monitoring System" intended for "monitoring of vital signs" and displaying data. It does not provide any treatment or therapy.
No
This device is a patient monitoring system that continuously measures and displays vital signs during MRI examinations. While it provides data that healthcare professionals use to assess a patient's condition, its primary function is monitoring, not diagnosing a specific disease or condition.
No
The device description explicitly lists multiple hardware components (sensors/measurement modules) that are part of the system, indicating it is not software-only.
Based on the provided information, the MRI Patient Monitoring System Tesla M3 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the living body.
- Tesla M3 Function: The Tesla M3 is a patient monitoring system that measures vital signs directly from the patient's body during an MRI procedure. It uses sensors applied to the patient to collect data on parameters like ECG, SpO2, NIBP, etc. This is in vivo monitoring, not in vitro testing of specimens.
- Intended Use: The intended use clearly states "monitoring of vital signs during MRI examinations of patients." This describes a direct patient monitoring function, not laboratory testing of samples.
- Device Description: The device description lists sensors and measurement modules that are applied to the patient to collect physiological data.
Therefore, the Tesla M3 falls under the category of patient monitoring devices, which are distinct from IVD devices.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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.
Adult and Pediatric populations for the continuous monitoring of Pulse Oximetry (SpO2).
Intended User / Care Setting
health care professionals.
in an MRI-environment at a maximum magnetic field strength of 20mT.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- 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: Compliance to IEC 60601-2-34:2011-05 - Passed
- NIBP: Compliance to IEC 80601-2-30:2009-01 (ed.1.0) - Passed
- ECG: Compliance to IEC 60601-2-27:2011-03 (ed.3.0) - Passed
- Thermometers: Compliance to ISO 80601-2-56; 2009 (ed. 1.0) - Passed
Clinical testing was not required as the indications for use are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (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
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: (+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 or |
| 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
DIFFERENCES |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Trade Name | MRI Patient Monitoring
System Tesla M3 | Tesla Guard | |
| 510(k) Number | K142032 | K071802 | N/A |
| Product Code | MWI | MWI | Equivalent |
| Manufacturer | MIPM | MIPM | SIGNIFICANT
DIFFERENCES |
| Trade Name | MRI Patient Monitoring
System Tesla M3 | Tesla Guard | |
| Regulation Number | 870.2300 | 870.2300 | Equivalent |
| Regulation Name | Monitor, Physiological,
Patient (without arrhythmia
detector or alarms) | Monitor, Physiological,
Patient (without arrhythmia
detector or alarms) | Equivalent |
| Indications for 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. | The Tesla Guard ®
Patient Monitor is capable of
monitoring:
• SpO2 (Arterial Oxygen
Saturation)
• ECG (3-Lead)
• IBP (Invasive Blood
Pressure)
• NIBP (Non-invasive Blood
Pressure)
• CO2 and Anesthetic Agents
(with optional multi-gas
module)
This device will produce visual
and audible alarms if any of
these parameters vary
beyond preset limits and
produce timed or alarm
recordings.
With the optional multi-gas
module installed, sampled
breathing gases from adults
and pediatrics can be
displayed. The multi-gas
module continuously
measures the content of CO2,
N2O, O2 and one of the
anesthetic agents, Halothane,
Isoflurane, Enflurane,
Sevoflurane and Desflurane in
any mixture, and
communicates real
time and derived gas
information to the Tesla
Guard ® Patient Monitor.
The device is intended to be
used in the environment
where patient care is
provided by Healthcare
Professionals, i.e. physicians,
nurses, and technicians,
trained on the use of the
device, who will determine
when
use of the device is indicated
based upon their professional | Substantially
equivalent.
Tesla Guard does not
have a Temperature
option |
| Manufacturer | MIPM | MIPM | SIGNIFICANT
DIFFERENCES |
| Trade Name | MRI Patient Monitoring
System Tesla M3 | Tesla Guard | |
| | | assessment of the patient's
medical condition.
The device is intended for use
in the Adult, Pediatric and
Neonatal populations.
MRI Compatibility Statement:
The Tesla Guard ® Patient
Monitor is designed for use in
an MRI-environment at a
maximum magnetic field
strength of 20mT. | |
| Material | Housing mainly coated
aluminium,
antimagnetic stainless steel,
plastics | Housing mainly coated
aluminium,
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 and
Anesthetic Agents
(Auto Detection)
(optional) | Waveform and Numeric | Waveform and Numeric | Equivalent |
| Temperature
(1 or 2)
(optional) | Numeric | No (the Tesla Guard does not
include optional temperature
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
10993-1 | Yes | Yes | Equivalent |
| Electrical Safety
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 | ||
| compatibility | Compliance to EN/IEC 60601-1-2: 2007 | Passed | |
| 3 | Multifunction | ||
| Patient 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 | |
| Risk | |||
| 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 | ||
| 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- | |
| 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.