(183 days)
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.
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)
The provided text describes the 510(k) submission for the MRI Patient Monitor TeslaDUO. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/ML study.
Therefore, many of the requested elements for an AI/ML study (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device clearance and not an AI/ML-driven device.
However, I can extract information related to the device's performance against established standards which serve as "acceptance criteria" for this type of device.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are compliance with various national and international standards for patient monitors, electrical safety, electromagnetic compatibility, and specific vital sign measurements. The reported device performance is simply "Passed" for each of these criteria.
| Test Title | Pass / Fail Criteria | Reported Device Performance |
|---|---|---|
| Electrical safety | Compliance to IEC 60601-1:2012 | Passed |
| Electromagnetic Compatibility | Compliance to EN/IEC 60601-1-2: 2007; Compliance to EN/IEC 60601-1-2: 2014 | 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 |
| NIBP (Non-Invasive Blood Pressure) | Compliance to IEC 80601-2-30:2009-01 (ed.1.0) | Passed |
| Batteries | IEC 62133:2012 | Passed |
| Usability | IEC 60601-1-6:2010-01 + A1:2013; IEC 62366:2007 (Ed. 1) + A1: 2014 | Passed |
| MRI Environment Compatibility | Measurement of Magnetostatic Forces, Magnetic Immunity, MRI Immunity, Radio Frequency field induced and Gradient field induced Heating | All tests passed |
2. Sample size used for the test set and the data provenance
Not applicable to this type of device submission. The testing involves compliance with standards, which typically involve specific test configurations and simulated data or controlled measurements, not a "test set" of clinical cases in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for these compliance tests is established by documented scientific/engineering principles outlined in the standards, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations, which is not the case for these objective performance and safety standard tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a patient monitor, not an AI-driven diagnostic or interpretative tool. Therefore, an MRMC study is not relevant or presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device measures vital signs and displays them; it does not contain an AI algorithm that performs a standalone diagnostic function. The "performance" is the accuracy and reliability of its measurements against established benchmarks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For vital sign measurements (SpO2, NIBP), the "ground truth" implicitly refers to the accuracy and precision of the measurements compared to reference standards or established physiological parameters as defined within the relevant IEC/ISO standards (e.g., ISO 80601-2-61 for Pulse Oximeter, IEC 80601-2-30 for NIBP). The other tests involve compliance with safety and compatibility standards, where "ground truth" is adherence to the specified technical requirements and limits.
8. The sample size for the training set
Not applicable. This device does not use machine learning, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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
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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
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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)
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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 |
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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.
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| Manufacturer | MIPM | MIPM | SignificantDifferences |
|---|---|---|---|
| Trade Name | MRI Patient MonitorTeslaDUO | MRI Patient MonitoringSystem 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(without arrhythmia detectoror alarms) | Monitor, Physiological,Patient (without arrhythmiadetector or alarms) | Equivalent |
| Indications for Use | The MRI Patient MonitorTeslaDUO is intended formonitoring of vital signsduring MRI examinations (MRIprocedures) of patients.The TeslaDUO is intended foruse in the Adult and Pediatricpopulations for continuousmonitoring of Pulse Oximetry(SpO2) | The MRI Patient MonitoringSystem Tesla M3 is intendedfor monitoring of vital signsduring MRI examinations (MRIprocedures) of patients.The Tesla M3 is intended foruse in the Adult, Pediatric andNeonatal populations for thecontinuous 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). | EquivalentTeslaDUO does nothave ECG, IBP, CO2,Temperature,Oxygen andAnesthetic Agentsoptions |
| The TeslaDUO is intended foruse in the Adult, Pediatric andNeonatal populations forcontinuous monitoring ofNon-Invasive Blood Pressure(NIBP).The TeslaDUO is intended foruse by health careprofessionals. | The Tesla M3 is intended foruse by health careprofessionals. | ||
| Intended Population | Adult, Pediatric, Neonatal | Adult, Pediatric, Neonatal | Equivalent |
| Mechanism ofAction | Data Acquisition | Data Acquisition | Equivalent |
| TechnologyOverview | PEMS and Software | PEMS and Software | Equivalent |
| Pulse Oximetry | Waveform and Numeric | Waveform and Numeric | Equivalent |
| NIBP | Numeric | Numeric | Equivalent |
| Manufacturer | MIPM | MIPM | SignificantDifferences |
| Trade Name | MRI Patient MonitorTeslaDUO | MRI Patient MonitoringSystem Tesla M3 | |
| 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 |
| 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 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
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 | Electromagneticcompatibility | Compliance to EN/IEC 60601-1-2: 2007Compliance to EN/IEC 60601-1-2: 2014 | 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 |
| 5 | Biocompatibility | Compliance to ISO 10993-1 | Passed |
| 6 | RiskManagement | Compliance to ISO 14971:2007 | Passed |
| 7 | Software | Compliance to IEC 62304:2006 | Passed |
| Table 5B – Performance Standards Testing Summary | ||
|---|---|---|
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| Test | Pass / fail criteria | Results | |
|---|---|---|---|
| 8 | Pulse Oximeter | Compliance to ISO 80601-2-61: 2011 | Passed |
| 9 | NIBP | Compliance to IEC 80601-2-30:2009-01 (ed.1.0) | Passed |
| 10 | Batteries | IEC 62133:2012 | Passed |
| 11 | Usability | IEC 60601-1-6:2010-01 + A1:2013IEC 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).
§ 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).