(130 days)
The TeslaGuard® 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 TeslaGuard Patient Monitor.
The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, no physicians or technicians, trained on the use of the device, who will determine when to rely on the information provided by the device based upon their professional assessment of the patient's medical condition.
The device is intended for use in the Adult, Pediatric and Neonatal populations.
The TeslaGuard design allows monitoring of intensive care patients while in an MRI-scanner. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m.
This 510(k) has been filed to establish substantial equivalence for an optional multi-gas module. With the 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 TeslaGuard Patient Monitor.
The provided 510(k) summary for the MIPM TeslaGuard® multi-gas module does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a definitive study demonstrating performance against those criteria. This type of submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance metrics.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding device performance. It generally states that "Laboratory bench testing was conducted to validate performance specifications of the multi-gas module." and "Simulated use testing was conducted to establish safety and effectiveness of the TeslaGuard multi-gas module under maximum intended MRI conditions." without providing the actual specifications or results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Laboratory bench testing" and "Simulated use testing." These typically involve controlled laboratory environments and simulated patient scenarios rather than a test set of patient data. Therefore, there's no mention of a sample size in terms of patient data or data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there is no mention of a test set based on patient data requiring ground truth establishment, this information is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Similarly, no information is provided regarding adjudication methods, as there's no evident test set requiring expert consensus.
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
The device is a patient monitor with an optional multi-gas module, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Laboratory bench testing" and "Simulated use testing" would be considered standalone performance assessments of the device's functionality. The device is designed to continuously measure gases and communicate information to a monitor, which is inherently a standalone algorithm/device function. Specific performance metrics (e.g., accuracy, precision) would have been assessed during these tests, but are not detailed in the summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For laboratory and simulated use testing of a multi-gas module, the ground truth would typically be established by:
- Reference gas mixtures: Using precisely calibrated gas mixtures with known concentrations of CO2, N2O, O2, and anesthetic agents as the "true" values.
- Reference instruments: Comparing the device's measurements against a highly accurate and calibrated reference instrument (e.g., a laboratory-grade gas analyzer) that serves as the gold standard.
The summary does not explicitly state which type of ground truth was used.
8. The sample size for the training set
The device is a hardware-based patient monitor with a sensing module, not a machine learning or AI-driven system that would typically require a "training set" in the conventional sense. The development and calibration of the module would involve engineering and physical sciences principles, and extensive testing with various gas concentrations and environmental conditions, rather than a data training set.
9. How the ground truth for the training set was established
As there is no "training set" as understood in AI, this question is not applicable. The calibration and design optimization of the device would rely on established scientific principles, precise laboratory measurements, and the use of reference standards.
Conclusion:
The 510(k) summary for the TeslaGuard® multi-gas module indicates that its performance was validated through "Laboratory bench testing" and "Simulated use testing" to establish its "safety and effectiveness." However, it does not provide specific acceptance criteria, quantitative performance results, or details about the methodology (e.g., sample sizes, ground truth establishment, expert involvement) in the way a clinical study for a diagnostic AI device would. This is typical for submissions of this nature, where the focus is on demonstrating equivalence to predicate devices and meeting general performance and safety requirements through engineering and controlled testing, rather than presenting a full-scale clinical trial report.
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| 510(k) Number: | K071802 |
|---|---|
| ---------------- | --------- |
Date: Date: Date:
Page 1 of 2
510(k) Summary
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR§807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Submitter
Mammendorfer Institut für Physik und Medizin GmbH (MIPM) Oskar-von-Miller-Strasse 6 82291 Mammendorf, Germany
NOV 0 9 2007
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors, Inc. 13605 West 7th Ave., Golden, CO 80401 USA Tel: +1 (303) 463-0900 / Fax: +1 (303) 234-9413
Date Prepared
June 25, 2007
Trade Name of Device
TeslaGuard®
Common Name of Device
MRI Compatible Patient Monitor
Classification
Name: Monitor, Physiological, Patient (without arrhythmia detector or alarms) Product Code: MWI Regulation Number: 21CFR§870.2300 Device Class: II
Device Description and Intended Use
The TeslaGuard design allows monitoring of intensive care patients while in an MRI-scanner. During use, the unit must be positioned in a way that the maximum field strength is not higher than 20 mT, and the distance to the magnet core is at least 1.5m.
This 510(k) has been filed to establish substantial equivalence for an optional multi-gas module. With the 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
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510(k) Number: _ K 0 718 0 2
Date: _
Page 2 of 2
of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any of the areasiness agence, teal time and derived gas information to the TeslaGuard Patient Monitor.
The other intended uses of the TeslaGuard remain unchanged.
Predicate Devices
MIPM TeslaGuard® as cleared under 510(k) # K052119 Draeger Infinity Gamma XL as cleared under 510(k) # K053484
Non Clinical Testing
Laboratory bench testing was conducted to validate performance specifications of the multi-gas module. Simulated use testing was conducted to establish safety and effectiveness of the TeslaGuard multi-gas module under maximum intended MRI conditions.
Risk Management
This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program.
Substantial Equivalence
Mammendorfer Institut für Physik und Medizin GmbH (MIPM) believes that the TeslaGuard multi-gas module is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping faces or profiles. The symbol is rendered in black and has a flowing, abstract design.
NOV 0 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mammendorfer Institut für Physik und Medizin GmbH c/o Mr. Robert N. Clark President and Senior Consultant Medical Device Regulatory Advisors, Inc. 13605 West 7th Ave. Golden, CO 80401
Re: K071802
Trade/Device Name: Tesla Guard Model EFT G04 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: October 7, 2007 Received: October 10, 2007
Dear Mr. Clark:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Robert N. Clark
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be actived that i Dr unstion that your device complies with other requirements of the Act that I Drehan statutes and regulations administered by other Federal agencies. You must or any I oderal statutes and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h your e FDA finding of substantial equivalence of your device to a legally premative included in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Blyminar 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):
Tesla Guard @ Device Name: _
Indications for Use:
The TeslaGuard® Patient Monitor is capable of monitoring:
- SpO2 (Arterial Oxygen Saturation)
- ECG (3-Lead)
- IBP (Invasive Blood Pressure) 0
- 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 vinti the optional motile gas module continuously measures the content of CO2, N2O, O2 and one of the ansthetic displayed. The hibiti-gas model continues and Desflurane in any mixtere, and communicates with and communicates real
agents, Halothane, Isoflurane, Sevolurane and Desfluran
The device is intended to be used in the environment where patient care is provided by Healthcare The device is intended to be assum the enternicians, trained on the use of the device, who will determine when r rolodionally, no pryliciance based upon their professional assessment of the patient's medical condition.
The device is intended for use in the Adult, Pediatric and Neonatal populations.
MRI Compatibility Statement
The Testa Suard® Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B.A. Summer
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071802
Page 1 of 1
MIPM TeslaGuard Special 510(k) Pace 16 of 215
§ 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).