(130 days)
Not Found
No
The summary describes a standard patient monitor with an optional multi-gas module. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The device focuses on real-time parameter measurement and alarming based on preset limits.
No
The device is a patient monitor, which measures physiological parameters and provides alarms. It does not provide any treatment or therapy.
Yes
The device monitors physiological parameters (SpO2, ECG, IBP, NIBP, CO2, anesthetic agents) and provides real-time data, enabling healthcare professionals to assess a patient's medical condition and determine when to rely on the information provided, which aligns with the definition of a diagnostic device.
No
The device description explicitly mentions a "multi-gas module" which is a hardware component that measures breathing gases. The 510(k) is specifically filed to establish substantial equivalence for this optional hardware module.
Based on the provided text, the TeslaGuard® Patient Monitor, even with the optional multi-gas module, is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TeslaGuard's Function: The TeslaGuard Patient Monitor measures physiological parameters directly from the patient (SpO2, ECG, IBP, NIBP) and analyzes sampled breathing gases. These are measurements taken in vivo (within the living body or its immediate environment), not in vitro (outside the body in a test tube or other container).
- Lack of Specimen Analysis: The device does not process or analyze biological specimens. It measures gases in the breathing circuit and electrical/pressure signals from the patient.
Therefore, the TeslaGuard Patient Monitor falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
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, 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 and/or trained technicians, trained on the use of the device, who will determine when to take medical action based upon their professional assessment of the patient's medical condition.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
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 of the areasiness agence, teal time and derived gas information to the TeslaGuard Patient Monitor.
The other intended uses of the TeslaGuard remain unchanged.
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
Intended User / Care Setting
Healthcare Professionals and/or trained technicians in the environment where patient care is provided.
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 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.
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
| 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
1
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.
2
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.
3
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
4
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
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