(152 days)
Not Found
No
The summary describes a standard patient monitor with basic physiological parameter monitoring and alarming capabilities, without mentioning any AI or ML functionalities.
No
The device is a patient monitor, which measures physiological parameters and provides alarms, but it does not treat a disease or condition. Its purpose is to provide monitoring, not therapy.
No
The device is described as a "Patient Monitor" and its functions are limited to monitoring physiological parameters (SpO2, ECG, IBP, NIBP) and alarming when these vary from preset limits. It does not provide a diagnosis itself but rather data for healthcare professionals to assess a patient's condition.
No
The device description explicitly mentions hardware components like a "fiber optic finger probe" and "additional shielding," indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Tesfacuard® Patient Monitor directly monitors physiological parameters within the patient's body (SpO2, ECG, IBP, NIBP). It does not analyze samples taken from the patient.
- Intended Use: The intended use describes monitoring vital signs of patients in a healthcare setting, particularly during MRI procedures. This is a direct patient monitoring function, not an in vitro diagnostic function.
Therefore, the Tesfacuard® Patient Monitor falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tesfacuard® Patient Monitor is capable of monitoring:
- SpO2 (Arterial Oxygen Saturation) .
- ECG (3-Lead) .
- IBP (Invasive Blood Pressure) .
- . NIBP (Non-invasive Blood Pressure)
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits.
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 assessment of the patient's medical condition.
The device is intended for use in the Adult, Pediatric and Neonatal populations.
MRI Compatibility Statement:
The Tesfa Guad® Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
The Tesla Guard® design allows examination of intensive care patients while in an MRI-scanner. The Tesla Guard® construction, fiber optic finger probe, and additional shielding make it possible to use the device within the magnetic and RF fields of the MRI examination room. 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.
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.
Intended User / Care Setting
Environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device.
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)
Safety Testing: The Tesla Guard complies with the Safety Testing requirements of EN 60601-1 (IEC 601-1).
EMC Compliance: The Tesla Guard complies with the EMC requirements of standard EN 60601-1-2.
Biocompatibility: The patient contact portions of the Tesla Guard fiber optic finger probe comply with the biocompatibility requirements of standard ISO 10993-1.
Verification and Validation: Testing was completed to determine the influence of the Tesla Guard on the MRI system, and the influence of the MRI system on the Tesla Guard®. Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment.
Laboratory Testing: Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications of the pulse oximeter fiberoptic sensors, and to demonstrate equivalency 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.
K033600, K030313, K017016, K990563, K983632
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: K052119
Date:
Page 1 of 2
Date:
510(k) Summary
Introduction
This summary is intended to comply with requirements of the SMDA and 21CFR8807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.
510(k) Applicant
Mammendorfer Institut für Physik und Medizin GmbH Oskar-von-Miller-Strasse 6 82291 Mammendorf, Germany
510(k) Correspondent
Robert N. Clark, President and Senior Consultant Medical Device Regulatory Advisors 13605 West 710 Ave., Golden, CO USA Tel: 303-234-9412 / Fax: 303-234-9413
Date Prepared
July 20, 2005
Trade Name of Device
Tesla Guard®
Common Name of Device
Patient Monitor
Classification Name
Monitor, Physiological, Patient (without arrhythmia detector or alarms)
510(k) Classification
21CFR8870.2300 / Class II Product Code: MWI
Device Description and Intended Use
The Tesla Guard® design allows examination of intensive care patients while in an MRI-scanner. The Tesla Guard® construction, fiber optic finger probe, and additional shielding make it possible to use the device within the magnetic and RF fields of the MRI examination room. 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.
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Page 2 of 2
Predicate Devices
Infinity Gamma XL manufactured by Dräger Medical Systems Inc. (K033600, K030313, K017016, K990563, K983632)
Safety & Effectiveness
Safety Testing
The Tesla Guard complies with the Safety Testing requirements of EN 60601-1 (IEC 601-1).
EMC Compliance
The Tesla Guard complies with the EMC requirements of standard EN 60601-1-2.
Biocompatibility
The patient contact portions of the Tesla Guard fiber optic finger probe comply with the biocompatibility requirements of standard ISO 10993-1.
Verification and Validation
Testing was completed to determine the influence of the Tesla Guard on the MRI system, and the influence of the MRI system on the Tesla Guard®.
Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment.
Laboratory Testing
Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications of the pulse oximeter fiberoptic sensors, and to demonstrate equivalency to the predicate device.
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.
The user must be qualified in MRI procedures, and must be familiar with all labeling and instructions for use associated with the device.
Mammendorfer Institut für Physik und Medizin GmbH believes that the Tesla Guard® is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate devices.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services, USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
JAN 3 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mammendorfer Institute for Physics and Medicine GmbH c/o Mr. Robert Clark President Medical Device Regulatory Advisors 13605 West 7th Ave. Golden, CO 80401-4604
Re: K052119 Trade Name: TeslaGuard@ Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: Novewmber29, 2005 Received: December 01, 2005
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 Clark
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 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Blymmemork
Brain 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): K052119
TeslaGuard ® Device Name:
Indications For Use:
The Tesfacuard® Patient Monitor is capable of monitoring:
- SpO2 (Arterial Oxygen Saturation) .
- ECG (3-Lead) .
- IBP (Invasive Blood Pressure) .
- . NIBP (Non-invasive Blood Pressure)
This device will produce visual and audible alarms if any of these parameters vary beyond preset limits.
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 assessment of the patient's medical condition.
The device is intended for use in the Adult, Pediatric and Neonatal populations.
MRI Compatibility Statement:
The Tesfa Guad® Patient Monitor is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.
Prescription Use × (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)
Blossomner
mdktdstslain.com
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