(152 days)
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.
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.
The provided 510(k) summary for the Tesla Guard® patient monitor primarily focuses on safety, EMC compliance, and biocompatibility, as well as a general statement about function and accuracy testing. It does not provide specific, quantifiable acceptance criteria or detailed results of a study designed to prove the device meets such criteria in the format or level of detail typically found for AI/ML device submissions.
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantifiable acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity for SpO2, ECG, IBP, NIBP) in a summarized table. It generally states that "Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment," and "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."
Without explicit criteria or detailed results in the provided text, a table cannot be constructed.
Regarding the study that proves the device meets acceptance criteria:
The summary refers to "Laboratory Testing" using human subjects for "functional and accuracy specifications of the pulse oximeter fiberoptic sensors" and to "demonstrate equivalency to the predicate device." However, no specific details about this study's design or quantitative results are provided.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided document. The document mentions "human subjects" for laboratory testing but doesn't quantify how many.
- Data Provenance: Not specified. It mentions "laboratory testing using human subjects," but details on country of origin, demographics, or whether the data was retrospective or prospective are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the device is a patient monitor taking physiological measurements rather than an AI/ML diagnostic tool that would typically rely on expert ground truth. The "ground truth" for a patient monitor would generally be a reference standard device or direct physiological measurement.
4. Adjudication method for the test set
- Not applicable/Not specified. Given the nature of a physiological monitor, adjudication in the sense of expert consensus for image or data interpretation is not relevant. The "ground truth" would be established by a reference standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The Tesla Guard® is a patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with AI assistance is not relevant to its evaluation as described in this summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied Standard Performance Assessment (Standalone): The document states, "Function and accuracy of the Tesla Guard was tested in both normal environment (Non MRI) and in MRI environment." This suggests a standalone performance evaluation of the device's ability to measure physiological parameters accurately. However, specific performance metrics (e.g., mean absolute error, bias, precision) for SpO2, ECG, IBP, or NIBP are not provided. The focus is on demonstrating its functionality and accuracy, and importantly, its equivalency to a predicate device, particularly in an MRI environment.
7. The type of ground truth used
- Reference Standard Comparison: For a physiological monitor, the ground truth would typically be established using a highly accurate reference standard device or method. For example, for pulse oximetry (SpO2), this could involve fractional arterial oxygen saturation measured from blood gas analysis. For ECG, IBP, and NIBP, it would be comparison to clinically accepted reference monitoring devices. The summary directly states, "demonstrate equivalency to the predicate device," implying the predicate device or its established performance characteristics served as a key reference for comparison.
8. The sample size for the training set
- Not applicable/Not provided. This device is a physiological monitor, not an AI/ML algorithm that undergoes a distinct "training" phase with a dataset. Its development would involve engineering design, calibration, and validation, rather than machine learning training.
9. How the ground truth for the training set was established
- Not applicable. As a traditional medical device (non-AI/ML), the concept of a "training set ground truth" does not apply in the described context. The device's accuracy would be established through engineering specifications, calibration against known standards, and clinical validation studies using reference methods.
{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.
{1}------------------------------------------------
| 510(k) Number: | |
|---|---|
| Date: |
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
Page 1 of 1
§ 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).