The TeslaOxySat Pulse Oximeter is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The pulse oximeter is indicated for use with adult, pediatric, and neonatal patients. The TeslaOxySat PulseOximeter is designed for use in an MRI-environment at a maximum magnetic field strength of 20mT.

Device Description

The Tesla OxySat® design allows examination of intensive care or sedated patients while in an MRI-scanner. The Tesla OxySat® 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.

AI/ML Overview

The Tesla OxySat® pulse oximeter was studied to demonstrate its safety and effectiveness, including compliance with safety, EMC, biocompatibility, and MRI compatibility standards, as well as functional and accuracy testing. Equivalency testing was performed through laboratory studies using human subjects to validate functional and accuracy specifications and demonstrate equivalency to the predicate device, Masimo SET® /Quartz 2500 Pulse Oximeter and Accessories (K993555).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	EN 60601-1 (IEC 601-1) compliance	Device complies with EN 60601-1 (IEC 601-1).
EMC Compliance	EN 60601-1-2 compliance	Device complies with EN 60601-1-2.
Biocompatibility	ISO 10993-1 compliance for patient-contact portions	Patient contact portions comply with ISO 10993-1.
MRI Compatibility	No undue influence on MRI system; no undue influence of MRI system on device (at max 20mT field strength, 1.5m from magnet core)	Testing completed to determine influence of device on MRI system and vice versa.
Functional & Accuracy	Functional and accuracy specifications met in both normal and MRI environments.	Function and accuracy tested in both normal (Non-MRI) and MRI environments. Laboratory testing using human subjects validated functional and accuracy specifications.
Equivalency	Demonstrates equivalency to predicate device (Masimo SET® /Quartz 2500)	Laboratory testing using human subjects demonstrated equivalency to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications... and to demonstrate equivalency to the predicate device," but does not specify the sample size of human subjects used for this testing, nor does it explicitly state the data provenance (e.g., country of origin) or whether the study was retrospective or prospective. Given the nature of laboratory testing with human subjects for device validation, it is highly likely to have been a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications. For a pulse oximeter, ground truth for oxygen saturation and pulse rate typically involves comparison against a reference method (e.g., arterial blood gas analysis for oxygen saturation) rather than expert consensus on images.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method, as the testing described focuses on functional and accuracy validation against established references rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not described. The study was focused on device accuracy and equivalency to a predicate device, not on how human readers improve with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

Yes, the functional and accuracy testing of the Tesla OxySat® in both normal and MRI environments, and the equivalency testing using human subjects, constitutes a standalone performance evaluation of the device itself (algorithm and hardware combined) without human-in-the-loop performance being a primary outcome of interest for this type of device.

7. The Type of Ground Truth Used

The ground truth for the functional and accuracy testing for a pulse oximeter would typically involve:

Physiological measurements: Direct physiological measurements (e.g., arterial blood gas analysis for oxygen saturation, ECG for heart rate) from human subjects.
Predicate device comparison: Performance comparison against a legally marketed predicate device (Masimo SET® /Quartz 2500 Pulse Oximeter) known to be accurate.

The document states "Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications of the pulse oximeter and sensors, and to demonstrate equivalency to the predicate device." This implies a comparison to a gold standard, likely either direct physiological measurements or the highly accurate predicate device.

8. The Sample Size for the Training Set

The provided document does not mention a training set sample size. For this type of medical device (pulse oximeter), the development likely involved engineering, calibration, and internal testing, but the public summary focuses on the final validation/testing in human subjects rather than details of an initial "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not explicitly mentioned or detailed in the context of this 510(k) summary, the method for establishing its ground truth is also not described.

Summary

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510(k) Number:	K050018
Date:

Page 1 of 2

510(k) Summary

JUL 0 1 2005

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 7th Ave., Golden, CO USA Tel: 303-234-9412 / Fax: 303-234-9413

Date Prepared

December 30, 2004

Trade Name of Device

Tesla OxySat®

Common Name of Device

Pulse Oximeter and Sensor

Classification Name

Oximeter

510(k) Classification

21CFR§870.2700 / Class II Product Code: DQA

Device Description and Intended Use

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510(k) Number:
Date:

Page 2 of 2

Predicate Devices

Masimo SET® /Quartz 2500 Pulse Oximeter and Accessories (K993555)

Safety & Effectiveness

Safety Testing

The Tesla OxySat complies with the Safety Testing requirements of EN 60601-1 (IEC 601-1).

EMC Compliance

The Tesla OxySat complies with the EMC requirements of standard EN 60601-1-2.

Biocompatibility

The patient contact portions of the Tesla OxySat fiber optic finger probe comply with the biocompatibility requirements of standard ISO 10993-1.

MRI Compatibility Tests

Testing was completed to determine the influence of the Tesla OxySat on the MRI system, and the influence of the MRI system on the Tesla OxySat®.

Functional Testing

Function and accuracy of the Tesla OxySat was tested in both normal environment (Non MRI) and in MRI environment.

Equivalency Testing

Laboratory testing using human subjects was conducted to validate the functional and accuracy specifications of the pulse oximeter and 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 and pulse oximeter 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 OxySat® 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mammendorfer Institute for Physics and Medicine GMBH C/o Mr. Robert N. Clark Medical Device Regulatory Advisors 13605 West 7th Avenue Golden, Colorado 80401

JUL 0 1 2005

Re: K050018

Trade/Device Name: Tesla OxySat® Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: May 6, 2005 Received: May 10, 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.

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.

Image /page/2/Picture/12 description: The image is a black and white emblem for the U.S. Department of Health & Human Services. The emblem features a stylized caduceus, a symbol often associated with healthcare, consisting of three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, framing the symbol.

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Page 2- Mr. Robert N. Clark

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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

Device Name:

TeslaOxySat®

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aun Sylionn

Division Sign-Off) Division of Anesthestotogy, General Hospital, Infection Control, Dental Devices

510(k) Number:

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).