(178 days)
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description focuses on hardware design for MRI compatibility.
No.
A therapeutic device is used to treat or prevent a disease or condition. This device is a pulse oximeter, which is a diagnostic device used for monitoring oxygen saturation and pulse rate. It does not provide any treatment.
Yes
The device is a pulse oximeter that monitors physiological parameters (SpO2 and pulse rate) to assess a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly mentions hardware components like a fiber optic finger probe and additional shielding, indicating it is not software-only.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- TeslaOxySat Function: The TeslaOxySat Pulse Oximeter measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate noninvasively through the finger. It does not analyze samples taken from the body.
- Intended Use: The intended use is for continuous noninvasive monitoring of physiological parameters (SpO2 and pulse rate) in patients, particularly in an MRI environment. This is a monitoring function, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the TeslaOxySat Pulse Oximeter falls under the category of a noninvasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
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.
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 patients
Intended User / Care Setting
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
| 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
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.
Image /page/0/Picture/21 description: The image shows the characters 'E 000002' in a bold, sans-serif font. The 'E' is larger than the numbers that follow it. The numbers are all zeros except for the last digit, which is a '2'.
1
| 510(k) Number: | |
|---|---|
| Date: |
Page 2 of 2
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.
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.
000003
2
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
4
Indications for Use
510(k) Number:
Device Name:
TeslaOxySat®
Indications for Use:
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.
(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)
OR
Over-The-Counter-Use