(178 days)
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.
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.
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.
§ 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).