(326 days)
Reprocessed Masimo Pulse Oximeter sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.
The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are light-emitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated hemoglobin within the blood.
The proposed devices of this submission do not differ from the predicate device. The only difference is that the proposed devices will be exposed to vaporized hydrogen peroxide instead of ethylene oxide.
The provided text describes the 510(k) premarket notification for reprocessed Masimo Pulse Oximeters. It focuses on demonstrating substantial equivalence to a predicate device, particularly regarding the change in the reprocessing sterilization method (from ethylene oxide to vaporized hydrogen peroxide).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based only on the provided text.
Acceptance Criteria and Study Details for Reprocessed Masimo Pulse Oximeters
The primary acceptance criteria for this reprocessed device appear to be maintaining the functional performance of the original device after reprocessing, particularly in light of a change in the sterilization method. The studies described are bench and clinical validation tests to demonstrate that the reprocessed device is substantially equivalent to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (as tested) |
|---|---|
| No open circuits (measured by continuity testing) | Met (Continuity testing was conducted to verify no open circuits) |
| Signal transmission between photodiode and LED (measured by sensitivity testing) | Met (Sensitivity testing was conducted to detect signal transmission) |
| Biocompatibility requirements met (per ANSI/AAMI/ISO 10993-1: 2009 for surface contacting devices with prolonged exposure to skin) | Met (All reprocessed pulse oximeter sensors materials in contact with the patient are replaced with medical grade adhesive tape during reprocessing and meet biocompatibility requirements.) |
| SpO2 performance under no motion (ARMS for SpO2 in the range of 70% to 100%) | ARMS for SpO2 was 1.48% (for woven tape) and 1.72% (for non-woven tape) over the range of 70-100%. (This is a specific performance metric, implying an acceptable range, although the acceptable range itself is not explicitly stated as a numerical threshold beyond the reported value). |
2. Sample Size Used for the Test Set and Data Provenance:
- Bench Testing (Continuity and Sensitivity): The text does not specify the exact sample size for the bench tests. It states that "Bench and laboratory testing was conducted to determine whether a pulse oximeter sensor is functional." No specific number of sensors or repetitions are mentioned.
- Clinical Validation Testing (SpO2 performance): The clinical validation testing was performed on "healthy, adult volunteers." The exact number of volunteers is not specified in the provided text.
- Data Provenance: The text does not explicitly state the country of origin for the clinical validation volunteers, nor does it specify if the data was retrospective or prospective. Given the nature of clinical validation testing for a medical device submission, it is typically presumed to be prospective, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not specify the number or qualifications of experts used to establish ground truth for any of the tests. For SpO2 performance, ground truth would typically be established by a reference oximetry device or arterial blood gas measurements, rather than expert consensus on image interpretation.
4. Adjudication Method for the Test Set:
This information is not provided in the text. Adjudication methods are typically relevant for studies involving human readers or subjective interpretations. The tests described (continuity, sensitivity, SpO2 performance) are largely objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not reported. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. This submission describes a reprocessed hardware device (pulse oximeter sensor) with objective performance measurements.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
The concept of "standalone" performance typically applies to algorithms. While the device contains electrical components, its performance is measured through physical and clinical tests, not as an algorithm's output. The "functional" tests (continuity, sensitivity) and clinical SpO2 performance are essentially "standalone" device performance metrics, as they evaluate the device's output and function directly, without human interpretation in the loop beyond connecting the device and reading its output.
7. The Type of Ground Truth Used:
- Bench Testing: The ground truth for continuity and sensitivity is based on engineering specifications and direct measurement (e.g., current flow, signal detection).
- Clinical Validation Testing: For SpO2 performance, the ground truth would typically be established by a primary reference method for oxygen saturation, such as co-oximetry (from arterial blood samples) or a highly accurate reference pulse oximeter. The text states "clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%," implying comparison to a reference standard, though the specific reference standard is not detailed. It is highly likely based on arterial blood gas analysis with co-oximetry, which is the standard for SpO2 ground truth.
8. The Sample Size for the Training Set:
This information is not applicable or not provided. This submission concerns a reprocessed medical device, not an AI/ML algorithm that requires a training set. The term "training set" is generally used in the context of machine learning model development.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no "training set" for this type of medical device submission.
§ 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).