(164 days)
The reprocessed pulse oximeter sensors are indicated for use for continuous noninvasive arterial oxygen saturation (SpO2) and pulse rate monitoring.
SterilMed's reprocessed pulse oximeter sensors consist of a sensor, integrated sensor cable, and a sensor plug which connects to the Pulse Oximeter. These devices feature a sensor that uses an optical means to determine the light absorption of functional arterial hemoglobin. The sensor contains three optical components: two light emitting diodes (LED's) that serve as light sources, and one photodiode, that acts as a light receiver. The oximeter sensor is positioned so that the LED's and photodiode oppose one another across the tissue. The sensor is connected via cable to a pulse oximeter, which provides continuous noninvasive, self-calibrated measurements of both oxygen saturation of functional hemoglobin and pulse rate.
The provided text describes a 510(k) summary for SterilMed, Inc.'s Reprocessed Pulse Oximeter Sensors. It details functional and safety testing, non-clinical tests, and clinical studies conducted to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Although specific numerical acceptance criteria (e.g., +/- 2% accuracy) are not explicitly stated in the document for SpO2 and pulse rate accuracy, the document indicates that the reprocessed sensors demonstrated "appropriate functional characteristics" and "SpO2 accuracy" in both bench and in vivo clinical validations.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| SpO2 Accuracy (Normal Perfusion) | Validated by bench testing and in vivo clinical studies |
| SpO2 Accuracy (Low Perfusion) | Validated by bench testing |
| Pulse Rate Accuracy (Normal Perfusion) | Validated by bench testing and in vivo clinical studies |
| Pulse Rate Accuracy (Low Perfusion) | Validated by bench testing |
| Structural Integrity after Reprocessing | Validated by physical tests |
| Sterilization Validation (ISO 11135, USP ) | Successfully validated |
| Ethylene Oxide Residual Testing (ISO 10993-7) | Successfully tested |
| Bioburden Testing | Successfully tested |
| Packaging Validation (ASTM D4169, ASTM F88) | Successfully validated |
| Shelf Life Validation (ASTM 1980-99) | Successfully validated |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "in vivo clinical studies were conducted on both adult volunteers and neonatal subjects" but does not specify the sample size for these clinical studies. It also does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given the nature of a 510(k) submission for a reprocessed medical device, clinical studies are typically prospective to demonstrate the safety and efficacy of the reprocessed version.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical studies. For pulse oximetry, the ground truth for SpO2 and pulse rate is typically established through a co-oximeter analyzing arterial blood samples for SpO2, and an ECG or manual pulse check for pulse rate. Expertise would be required for proper blood gas analysis and clinical assessment, but the document does not elaborate on this.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set in the clinical studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging devices) where human readers interpret output. Pulse oximeters provide direct quantitative measurements, so an MRMC study is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, in the context of a pulse oximeter sensor, its performance is inherently "standalone" in how it acquires and transmits raw physiological data (light absorption). The "algorithm" here refers to the internal processing within the oximeter (which is not part of this 510(k) submission) to convert light absorption into SpO2 and pulse rate. The tests described (SpO2 and pulse rate accuracy using a simulated tester, and in vivo clinical studies) are evaluations of the sensor's ability to accurately provide these measurements.
7. The Type of Ground Truth Used
The ground truth for the clinical studies would have been established using reference standard methods for measuring SpO2 and pulse rate. For SpO2, this typically involves arterial blood gas analysis (co-oximetry). For pulse rate, this could be from electrocardiography (ECG) or other accurate physiological monitoring. The document states "in vivo clinical studies were conducted... to demonstrate SpO2 accuracy," implying comparison against such a reference.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of device performance evaluation. For a reprocessed pulse oximeter sensor, there isn't typically a "training set" in the machine learning sense. The "training" here refers to the development and validation of the reprocessing protocol itself, and the document discusses "process validation testing" for sterilization and "validation of functional performance" for the reprocessed devices. However, no specific sample size for this developmental "training" is provided.
9. How the Ground Truth for the Training Set Was Established
Given that a "training set" in the machine learning sense is not applicable, the concept of establishing ground truth for it is also not applicable here. Instead, the ground truth for validating the reprocessing process is established by demonstrating that the reprocessed sensors meet the same functional and safety requirements as new devices. This is achieved through the various non-clinical tests (sterilization, bioburden, packaging, shelf life) and the functional bench testing and clinical studies mentioned.
§ 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).