(154 days)
EnviteC Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult and pediatric (excluding neonatal and infant) patients in hospitals, hospital-type facilities, mobile units and home environments. Prescription device.
The EnviteC Reusable SpO2 Sensors are a family of oximeter sensors designed and validated for compatibility with the predicate oximeter manufacturers listed above. EnviteC's Reusable SpO2 Sensors are comprised of a connector and a cable which terminates into a sensor housing. One housing half contains a dual LED light source, and the other half contains a light sensitive photodetector for pulse oximetry by transmittance method. Three types of sensor housings are offered in this submission: A finger clip with rigid halves positioned by mild spring force, An ear clip with rigid halves positioned by mild spring force and an I ear hanger for the cable, I A soft rubber finger sensor with unitary sealed tube type construction. A unique sensor type exists for each compatible manufacturer above, and each sensor has unique labeling and specifications designed for compatibility with the specific monitor manufacturer (HP/Philips, Minolta). Each sensor type includes the following features: r Connector pin-outs specific for the manufacturer type, Component specifications specific for the manufacture type. Each sensor clearly specifies the manufacturer type with two compatibility statements: One printed on or attached to the sensor r, 트 One on the instructions for use.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: EnviteC Reusable SpO2 Sensors
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for the clinical study (e.g., a specific SpO2 accuracy range with a defined root mean square error (RMSE) or bias/precision). Instead, it states that the clinical test results "support the stated accuracy claims for the specified range of 70% to 100% SaO2."
However, based on regulatory expectations for SpO2 devices, the general acceptance criteria for accuracy are often inferred from standards like ISO 80601-2-61 (which might not have been fully in effect or the exact version used at the time of this filing in 2009 for the clinical study). A common requirement for pulse oximeters is an accuracy of ±2% or ±3% across the specified range.
Therefore, the table below reflects what can be inferred rather than explicitly stated.
| Acceptance Criterion (Inferred from regulatory standards) | Reported Device Performance (Summary from clinical study) |
|---|---|
| Accuracy of SpO2 measurement across a range of 70% to 100% SaO2 must be clinically acceptable. (Typically, SpO2 accuracy within ±2% or ±3% compared to co-oximetry reference.) | Clinical test results "support the stated accuracy claims for the specified range of 70% to 100% SaO2." |
| Device must be compatible with predicate oximeter manufacturers. | Device validated for compatibility with predicate oximeter manufacturers. |
| Compliance with electrical safety and electromagnetic compatibility (EMC) standards. | Device "passed all of the tests" for electrical safety and EMC. |
| Biocompatibility of patient contact materials. | Patient contact materials "meet applicable standards for biocompatibility." |
| Accurate pulse rate measurement. | Tested for pulse rate with a listed simulator and sensor electro-optical parameters were measured and compared to predicate devices; passed all tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "patients" and "subjects" but does not provide a specific number for the cohort involved in the clinical testing.
- Data Provenance:
- Country of Origin: Not explicitly stated whether the clinical study was conducted in a specific country. However, the manufacturer is German (EnviteC-Wismar GmbH, Germany), and the 510(k) submission is to the FDA in the USA, implying potential international or US-based studies.
- Retrospective or Prospective: The study was prospective. This is indicated by the statement: "All testing was performed under an institutionally approved protocol with subject informed consent." This implies a planned, ethics-committee-approved study with new data collection.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated, though "co-oximetry" is the gold standard for measuring SaO2 in these types of studies, typically performed by trained laboratory personnel or medical professionals. The interpretation of the co-oximetry results themselves does not usually require "experts" in the sense of physicians reviewing images, but rather proper execution and interpretation of laboratory-based physiological measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not mentioned. The ground truth for SpO2 studies is typically a direct physiological measurement (co-oximetry), which does not usually involve multi-reader adjudication as seen in image-based diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. The EnviteC device is a sensor for direct physiological measurement (SpO2 and pulse rate), not an imaging device requiring human interpretation of output data for primary diagnosis.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Standalone Performance Study: Yes, a standalone performance study was performed. The clinical testing described directly assesses the accuracy of the EnviteC Reusable SpO2 Sensors (the algorithm/device only) against a reference standard (co-oximetry) under controlled conditions. This is the primary method for evaluating pulse oximeter accuracy.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was co-oximetry. The text states: "Clinical testing was performed to validate the performance and accuracy of the EnviteC Reusable SpO₂ Sensors under controlled hypoxia versus arterial oxygen saturation as determined by co-oximetry." Co-oximetry is considered the gold standard for measuring fractional hemoglobin oxygen saturation.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not mentioned. The document describes a medical device sensor, not an AI/ML algorithm that typically undergoes a distinct training phase with a dedicated dataset. The "validation" studies are for performance evaluation, not algorithm training. If there were internal iterative design/development tests, those datasets (and their sizes) are not detailed here.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable/not mentioned, as there is no indication of a distinct "training set" for an AI/ML algorithm. The device's underlying technology relies on established pulse oximetry principles and sensor design rather than a trainable model.
§ 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).