(100 days)
The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories).
The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.
The OxiPen Pulse Oximeter is a compact battery-powered handheld monitor designed for simplicity and portability for spot checking applications. It does not provide alarms or settable alarm limits.
The OxiPen features large readable numeric displays for SpO2 and pulse rate and a pulse bar indicator for visual assessment of pulsation. Additional indicators include a signal quality LED and heart symbol which show pulsation, a sensor symbol for disconnection alert, and a battery capacity symbol.
Like the referenced predicate device, the OxiPen provides an audible pulse tone which varies with saturation level, as well as audible and visual alerts for conditions like sensor disconnect and power-off. The LCD display may be backlit by briefly pressing any key.
The OxiPen is provided with sensors specifically designed for use with the device, and features a compact connector with EnviteC proprietary pinout.
The EnviteC OxiPen Pulse Oximeter and accessory sensors employ the same technological characteristics as the predicate device and other oximeters to determine functional arterial oxygen saturation - arterially perfused tissue is illuminated sequentially by two wavelengths of light emitted by light emitting diodes (LED's), and the time varying absorbance of the tissue is measured from a photodiode light sensor. The resultant electrical signal is amplified, digitized, and analyzed to determine the functional oxygen saturation and pulse rate. The information is displayed on a liquid crystal display with pulse bar graph and audible pulse tone.
The OxiPen utilizes a two-layer architecture in which the oximeter-specific functions are managed by a dedicated subsystem (ChipOx) and the monitor functions including power management, display, and user interface are controlled separately.
Here's a summary of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance Study for EnviteC OxiPen Pulse Oximeter
The document primarily focuses on demonstrating substantial equivalence to a predicate device and fulfilling regulatory requirements for safety and efficacy. While it states that clinical tests were performed to validate accuracy claims, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy range for SpO2 or pulse rate) in a table format. Instead, it broadly states that the device "passed all of the tests" and "Clinical test results support the stated accuracy claims for the specified range of 70% to 100% SaO2."
Therefore, the table below reflects what can be inferred or directly stated from the provided text regarding performance. Specific numerical acceptance criteria are not available in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Accuracy of SpO2 measurement (70-100% SaO2) | Clinical test results support the stated accuracy claims for the specified range. (Specific numerical accuracy not provided in this document) |
| Accuracy of Pulse Rate measurement | The monitor and accessory sensors were tested for pulse rate with a listed simulator. The device passed all of the tests. (Specific numerical accuracy not provided in this document) |
| Electrical Safety (Applicable standards) | The device passed all tests. |
| Electromagnetic Compatibility (Applicable standards) | The device passed all tests. |
| Environmental Operation and Storage (Applicable standards) | The device passed all tests. |
| Resistance to Moisture Ingress (Applicable standards) | The device passed all tests. |
| Shock and Vibration (Applicable standards) | The device passed all tests. |
| Software Verification and Validation | Verified to requirements and validated to meet intended use by software and system level performance testing. |
| Biocompatibility of Patient Contact Materials | Meet applicable standards for biocompatibility. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of subjects or cases used in the clinical testing. It only states, "Clinical testing was performed... All testing was performed under an institutionally approved protocol with subject confidentiality and informed consent."
- Data Provenance: The document does not explicitly state the country of origin of the clinical data. It is a submission by a German company, so it is plausible it could be European or international.
- Retrospective or Prospective: Not explicitly stated, but the phrase "Clinical testing was performed... under an institutionally approved protocol with subject confidentiality and informed consent" strongly suggests a prospective study.
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- No adjudication method is described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The study described focuses on standalone device performance against cooximetry.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was conducted. The clinical testing "validated the performance and accuracy of the EnviteC OxiPen Pulse Oximeter and accessory sensors under controlled hypoxia versus arterial oxygen saturation as determined by cooximetry." This is a direct measure of the device's accuracy without human interpretation influencing the measurement itself.
7. Type of Ground Truth Used
- Expert Consensus: Not explicitly stated.
- Pathology: Not applicable for SpO2 measurement.
- Outcomes Data: Not applicable for SpO2 measurement.
- Other: Cooximetry was used as the ground truth for arterial oxygen saturation (SaO2). The document states, "...versus arterial oxygen saturation as determined by cooximetry."
8. Sample Size for the Training Set
- The document does not describe a machine learning model or a training set. It refers to "Embedded software in the device," but this would typically involve traditional software development and verification/validation, not a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no machine learning training set is 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).