(48 days)
The 3402 Digital Handheld Oximeter is a handheld, low cost pulse oximeter for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength. It may be used in all critical environments, including clinical and EMS (Emergency Medical Services), patient ground transport, and for use in sleep screening or in the home. The oximetry parameter works with all BCI oximetry sensors, providing SpO2 and pulse rate on all patients from neonate to adult. The 3402 Digital Handheld Oximeter permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. The BCI 3402 is not designed or intended to be used as an apnea monitor.
The BCI 3402 Digital Handheld Oximeter monitor is an updated version of an existing pulse oximeter legally marketed by BCI International. The system consists of an oximeter sensor interface, LED display, front and side keypads, and an infra-red LED printer output port. The device is powered by six "AA" batteries.
The BCI Digital Handheld Oximeter (model 3402) is a pulse oximeter intended for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength in various environments.
Here's an analysis of the acceptance criteria and study data provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy Limits | Not explicitly stated as a separate acceptance criterion, but the performance is measured against a co-oximeter. |
| Statistical Accuracy (SpO2 70-100%) | Standard deviation of 1.49% |
| Correlation (SpO2 entire range, likely 0-100% or 70-100%) | R-squared value of 0.98 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified, but implied to be sufficient for a "clinically controlled desaturation study."
- Data Provenance: The study involved "clinically controlled desaturation studies," which are prospective in nature, as subjects are actively desaturated. The country of origin is not specified but it usually means it was done in the USA since it is submitted in the USA for FDA Approval.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the study used a "co-oximeter (OSM-3)" to establish the ground truth for blood oxygen levels. The co-oximeter itself serves as the reference standard, and medical professionals would operate and interpret its results, but their specific qualifications are not detailed.
4. Adjudication Method
- Adjudication Method: Not applicable. The ground truth was established by a co-oximeter, which provides objective measurements, rather than expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this device is a standalone medical device for direct measurement, not an AI-assisted diagnostic tool that would typically involve human reader performance comparisons. Therefore, an MRMC study is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, the study describes the performance of the BCI 3402 Digital Handheld Oximeter in a standalone capacity. It directly compares the device's measurements to a co-oximeter, without human intervention in the measurement process itself.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical desaturation studies was established using a co-oximeter (OSM-3). This is an objective laboratory reference method for measuring blood oxygen saturation.
8. Sample Size for the Training Set
- Sample Size for Training Set: This device is a traditional hardware-based pulse oximeter, not an AI/Machine Learning algorithm. Therefore, the concept of a "training set" for an algorithm to learn from is not applicable. Its performance is based on its sensor technology and signal processing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable as it's not an AI/ML device. The device's design and calibration would have been based on established engineering principles and validation against reference standards during its development.
§ 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).