(121 days)
The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is a modification of the OxiMax N-600X Pulse Oximetry Systems. When connected to a qualified host display monitor, it is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate using Nellcor pulse oximetry sensors with OxiMAX technology. The cable provides digital values of SpO2 and Pulse Rate, which are displayed on the host monitor. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Nellcor™ USB Pulse Oximetry Monitor Interface Cable is connected via USB2 and is powered by the host monitor.
The Nellcor™ USB Pulse Oximetry Monitor Interface Cable (the "monitoring cable") is a cable with Oximetry PCBA "engine" embedded in the sensor connector to provide external Oximetry-in-the-cable solution for devices with USB connectivity. The cable uses pulse oximetry to measure functional oxygen saturation in the blood. The cable is powered by and achieves its mechanism of action through connection to a host system. To connect the monitoring cable to a host monitoring system, insert the monitoring cable's USB connector into a compatible USB port on the host system. Then connect the Nellcor SpO2 sensor to the port in the sensor connector end of the cable.
Functionally, the Nellcor USB Pulse Oximetry Monitor Interface Cable consists of the following electrical subsystems:
- USB Connector Cable to Host
- Isolation module
- Sp02 Module measures the oxygen saturation and contains pulse oximetry software.
The provided FDA 510(k) summary describes the acceptance criteria and the study that proves the Nellcor™ USB Pulse Oximetry Monitor Interface Cable meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Measurement Range | 1% to 100% | 1% to 100% (Requirement and testing done at 0 to 100%) |
| SpO2 Accuracy (Without Motion - Adults) | 70-100% ± 2 digits | 70-100% ± 2 digits |
| SpO2 Accuracy (Without Motion - Neonates) | 70-100% ± 2 digits | 70-100% ± 2 digits |
| SpO2 Accuracy (With Motion - Adults, Neonates) | 70-100% ± 3 digits | 70-100% ± 3 digits |
| SpO2 Accuracy (Low Perfusion) | 70-100% ± 2 digits | 70-100% ± 2 digits |
| SpO2 Accuracy (LoSat) | 60-80% ± 3 digits | 60% to 80% ± 3 digits |
| Pulse Rate Measurement Range (BPM - Without Motion) | 20 to 250 BPM ± 3 digits | 20 to 250 BPM ± 3 digits |
| Pulse Rate Measurement Range (BPM - With Motion) | 20 to 250 BPM ± 5 digits | 20 to 250 BPM ± 5 digits |
| Pulse Rate Measurement Range (BPM - Low Perfusion) | 20 to 250 BPM ± 3 digits | 20 to 250 BPM ± 3 digits |
Note: The document explicitly states the subject device has the "same" performance specifications as the predicate which are detailed in the table for the Nellcor OxiMAX N-600X Pulse Oximeter.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Data from 12 healthy volunteers were included in the analysis for the controlled hypoxia blood studies.
- Data Provenance: Prospective. The study involved recruiting healthy non-smoking adult volunteers from the local population. The country of origin is not explicitly stated but implies a single location for the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention experts being used to establish the ground truth for the test set. The ground truth was established through direct physiological measurements (blood samples analyzed by CO-oximeter).
4. Adjudication Method for the Test Set
No adjudication method is described as the ground truth was established by objective measurements (CO-oximetry of drawn blood samples), not by expert opinion requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a pulse oximetry monitor interface cable, and its performance is evaluated against physiological ground truth rather than against human interpretation of medical images or data. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this type of device.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The clinical data section describes the direct comparison of the pulse oximeter SpO2 readings to SaO2 values from drawn blood samples. This evaluates the algorithm's performance independent of human interpretation for the core functions of SpO2 and pulse rate measurement.
7. The Type of Ground Truth Used
The ground truth used was physiological measurements from blood samples analyzed by a CO-oximeter (hemoximetry). This is considered highly objective and directly correlates to arterial oxygen saturation (SaO2).
8. The Sample Size for the Training Set
The document does not explicitly state a separate "training set" or its size for the Nellcor™ USB Pulse Oximetry Monitor Interface Cable in the context of machine learning. The device is a "line extension" of existing pulse oximeters, and it uses the "same oximetry software" and "same specifications as N-600X". The information shared describes the clinical validation, not necessarily a machine learning model training process.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of machine learning model development is not explicitly described. However, the device's underlying oximetry software, which would have been "trained" or designed to perform accurately, likely relied on extensive physiological data and controlled studies similar to the validation study described for this device, or those for its predicate device (N-600X Pulse Oximeter). The document states that "The clinical performance when used with adult, pediatric and neonatal patients meets the same acceptance criteria as in the N-600X pulse oximeter clinical evaluations submitted in K060576 and K141518." This implies that the design and performance were established through similar rigorous clinical studies using CO-oximetry as the ground truth for those prior devices.
§ 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).