(59 days)
The SPO2.COM oximetry sensors and cables are intended for the continuous nominvasive monitoring of functional oxygen saturation of arterial hermoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, infant, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The SPO2.COM Oximetry Sensors are fully compatible disposable replacement sensors for use with Nellon and Nelloor compatible pulse oximeter monitors. They represent a design change to the Masimo LNOP Oximetry Sensors.
The SPO2.COM RSI reusable sensor is essentially identical to Masimo LNOP-DCI sensor except for the end of the cable which interfaces with the Neller. The emitter and detector are mounted in opposing halves of the molded clothespin style sensor with contoured pads to maintain contact with the patient's fingers. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) and detector are used in both the SPO2.COM RSI and LNOP-DCI sensors. The patient contacting materials in the SPO2.COM RSI and LNOP-DCI sensors are the same. The SPO2.COM RSI sensors are supplied non-sterile.
The SPO2.COM disposable sensors are similar in construction to the predicate devices. The emitter and detector are connected to the cable assembly. The sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger or toe. The same emitter (with Red wavelength of 658 nm and Infrared wavelength of 905 nm) is used in Masimo's LNOP series of stime that that tour sizes of disposable SPO2.COM sensors are available for use with adult, pediatric, infant and neonatal cuspount our sensors are cssentially identical except for the emitter and detector spacing and size and orientation of the bandage material. The patient contacting materials in the SPO2.COM disposable schsors are the same that is used in Masimo's LNOP sensor line. The SPO2.COM disposable sensors are supplied non-sterile for single patient use.
The SPO2.COM patient cables are similar in construction to the predicate device enabling the SPO2.COM Oximetry Sensors to be connected to Nellcor and Nellcor The or oz. Out oximeters. The SPO2. COM oximetry sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices.
Acceptance Criteria and Study for SPO2.COM Oximetry Sensors
This response describes the acceptance criteria and the study conducted to demonstrate that the SPO2.COM Oximetry Sensors meet those criteria, based on the provided 510(k) summary.
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Equivalent) | Reported Device Performance (SPO2.COM) |
|---|---|---|
| SpO2 Accuracy (Adults, Pediatrics, Infants) | Not explicitly stated, implied to be equivalent to predicate. Predicate typically ±2% SpO2 between 70-100% SaO2 | Less than 2% SpO2 accuracy between 70-100% SaO2 |
| SpO2 Accuracy (Neonates) | Not explicitly stated, implied to be equivalent to predicate. Predicate typically ±3% SpO2 between 70-100% SaO2 | Less than 3% SpO2 accuracy between 70-100% SaO2 |
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing | Materials demonstrated to be non-toxic, non-irritating, and non-sensitizing |
| Environmental Testing | Pass electrical, mechanical, and environmental tests per Reviewers Guidance | All tests passed (electrical, mechanical, environmental) |
Note: The 510(k) summary explicitly states that "The accuracy of the SPO2.COM oximetry sensors is equivalent to those of the predicate devices." While specific numerical acceptance criteria for accuracy of the predicate devices are not provided in the summary, the reported performance of SPO2.COM sensors aligns with typical accuracy requirements for pulse oximeters.
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated. The study involved "healthy adult volunteer[s]" but the exact number of subjects or data points is not provided.
- Data Provenance: Prospective. The clinical studies were "performed using the SPO2.COM Adult and Reusable oximetry sensors on healthy adult volunteer[s]... who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This describes a prospective study design. The country of origin is not specified but implicitly implies the US, given the FDA submission.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not applicable for establishing ground truth as the ground truth was based on arterial blood samples analyzed by a CO-Oximeter.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. Ground truth was established by direct measurement from a CO-Oximeter from arterial blood samples. There was no expert consensus adjudication process described for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the accuracy of the device itself against a direct physiological measurement, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
- Standalone Study: Yes, a standalone (algorithm only) performance study was conducted. The clinical studies directly measured the performance of the SPO2.COM oximetry sensors (the device itself) against a CO-Oximeter, without human interpretation in the loop impacting the accuracy measurement.
7. Type of Ground Truth Used
- Type of Ground Truth: Direct physiological measurement (reference standard). The ground truth for the clinical accuracy study was "arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter." This is considered a gold standard for oxygen saturation measurement.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. Pulse oximeters operate on established physical principles (spectrophotometry) and typically do not involve AI/machine learning models that require a distinct "training set" in the conventional sense. The device's calibration and performance are based on the design of the emitter, detector, and the algorithms implemented to process the optical signals, which are validated in clinical trials.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there isn't a traditional "training set" for AI/ML in this device. The device's underlying principles and algorithms are based on established physiological and optical physics. The extensive validation through clinical trials (as described above) serves to confirm the device's accuracy against recognized reference standards.
§ 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).