(58 days)
The Model 8006CA reusable, non-sterile, regional oximetry sensor is intended for use as an absolute realtime adjunct monitor of regional hemoglobin oxygen saturation (rSO2) of blood underneath the sensor of adult and pediatric patients weighing ≥ 88 pounds (≥ 40 kilograms). The sensor and/or the patient interface may be repositioned or replaced with another 8006CA sensor without baseline re-establishment.
Nonin's Model 8006PI single patient use, non-sterile disposable patient interface is designed for use with Nonin's Model 8006CA sensor.
The sensor and patient interface is in hospitals, long-term care, medical facilities, sleep laboratories, and subacute environments.
The Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface work together for use with the Nonin Medical SenSmart Model X-100 Universal Oximetry System (Model X-100).
The Nonin Medical, Inc. Model 8006CA Reusable Regional Oximetry Sensor and Model 8006PI Disposable Patient Interface have undergone testing to establish substantial equivalence to predicate devices (Model 8004CA and Model 8204CA Regional Oximetry Sensors).
Here is a summary of the acceptance criteria and performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Predicate Device) | Reported Device Performance (Model 8006CA/8006PI) |
|---|---|---|
| Functional and Safety Testing | ||
| Electrical Safety | Complies with IEC 60601-1 | Pass |
| Temperature and Humidity | Complies with IEC 60601-1, EN 1789, IEC 60601-1-12 | Pass |
| Atmospheric Pressure (Altitude) | Complies with IEC 60601-1, IEC 60601-1-12 | Pass |
| Electromagnetic Immunity and Emissions | Complies with IEC 60601-1-2 | Pass |
| Performance | Complies with ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6, IEC 60601-1-12, IEC 62304, ANSI/AAMI EC13, ISO 14155 | Pass |
| Ingress Protection | Complies with IEC 60601-1, ISO 80601-2-61 | Pass |
| Mechanical Durability | Complies with IEC 60601-1, ISO 80601-2-61 | Pass |
| Biocompatibility | Complies with ISO 10993-1 | Biocompatible |
| Regional (rSO2) Accuracy | ||
| rSO2 Accuracy (Arms) | Absolute: Right 4.1, Left 3.8, Both 3.9, Hypercapnia 5.1, Hypocapnia 3.3 (from K102715) | Not explicitly re-tested, but "critical sensor optics technology... remains unchanged" and "prior clinical testing... is applicable." It "performs equivalently to the same specifications." |
| Declared range | 50 - 100% (from K102715) | "Performs equivalently to the same specifications." |
| Inter-/Intra-sensor repeatability | ± 2 digits (from K102715) | "Performs equivalently to the same specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "prior clinical testing provided in K102715 is applicable for the proposed Model 8006CA sensor and Model 8006PI patient interface" because "The critical sensor optics technology of the proposed devices remains unchanged from the predicate devices." Therefore, the clinical test set data for Regional (rSO2) Accuracy testing is from the K102715 submission for the predicate Model 8004CA Sensor. The specific details of the sample size, data provenance (country of origin, retrospective/prospective), etc., for that original clinical study are not provided in this document (K190560).
The current submission (K190560) relies on "detailed device comparison, analysis and testing" and the equivalency of the critical sensor optics.
For the Functional and Safety Testing, the tests were performed on the proposed devices (Model 8006CA and Model 8006PI) and are likely prospective tests conducted specifically for this submission. The sample sizes for these engineering tests are not specified but are typically small (e.g., a few units) sufficient to demonstrate compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The regional oximetry accuracy is derived from clinical testing, but the specifics of expert involvement in establishing ground truth (e.g., from an arterial blood gas reference for SpO2) are not detailed within this 510(k) summary. It refers back to a previous submission (K102715).
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is an oximeter, which provides a direct measurement, not an interpretative tool that requires human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the functional, safety, and performance tests assess the standalone performance of the device (Model 8006CA/8006PI) in conjunction with the Nonin Medical SenSmart Model X-100 Universal Oximetry System. The regional oximetry accuracy cited from the predicate device's clinical testing also represents standalone algorithm performance in measuring rSO2.
7. The Type of Ground Truth Used
For the regional oximetry accuracy (rSO2), the ground truth typically involves a reference method for measuring regional oxygen saturation, often arterial blood gas analysis or other established physiological measurements, in a controlled hypoxemic study. However, the specific type of ground truth used for the predicate device's clinical testing (K102715) is not explicitly stated in this document. Given the nature of oximetry, it would likely be a direct physiological measurement.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. Since the validation relies on the "critical sensor optics technology... remains unchanged" from predicate devices and the device is a measurement sensor rather than an AI/machine learning algorithm that requires extensive training data, the concept of a "training set" in the context of machine learning is not directly applicable here.
9. How the Ground Truth for the Training Set was Established
As no training set is discussed or implied for an AI/ML model, this information is not applicable here. The device's performance is based on its physical and optical design, not on learned patterns from a dataset.
§ 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).