(101 days)
Model 8203CA
The Model 8203CA single-patient use, non-sterile, disposable sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8203CA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
Model 8204CA
The Model 8204CA single-patient use, non-sterile, disposable sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8204CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care, and mobile environments.
The SenSmart Model 8203CA Regional Oximetry Sensor (Model 8203CA) and SenSmart Model 8204CA Regional Oximetry Sensor (Model 8204CA) are single-patient use, non-sterile disposable regional (tissue saturation) sensors intended for use with the Nonin Medical Model X-100 SenSmart Regional Oximetry System (Model X-100). The proposed devices are also compatible with the Nonin Model 7600 Regional Oximeter (Model 7600).
Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria for typical performance metrics like sensitivity and specificity. The testing performed is more about compliance with general safety, functional, and performance standards.
| Test / Criterion | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Pass |
| Temperature and Humidity | Compliance with IEC 60601-1, EN 1789 | Pass |
| Atmospheric Pressure (Altitude) | Compliance with IEC 60601-1 | Pass |
| Electromagnetic Immunity and Emissions | Compliance with IEC 60601-1-2 | Pass |
| Performance | Compliance with ISO 80601-2-61, IEC 60601-1, IEC 60601-1-6; IEC 60601-1-12; IEC 62304; ANSI/AAMI EC13; ISO 14155-1; ISO 14155-2 | Pass |
| Ingress Protection | Compliance with ISO 80601-2-61 | Pass |
| Diaphoretic related ingress | Internal performance characterization | Pass |
| Mechanical Durability | Compliance with IEC 60601-1, ISO 80601-2-61, ISTA 2A, ASTM D-4169 | Pass |
| Biocompatibility | Compliance with ISO 10993-1 | Biocompatible |
| rSO2 Accuracy | Critical sensor optics technology unchanged from predicate devices; accuracy demonstrated through detailed device comparison, analysis, and testing. | Demonstrated |
| Clinical Performance | Critical sensor optics technology unchanged from predicate devices; prior clinical testing from predicate (K102715) is applicable. | Applicable (from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of efficacy for the new devices. Instead, it relies on the fact that "the critical sensor optics technology of the proposed devices remains unchanged from the predicate devices." Therefore, the clinical data proving efficacy is derived from the predicate devices (Nonin SenSmart Model 8003CA and Model 8004CA Regional Oximetry Sensors cleared under K102715).
- Sample Size: Not specified for the current submission, as it defers to the predicate device's clinical testing. The sample size for the predicate's clinical testing would be in K102715.
- Data Provenance: Not explicitly stated for the predicate's clinical data from K102715, but it would have been part of that prior submission. The current submission relies on this existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The current submission does not involve new clinical trials requiring expert-established ground truth for a test set. It relies on the clinical performance previously established for the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. As no new clinical test set with human interpretation is presented in this submission, there's no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned for these specific devices. The submission focuses on substantial equivalence based on unchanged critical sensor optics technology and functional performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The device is a regional oximetry sensor, which measures physiological parameters. Its performance is inherent in its measurement accuracy and compliance with physical and electrical standards, not in an "algorithm only" sense like an AI diagnostic tool. The "rSO2 Accuracy testing" mentioned is a standalone assessment of the sensor's measurement capability, concluding it is demonstrated due to the unchanged optics from the predicate.
7. The Type of Ground Truth Used
For the functional and safety testing, the ground truth is established by compliance with recognized international and national standards (e.g., IEC 60601-1, ISO 80601-2-61, ISO 10993-1).
For the rSO2 accuracy and clinical performance, the ground truth is implicitly based on the clinical validation data and reference methods used during the clearance of the predicate devices (K102715). Without access to K102715, the precise nature of that ground truth (e.g., arterial blood gas analysis for oxygen saturation) isn't specified in this document.
8. The Sample Size for the Training Set
Not applicable. This device is a medical sensor, not an AI/ML algorithm that requires a "training set" in the typical machine learning sense. Its design and calibration are based on established engineering principles and physiological models, rather than learned patterns from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for an AI/ML algorithm is not relevant here.
§ 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).