(267 days)
The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensor in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.
When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.
When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and
The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the O3 Module, O3 Sensors (e.g., O3 Adult, O3 Pediatric, O3 Infant/Neonatal sensors), and a Host/Backboard Device (e.g., Root).
The Masimo O3 Regional Oximeter System provides the following measurements and calculated features:
- Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
- Delta Baseline (Δbase): Calculation of the relative difference in rSO2 with respect to baseline rSO2.
- Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user defined rSO2 low alarm limit (LAL).
- Delta SpO2 (ΔSpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
- Delta HHb (ΔHHb): Index associated with the relative change in deoxygenated hemoglobin.
- Delta O2Hb (ΔO2Hb): Index associated with the relative change in the oxygenated hemoglobin.
- Delta cHb (ΔcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, associated with the change in the total (oxygenated and deoxygenated) hemoglobin.
The provided FDA 510(k) clearance letter and summary for the Masimo O3 Regional Oximeter (K243324) states that the submission is for an expansion of indications for existing "delta features" (ΔO2Hb, ΔHHb, ΔcHb) of the device. This means the core rSO2 measurement accuracy was not re-evaluated, as it was previously cleared under the predicate (K214072) and no changes were made to the device's fundamental operation.
Therefore, the acceptance criteria and study detailed below focus specifically on the expansion of trending ability of the delta features to new patient populations (pediatric and neonates) and non-cerebral sites.
Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter (K243324)
Based on the provided document, the acceptance criteria and study focus on confirming the trending ability of the delta features (ΔO2Hb, ΔHHb, ΔcHb) for expanded indications. The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range) for these delta features, unlike the rSO2 accuracy (ARMS) specifications which are quantitative. Instead, it speaks of "strong correlation" and "equivalent performance."
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Trending ability of delta features (ΔO2Hb, ΔHHb, ΔcHb) on non-cerebral sites | Demonstration of effective trending. | "The results of the study supported the strong correlation of the non-cerebral trending performance of O3 delta features." |
| Trending ability of delta features (ΔO2Hb, ΔHHb, ΔcHb) with Pediatric and Neonate sensors | Demonstration of equivalent trending performance to adults (implied comparison to previously cleared adult indication). | "The results of the analysis supported the equivalent performance of the delta features when using Masimo O3 Pediatric and O3 Neonatal sensors." |
2. Sample Size and Data Provenance for the Test Set
- Non-cerebral trending study: Data from 25 subjects.
- Pediatric/Neonatal trending study: Data from 29 subjects.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Clinical studies for 510(k) submissions are typically prospective, but this is not confirmed here.
3. Number of Experts and Qualifications for Ground Truth
- The document describes studies for "trending ability" of physiological parameters (hemoglobin changes). For such physiological measurements, the ground truth is typically established by direct physiological measurement or well-established reference methods, not by expert panel review of images or clinical assessments. Therefore, the concept of "experts establishing ground truth" in the manner of diagnostic imaging studies (e.g., radiologists) is not applicable here. The ground truth would be the actual physiological changes occurring in the subjects, measured by a gold standard method (though not explicitly detailed in the summary).
4. Adjudication Method for the Test Set
- Given that the studies are evaluating the trending ability of physiological measurements against an assumed physiological ground truth (not expert interpretations), an "adjudication method" in the sense of reconciling multiple expert opinions (e.g., 2+1, 3+1) is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret medical images or data with and without AI assistance to measure improvement in reader performance. The Masimo O3 Regional Oximeter is a physiological monitoring device that provides direct measurements, and the current submission is about expanding the trending indications of those measurements, not assisting human interpretation of complex medical cases.
6. Standalone (Algorithm Only) Performance
- Yes, implicitly. The studies described evaluate the device's ability to trend delta features. This is a direct measurement of the device's algorithm performance in a clinical setting against physiological changes. The device itself produces these measurements, so the performance reported is inherently "algorithm only" in terms of its output, even though it's measured on human subjects.
7. Type of Ground Truth Used
- The ground truth for studies of physiological monitoring devices like oximeters is typically actual physiological values measured concurrently by a highly accurate or gold-standard reference method. For regional oximetry and hemoglobin changes, this might involve induced changes in oxygenation/perfusion and simultaneous measurement with a more invasive or laboratory-based technique, though the summary does not detail the specific reference method used for these "delta features" studies. It is implied to be a quantitative, objective physiological ground truth, not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic imaging.
8. Sample Size for the Training Set
- The document does not provide information on the training set sample size. This submission is for an expanded indication based on clinical study data, not a new algorithm development submission where training data sets are typically detailed. It is assumed the algorithms for the delta features were trained/developed prior to the predicate device clearance (K214072) or during earlier development cycles, and the current submission is about validating their performance for new uses.
9. How Ground Truth for Training Set was Established
- The document does not provide information on how the ground truth for any potential training set was established. As this submission pertains to an expanded indication for existing features, the focus is on clinical validation of those features in new contexts rather than the de novo development process.
§ 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).