(212 days)
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood.
The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, calibrator packs, auto-cartridge quality control packs (internal controls), ampuled quality control materials (external controls) and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).
The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).
The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards.
Similar to the predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes, and small cups. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
The provided text describes the Nova Stat Profile Prime Plus Analyzer System, an in vitro diagnostic device. This document is a 510(k) summary submitted to the FDA, detailing the device's substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
The general acceptance criteria for "Method Comparison Studies" is that "The blood comparison data for Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin for the Stat Profile Prime Plus analyzers meet the acceptance criteria." Specific numerical acceptance criteria are not explicitly detailed in the provided text, but the study concluded that the device did meet them.
Similarly, for "Precision/Reproducibility," the text states: "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." and "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." No specific numerical targets for imprecision are given.
For "Linearity Testing", the conclusion is: "The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."
The table below summarizes the claimed measurement ranges, which serve as a form of acceptance criteria for the operational limits of the device. The reported performance is a general statement that the device meets "the acceptance criteria."
| Parameter | Acceptance Criteria (Measurement Range) - as per Proposed Device | Reported Device Performance (as stated in sections 6 & 7) |
|---|---|---|
| SO2 | 30-100% | Met acceptance criteria for Method Comparison, Precision, and Linearity. |
| Hct | 12-70% | Met acceptance criteria for Method Comparison, Precision, and Linearity. |
| tHb | 5.0 - 25.0 g/dL | Met acceptance criteria for Method Comparison, Precision, and Linearity. |
| O2Hb | 1.8-100% | Met acceptance criteria for Method Comparison, Precision, and Linearity. |
| COHb | 0.3-60% | Met acceptance criteria for Method Comparison, Precision, and Linearity. |
| MetHb | 0.3-60% | Met acceptance criteria for Method Comparison, Precision, and Linearity. |
| HHb | 0.4-40% | Met acceptance criteria for Method Comparison, Precision, and Linearity. |
Note on "Reported Device Performance": The document states that the studies "meet the acceptance criteria." It does not provide specific numerical results or performance metrics (e.g., bias, CV%) for the Nova Stat Profile Prime Plus Analyzer System itself, but rather confirms that its performance is equivalent to the predicate and within acceptable ranges.
Study Information:
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Sample size used for the test set and the data provenance:
- Method Comparison Studies: The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using an unspecified number of "heparinized whole blood" samples. The provenance of this blood data (country, retrospective/prospective) is not specified.
- Precision/Reproducibility - Within Run and Run to Run Studies:
- Within Run Precision: "one run of each of the following sample types and levels was performed, 20 replicates per run." Sample types included: Stat Profile Prime Plus Internal Controls (Levels 1-5), Stat Profile Prime Plus Ampuled Controls (Levels 1-5), and "Two whole bloods, sampled from syringes."
- Run to Run Precision: "triplicate analyses were performed on a single whole blood sample in ten separate runs during a single day."
- The provenance of these whole blood samples (country, retrospective/prospective) is not specified.
- Linearity Testing: Used "whole blood" to establish/verify the Analytical Measurement Range (AMR). The number of samples is not specified. Provenance is not specified.
- Specificity / Interference Testing: "whole blood collected in lithium heparin vacutainers." The number of samples for screening or dose-response is not specified. Provenance is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic analyzer that measures objective chemical and physiological parameters in blood samples, not image interpretation or diagnosis by experts. The "ground truth" for the performance studies would be established by the reference methods (e.g., the predicate device or other highly accurate laboratory methods) against which the new device's measurements are compared.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts) to reach a consensus for ground truth. This is a device measuring objective parameters.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device requiring human interpretation; it directly measures parameters.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The studies described (Method Comparison, Precision, Linearity, Interference) assess the standalone performance of the device's measurement capabilities. The device is designed to provide quantitative measurements and does not involve a human-in-the-loop for interpreting its direct output in the way an AI diagnostic tool might.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance studies appears to be:
- Method Comparison: Measurements from the legally marketed predicate device (Stat Profile pHOx Ultra analyzer) served as the reference.
- Precision: Internal controls, ampuled controls, and whole blood samples with expected values.
- Linearity: Comparison against a "reference analyzer and/or the product specifications."
- Specificity/Interference: Comparison of measurements with and without potential interfering substances.
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The sample size for the training set: Not applicable. This device does not appear to employ machine learning algorithms that require a separate "training set" in the conventional sense. Its principles of measurement are based on established spectrophotometric and impedance sensor technologies.
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How the ground truth for the training set was established: Not applicable, as there is no mention of a machine learning training set. The device's underlying principles are based on known physical and chemical measurement techniques.
§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.