(215 days)
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of pH, Partial Pressure of Carbon Dioxide, and Partial Pressure of Oxygen in heparinized arterial and venous whole blood.
pH, pCO2, pO2 Measurements are used in the diagnosis and treatment of life-threatening acid base disturbances.
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, 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 primary 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.
Primary Sensor Card Port:
There are two options for the primary sensor card:
- Primary Sensor Card 1 shall enable and report the following listed analytes: o PO2, PCO2, pH
- . Primary Sensor Card 2 shall enable and report the following listed analytes: o PO2, PCO2, pH
Similar to the primary 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 uL.
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.
Stat Profile Prime Plus Analyzer System Components:
The Stat Profile Prime Plus Analyzer System is comprised of the following components.
- . Stat Profile Prime Plus Analyzer System
- Primary Sensor Cartridge
- Auxiliary Sensor Cartridge ●
- Stat Profile Prime Plus Auto-Cartridge Quality Control Pack .
- Stat Profile Prime Plus Calibrator Cartridge ●
- Stat Profile Prime Plus External Ampuled Control
- . IFU/Labeling
Sample Types:
The Stat Profile Prime Plus Analyzer System accepts lithium heparinized arterial and venous whole blood.
Measured Parameters:
The Stat Profile Prime Plus Analyzer measures:
- . pH
- Partial Pressure of Carbon Dioxide (pCO2)
- Partial Pressure of Oxygen (pO2)
Calculated Parameters:
The following parameters are calculated by the Prime Plus Analyzer based on results of the directly measured parameters.
- Base Excess of Extracellular Fluid (BE-ecf)
- Base Excess of the Blood (BE-b)
- Standard Bicarbonate Concentration (SBC) ●
- Bicarbonate level (HCO3) ●
- Oxygen Content (O2Ct) .
- P50 ●
- Respiratory Index (RI)
- PO2 to FIO2 Ratio (PO2/FIO2) ●
- Normalized Calcium (nCa) ●
- Normalized Magnesium (nMq)
- Anion Gap (Gap) ●
- nCA to nMg Ratio (nCa/nMg) ●
- Arterial Oxygen Content (CaO3) .
Here's a breakdown of the acceptance criteria and the study proving the device's performance, based on the provided FDA 510(k) summary for the Stat Profile Prime Plus Analyzer System:
Device: Stat Profile Prime Plus Analyzer System
Intended Use: Quantitative determination of pH, Partial Pressure of Carbon Dioxide, and Partial Pressure of Oxygen in heparinized arterial and venous whole blood by healthcare professionals in clinical laboratory settings.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for each test in a formal table format. Instead, it describes general compliance with "acceptance criteria" and "specifications" for each study. However, the "Measurement Range" provides a key acceptance criterion for the device's operational limits. The study's reported "performance" is stated as meeting these range and precision requirements.
| Performance Metric / Parameter | Acceptance Criteria (Implicit/Stated Range) | Reported Device Performance (as stated in the document) |
|---|---|---|
| pH Measurement Range | 6.500 to 8.000 pH units | "Good correlation and linearity to the reference analyzers across the claimed measurement range... and met the acceptance criteria." |
| PCO2 Measurement Range | 3.0 to 200.0 mmHg | "Good correlation and linearity to the reference analyzers across the claimed measurement range... and met the acceptance criteria." |
| PO2 Measurement Range | 5.0 to 765 mmHg | "Good correlation and linearity to the reference analyzers across the claimed measurement range... and met the acceptance criteria." |
| Method Comparison (pH, PCO2, PO2) | Implicit: Equivalence to predicate device | "The blood comparison data for pH, PCO2, and PO2 for the Stat Profile Prime Plus analyzers meet the acceptance criteria." |
| Within Run Precision | Implicit: Within run imprecision specifications | "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." |
| Run to Run Precision | Implicit: Between analyzer run to run imprecision specifications | "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." |
| Linearity | Implicit: Linearity across the Analytical Measurement Range (AMR) | "The linearity comparison data for all parameters... shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria." |
| Specificity/Interference | Implicit: No significant interference identified | "There were no interfering substances related to pH, pCO2, or pO2 identified in the study." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Method Comparison: Not explicitly stated as a number, but involved "blood comparison data" for pH, PCO2, and PO2. The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer.
- Sample Size for Precision/Reproducibility (Within Run):
- 20 replicates per run for each of the following:
- Stat Profile Prime Plus Internal Controls: Levels 1-3
- Stat Profile Prime Plus Ampuled Controls: Levels 1-3
- Two whole blood samples (from syringes)
- 20 replicates per run for each of the following:
- Sample Size for Precision/Reproducibility (Run to Run): Triplicate analyses of a single whole blood sample performed in ten separate runs during a single day.
- Sample Size for Linearity Testing: Not explicitly stated as a number, but covered "lower and upper limits of the AMR and various medical decision limits" using whole blood.
- Sample Size for Specificity/Interference Testing: Not explicitly stated as a number, but "Many substances were screened" using whole blood collected in lithium heparin vacutainers, with potential interferents tested at two analyte concentrations.
- Data Provenance: The studies were conducted in a "clinical laboratory setting." The document does not specify the country of origin of the data or explicitly state whether the studies were retrospective or prospective, but clinical laboratory testing for device validation is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a medical device (analyzer) that quantifies blood gas parameters, not an AI or imaging diagnostic tool. Therefore, the concept of "experts" establishing ground truth in the way it applies to image interpretation (e.g., radiologists) is not applicable here.
- Ground Truth Establishment: The ground truth for the test set (e.g., blood gas values) was established by reference analyzers (specifically, the Nova Stat Profile pHOx Ultra analyzer for method comparison, and potentially other reference analyzers for linearity calibration). The performance is assessed against these established values, not against human expert interpretations.
4. Adjudication Method for the Test Set
Not applicable. This is a measurement device where the "ground truth" is established by a reference method/analyzer, not by human interpretation requiring adjudication.
5. 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 a standalone medical device for quantitative measurement, not an AI-assisted diagnostic tool that aids human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (Method Comparison, Precision/Reproducibility, Linearity, Specificity/Interference) are all forms of standalone performance studies for the Stat Profile Prime Plus Analyzer System. The device measures the parameters without human interpretation of its internal "algorithm" or direct human intervention in the measurement itself, other than sample loading. The "algorithm" here refers to the device's internal measurement processes and calculations.
7. The Type of Ground Truth Used
The ground truth used was comparative analytical data against:
- Reference Analyzers: Specifically, the predicate device (Nova Stat Profile pHOx Ultra analyzer) for method comparison. It also states "comparison to the reference analyzer and/or the product specifications" for linearity.
- Known Control Values: For precision studies, internal controls and ampuled controls with known analyte levels were used.
This is a form of analytical or technical ground truth, not clinical outcomes or pathology.
8. The Sample Size for the Training Set
Not applicable. This is a traditional medical device (analyzer) cleared through a 510(k) pathway, not an AI/Machine Learning device that requires a distinct "training set" in the context of model development. The device's measurement principles are based on established electrochemistry and physics, not statistical learning from a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML sense for this device. The device's operational parameters and measurement principles are designed and validated based on scientific understanding, not learned from a data set.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.