(287 days)
The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood.
PCO2, PO2, pH: Whole blood measurement of certain gases in whole blood, or pH of whole blood, is used in the diagnosis and treatment of life-threatening acid-base disturbances.
Hct: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
Na +: Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.
K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.
Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
ICa: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabollsm disturbances Including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.
The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.
The Stat Profile Prime Calibrator Cartridge CCS is intended for the callbration of pH, PCO2, PO2, Hct, Na+, K+, C-, ICa, and Glucose using the Stat Profile Prime CCS Analyzer.
Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from callbrator cartridge or analytical instrument variation.
The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyte analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation.
Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes, or capillary blood collection devices using a peristaltic pump and a sampling probe. The disposable microsensor card contains the analytical flowpath and all of the measurement sensors (pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Glucose). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flowpath and into a self contained waste collection bag contained within the disposable calibrator carridge.
The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an onboard Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.
As with the predicate, the Stat Profile Prime CCS Analyzer is microprocessor-based and incorporates:
- . traditional sensor technology to measure blood pO2
- ion selective electrode technology to measure pH, pCO₂, blood sodium, potassium, . chloride, and ionized calcium
- enzyme/Amperometric technology for glucose measurements .
Liquid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.
Internal Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood gas electrodes using external compressed gas cylinders. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with a septa that is pierced during the insertion of the cartridge into the analyzer. The Calibration Cartridge aqueous solutions allow for 2 point calibration of each parameter as follows.
- Calibrator A pH, PCO2, Na, K, Cl, iCa, and Glu (Volume > 500 mL) .
- Calibrator B pH, PO2, Na, K, Cl, iCa, and Glu (Volume > 250 mL) .
- . Calibrator F - PCO2, PO2 (Volume > 720 mL)
- Reference Solution KCI (Volume > 300 mL) .
The external glass ampule controls contain a buffered bicarbonate solution with a known pH and known levels of Na, K, CI, iCa, and Glu. The solutions are equilibrated with known levels of O2, CO2, and N2. Each ampule contains 1.7 ml volume.
The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2, PO2, hematocrit (Hct) Na, K, Cl, iCa, and Glucose (Glu). The aqueous quality control materials are composed of a buffered bicarbonate solution, each with a known pH and known level of Na, K, Cl, iCa, and Glu. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL. The aqueous quality control materials are formulated at three levels:
- . Control 1: Acidosis, with High Electrolyte, Low Normal Glu
- . Control 2: Normal pH, Low-Normal Hct, Normal Electrolyte, High Glu
- Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu, .
Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, K+, and Cl-. Each ampule contains 1.8 ml volume.
The Stat Profile Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 100 µL.
Measured Parameters:
The Stat Profile Prime CCS Analyzer measures pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glu (Note: Glucose is optional).
Calculated Parameters:
- . pH, PCO2, PO2 (corrected to patient temperature)
- . Bicarbonate level (HCO3-)
- Total Carbon Dioxide (TCO2) .
- Base Excess of the blood (BE-b) .
- Base Excess of extracellular fluid (BE-ecf) .
- Standard Bicarbonate Concentration (SBC) .
- . Oxygen Content (O2Ct)
- . Oxygen Capacity (O2Cap)
- Alveolar Oxygen (A) .
- Arterial Alveolar Oxygen Tension Gradient (AaDO2) .
- Arterial Alveolar Oxygen Tension Ratio (a/A) .
- Respiratory Index (RI) .
- P50 .
- PO2/FIO2 ratio .
- Oxygen Saturation (SO2%) .
- Hemoglobin .
- Anion Gap .
- Normalized Calcium, nCa ●
The Nova Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use for the quantitative determination of blood gases (pH, PCO2, PO2), hematocrit (Hct), and electrolytes/metabolites (Na+, K+, Cl-, iCa, and Glucose) in heparinized whole blood. The acceptance criteria for the device's performance are established through bench testing, demonstrating substantial equivalence to its predicate device, the Nova Stat Profile pHOx Ultra Analyzer System (K110648).
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria by comparing the proposed device to the predicate device and asserting substantial equivalence. While explicit numerical acceptance ranges are not provided for all parameters in a pass/fail format, the comparison table and the conclusion of the study indicate that the Stat Profile Prime CCS Analyzer met the performance levels demonstrated by the predicate.
| Characteristic | Predicate: K110648 Stat Profile pHOx Ultra Analyzer | Proposed: Stat Profile Prime CCS Analyzer (Reported Performance) |
|---|---|---|
| Measurement Range | ||
| pH | 6.500-8.000 | Same (6.500-8.000) |
| PCO2 | 3.0-200 mmHg | Same (3.0-200 mmHg) |
| PO2 | 0-800 mmHg | 5-765 mmHg |
| Hct | 12%-70% | Same (12%-70%) |
| Na+ | 80-200 mmol/L | Same (80-200 mmol/L) |
| K+ | 1.0-20.0 mmol/L | Same (1.0-20.0 mmol/L) |
| Cl- | 50-200 mmol/L | Same (50-200 mmol/L) |
| Ca (Ca++) (iCa) | 0.10-2.70 mmol/L | 0.20-2.70 mmol/L |
| Glu | 15-500 mg/dL | Same (15-500 mg/dL) |
| Other Performance | ||
| Method Comparison | Performance demonstrated by predicate | Substantial equivalence demonstrated |
| Precision/Reproducibility | Performance demonstrated by predicate | Substantial equivalence demonstrated |
| Run to Run Precision | Performance demonstrated by predicate | Substantial equivalence demonstrated |
| Within Run Precision | Performance demonstrated by predicate | Substantial equivalence demonstrated |
| Linearity Testing | Performance demonstrated by predicate | Substantial equivalence demonstrated |
| Specificity / Interference Testing | Performance demonstrated by predicate | Substantial equivalence demonstrated |
| Detection Limit | Performance demonstrated by predicate | Substantial equivalence demonstrated |
2. Sample Sizes used for the Test Set and Data Provenance:
The document states that "Bench testing was completed to demonstrate that the Stat Profile Prime CCS Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile pHOx Ultra Analyzer System." However, it does not provide specific sample sizes for the test sets used in the method comparison, precision, linearity, specificity/interference, or detection limit studies.
The data provenance is not explicitly stated. Given that the testing was bench testing for regulatory submission, it is highly likely to be prospective data collected specifically for this submission, rather than retrospective. The country of origin for the data is also not specified, but the applicant, Nova Biomedical Corporation, is based in Waltham, MA, USA, suggesting the testing likely occurred in the USA.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in-vitro diagnostic (IVD) analyzer for quantitative measurements. The ground truth for such devices is typically established through reference methods or certified reference materials, not by expert consensus in the same way an image analysis AI might be. Therefore, the concept of "experts used to establish ground truth" with specific qualifications like "radiologist with 10 years of experience" does not apply in this context. The ground truth would be determined by the accuracy of the reference methods or the certified values of the reference materials used in the bench testing.
4. Adjudication Method for the test set:
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are making subjective interpretations, such as in medical imaging. For an IVD analyzer performing quantitative measurements, the ground truth is objective (e.g., a measured concentration or value). Therefore, the concept of an adjudication method does not apply to the bench testing conducted for this device. Discrepancies would be resolved through re-testing, calibration, or investigation of the reference method's accuracy.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study is used to assess the impact of an AI algorithm on human readers' performance, typically in diagnostic imaging. This device is an automated IVD analyzer, not an AI-assisted diagnostic tool that aids human interpretation. Therefore, an MRMC study was not performed, and the concept of human readers improving with/without AI assistance does not apply.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The performance evaluation described ("Method Comparison Studies," "Precision/Reproducibility Studies," "Linearity Testing," "Specificity / Interference Testing," "Detection Limit") primarily assesses the standalone performance of the Stat Profile Prime CCS Analyzer. This type of testing evaluates the algorithm and hardware's ability to accurately and precisely measure the specified analytes without direct human intervention in the measurement process (beyond sample loading and initiation). The human role is in setting up the device and interpreting the final quantitative result.
7. The type of ground truth used:
The ground truth for the performance testing (method comparison, precision, linearity, etc.) would be established using:
- Reference methods: Comparing the device's measurements to established, highly accurate laboratory methods for each analyte.
- Certified reference materials: Using materials with known, precisely determined concentrations of the analytes.
The document does not explicitly state which specific reference methods or certified materials were used, but these are standard practices for IVD device validation.
8. The sample size for the training set:
This document describes a submission for an in-vitro diagnostic analyzer based on established sensor technologies and measurement algorithms, not a machine learning or AI model that requires a distinct "training set." Therefore, the concept of a "training set sample size" as understood in AI/ML development does not apply in this context. The underlying algorithms for measurement are based on known chemical and physical principles and extensive historical validation, not iterative training on a large dataset.
9. How the ground truth for the training set was established:
As mentioned above, this device does not utilize a training set in the AI/ML sense. The "ground truth" for the device's core measurement principles is based on validated scientific principles, sensor calibration procedures, and the established performance characteristics of the predicate device. Changes or improvements from the predicate would be validated against established reference methods.
§ 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.