(178 days)
The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.
The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.
The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.
The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter.
Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.
As in the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830) predicate device, the Nova Stat Profile pHOx Ultra Analyzer System combines Blood Gas/pH, Chemistry, bilirubin and CO-Oximetry testing into one Point-of-Care Analyzer. This device is analyte configurable by the end user, based on tests needed.
As with the predicate, this device is microprocessor-based and incorporates:
- traditional electrode technology to measure blood pH, pCO2, pO2 .
- Nova Biomedical proprietary optical reflectance technology for the measurement of oxygen . saturation
- ion selective electrode technology to measure blood sodium, chloride, ionized . calcium, ionized magnesium
- enzyme/amperometric technology for glucose, urea nitrogen, lactate and creatinine . measurements
- conductivity/Na+ correction for hematocrit .
- multi-wavelength reflectance/conductivity correction for hemoglobin. .
Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood qas electrodes using external compressed gas cylinders. Quality control materials are available as external ampules and as internal auto-cartridge quality control packs. Sampling, calibration and quality control are fully automated.
Nova will market the Nova Stat Profile pHOx Ultra Analyzer System in two configurations. The proposed Nova Stat Profile pHOx Ultra Analyzer System with CO-Ox module (Catalog #42013) will be offered with all the parameters listed above. A second configuration will be offered, called the Nova Stat Profile pHOx Ultra Analyzer System without the CO-Ox module (Catalog #42014). This configuration will not have the capability to measure Oxyhemoglobin (O₂Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), and Reduced Hemoglobin (HHb) or bilirubin.
This 510(k) summary (K110648) describes the Nova Stat Profile pHOx Ultra Analyzer System as substantially equivalent to the predicate device, the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830). The submission primarily focuses on demonstrating equivalence due to component obsolescence, rather than presenting a study to prove new performance criteria.
Therefore, the acceptance criteria are implicitly those established for the predicate device, and the "study" is a comparison and verification that the changes to the Nova Stat Profile pHOx Ultra Analyzer System did not affect the performance and maintain equivalence.
Here's the information broken down based on the provided text, recognizing the nature of this 510(k) (substantial equivalence based on component updates):
1. Table of Acceptance Criteria and Reported Device Performance
(Note: Since this is a substantial equivalence claim based on component changes, explicit acceptance criteria values for each analyte are not provided in this document. Instead, the "acceptance criteria" for the new device is to perform equivalently to the predicate. The reported device performance is that it met this equivalence.)
| Characteristic | Acceptance Criteria (based on predicate performance) | Reported Device Performance (Nova Stat Profile pHOx Ultra) |
|---|---|---|
| Analyte Measurement | Performance equivalent to predicate for all analytes (pH, PCO2, PO2, SO2%, Hct, tHb, O2Hb, COHb, MetHb, HHb, tBil, Na+, K+, Cl-, Ca++, Mg++, Glu, Lac, BUN, Creat) | "the results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device." |
| User Interface | Functionality equivalent to predicate | "Functionality is equivalent to the predicate." |
| Accuracy | Equivalent to predicate | Confirmed through performance verification testing |
| Precision | Equivalent to predicate | Confirmed through performance verification testing |
| Reproducibility | Equivalent to predicate | Confirmed through performance verification testing |
| Software Validation | All software requirements met | Successfully validated |
| Performance Verification | All performance specifications met against predicate | Successfully verified |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size or data provenance (country of origin, retrospective/prospective) for the "performance verification testing." Given the nature of a 510(k) for component changes, this testing would typically involve a series of internal laboratory tests comparing the updated device's output to the predicate's output across a range of relevant samples (e.g., blood controls, patient samples).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of 510(k) submission, focused on component equivalence for an in vitro diagnostic device, typically relies on established reference methods or calibrated controls as the "ground truth" rather than expert consensus on individual cases. The document does not specify the use of "experts" to establish ground truth for a test set in the traditional sense of clinical imaging or diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. This submission does not describe a process involving adjudication of test results, as it is focused on technical equivalence to a predicate device rather than human interpretation or complex diagnostic assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an IVD device for quantitative measurements, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this submission.
6. Standalone Performance Study
Yes, in essence, a "standalone" performance verification for the new device was implicitly conducted against the predicate device. The submission states: "The results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device." This indicates that the device was tested to ensure its standalone performance matches that of the predicate.
7. Type of Ground Truth Used
The ground truth for this device would be established through a combination of:
- Traceability to Reference Methods: Calibrators and controls used for the device would be traceable to recognized reference measurement procedures or certified reference materials for each analyte.
- Comparison to Predicate Device: The primary "ground truth" in this context is the established performance of the legally marketed predicate device (Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System). The new device's performance was verified to be equivalent.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that relies on a "training set" to learn. It is a measurement device with established electrochemical and optical principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of IVD device.
§ 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.