The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals for the quantitative determination of pH, pCO2, pO2, SO2%, Hct, Hb, Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Lac and Creat in heparinized whole blood, and Na+, K+, Cl-, Ca++, Mg++, Glu, BUN, Lac and Creat in serum and plasma.

Device Description

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AI/ML Overview

The provided document is a 510(k) premarket notification letter for the Stat Profile Critical Care Xpress Analyzer. It outlines the device's indications for use and states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria, beyond the general statement of substantial equivalence.

Therefore, I cannot directly extract the specific acceptance criteria and detailed study information as requested.

However, I can interpret what would typically be expected for a device like this based on the document's content and general FDA regulatory requirements for in vitro diagnostic devices.

Based on the typical requirements for devices like the Stat Profile Critical Care Xpress Analyzer, and the provided document's limited information, here's what can be inferred or generally expected for such a submission:

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which means demonstrating that the new device is as safe and effective as a legally marketed device. This typically involves performance data, but the specifics are not included in this letter.

Hypothetical Acceptance Criteria and Study Information (Based on typical performance studies for similar IVDs, NOT explicitly stated in the document):

Given that this is an in vitro diagnostic (IVD) device for measuring various analytes in blood, serum, and plasma, the acceptance criteria would typically revolve around:

Accuracy/Bias: How close the device's measurements are to a reference method or true value.
Precision/Reproducibility: How consistent the device's measurements are when repeated under similar conditions.
Linearity/Measuring Range: The range over which the device can accurately measure the analytes.
Interference: How various substances in the sample (e.g., hemolysis, lipemia, common medications) affect the measurements.
Sample Matrix Equivalency: Ensuring comparable performance across different stated sample types (whole blood, serum, plasma).

Disclaimer: The following table and sections contain assumed information based on general IVD performance claims, as the specific data is not present in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter (Analyte)	Acceptance Criteria (Hypothetical)	Reported Device Performance (Hypothetical)
pH	Bias ≤ ±0.02 pH units (vs. reference)	Bias: ±0.015 pH units
pCO2	Bias ≤ ±2 mmHg or 5% (whichever is greater)	Bias: ±1.5 mmHg
pO2	Bias ≤ ±3 mmHg or 5% (whichever is greater)	Bias: ±2.0 mmHg
Na+	Bias ≤ ±2.0 mmol/L or 2% (whichever is greater)	Bias: ±1.5 mmol/L
K+	Bias ≤ ±0.15 mmol/L or 4% (whichever is greater)	Bias: ±0.10 mmol/L
Cl-	Bias ≤ ±2.0 mmol/L or 2% (whichever is greater)	Bias: ±1.8 mmol/L
Glucose	Bias ≤ ±6 mg/dL or 10% (whichever is greater)	Bias: ±5 mg/dL
Precision (CV%)	≤ 2.0% for most analytes at medical decision levels	< 1.5% for most analytes
Measuring Range	For example, pH: 6.8 - 7.8	For example, pH: 6.75 - 7.85

Note: These are hypothetical acceptance criteria and performance values, typically established against a recognized standard or predicate device in a comparative study.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size or data provenance for any test set. For an IVD device, a typical test set for a 510(k) submission would involve:

Sample Size: Hundreds to thousands of patient samples would typically be used across various studies (accuracy, precision, linearity, interference). For accuracy studies, 40-100 patient samples spanning the measuring range are often used per analyte, compared against a reference method or predicate. For interference, numerous potential interferents would be tested.
Data Provenance: Studies would typically be conducted at multiple clinical sites (e.g., hospitals, reference labs) within the country where regulatory approval is sought (e.g., USA). The data would be prospective (samples collected and analyzed during the study) or retrospective clinical samples with known characteristics, sometimes spiked to cover specific ranges or interference conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

For in vitro diagnostic devices like the Stat Profile Critical Care Xpress Analyzer, "ground truth" for the test set is established by:

Reference Methods: Using highly accurate and precise laboratory reference methods (e.g., a gas chromatograph for blood gases, atomic absorption spectroscopy for electrolytes) or a well-validated predicate device.
Not human expert consensus related to image interpretation: This section typically applies to diagnostic imaging AI, not directly to quantitative chemical analyzers. The "ground truth" is analytical.

Thus, there are no human experts establishing ground truth in the sense of adjudication for this type of device documentation. Instead, highly trained clinical laboratory scientists and specialists operate the reference instrumentation.

4. Adjudication Method for the Test Set

Not applicable for this type of IVD device. "Adjudication" typically refers to resolving disagreements among human reviewers of images or clinical assessments. For quantitative laboratory analyzers, the ground truth is determined by the output of a reference method or predicate device, and statistical agreement/difference is calculated.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

Not applicable. MRMC studies are relevant for diagnostic imaging or subjective clinical assessments where multiple human readers interpret cases. This device is a quantitative in vitro diagnostic analyzer, not an imaging or interpretive AI system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is also not directly applicable in the same way it would be for an AI algorithm. The device is a standalone instrument that provides quantitative measurements. Its "performance" is measured by its analytical accuracy, precision, etc., without direct human interpretation being part of the primary output. Human operators initiate the tests and interpret the results, but the measurement itself is standalone.

7. The Type of Ground Truth Used

The ground truth used for performance validation of this IVD device would be:

Reference Method Analysis: Measurements obtained from highly accurate and well-established laboratory reference methods for each analyte.
Predicate Device Comparison: Measurements obtained from the legally marketed predicate device to which substantial equivalence is claimed.
Certified Reference Materials/Calibrators: For linearity, accuracy, and calibration verification.

8. The Sample Size for the Training Set

The document does not specify a "training set" in the context of an AI model.

For traditional IVDs, "training" is more about:

Calibration: Using a small set of known-value calibrator materials to establish the instrument's measurement curve.
Algorithm Development/Optimization: This is proprietary but would involve internal R&D with a dataset to fine-tune the sensor readings to final concentration values. This is not typically disclosed as a "training set" in regulatory filings but is part of product development.

9. How the Ground Truth for the Training Set Was Established

Again, "training set" refers more to AI/machine learning. For an IVD, the ground truth for calibration and internal development would be established through:

Certified Reference Materials: Materials with precisely known analyte concentrations.
Traceability to International Standards: Ensuring accuracy is traceable to recognized international measurement standards.
Comparative Analysis: Running samples alongside established reference methods or predicate devices during the development phase.

Summary

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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with stylized lines representing hair or feathers above them. The overall design is simple and monochromatic.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 0 2002

Mr. Paul W. MacDonald Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham. MA 02454-9141

K020297 Re:

Trade/Device Name: Stat Profile Critical Care Xpress Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases(P 002, Po2) and blood pH test system Regulatory Class: Class II Product Code: CHL Dated: April 12, 2002 Received: April 15, 2002

Dear Mr. MacDonald:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours.

Steven Dutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number:

Device Name: Stat Profile Critical Care Xpress Analyzer

Indications for Use:

Intended Use

Clinical Utility

The following list includes the clinical utility information for each of the analytes measured on the CCX Analyzer.

Blood Gases (PCO2, PO2 and pH): Whole blood measurement of blood gases is used inthe diagnosis, and treatment of life-threatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases.

Oxygen Saturation: Used to assess the oxygenation of hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Also used in the diagnosis and treatment of cyanosis.

Hematocrit: Whole blood measurement of hematocrit is used to estimate that red blood cells are present in sufficient quantity to carry oxygen and carbon dioxide.

Hemoglobin: Oxygen is carried from the lungs throughout the body by hemoglobin presentin red blood cells. Measurement of hemoglobin provides the clinician with information regarding the evaluation of chronic and acute anemias and also with information pertaining to the potential oxygen transport capability of the hemoglobin.

Sodium: Measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involving electrolyte imbalance.

Potassium: Measurement of potassium is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels.

Chloride: Measurement of chloride is used in the diagnosis and treatment of electrolyte

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and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Ionized Calcium: Used in the diagnosis and treatment of hypertension, renal disease, and vitamin D related disorders. Also useful in the diagnosis and treatment of patients with increased total protein and/or albumin levels, as in dehydration.

Ionized Magnesium: Measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).

Creatinine: Measurement of creatinine is used in the diagnosis and treatment of certain renal conditions and is used for monitoring adequacy of dialysis, for example, peritoneal dialysis and peritoneal equilibration testing.

Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohvdrate metabolism disturbances including diabetes mellitus. neonatal hypoglycemia. and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate: Measurement of lactic acid (lactate) in whole blood, serum, and plasma is used to evaluate the acid-base status of patients suspected of having lactic acidosis.

Urea Nitrogen: Measurement of urea nitrogen is used in the diagnosis and treatment of certain renal and metabolic diseases.

Ref. 1.Tietz, N.W. ed. 1986. Textbook of Clinical Chemistry. W. B. Saunders Co.

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020297

Regulation Number and Section

§ 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.