The Stat Profile® Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.

PCO2, PO2, pH: Whole blood measurement of blood gases is used in the diagnosis and treatment of life threatening acid-base disturbances.

Device Description

The Stat Profile® Prime ABG Analyzer is a small, low cost blood gas analyzer for laboratory and point-of-care 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 flow path and the measurement sensors (pH, PCO2, and PO2). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.

The Stat Profile Prime ABG Analyzer has an enhanced test menu and multiple quality control options. Both traditional Internal and External liquid QC shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly.

As with the predicate, the Stat Profile Prime ABG Analyzer is microprocessor-based and incorporates:

traditional sensor technology to measure blood pO2 ●
ion selective electrode technology to measure pH and pCO2

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Stat Profile® Prime ABG Analyzer System, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document describes performance in terms of Method Comparison Studies (slope, intercept, correlation coefficient 'r') and Total Imprecision (SD and %CV). While explicit "acceptance criteria" are not listed as pass/fail thresholds in a dedicated table, the study aims to demonstrate substantial equivalence to a predicate device and safety/effectiveness for point-of-care use. The reported performance shown below reflects typical metrics for establishing analytical performance.

Method Comparison (POC vs. Trained Healthcare Professional)

Parameter	Whole Blood Range	Slope	Intercept	r	Notes
pH
Syringe Mode	6.785 - 7.767	0.997	0.018	0.999	Good correlation and agreement
Capillary Mode	6.791 - 7.737	0.993	0.047	0.998	Good correlation and agreement
PCO2 mmHg
Syringe Mode	4.3 - 193.0	1.001	1.063	0.998	Good correlation and agreement
Capillary Mode	3.2 - 192.2	0.984	1.347	0.997	Good correlation and agreement
PO2 mmHg
Syringe Mode	11.8 - 755.3	1.015	-0.939	1.000	Excellent correlation and agreement
Capillary Mode	13.1 - 672.9	1.041	-2.761	0.999	Excellent correlation and agreement

Total Imprecision Performance (Combined External Controls)

Parameter	Pooled Mean	N	Within Run SD (Sr)	Within Run %CV	Total Imprecision SD (St)	Total Imprecision %CV
Level 1
pH	7.152	120	0.004	0.056	0.005	0.070
PCO2	61.3	120	0.8	1.3	1.7	2.7
PO2	64.0	120	1.6	2.5	3.2	5.0
Level 2
pH	7.367	120	0.002	0.027	0.003	0.041
PCO2	41.4	120	0.4	1.0	0.6	1.5
PO2	101.7	120	1.4	1.4	3.0	2.9
Level 3
pH	7.560	120	0.006	0.079	0.007	0.093
PCO2	25.5	120	0.8	3.1	1.2	4.7
PO2	139.8	120	1.7	1.2	4.0	2.8

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

Sample Size (Method Comparison):
- Syringe Mode: 188 specimens
- Capillary Mode: 127 specimens
Data Provenance: The method comparison data was collected from three point-of-care (POC) sites: a cardiovascular intensive care unit (CVICU), a medical intensive care unit (MICU), and a pulmonary care unit (PCU). The specimens used were described as "quality control materials or discarded blood gas specimens." This implies the data is prospective in nature, collected specifically for this study. The country of origin is not explicitly stated but implied to be the USA given the FDA submission.
Sample Size (Imprecision): For total imprecision, "3 levels of Stat Profile Prime External Quality Control material (Levels 1-3)" were run in duplicate each day for 20 runs on 3 Stat Profile Prime ABG analyzers. This resulted in 120 data points (N=120) for each parameter at each level (3 levels x 2 duplicates x 20 runs = 120; or 3 analyzers x 20 runs x 2 duplicates = 120).

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

The study involved a comparison between "trained Healthcare Professionals" (THPs) and "POC personnel". The THPs likely represent the reference standard against which the POC measurements were compared.

Number of Experts: The document does not specify a distinct number of "experts" for establishing ground truth in the traditional sense. Instead, it compares results from "trained Healthcare Professionals" to those from "POC personnel." It mentions that a total of 35 respiratory therapy and 17 Nursing POC personnel participated from the 3 POC settings. The THPs would be the analogous "experts" in this context.
Qualifications of Experts: The POC personnel are described as "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized." The "Trained Healthcare Professional" (THP) group implies similarly qualified individuals. Specific years of experience or credentials (e.g., "Radiologist with 10 years of experience") are not specified in the document.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison was reported as direct measurement agreement between two groups of users (POC vs. THP) on the same specimens or between the device and its own external quality controls. There is no mention of a third-party review or consensus process for discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This document describes a submission for an in vitro diagnostic device (a blood gas analyzer), not a medical imaging device that typically uses MRMC studies to evaluate reader performance. The study assesses the device's analytical performance and its usability by different user groups (THP vs. POC personnel), not the diagnostic accuracy improvement of human readers using AI.

6. Standalone Performance Study (Algorithm only without human-in-the loop)

Yes, in essence. The entire evaluation of the Stat Profile® Prime ABG Analyzer is focused on its standalone analytical performance. The comparisons are between the device operated by different user groups or against quality control materials. The device is the "algorithm" and instrument combined. The "method comparison studies" and "precision/reproducibility studies" are precisely standalone performance evaluations comparing the device's output to a recognized reference or against itself over time. The "POC vs Trained Healthcare Professional" comparison demonstrates that the device performs equivalently when used by different types of trained personnel, implying a robust standalone performance regardless of minor user variation.

7. Type of Ground Truth Used

Reference Method / External Quality Controls:
- For the method comparison study (POC vs. THP), the device measurements obtained by "Trained Healthcare Professionals" served as the reference standard against which the "POC personnel" measurements were compared. This implies a comparison against a clinical reference measurement established by experienced users of the device or similar devices.
- For the imprecision study, Stat Profile Prime External Quality Control material (Levels 1-3) served as the ground truth, as the device's performance was assessed by measuring these known control materials.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning. This is a medical device submission based on analytical performance and substantial equivalence, not typically an AI/ML device that requires distinct training and test sets for model development. The device uses "traditional sensor technology" and "ion selective electrode technology," implying established electrochemical principles rather than data-driven machine learning models requiring extensive training data.

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

As there's no explicit mention of a machine learning "training set," the concept of establishing ground truth for it is not applicable to this document. The device's performance is validated against established laboratory practices, reference methods, and quality control materials.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NOVA BIOMEDICAL CORPORATION PAUL MACDONALD CHIEF QUALITY AND REGULATORY AFFAIRS OFFICER 200 PROSPECT ST. WALTHAM MA 02454

September 10, 2015

Re: K151982

Trade/Device Name: Stat Profile® Prime ABG Analyzer System Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL Dated: July 16, 2015 Received: July 17, 2015

Dear Paul Macdonald:

We have reviewed your 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151982

Device Name

Stat Profile® Prime ABG Analyzer System

Indications for Use (Describe)

The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.

PCO2, PO2, pH: Whole blood measurement of blood gases is used in the diagnosis and treatment of life threatening acid-base disturbances.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

510(K) Owner:	Nova Biomedical Corporation
Registration Number:	1219029
Address:	200 Prospect St.Waltham, MA 02454
Phone:	781-894-0800
Fax Number:	784-891-4806
Contact Person:	Paul W. MacDonald
Date Prepared:	August 14, 2015

Proprietary Name: Stat Profile® Prime ABG Analyzer

Common or Usual Name: Blood gases (PCO2, PO2) and blood pH Test System

Classification Name: Multiple

Classification Names:	Class No.	Reg. No.	Class
Blood Gases and Blood pH system	75CHL	862.1120	II

Product Codes: CHL

Predicate Device: K142220 - Stat Profile® Prime ABG Analyzer System

Device Description:

As with the predicate, the Stat Profile Prime ABG Analyzer is microprocessor-based and incorporates:

traditional sensor technology to measure blood pO2 ●
ion selective electrode technology to measure pH and pCO2

The following items are intended for use on the Stat Profile Prime ABG Analyzer and were previously cleared on the predicate Stat Profile Prime ABG Analyzer System, K142220:

The Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat

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Profile Prime ABG Analyzer.

The Stat Profile Prime Ampule 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 ABG Analyzer.

The Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO2, and PO2 using the Stat Profile Prime ABG Analyzer.

The Stat Profile Prime ABG 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 50 uL.

Measured Parameters:

The Stat Profile Prime ABG Analyzer measures pH, PCO2, and PO2.

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) ●
PO2/FIO2 ratio
Oxygen Saturation (SO2%) ●

Intended Use:

The Stat Profile Prime ABG Analyzer is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.

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

Summary of the Technological Characteristics:

The Stat Profile Prime ABG Analyzer is substantially equivalent to the previously cleared Stat Profile Prime ABG Analyzer System in intended use. It uses the same sensor technology and measurement algorithms for pH, PCO2, and PO2, and the formulations of the internal and external controls and the calibration cartridge are the same for the tested parameters.

Summary of Performance Testing:

Bench testing was previously completed to demonstrate that the Stat Profile Prime ABG Analyzer is substantially equivalent in performance, safety and efficacy in the predicate submission.

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The bench testing included:

Method Comparison Studies
. Precision/Reproducibility Studies
Run to Run Precision
Within Run Precision .

The results of that testing confirmed that the performance of the Stat Profile Prime ABG Analyzer is substantially equivalent to that of the Nova Stat Profile Prime ABG Analyzer System (predicate device).

Summary of Point-of-Care Testing

A Point-of-Care study was conducted to demonstrate that the analyzer was safe and effective for use in the POC setting. The testing compared results obtained by trained Healthcare Professionals to results obtained by POC personnel on the same specimens using the same analyzer. The Stat Profile Prime ABG Analyzer was evaluated by point-of-care (POC) personnel in 3 POC sites including a cardiovascular intensive care unit (CVICU), a medical intensive care unit (MICU) and a pulmonary care unit (PCU). A total of 35 respiratory therapy and 17 Nursing POC personnel participated from the 3 POC settings over the study. The personnel represent trained, qualified staff found in typical POC sites where blood gas analyzers are utilized. All testing was performed using quality control materials or discarded blood gas specimens.

Combined method comparison data from all 3 POC settings is summarized in Tables 2-1 and 2-2.

Parameter	Total # specimens	Whole Blood Range	Slope	Intercept	r
pH	188	6.785 - 7.767	0.997	0.018	0.999
PCO2 mmHg	188	4.3 - 193.0	1.001	1.063	0.998
PO2 mmHg	188	11.8 - 755.3	1.015	-0.939	1.000

Table 2-1: Prime ABG: POC v Trained Healthcare Professional (THP) - Syringe Mode

Table 2-2: Prime ABG: POC v Trained Healthcare Professional (THP) - Capillary Mode

Parameter	Total # specimens	Whole Blood Range	Slope	Intercept	r
pH	127	6.791 - 7.737	0.993	0.047	0.998
PCO2 mmHg	127	3.2 - 192.2	0.984	1.347	0.997
PO2 mmHg	127	13.1 - 672.9	1.041	-2.761	0.999

Total Imprecision Performance

The total imprecision data included in the following table was obtained from different POC site personnel running 3 levels of Stat Profile Prime External Quality Control material (Levels 1-3) in duplicate each day for a total of 20 runs on 3 Stat Profile Prime ABG analyzers. The protocol was based upon methods described in CLSI "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second edition." CLSI EP5-A2. The test data is representative of the expected total imprecision between analyzer performances obtainable by POC personnel using the Stat Profile Prime ABG analyzer using external quality control materials.

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Table 2-3: Prime ABG: Total Imprecision Results – Combined – External Controls

Parameter	PooledMean	N	Within RunSD (Sr)	Within Run%CV	TotalImprecisionSD (St)	TotalImprecision%CV
Combined Total Imprecision Data - Level 1
pH	7.152	120	0.004	0.056	0.005	0.070
PCO2	61.3	120	0.8	1.3	1.7	2.7
PO2	64.0	120	1.6	2.5	3.2	5.0
Combined Total Imprecision Data - Level 2
pH	7.367	120	0.002	0.027	0.003	0.041
PCO2	41.4	120	0.4	1.0	0.6	1.5
PO2	101.7	120	1.4	1.4	3.0	2.9
Combined Total Imprecision Data - Level 3
pH	7.560	120	0.006	0.079	0.007	0.093
PCO2	25.5	120	0.8	3.1	1.2	4.7
PO2	139.8	120	1.7	1.2	4.0	2.8

and the contraction of the comments of the comments of

Point-of-Care Study - Stat Profile Prime External Quality Control Materials (N=20 runs)

: 上一篇:

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Table 2-4: Comparison of Predicate and Proposed devicesCharacteristic	K142220 - Stat Profile® Prime ABG Analyzer	Proposed: Stat Profile® Prime ABG Analyzer
Indication ForUse	The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.	The Stat Profile Prime ABG Analyzer is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.
	PCO2, PO2, pH - Whole blood measurement of blood gases is used in the diagnosis and treatment of life-threatening acid-base disturbances in critically ill patients with numerous metabolic and pulmonary diseases.	Same
AcceptableSamples	Lithium heparinized whole blood from syringes, open tubes, small cups, and capillary tubes.	Same
Sample Volumes	50µL (syringe and capillary)	Same
MeasurementRange
pH	6.500-8.000	Same
PCO2	3.0-200 mmHg	Same
PO2	5-765 mmHg	Same
Principles ofMeasurement
pH	Hydrogen ion-selective sensor	Same
PCO2	Severinghaus-type sensor	Same
PO2	Polarographic Clark-type sensor	Same
Touch Screen	5.7" VGA full color display with LED backlight and integrated touch panel	Same

ડ-ર

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Characteristic	K142220 - Stat Profile® Prime ABG Analyzer	Proposed: Stat Profile® Prime ABG Analyzer
Menu	Fully configurable test menu based on above sensors	Same
Bar Code Scanner	Internal Integrated 1D/2D	Same
Printer	2" Roll, Thermal Transfer	Same
Pump	Peristaltic Pump w/ Pressure Plate, TPE Tubing (Pharmed BPT)	Same
Analog Board	Precision low level analog front end w/ amperometrically and potentiometric amplifiers, air detector circuitry and temperature control circuitry	Same

Conclusion:

The results of software valication testing confirmed that the Stat Profile Pime ABG Analyzer is safe and effective for
its intended purpose and that the Stat Profile Prime AB

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.