(55 days)
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No
The description focuses on traditional sensor technology and a microprocessor-based system for blood gas analysis. There is no mention of AI or ML.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for quantitative determination of pH, PCO2, and PO2 in whole blood, which aids in the diagnosis and treatment of acid-base disturbances. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Stat Profile® Prime ABG Analyzer System is intended for in vitro diagnostic use." It also mentions that the measurement of blood gases is "used in the diagnosis and treatment of life threatening acid-base disturbances." This clearly identifies it as a diagnostic device.
No
The device description clearly outlines physical components such as sensors, a flow path, a peristaltic pump, a sampling probe, and a waste collection bag, indicating it is a hardware device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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."
This statement directly identifies the device as being used for diagnostic purposes on samples taken from the human body (in vitro).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CHL
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
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
health care professionals in clinical laboratory settings and for point-of-care usage
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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).
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.
Table 2-1: Prime ABG: POC v Trained Healthcare Professional (THP) - Syringe Mode
Parameter: pH, Total # specimens: 188, Whole Blood Range: 6.785 - 7.767, Slope: 0.997, Intercept: 0.018, r: 0.999
Parameter: PCO2 mmHg, Total # specimens: 188, Whole Blood Range: 4.3 - 193.0, Slope: 1.001, Intercept: 1.063, r: 0.998
Parameter: PO2 mmHg, Total # specimens: 188, Whole Blood Range: 11.8 - 755.3, Slope: 1.015, Intercept: -0.939, r: 1.000
Table 2-2: Prime ABG: POC v Trained Healthcare Professional (THP) - Capillary Mode
Parameter: pH, Total # specimens: 127, Whole Blood Range: 6.791 - 7.737, Slope: 0.993, Intercept: 0.047, r: 0.998
Parameter: PCO2 mmHg, Total # specimens: 127, Whole Blood Range: 3.2 - 192.2, Slope: 0.984, Intercept: 1.347, r: 0.997
Parameter: PO2 mmHg, Total # specimens: 127, Whole Blood Range: 13.1 - 672.9, Slope: 1.041, Intercept: -2.761, r: 0.999
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See performance studies for r-values and total imprecision results.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a symbolic representation of a wing or feather extending from the head of the first profile.
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.
1
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
2
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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3
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:
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
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
4
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 | Pooled
Mean | N | Within Run
SD (Sr) | Within Run
%CV | Total
Imprecision
SD (St) | Total
Imprecision
%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:
i
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| Table 2-4: Comparison of Predicate and Proposed devices
| Characteristic | K142220 - Stat Profile® Prime ABG Analyzer | Proposed: Stat Profile® Prime ABG Analyzer |
|---|---|---|
| Indication For | ||
| Use | 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 | |
| Acceptable | ||
| Samples | Lithium heparinized whole blood from syringes, open tubes, small cups, and capillary tubes. | Same |
| Sample Volumes | 50µL (syringe and capillary) | Same |
| Measurement | ||
| Range | ||
| pH | 6.500-8.000 | Same |
| PCO2 | 3.0-200 mmHg | Same |
| PO2 | 5-765 mmHg | Same |
| Principles of | ||
| Measurement | ||
| 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
.