NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM

K110648 · Nova Biomedical Corporation · CHL · Aug 29, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110648
• Device Name: NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
• Applicant: Nova Biomedical Corporation
• Product Code: CHL · Clinical Chemistry
• Decision Date: Aug 29, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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.

Device Story

Nova Stat Profile CCX 1+ System; point-of-care blood analyzer; measures analytes in whole blood. Modifications include touchscreen/printer resizing, sample probe length adjustment, sampler motor update, peristaltic pump material changes, and deproteinizing algorithm update. Device operates via automated sample aspiration and electrochemical/biosensor analysis. Healthcare professionals use output for clinical decision-making regarding patient metabolic status. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by software validation and performance verification testing confirming that hardware/software modifications did not affect system safety, efficacy, or performance.

Technological Characteristics

Point-of-care blood analyzer. Hardware includes touchscreen, printer, sample probe, sampler motor, and peristaltic pump. Sensing principle: electrochemical/biosensor. Software includes deproteinizing algorithm. Design controls per 21 CFR 820.30.

Indications for Use

Indicated for use by healthcare professionals for quantitative measurement of analytes in whole blood samples in clinical settings.

Regulatory Classification

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.

Predicate Devices

• Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER (k)110648

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k061830, Nova Stat Profile Clinical Care Xpress (CCX 1+) System
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for touchscreen and printer resizing, sample probe length, sampler motor, peristaltic pump materials, and deproteinizing algorithm.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and software validation and verification.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.