(35 days)
The AVL OPTI 1 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood in either a traditional blood gas or clinical Iaboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
The AVL OPTI 1 is a microprocessor-based instrument using optical fluorescence for the measurement of pH, PCO2 and PO2 in samples of whole blood. A disposable, single-use cassette containing three optical fluorescence sensors is packaged in a sealed, foil pouch which bears a bar coded label with calibration and identification information. Immediately prior to use, the bar coded calibration information is read into the instrument and the cassette positioned in the instrument for calibration verification prior to measurement using a liquid buffer contained within the cassette, und a precision calibration gas contained in a cylinder inside the OPTI 1.
In order to provide our customers with an additional level of security in the quality control of results obtained with the OPTI 1, AVL has modified the operation of the OPTI 1 to allow the measurement of a traditional, ampouled, aqueous quality control product prior to any measurement of a patient's blood specimen in the same cassette.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The provided 510(k) summary does not explicitly state pre-defined "acceptance criteria" in the traditional sense (e.g., "The device must achieve a correlation coefficient of X for pH"). Instead, the document presents comparative performance data against predicate devices or known standards as evidence of substantial equivalence and safety/effectiveness. The implicit acceptance criteria are that the device's performance should be comparable to, and not significantly different from, legally marketed predicate devices.
The reported device performance is presented as regression statistics (slope, Y-intercept, correlation coefficient, Sy*x) comparing the AVL OPTI 1 to either a reference method (tonometered blood, AVL 995 with NIST traceable buffers) or other predicate devices in clinical settings.
| Parameter | Implicit Acceptance Criteria (Comparative) | Reported Device Performance (Nonclinical - vs. AVL 995/Tonometered Blood) | Reported Device Performance (Clinical - vs. IL 1312) |
|---|---|---|---|
| pH | Comparable to predicate device/reference method (Slope ~1, Y-intercept ~0, High Correlation) | OPTI-trol Mode: Slope 1.0081, Y-Int -0.046, Corr 0.9994, Sy*x 0.0067 | OPTI-trol Mode: Slope 1.0174, Y-Int -0.1285, Corr 0.9869, Sy*x 0.0210 |
| No significant difference (P |
§ 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.