(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<0.05) between measurement modes | No significant difference (P<0.05) between modes | No significant difference (P<0.05) between modes | |
| Patient Mode: Slope 0.9905, Y-Int 0.076, Corr 0.9997, Sy*x 0.0047 | Patient Mode: Slope 1.0392, Y-Int -0.2924, Corr 0.9881, Sy*x 0.0181 | ||
| PCO2 | Comparable to predicate device/reference method (Slope ~1, Y-intercept ~0, High Correlation) | OPTI-trol Mode: Slope 0.9954, Y-Int 0.119, Corr 0.9998, Sy*x 0.6822 | OPTI-trol Mode: Slope 1.0924, Y-Int -4.1204, Corr 0.9951, Sy*x 1.5905 |
| No significant difference (P<0.05) between measurement modes | No significant difference (P<0.05) between modes | No significant difference (P<0.05) between modes | |
| Patient Mode: Slope 1.0038, Y-Int -0.084, Corr 0.9998, Sy*x 0.6697 | Patient Mode: Slope 1.0806, Y-Int -2.9589, Corr 0.9930, Sy*x 1.7704 | ||
| PO2 | Comparable to predicate device/reference method (Slope ~1, Y-intercept ~0, High Correlation) | OPTI-trol Mode: Slope 0.9636, Y-Int 1.1497, Corr 0.99996, Sy*x 1.5635 | OPTI-trol Mode: Slope 0.9295, Y-Int 9.0345, Corr 0.9850, Sy*x 6.4536 |
| No significant difference (P<0.05) between measurement modes | No significant difference (P<0.05) between modes | No significant difference (P<0.05) between modes | |
| Patient Mode: Slope 0.9704, Y-Int 0.8665, Corr 0.99994, Sy*x 1.8235 | Patient Mode: Slope 0.9590, Y-Int 4.7543, Corr 0.9918, Sy*x 5.1072 | ||
| Carry-over/Memory | No significant difference (P<0.05) between measurement modes | Demonstrated no significant difference (P<0.05) | Demonstrated no significant difference (P<0.05) |
2. Sample Sized Used for the Test Set and the Data Provenance
-
Nonclinical Study:
- Sample Size: Not explicitly stated as a single number for each parameter. The study involved:
- "Each measurement of OPTI-trol was followed by a blood measurement in the same cassette, then a second measurement taken in the same instrument with a second cassette. This protocol was repeated to obtain 3 sets of measurement for each mode of operation for each of 5 levels of gas containing CO2 and then repeated for each of the three levels of OPTI-trol." This suggests a substantial number of measurements were taken across the levels and modes for the carry-over study.
- "Whole blood samples were analyzed on four (4) OPTI 1 systems and on 1 AVL 995 after being tonometered at 37 ℃ to various concentrations of CO2 and O2 concentrations certified to 0.03% absolute by the manufacturer." The table later shows the ranges for pH (7.0 - 7.6), PCO2 (11-104), and PO2 (21-515), implying multiple samples across these ranges were tested.
- Data Provenance: Not specified regarding country of origin. The study was conducted internally by AVL Scientific Corporation. It appears to be retrospective in the sense that existing methods/samples (tonometered blood, OPTI-trol) were used in a controlled laboratory setting.
- Sample Size: Not explicitly stated as a single number for each parameter. The study involved:
-
Clinical Study:
- Sample Size:
- pH: 92 measurements in OPTI-trol Mode, 92 in Patient Mode, and a Total of 101 measurements for the combined data when compared to the IL 1312 predicate device.
- PCO2: Same as pH (92/92/101).
- PO2: Same as pH (92/92/101).
- Data Provenance: "Three field tests were conducted... Specimens analyzed in these tests were remnant from patient specimens collected for routing analysis on existing instrumentation." This indicates the data is retrospective, using remaining portions of previously collected patient samples. The specific country of origin is not stated but implied to be where the three clinical sites were located.
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided. The "ground truth" for the nonclinical study was established by laboratory methods (tonometered blood with certified gas concentrations and NIST traceable pH buffers) and for the clinical study by comparative measurements on predicate devices which are themselves assumed to have a well-established accuracy in routine clinical use. There is no mention of human experts establishing ground truth for individual measurements.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct physical/chemical measurements or comparison to predicate devices, not by human expert review that would require an adjudication method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a blood gas analyzer, not an AI-assisted diagnostic imaging device that involves human readers. The study focuses on the device's analytical performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance of the device without human interpretation (beyond operating the instrument) was the primary focus of the studies. The device itself performs the measurements and outputs results. The clinical study compares its output directly to other devices' outputs. The "human-in-the-loop" here refers to trained personnel performing the tests and reporting results, but not interpreting raw data from the device to establish a diagnosis or ground truth.
7. The Type of Ground Truth Used
- Nonclinical Study:
- For pH: NIST traceable pH buffer solutions (QUALIDATA, RNA Medical)
- For PCO2 and PO2: Tonometered whole blood specimens with gas concentrations certified to 0.03% absolute by the manufacturer.
- Clinical Study:
- Comparative analysis against legally marketed predicate devices (IL Model 1312 pH/Blood Gas Analyzer, AVL 995 pH / Blood Gas Analyzer, and AVL OMNI pH / Blood Gas / Electrolyte and tHb Analyzer). The assumption is that these predicate devices provide an accepted clinical reference or "ground truth" for the context of demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a medical device (blood gas analyzer) for FDA 510(k) clearance, not a machine learning or AI model that requires a "training set" in the computational sense. The device is based on fluorescence optode technology, not an adaptive learning algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI model. For the device's internal calibration, the document states: "The pH channel is calibrated with precision pH buffer solution contained in the cassette" and "performs a calibration verification on the sensors for pH, pCO2 and pO2 by passing a precision calibration gas mixture across the optode sensors." This internal calibration process relies on known standards embedded within the cassette or instrument.
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Pollico
19 March 1996
510(k) Summary
Submitter's name, address (a) (1) AVL Scientific Corporation 33 Mansell Court Roswell, GA 30076
Contact Person Randy Byrd Quality Assurance Manager (770) 587-4040 x 631
Date of preparation of this summary:
Device trade or proprietary name:
AVL OPTI 1 pH/Blood Gas Analyzer
Device common or usual name or classification name pH / Blood Gas Analyzer
| Product Nomenclature | Classification Number | Class Panel | |
|---|---|---|---|
| BLOOD GASES / PH | 75 CHL | II | CHEMISTRY |
(3) Substantial Equivalence
Under 510(k) notification number K944089, AVL currently markets the AVL OPTI 1 pH/Blood Gas Analyzer.
Additionally, as in the former 510(k) submission, the AVL OPTI 1 is substantially equivalent to the AVL Model 995 pH / Blood Gas Analyzer [K895317] and AVL COMPACT 2 pH / Blood Gas Analyzer [K942616].
(4) Description of the new device
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. In this way, the customer is provided the advantage to develop a quality control program for the OPTI 1 from a selection or combination of traditional and non-traditional methods which fulfills the real and perceived requirements under CLIA '88 and various laboratory accreditation organizations.
(2)
Image /page/0/Picture/17 description: The image contains a hand-drawn figure of the number 8 inside of a circle. The number 8 is drawn in a simple, slightly irregular style, with the top loop smaller than the bottom loop. The circle encloses the number 8, and it is also drawn in a freehand style, with some variation in thickness.
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Intended use of the device. (ર)
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.
Technological characteristics of the device. (6)
The OPTI 1 pH Blood Gas Analyzer uses fluorescence optode technology similar to that used in commercially available products since late 1983 and is unchanged in principle of operation from the originally submitted 510(k) for this device.
Calibration
A disposable, single-use cassette contains all the elements needed for calibration, QC sample measurement, patient sample measurement and waste containment. After reading the calibration information specific to a cassette into the instrument by 'swiping' the cassette packaged through a convenient bar code reader, the cassette is placed into the measurement chamber. The analyzer warms the cassette to 37.0 ± 0.1 ℃, and performs a calibration verification on the sensors for pH, pCO2 and pO2 by passing a precision calibration gas mixture across the optode sensors. The pH channel is calibrated with precision pH buffer solution contained in the cassette.
Technical Specifications
Measured Values
| Parameter | Range | Display Resolution | units |
|---|---|---|---|
| pH | 6.9 to 7.7 | 0.001 | pH units |
| PCO2 | 10 to 120 | 0.1 | mmHg |
| PO2 | 20 to 500 | 0.1 | mmHg |
| Barometric Pressure | 300 to 800 | 0.1 | mmHg |
Operating Conditions
| · Minimum Sample Size: | ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 80 µL |
|---|---|
| · Sample Type: | ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… heparinized whole blood |
| · Sample Application: | ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… syringe, capillary or AVL Microsampler |
| · Sample Input | ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… automatic aspiration |
| · Ambient Temperature: | ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 15 - 32 °C (59 - 90 °F) |
| · Relative Humidity: | ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… 5% to 95% (non-condensing) |
| · Type of Measurement: | ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… fluorescence |
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Data Management
- Printout .....................................................................................................................................................................
- Interface ....................................................................................................................................................................
- Format ..................8 bits, no parity, 1 stop bit, ASCII or ASTM (bi-directional)
Electrical Supply
- Voltage ...................................................................................................................................................................... Power Consumption (max.) .....................................................................................................................................................
Dimensions and Weight
- Height x width x depth .... 4.87 x 14.25 x 9.75 inches (12.5 x 36.2 x 24.8 cm)
- Weight .......................................................................................................................................................................
Summary of nonclinical tests submitted with the premarket notification for the (b) (1) device.
In order to assess the effects of carry-over or memory between the measurement of OPTItrol and a whole blood patient specimen, tonometered whole blood specimens were analyzed on a group of four (4) OPTI 1 instruments in both modes of operation: OPTI-trol and Patient. Each measurement of OPTI-trol was followed by a blood measurement in the same cassette, then a second measurement taken in the same instrument with a second cassette. This protocol was repeated to obtain 3 sets of measurement for each mode of operation for each of 5 levels of gas containing CO2 and then repeated for each of the three levels of OPTI-trol. No significant difference (P<0.05) was demonstrated between the measurement of the blood specimens in either of the measurement modes; or between any of the levels of OPTI-trol.
Whole blood samples were analyzed on four (4) OPTI 1 systems and on 1 AVL 995 after being tonometered at 37 ℃ to various concentrations of CO2 and O2 concentrations certified to 0.03% absolute by the manufacturer. The 995 was confirmed to have measurement of N.I.S.T. traceable pH buffer solutions (QUALIDATA, RNA Medical), at 6.841 ± 0.005, 7.100 ± 0.005, 7.383 ± 0.005 and 7.600 ± 0.005 each day prior to measurement of blood specimens.
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| Parameter | Slope | Y-Intercept | CorrelationCoefficient | Sy*x | Range |
|---|---|---|---|---|---|
| pH | |||||
| OPTI-trol Mode | 1.0081 | -0.046 | 0.9994 | 0.0067 | 7.0 - 7.6 |
| Patient Mode | 0.9905 | 0.076 | 0.9997 | 0.0047 | " |
| Total | 0.9993 | 0.015 | 0.9996 | 0.0051 | " |
| PCO2 | |||||
| OPTI-trol Mode | 0.9954 | +0.119 | 0.9998 | 0.6822 | 11-104 |
| Patient Mode | 1.0038 | -0.084 | 0.9998 | 0.6697 | " |
| Total | 0.9996 | +0.017 | 0.9998 | 0.6243 | " |
| PO2 | |||||
| OPTI-trol Mode | 0.9636 | 1.1497 | 0.99996 | 1.5635 | 21-515 |
| Patient Mode | 0.9704 | 0.8665 | 0.99994 | 1.8235 | " |
| Total | 0.9670 | 1.0081 | 0.99996 | 1.5773 | " |
Model equation for regression statistics is: [results of OPT] 1 Analyzer] = slope(m) {comparative method results} + intercept(b).
Summary of clinical tests submitted with the premarket notification for the device. (b) (2)
Three field tests were conducted to demonstrate the correlation of the AVL OPTI 1 to legally marketed predicate devices in a clinical setting, operated by personnel trained to perform and report these analyses. Specimens analyzed in these tests were remnant from patient specimens collected for routing analysis on existing instrumentation. Measurement was accomplished in both modes of operation (OPTI-trol Mode and Patient Mode) on whole blood specimens for pH, PCO2 and PO2 in comparison to:
IL Model 1312 pH/Blood Gas Analyzer, AVL 995 pH / Blood Gas Analyzer and AVL OMNI pH / Blood Gas / Electrolyte and tHb Analyzer
In all evaluations, there was no difference in mean values (P<0.05) obtained on blood sample measurement performed with our without the prior analysis of OPTI-trol. The table below provides data representative of that collected in these field tests.
| IL 1312 pH/Blood Gas Analyzer | |||||||
|---|---|---|---|---|---|---|---|
| Parameter | Slope | Y-Intercept | CorrelationCoefficient | Sy*x | n | Range | |
| pH | OPTI-trol Mode | 1.0174 | -0.1285 | 0.9869 | 0.0210 | 92 | 6.90 - 7.58 |
| Patient Mode | 1.0392 | -0.2924 | 0.9881 | 0.0181 | 92 | " | |
| Total | 1.0304 | -0.2266 | 0.9908 | 0.0173 | 101 | " | |
| PCO2 | OPTI-trol Mode | 1.0924 | -4.1204 | 0.9951 | 1.5905 | 92 | 23 - 110 |
| Patient Mode | 1.0806 | -2.9589 | 0.9930 | 1.7704 | 92 | " | |
| Total | 1.0938 | -3.8301 | 0.9951 | 1.5302 | 101 | " | |
| PO2 | OPTI-trol Mode | 0.9295 | 9.0345 | 0.9850 | 6.4536 | 92 | 30 - 271 |
| Patient Mode | 0.9590 | 4.7543 | 0.9918 | 5.1072 | 92 | " | |
| Total | 0.9532 | 6.0512 | 0.9904 | 5.3436 | 101 | " |
Comparative Method:
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Conclusions drawn from the clinical and nonclinical trials. (b) (3)
Analysis of the comparative measurement presented in the 510(k) for this device, together with the linearity and precision data collected during these clinical and nonclinical trials demonstrates that the AVL OPTI 1, with the additional feature allowing the analysis of OPTI-trol quality control liquid prior to patient sample analysis, is safe and effective. There is no significant difference in the measurement values obtained on whole blood with the AVL OPTI 1 and those obtained with predicate devices in this study, with or without the analysis of OPTI-trol as a quality control specimen prior to patient sample analysis.
§ 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.