(58 days)
The AVL COMPACT 3 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood.
The AVL COMPACT 3 pH / Blood Gas Analyzer is a fully automatic, microprocessor-controlled medical instrument that measures pH, PCO2 and PO2. Communication to the device is accomplished simply with the use of a keypad. The analyzer communicates to the user through a 4-line alphanumeric display with 20 characters per line and with a thermal printer using heat sensitive paper to output measured values, calibration reports, electrode voltages and other information.
Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:
Device: AVL COMPACT 3 pH/Blood Gas Analyzer
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating that the AVL COMPACT 3 is substantially equivalent to its predecessor (COMPACT 2) and that the changes made (numeric keypad, optimized sample volume requirements) do not introduce significant differences in performance. The acceptance criteria are implicitly derived from the existing performance of the COMPACT 2 and the statistical comparison to the "gold standard" methods (tonometry and AVL OMNI).
| Metric / Parameter | Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance (AVL COMPACT 3) |
|---|---|---|
| Numeric Keypad Function | Correct input/output of values across full range. | "Operation of the numeric keypad was validated by test of input values from the upper and lower limits in addition to typical input values. The numeric keypad function test was judged passed." |
| pH Measurement | No significant difference (P < 0.05) compared to AVL OMNI or tonometry results across various sample modes. | Across all modes (syringe, capillary, mini, micro) vs. OMNI: Mean pH values compared to AVL OMNI found "no significant difference (P < 0.05)".Quantitative results for pH vs OMNI (range: 7.00 to 7.48):- Syringe: bias -0.016, slope 1.0334, correlation 0.99945- Capillary: bias -0.016, slope 1.0321, correlation 0.99923- Mini: bias -0.010, slope 1.0209, correlation 0.99950- Micro: bias -0.010, slope 1.0078, correlation 0.99904 |
| PCO2 Measurement | No significant difference (P < 0.05) compared to gravimetrically prepared gas mixtures (tonometry) across various sample modes. | Across all modes (syringe, capillary, mini, micro) vs. Tonometry (range: 21 to 140 mmHg): No explicit "no significant difference" P-value reported but linearity and correlation are very high, suggesting equivalence.- Syringe: bias +0.43, slope 0.9963, correlation 0.99991- Capillary: bias +0.56, slope 1.0025, correlation 0.99995- Mini: bias +0.26, slope 0.9861, correlation 0.99977- Micro: bias +0.77, slope 1.0120, correlation 0.99992 |
| PO2 Measurement | No significant difference (P < 0.05) compared to gravimetrically prepared gas mixtures (tonometry) across various sample modes. | Across all modes (syringe, capillary, mini, micro) vs. Tonometry (range: 0 to 660 mmHg): No explicit "no significant difference" P-value reported but linearity and correlation are very high, suggesting equivalence.- Syringe: bias -4.48, slope 0.9708, correlation 0.99995- Capillary: bias -2.82, slope 0.9781, correlation 0.99995- Mini: bias -3.89, slope 0.9725, correlation 0.99993- Micro: bias -2.88, slope 0.9759, correlation 0.99990 |
| Calculated Values | Correct calculation based on NCCLS recommendations, covering full range and typical values. | "The equations used for all calculated values on the Compact 3 are listed in the Appendix of the Operators Manual included with this submission and have been verified by input of values representing the range and typical values for each parameter." |
| Within Run Precision | pH: ≤ 0.005 SD; PCO2 (0-40): ≤ 0.8 mmHg SD; PCO2 (40-200): ≤ 3.0 mmHg SD; PO2 (0-143): ≤ 1.2 mmHg SD; PO2 (143-742): ≤ 15.0 mmHg SD. (Inherited from existing device) | Performance data for within-run precision of the COMPACT 3 itself is not explicitly stated in this section, but the study aims to show it's equivalent to the COMPACT 2, which presumably met these precision criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- Numeric Keypad: Not explicitly stated, but "input values from the upper and lower limits in addition to typical input values" were tested. This suggests a qualitative rather than large quantitative test.
- Optimization of Sample Volume Requirements (pH, PCO2, PO2): "The means of five measurements in each mode taken at 10 levels of CO2 and O2 gas mixtures spanning the reportable range" were compared. This means for each parameter (pH, PCO2, PO2) and each sample mode (syringe, capillary, mini, micro), 10 levels of gas mixtures were used, with 5 measurements per level.
- Total measurements per parameter per mode: 10 levels * 5 measurements/level = 50 measurements.
- Total measurements for all 3 parameters across all 4 modes: 3 parameters * 4 modes * 50 measurements/mode = 600 measurements.
- For pH specifically, the comparison with AVL OMNI used "7 of the CO2 gas concentrations used" (tonometry levels), so presumably 7 levels * 5 measurements/level = 35 measurements per mode for this specific comparison.
- Data Provenance: The document does not specify the country of origin of the data. The data is presented as prospective in nature, as it describes validation tests conducted on the new device and its specific modifications. It does not appear to be retrospective analysis of existing clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The ground truth for the device's performance validation was established using objective scientific methods:
- Tonometry: Gravimetrically prepared gas mixtures serve as the "gold standard" for PCO2 and PO2.
- AVL OMNI pH/Blood Gas Analyzer: This is a pre-existing, presumably validated, reference device used for pH comparison.
- Qualifications of Experts: Not applicable. The ground truth relies on established laboratory methodologies and reference instruments, not human expert interpretation.
4. Adjudication Method for the Test Set:
Not applicable. The study involved direct measurement and statistical comparison to objective standards (tonometry and a reference instrument), rather than subjective interpretation requiring adjudication among multiple human readers.
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:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- This device is a diagnostic instrument (pH/Blood Gas Analyzer), not an AI-assisted diagnostic imaging tool or a system involving human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are, in effect, standalone performance evaluations of the device. The "algorithm" here refers to the instrument's internal measurement and calculation processes. The validation tests directly assess the accuracy of these measurements and calculations against recognized standards, without human intervention in the measurement or interpretation process.
7. The Type of Ground Truth Used:
- Tonometry: For PCO2 and PO2, the ground truth was established using gravimetrically prepared gas mixtures (a highly accurate, fundamental measurement method).
- Reference Instrument: For pH, the ground truth included comparison to measurements obtained from an AVL OMNI pH/Blood Gas Analyzer, which serves as a validated reference device. This falls under the category of a "reference standard" or "comparative method."
8. The Sample Size for the Training Set:
Not applicable. This device is a traditional analytical instrument, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The instrument's algorithms are based on established electrochemical principles and fixed mathematical equations.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design and physical chemistry principles, rather than learning from data. The document mentions "Calibration is performed automatically by the instrument on power-on" and describes various calibration modes, but this refers to internal self-calibration using known reference solutions, not a machine learning training process.
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Image /page/0/Picture/0 description: The image shows the letters AVL in a bold, sans-serif font. Below the letters, there is a handwritten number, K963964. The letters AVL are large and take up the majority of the image, while the number is smaller and located in the bottom left corner.
510(k) Summary
NOV 2 9 1996
(a) (1) Submitter's name. address AVL Scientific Corporation 33 Mansell Court
Roswell, GA 30076
Date of preparation of this summary:
(2) Device trade or proprietary name: AVL COMPACT 3 pH/Blood Gas Analyzer
Contact Person
1 October 1996
Quality Assurance Manager
(770) 587-4040 x 631
Randy Byrd
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 K942616, AVL currently markets the AVL COMPACT 2 pH/Blood Gas Analyzer.
Additionally, as in the former 510(k) submission, the AVL COMPACT 3 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
We do not consider the AVL COMPACT 3 a new device, but a re-engineering of our existing, COMPACT 2 to increase its utility in the hands of our customers. The most externally apparent modification enhances the current display and simplified YES. NO keypad with a full 10-key numeric keypad for the easy input of patient identification and other such numeric data.
The AVL COMPACT 3 pH / Blood Gas Analyzer is a fully automatic, microprocessor-controlled medical instrument that measures pH, PCO2 and PO2. Communication to the device is accomplished simply with the use of a keypad. The analyzer communicates to the user through a 4-line alphanumeric display with 20 characters per line and with a thermal printer using heat sensitive paper to output measured values, calibration reports, electrode voltages and other information.
Calibration is performed automatically by the instrument on power-on. One-point calibration of PCO2 and PO2 occurs continually during operation and following each sample analysis. One-point calibration of pH is performed automatically either at 1, 2 or 3 hour intervals determined by the instrument based on calibration drift, or selected to be performed automatically at 30 minute or 1 hour, fixed intervals by the user. A complete, 2 point calibration of all sensors may be selected to occur automatically at 8 or 12 hour intervals by the user. All calibrations may be initiated by the user as desired.
AVL SCIENTIFIC CORPORATION
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Automatic cleaning is performed by the instrument on initial power-on and prior to each 2point full calibration. The device contains additional diagnostic programs features to enable the user to easily customize some features of operation, or to troubleshoot the cause of any operational errors.
Quality control processing is provided for up to 34 samples of each of 3 levels of control material and to calculate mean, standard deviation and coefficient of variation on these samples to aide the user in performance and documentation of quality control for this instrument.
(5) Intended use of the device.
The AVL COMPACT 3 pH / Blood Gas Analyzer is intended to be used for the measurement of pH, PCO2 and PO2 in samples of whole blood.
Technological characteristics of the device (6)
The COMPACT 3 utilizes conventional technology for measurement (galvenometric for pH and PCO2, polarographic for PO2) with microprocessor controlled, fully automatic calibration and measurement.
| DisplayedRange | Resolutionof Display | Units | ||
|---|---|---|---|---|
| Measured Values | ||||
| pH | 6.0 - 8.0 | 0.001 | ||
| PCO2 | 4 - 200 | 0.01 | mmHg | |
| PO2 | 0 - 742 | 0.01 | mmHg | |
| barometric pressure | 300 - 800 | 0.1 | mmHg | |
| 375 - 1058 | 1 | mBar | ||
| Within Run Precision | Measurement | |||
| Whole Blood Measurement | Range | SD | Units | |
| pH | 6.0 - 8.0 | ≤ 0.005 | ||
| PCO2 | 0 - 40 | ≤ 0.8 | mmHg | |
| 40-200 | ≤ 3.0 | mmHg | ||
| PO2 | 0 - 143 | ≤ 1.2 | mmHg | |
| 143 - 742 | ≤ 15.0 | mmHg | ||
| Input Values | Range (conv.)* | Default | Units | |
| Patient temperature | T | 14 - 44 | 37 | °C |
| Total hemoglobin | tHb | 1 - 26 | 15 | g/dL |
| Hemoglobin type | adult / fetal | adult | -- | |
| P50 adult | 15 - 40 | 26.7 | mmHg | |
| P50 fetal | 150- 40 | 21.5 | mmHg | |
| Fraction of Inspired Oxygen | FIO2 | 0.11 - 0.99 | 0.21 | mmHg |
| Respiratory Quotient | RQ | 0.71 - 1.99 | 0.84 | -- |
| Patient age | 0 - 99 | -- | years | |
| Patient sex | male / female | -- | -- |
Technical Specifications
- SI units are also available
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Marcel Property
| Data Management | |
|---|---|
| Printout | built-in thermal printer |
| Interface | 2 x RS 232, 9-pin SUBMIN D / F1 x RS 232, 25-pin SUBMIN D / F |
| Gas Supply | |
| Calibration Gas 1 | 20% O2, 5.5% CO2, bal N2 (±0.03% absolute) |
| Calibration Gas 2 | 10% CO2, bal N2 (±0.03% absolute) |
| Input pressure | 3 - 4 bar (43.5 - 58 psi) |
| Sample Data | |
| Sample type | blood (serum or plasma for pH only) |
| Sample input via | syringe, capillary, Microsampler |
| Sample volume | ≥ 90 µL syringe mode |
| ≥ 55 µL capillary mode | |
| 60 µL Mini sample with capillary | |
| 25 - 55 µL Micro sample with capillary | |
| Reported units | conventional, SI |
| Sample rate | ≤ 32 samples/hour with interruption of conditioning |
| ≤ 28 samples/hour without interruption of conditioning | |
| Temperature / Humidity | |
| Ambient temperature | 15 °C - 32 °C, ( 59 °F - 89.6 °F ) |
| Measuring chamber temperature | 37 °C ± 0.1 °C, 98.6 °F ± 0.18 °F |
| Relative humidity | 20 - 90% (non-condensing) |
| Electrical Supply | |
| Voltage range | 100 - 240 V AC, self adapting |
| Frequency | 50 - 60 Hz |
| Power consumption (max.) | typical 65 VA |
| max. 110 VA, depending on actual operating mode | |
| Dimensions / Weight | |
| Width | 34 cm (13.4 inch) |
| Depth | 31.5 cm (12.4 inch) |
| Height | 34 cm (13.4 inch) |
| Weight | 13 kg (28.7 pounds) |
| Classification | |
| Safety category | I |
| Instrument type | B (following ÖVE - MG/EN 60 601-1, IEC 601-1) |
| Operation type | for continuous operation |
| Protective system | IP20 |
| EX protection | The device is not specified for operation insideexplosion-hazardous areas |
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Summary of nonclinical tests submitted with the premarket notification for the (b) (1) device.
The scope of nonclinical tests for the COMPACT 3 is limited only to the differences between the COMPACT 3 and the preexisting COMPACT 2 pH / Blood Gas Analyzer [K942616]. Below are listed summarized descriptions of the validation performed for these changes.
Numeric Keypad
Operation of the numeric keypad was validated by test of input values from the upper and lower limits in addition to typical input values. The numeric keypad function test was iudged passed.
Optimization of Sample Volume Requirements
With the addition of the "Mini" sample mode, the COMPACT 3 provides the user with four modes of sample measurement: Syringe, Capillary, Mini and Micro sample modes,
The measurement in each of these sampling modes was optimized independently, then validated through the measurement of whole blood samples which have been tonometered to gravimetrically prepared gas mixtures in each of these 4 sample modes. The means of five measurements in each mode taken at 10 levels of CO2 and O2 gas mixtures spanning the reportable range of the COMPACT were compared using standard statistical methods to determine that no significant difference ( P < 0.05) exists between measurement results in each of these 4 modes.
| mode | mean | bias | slope | y-intercept | s(y*x) | correlationcoefficient |
|---|---|---|---|---|---|---|
| pH vs OMNI | range: 7.00 to 7.48 | |||||
| syringe | 7.263 | -0.016 | 1.0334 | -0.262 | 0.0066 | 0.99945 |
| capillary | 7.247 | -0.016 | 1.0321 | -0.248 | 0.0078 | 0.99923 |
| mini | 7.254 | -0.010 | 1.0209 | -0.162 | 0.0062 | 0.99950 |
| micro | 7.254 | -0.010 | 1.0078 | -0.065 | 0.0085 | 0.99904 |
| PCO2 vs Tonometry | range: 21 to 140 mmHg | |||||
| syringe | 55.6 | +0.43 | 0.9963 | +0.631 | 0.5696 | 0.99991 |
| capillary | 55.7 | +0.56 | 1.0025 | +0.439 | 0.4089 | 0.99995 |
| mini | 55.4 | +0.26 | 0.9861 | +1.012 | 0.9013 | 0.99977 |
| micro | 55.91 | +0.77 | 1.0120 | +0.104 | 0.5499 | 0.99992 |
| PO2 vs Tonometry | range: 0 to 660 mmHg | |||||
| syringe | 213.4 | -4.48 | 0.9708 | +2.077 | 2.3981 | 0.99995 |
| capillary | 215.1 | -2.82 | 0.9781 | +1.925 | 2.2952 | 0.99995 |
| mini | 214.7 | -3.89 | 0.9725 | +2.575 | 2.6803 | 0.99993 |
| micro | 215.0 | -2.88 | 0.9759 | +2.351 | 3.3438 | 0.99990 |
table 1: summary of comparisons between measurement modes COMPACT 3
1 Bland JM, Altman DG. Statistical Methods for Assessing Agreement Between Two Methods of Clinical Measurement. The Lancei, Feb 8, 1986, 307-10.
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Additionally, the mean pH value in each mode was compared to the nH measurement obtained on the same from an AVL OMNI pH/Blood Gas Analyzer at pH values resulting from tonometry at each of 7 of the CO2 gas concentrations used and found to have no significant difference (P < 0.05 ).
Adoption of NCCLS Recommendations for Calculated Values
The equations used for all calculated values on the Compact 3 are listed in the Appendix of the Operators Manual included with this submission and have been verified by input of values representing the range and typical values for each parameter.
- (b) (2) Summary of clinical tests submitted with the premarket notification for the device. Because of the limited scope of changes between COMPACT 3 and the preexisting COMPACT 2 pH / Blood Gas Analyzer [K942616], no clinical tests are submitted with the premarket notification for the device.
(b) (3) Conclusions drawn from the clinical and nonclinical trials.
There is no significant difference in the measurement values obtained in analysis of whole blood between any of the sampling modes available on the COMPACT 3 pH/Blood Gas Analyzer.
§ 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.