AVL COMPACT 3 PH/BLOOD GAS ANALYZER
Device Facts
| Record ID | K963964 |
|---|---|
| Device Name | AVL COMPACT 3 PH/BLOOD GAS ANALYZER |
| Applicant | Avl Scientific Corp. |
| Product Code | CHL · Clinical Chemistry |
| Decision Date | Nov 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
The AVL COMPACT 3 is a microprocessor-controlled, fully automatic blood gas analyzer measuring pH, PCO2, and PO2. It accepts whole blood samples via syringe, capillary, or microsampler. The device uses galvanometric sensors for pH and PCO2 and polarographic sensors for PO2. It features a 10-key numeric keypad for patient data entry, a 4-line alphanumeric display, and a thermal printer for output. Calibration is automatic at power-on, with continuous one-point calibration for PCO2/PO2 and periodic one-point calibration for pH. It includes quality control processing for up to 34 samples. The device is intended for clinical use to provide diagnostic blood gas values, aiding healthcare providers in patient assessment. It is a re-engineered version of the AVL COMPACT 2, adding a numeric keypad and optimized sample volume modes (Syringe, Capillary, Mini, Micro).
Clinical Evidence
No clinical tests were submitted. Nonclinical bench testing validated the new numeric keypad and the four sample measurement modes (Syringe, Capillary, Mini, Micro). Validation involved measuring whole blood samples tonometered to gravimetrically prepared gas mixtures across the reportable range. Statistical comparison (P < 0.05) confirmed no significant difference between measurement modes. Additional validation compared results against the AVL OMNI analyzer.
Technological Characteristics
Microprocessor-controlled analyzer. Measurement principle: galvanometric (pH, PCO2) and polarographic (PO2). Dimensions: 34 x 31.5 x 34 cm; Weight: 13 kg. Connectivity: 3x RS 232 ports. Power: 100-240 V AC, 50-60 Hz. Operating temperature: 15-32 °C. Measurement chamber temperature: 37 °C ± 0.1 °C. Safety: Class 1, Type B (IEC 601-1).
Indications for Use
Indicated for the measurement of pH, PCO2, and PO2 in whole blood samples for clinical diagnostic purposes.
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
Reference Devices
- AVL OMNI pH/Blood Gas Analyzer
Related Devices
- K142220 — Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) · Nova Biomedical Corporation · Oct 17, 2014
- K974526 — EASYBLOOD GAS ANALYZER · Medica Corp. · Feb 5, 1998
- K240998 — ABL90 FLEX PLUS System · Radiometer Medicals Aps · Dec 13, 2024
Submission Summary (Full Text)
{0}
AVL
K963964
# 510(k) Summary
NOV 29 1996
## (a) (1) Submitter's name, address
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:**
1 October 1996
## (2) Device trade or proprietary name:
AVL COMPACT 3 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 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, $PCO_2$ and $PO_2$. 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 $PCO_2$ and $PO_2$ 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
Page 5
13
{1}
510(k) Summary
AVL COMPACT 3 pH / Blood Gas Analyzer
Automatic cleaning is performed by the instrument on initial power-on and prior to each 2-point 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, $PCO_2$ and $PO_2$ in samples of whole blood.
## (6) Technological characteristics of the device
The COMPACT 3 utilizes conventional technology for measurement (galvenometric for pH and $PCO_2$, polarographic for $PO_2$) with microprocessor controlled, fully automatic calibration and measurement.
### Technical Specifications
| Measured Values | Displayed Range | Resolution of Display | Units |
| --- | --- | --- | --- |
| pH | 6.0 - 8.0 | 0.001 | |
| $PCO_2$ | 4 - 200 | 0.01 | mmHg |
| $PO_2$ | 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 | |
| $PCO_2$ | 0 - 40 | ≤ 0.8 | mmHg |
| | 40-200 | ≤ 3.0 | mmHg |
| $PO_2$ | 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 | -- |
| | Pso adult | 15 - 40 | 26.7 | mmHg |
| | Pso 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 | -- | -- |
* SI units are also available
Page 2
10
{2}
510(k) Summary
AVL COMPACT 3 pH / Blood Gas Analyzer
## Data Management
| Printout | built-in thermal printer |
| --- | --- |
| Interface | 2 x RS 232, 9-pin SUBMIN D / F
1 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 | 1 |
| --- | --- |
| 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 inside explosion-hazardous areas. |
Page 3
11
{3}
510(k) Summary
AVL COMPACT 3 pH / Blood Gas Analyzer
(b) (1) Summary of nonclinical tests submitted with the premarket notification for the 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 judged 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 $\mathrm{CO}_{2}$ and $\mathrm{O}_{2}$ 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) | correlation coefficient |
| --- | --- | --- | --- | --- | --- | --- |
| 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
12
{4}
510(k) Summary
AVL COMPACT 3 pH / Blood Gas Analyzer
Additionally, the mean pH value in each mode was compared to the pH 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.
Page 5
③
