(58 days)
Not Found
No
The description focuses on standard microprocessor control and measurement of blood gas parameters, with no mention of AI or ML terms or functionalities.
No.
The device measures chemical properties of blood samples and is intended for diagnostic purposes, not for treating a disease or condition.
Yes
The device is intended for the measurement of pH, PCO2, and PO2 in whole blood samples, which are diagnostic indicators.
No
The device description explicitly states it is a "fully automatic, microprocessor-controlled medical instrument" with a keypad, display, and thermal printer, indicating it includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used for the measurement of pH, PCO2, and PO2 in samples of whole blood. This is a key characteristic of an in vitro diagnostic device – it analyzes samples taken from the human body.
- Device Description: The device description confirms that it's a medical instrument designed to measure these parameters.
- Performance Studies: The performance studies describe testing performed on whole blood samples.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The AVL COMPACT 3 fits this definition by analyzing blood samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
75 CHL
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patient age: 0 - 99 years
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests:
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].
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: The measurement in four sampling modes (Syringe, Capillary, Mini, and Micro) was optimized independently and then validated. This was done 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. It was determined that 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.
0
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
1
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.
| | | Displayed
Range | Resolution
of 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
2
Marcel Property
| 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 | 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 inside |
| explosion-hazardous areas |
3
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