(35 days)
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No
The description focuses on microprocessor-based optical fluorescence technology and standard calibration/quality control procedures. There is no mention of AI, ML, or related concepts.
No.
The device is a diagnostic tool that measures pH, PCO2, and PO2 in blood samples, providing information for diagnosis, but it does not directly treat or alleviate a condition.
Yes
Explanation: The device measures pH, PCO2, and PO2 in whole blood samples, which are values used to assess and diagnose a patient's acid-base balance and respiratory status.
No
The device description clearly outlines a microprocessor-based instrument with optical fluorescence sensors, a disposable cassette, and a gas cylinder, indicating 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 classic definition of an in vitro diagnostic test, as it involves analyzing a biological sample (whole blood) outside of the body to provide information about a patient's health status.
- Device Description: The description details how the device uses optical fluorescence to measure analytes in a blood sample. This further confirms its function as an in vitro diagnostic tool.
- Clinical Setting: The intended use specifies that the device is used in "traditional blood gas or clinical laboratory setting or point-of-care locations," which are typical environments for performing IVD tests.
- Performance Studies: The document describes both nonclinical and clinical tests performed on blood specimens to evaluate the device's performance, which is a requirement for demonstrating the safety and effectiveness of an IVD.
- Predicate Devices: The listed predicate devices are also pH/Blood Gas Analyzers, which are well-established categories of IVD devices.
The device analyzes biological samples (whole blood) in vitro to provide diagnostic information (pH, PCO2, and PO2 measurements). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
75 CHL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
personnel minimally qualified to perform and report these results / traditional blood gas or clinical laboratory setting or point-of-care locations
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)
Summary of nonclinical tests submitted with the premarket notification for the (b) (1) device.
Study type: Carry-over or memory assessment.
Sample size: Not explicitly stated, but tonometered whole blood specimens were analyzed on four (4) OPTI 1 instruments. The protocol was repeated to obtain 3 sets of measurements 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.
Key results: 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
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.
1
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 |
2
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