AVL OPTI-check assayed control is intended to be used to monitor the measurement of pH, PCO2, PO2, sodium, potassium, total hemoglobin content and oxygen saturation in the AVL OPTI Critical Care Analyzer, as well as other devices measuring the same parameters and ionized calcium and chloride.

For In Vitro Diagnostic Use

The determination of acid-base status, and concentration of carbon dioxide, oxygen, electrolytes, total hemoglobin and oxygen saturation is an important adjunct to patient monitoring for a variety of clinical conditions described in the labeling for those devices used for these purposes. Since therapeutic regimes are often determined by the results obtained in patient samples, the instruments used for these analyses must meet stringent requirements for accuracy and precision of measurement. It should be the goal of the quality control program in institutions performing these analyses to determine the instrumentation is working properly before the analysis and report of patient specimens, or after any suspicious results have been obtained.

Device Description

OPTI-check is a specially formulated aqueous liquid material intended to for use to monitor all analytes measured by the OPTI. It contains a stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the AVL OPTI Critical Care Analyzer. The three control levels contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples. OPT-check provides a convenient method of performing daily QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.

While the product is optimized for performance on the AVL OPTI Critical Care Analyzer, it may be used to monitor the measurement of blood gas and electrolyte values in conventional instrumentation. OPTI-check contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride, and suitable concentrations of microbeads to simulate clinically relevant values of tHb and oxygen saturation.

AI/ML Overview

The provided document describes the AVL OPTI-check Control, a multi-analyte control solution. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Analyte	Acceptance Criteria (implied from study conclusion)	Reported Device Performance (implied from study conclusion)
pH, PCO2, PO2, Na, K, ctHb, SO2, ionized calcium, chloride	Within manufacturer's stated claims for imprecision	Within manufacturer's stated claims for imprecision
pH, PCO2, PO2, Na, K, ctHb, SO2	No significant difference (P < 0.05) to predicate devices in correlation studies	No significant difference (P < 0.05) to predicate devices in correlation studies

Explanation of the "Implied" nature: The document does not explicitly state numerical acceptance criteria. Instead, it concludes that the device's performance "was within manufacturer's stated claims" for precision and showed "no significant difference (P < 0.05)" in correlation studies with predicate devices. This implies that the manufacturer's stated claims and the statistical significance threshold of P < 0.05 were the acceptance criteria for these aspects.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document mentions that for precision studies, two runs per day with 2 replicates per run were conducted for 20 days. This translates to a total of 80 measurements per analyte for each AVL OPTI Critical Care Analyzer used in the precision study (2 runs/day * 2 replicates/run * 20 days). For correlation studies, the number of patient specimens collected is not explicitly stated, but they were "remnant from patient specimens of both whole blood and serum collected for routing analysis."
Data Provenance: The document does not specify the country of origin. The test data for correlation studies came from "remnant from patient specimens... collected for routing analysis on existing instrumentation," indicating a retrospective or opportunistic use of clinical samples. The precision studies were conducted internally on AVL OPTI Critical Care Analyzers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the device's performance. The "ground truth" for the correlation studies would be the results obtained from the "predicate devices" or "existing instrumentation" in a clinical setting.
The personnel operating the instrumentation for the clinical correlation studies were "trained to perform and report these analyses." Their specific qualifications (e.g., radiologist, lab technician with X years of experience) are not detailed.

4. Adjudication Method for the Test Set:

No adjudication method is described. The comparison was made against results from existing instrumentation (predicate devices).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No MRMC comparative effectiveness study was done as this device is a control solution, not an interpretive diagnostic tool that involves human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This device is a control solution for analyzers, not an algorithm. Therefore, the concept of "standalone performance" for an algorithm does not apply in this context. The described studies evaluate the control solution's performance in ensuring the accuracy and precision of the analytical instruments.

7. The Type of Ground Truth Used:

For precision studies, the "ground truth" is typically the expected value of the control solution itself, as established by the manufacturer, against which the measured variance is compared.
For correlation studies, the "ground truth" was the measurements obtained from "predicate devices" or "existing instrumentation" using patient specimens. This could be considered a form of "reference method" comparison, which is close to "outcomes data" in the sense that it reflects real-world clinical measurements. However, it's more specifically a comparison to established, legally marketed devices.

8. The Sample Size for the Training Set:

The document does not explicitly describe a "training set" in the context of machine learning or AI. This product is a control solution, and its development would likely involve formulation and stability studies, rather than a data training pipeline.

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a "training set" in an AI/machine learning context, this question is not applicable. The control levels in the solution "contain three different concentrations of microbeads to simulate low, medium, and high hematocrit blood samples" and "clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride." These concentrations would be established during the product's development and manufacturing process based on clinical relevance and analytical needs.

Summary

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510(k) Summary

JAN 2 2 1998

cientific corporat

(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:

Device trade or proprietary name: (2)
AVL OPTI-Check Control

8 January 1998

Device common or usual name or classification name

Multi Analyte Control Solution

	CLASSIFICATION
PRODUCT NOMENCLATURE	NUMBER	CLASS	PANEL
MULTI ANALYTE CONTROL SOLUTION	75 JJY	I	CHEMISTRY

(3) Substantial Equivalence

A VL OPTI-check is substantially equivalent in function, safety and efficacy to a number of currently marketed devices known as 'Combi' or 'Multi-Analyte' control solutions, namely:

Multi-Function Blood Gas Control, Bionostics, Inc., K880447

Control for Blood Gases, Electrolytes and Glucose, Bionostics, Inc., K911755

Description of the new device (4)

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Intended use of the device (ર)

Technological characteristics of the device. (6)

AVL OPTI-check is technologically equivalent to currently marketed products to which substantial equivalence is claimed. It contains a low concentration, stable suspension of polystyrene microbeads which reflect and partially absorb red and infrared light similar to erythrocytes, allowing true simulation of the measurement of tHb and SO2 in exactly the same manner as these analytes are determined in whole blood by the AVL OPTI Critical Care Analyzer.

(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.

Typical Within-Run (Swr), Between-Day (Sdd) and Total (ST) precision were determined from two runs per day with 2 replicates per run for 20 days on two AVL OPTI Critical Care Analyzers.

(b) (2) Summary of clinical tests submitted with the premarket notification for the device.

Typical Within-Run (Swr), Between-Dav (Sdd) and Total (ST) precision were determined from two runs per day with 2 replicates per run for 20 days on a single AVL OPTI Critical Care Analyzer. Additionally, clinical testing was conducted to demonstrate the correlation of AVL OPTI Critical Care Analyzer to 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 of both whole blood and serum collected for routing analysis on existing instrumentation.

(b) (3) Conclusions drawn from the clinical and non-clinical trials.

All evaluation of measurement imprecision was within manufacturer's stated claims and comparison of measurement between the OPTI Critical Care Analyzer and other instrumentation showed no significant difference (P < 0.05) for all analytes evaluated. Acceptable performance on precision evaluation conducted concurrently to acceptable correlation to predicate devices in measurement of pH, PCO2, PO2, Na, K, ctHb and SO2 supports the use of AVL OPTI-check to monitor the measurement of these analytes, and demonstrates it substantially equivalent to other products with similar intended uses.

Image /page/1/Picture/13 description: The image contains a hand-drawn illustration of a hand with the index finger pointing upwards. The hand is drawn in a simple, cartoonish style with thick black lines. The drawing is not very detailed, but it is clear that the hand is meant to be pointing upwards.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 2 1998

Randy Byrd · Quality Assurance Manger AVL Scientific Corporation 33 Mansell Court 30076 Roswell, Georgia

Re : K974822 AVL OPTI-check pH Control Regulatory Class: I Product Code: JJY December 19, 1997 Dated: Received: December 24, 1997

Dear Mr. Byrd:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set -forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity To determine if it does, you should contact categorization. the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K974822

AVL OPTI-check Control Solution Device Name:

For In Vitro Diagnostic Use

Indications for Use

974822

(Division Sign-Off Division of Clinical Laboratory Devic 510(k) Number

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _______

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.