Medica EasyQC Blood Gas / Electrolyte assayed controls are intended to be used to monitor and evaluate the analytical performance of instruments and analytes listed in the package insert.
For In Vitro Diagnostic Use

Device Description

Medica EasyQC is a specially formulated, three-level, aqueous liquid material intended for use to monitor all analytes measured by the Medica EasyStat and Easy Blood Gas analyzers. Medica EasyQC provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program.
Medica EasyQC contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride in three levels suitable to evaluate the measurement of the Medica EasyStat Analyzer and Medica Easy Blood Gas Analyzers.
Medica EasyQC is a non-hazardous aqueous solution containing no biological materials.

AI/ML Overview

The provided 510(k) summary for Medica EasyQC Blood Gas / Electrolyte Control describes a medical device, but it does not include a study that establishes performance against acceptance criteria in the way a typical AI/ML medical device submission would. This submission is for an in-vitro diagnostic quality control material, not an AI/ML algorithm.

Therefore, many of the requested categories in your template (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set size) do not apply to this type of submission.

However, I can extract the relevant information regarding the non-clinical tests and the basis for substantial equivalence.

Here's a summary tailored to the information provided in the 510(k) for Medica EasyQC:

Acceptance Criteria and Study for Medica EasyQC Blood Gas / Electrolyte Control

1. Table of Acceptance Criteria and Reported Device Performance
The K021930 submission for Medica EasyQC (a quality control solution, not an AI/ML device) does not define explicit "acceptance criteria" and "reported device performance" in the manner of an AI/ML algorithm's diagnostic accuracy. Instead, the "performance" is demonstrated through its formulation and intended use matching that of predicate devices and through non-clinical stability and precision tests.

Characteristic	Description of Performance/Demonstration (for a QC solution)
Stability	Real-time evaluation of products with similar formulation was conducted to support stability. Specific acceptance criteria (e.g., shelf-life, analyte drift limits) are not detailed in this summary but would be part of the underlying study.
Precision	Test precision was conducted. Specific metrics (e.g., CV%) and acceptance criteria for precision are not detailed in this summary but would be part of the underlying study.
Formulation Match	Therapeutically relevant quantities of pH, PCO2, PO2, Na+, K+, iCa++, Cl- in three levels. Buffered, aqueous electrolyte solution equilibrated with gas mixtures. This matches the predicate devices.
Intended Use Match	To monitor and evaluate analytical performance of instruments (Medica EasyStat and Easy Blood Gas analyzers). This matches the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of an AI/ML algorithm's diagnostic accuracy. For the non-clinical tests (stability and precision), the sample sizes for the conducted tests are not specified in this 510(k) summary.
Data Provenance: Not specified, but likely from internal Bionostics, Inc. lab testing, given it's a quality control solution.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a quality control material, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for a QC material is its assayed values, established through reference methods and internal validation by the manufacturer.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. This is for a quality control material where performance is assessed through analytical testing, not human adjudication of diagnostic findings.

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. This is a quality control material. MRMC studies are not relevant for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. There is no algorithm for this device. Its performance is intrinsic to the chemical properties and stability of the solution.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For quality control materials, the "ground truth" for the analyte values is established through the manufacturer's gravimetric, volumetric, and analytical processes using reference methods and traceable standards. The analytical results from precision and stability tests are compared against these established values.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. No training set for this device.

Summary

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K621930

JUN 2 5 2002

510(k) Summary*

(a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 772-7070 x 220

Date of preparation of this summary: 7 June 2002

Device trade or proprietary name: Medica EasyQC (2) Blood Gas / Electrolyte Control

Device common or usual name or classification name:

Multi Analyte Control Solution, All Types (Assayed and Unassayed)

PRODUCT NOMENCLATURE	CLASSIFICATION	NUMBER	CLASS	PANEL
MULTI-ANALYTE CONTROLS – ALL KINDS		862.1660	75 JJY	CHEMISTRY

(3) Substantial Equivalence

Medica EasyQC is substantially equivalent in function, safety and efficacy to currently marketed devices produced by Bionostics. In example:

Comparison of Medica EasyQC to predicate devices for substantial equivalency

Characteristic	Predicate Devices	Modified Device
Name:	RNA QC623 Blood Gas andElectrolyte Control	Medica EasyQC Blood Gas /Electrolyte Control
510(k), Date:	K880447
Number of levels:	3	3
Analytes:	pH, blood gases, Na+, K+, iCa++, Cl-	pH, blood gases, Na+, K+, iCa++, Cl-
Container:	clear, glass ampoule	clear, glass ampoule
Fill volume:	2.5 mL	1.7 mL
Color:	clear	clear
Matrix:	Buffered, aqueous electrolyte solutionequilibrated with carbon dioxide andoxygen gas mixture	Buffered, aqueous electrolyte solutionequilibrated with carbon dioxide andoxygen gas mixture

* This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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(4) Description of the new device

Medica EasyQC contains clinically relevant quantities of pH, PCO2, PO2, sodium, potassium, ionized calcium and chloride in three levels suitable to evaluate the measurement of the Medica EasyStat Analyzer and Medica Easy Blood Gas Analyzers.

Medica EasyQC is a non-hazardous aqueous solution containing no biological materials.

(5) Intended use of the device

Medica EasyQC Blood Gas/Electrolyte assayed controls are intended to be used to monitor and evaluate the analytical performance of instruments and analytes listed in the package insert.

(6) Technological characteristics of the device.

This material consists of buffered aqueous electrolyte solutions with clinically relevant concentrations of the targeted analytes, tonometered with precision gas mixtures of carbon dioxide and oxygen to achieve pH and blood gas values which span the range of values typical for such products with the same intended use.

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

Tests were conducted to verify specific performance requirements:

a) Real-time evaluation of products with essentially similar formulation and failure mode to support stability.
b) Test precision

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

N/A

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

Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circle around the caduceus.

Food and Drug Administration 2098 Gaither Road Bockville MD 20850

JUN 2 5 2002

Ms. Kathleen Storro Director. OA and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens. MA 01432

Re: K021930

Trade/Device Name: Medica EasyOC Blood Gas/Electrolyte Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: June 7, 2002 Received: June 12, 2002

Dear Ms. Storro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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:

Medica EasyQC Blood Gas / Electrolyte Controls Device Name:

Indications for Use:

Medica EasyQC Blood Gas / Electrolyte Controls are intended to be used to monitor and evaluate the analytical performance of instruments and analytes listed in the package insert.

For In Vitro Diagnostic Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109) OR

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.