The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cC22+, cClu, cLac, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters p02 and for In vitro testing of pleura samples for the pH parameter.

pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.

pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.

pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.

Potassium (cK+): the measurements of the concentration of plasma are used to monitor the electrolyte balance.

Sodium (cNa+); the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.

Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.

Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.

Glucose (cGlu): The glucose measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia.

Lactate (cLac): The lactate measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.

Bilirubin (ctBil): The bilirubin measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.

Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.

Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.

Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the potential oxygen transport capacity; that is the fraction of oxyhemoglobins present (tHb) including dyshemoglobins.

Fraction of Carboxyhemoglobin (FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.

Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.

Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.

Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two a-chains and two B-chains, and has a higher oxygen affinity than adult Hb.

Creatinine (cCrea): The creatinine measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of <7.3 are referred as complicated parapneumonic effusions; they are exudative in nature.

Device Description

ABL800 FLEX with AQURE connectivity is a stationary, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions F02Hb, FCOHb, FMetHb, FHHb and FHbF).

The modification consists of integration with the Medical Device Data System (MDDS) called AQURE system. The software enables the initiation of device actions on connected ABL800 series analyzers.

AI/ML Overview

The provided text is a 510(k) summary for the Radiometer ABL800 FLEX with AQURE connectivity. This document focuses on demonstrating substantial equivalence to a predicate device and addresses a software modification (integration with the AQURE system), not a study proving the original device's performance against detailed acceptance criteria for its clinical parameters.

Therefore, the information required to fully answer your request regarding performance criteria and a study proving the device meets those criteria for the measured clinical parameters (pH, pO2, pCO2, etc.) is not present in this document. This document specifically states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K041874 as modified by K043218, K050869, K051968, K100777 and K110416) still apply."

However, I can extract information related to the software modification and its acceptance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for AQURE integration)	Reported Device Performance (Adherence to criteria)
Mitigation of all identified hazards to As Low As Reasonably Practicable (ALARP) as per ISO 14971.	FMEA risk analysis conducted, and all identified hazards mitigated to ALARP.
Verification of software mitigations by using test protocols.	Software mitigations verified by using test protocols.
Results met predefined acceptance criteria.	Results met predefined acceptance criteria. (Specific criteria for software functionality are not detailed in this summary document.)
Remote control functionality to other devices than ABL90 FLEX not available in US.	The functionality is not available to the customer, and any information regarding this functionality is either removed from the manual or indicated as unavailable. Device actions for other analyzers have a note added stating "This feature is not available in the USA".

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated for the software verification. The document mentions "test protocols" were used.
Data Provenance: Not specified, but given it's a product from Radiometer Medical ApS in Denmark, it can be inferred that the testing likely occurred in a controlled lab or manufacturing environment. The study is retrospective in the sense that it relies on previously established performance data for the core ABL800 FLEX device and focuses on the impact of the new software integration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts or ground truth establishment for the software verification. The assessment appears to be based on engineering and risk management principles (FMEA, test protocols).

4. Adjudication method for the test set

Not applicable as this is a software modification verification, not a clinical study involving human judgment.

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, an MRMC comparative effectiveness study was not done. The device is for in-vitro diagnostic testing (blood gas, electrolytes, metabolites, oximetry), not an imaging or interpretive AI device where MRMC studies are typically performed. The software modification is for data management connectivity (MDDS), not AI-assisted interpretation.

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

The device itself (ABL800 FLEX) is a standalone automated diagnostic system. The AQURE connectivity is a software integration to manage data and device actions. The validation of the software integration focuses on its functionality and safety, not standalone diagnostic performance, as the diagnostic performance relies on the already established ABL800 FLEX analyzer.

7. The type of ground truth used

For the software modification, the "ground truth" would be the expected functional behavior and safety requirements defined during the design and risk analysis phases. For example, a "ground truth" might be that a specific command sent via AQURE results in the correct action on the ABL800 FLEX analyzer, or that data transfer is accurate. However, this is not a biological or clinical ground truth.

8. The sample size for the training set

Not applicable. This is a medical device connectivity software update and risk assessment, not a machine learning or AI algorithm requiring a training set in the conventional sense.

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

Not applicable for the same reason as above.

In summary: This 510(k) summary explicitly states that the software modification (AQURE connectivity) does not affect the performance characteristics of the ABL800 FLEX analyzer. Therefore, performance data for the clinical parameters refers back to the original submissions (K041874 and subsequent modifications), which are not detailed in this document. The provided text only describes the verification and validation activities conducted for the software change itself, primarily focusing on risk management and functional testing rather than clinical performance studies.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 17, 2015

RADIOMETER MEDICAL APS. LASSE POST MOLLER REGULATORY AFFAIRS SPECIALIST AAKANDEVEJ 21 BROENSHOEJ 2700 DENMARK

Re: K142898

Trade/Device Name: ABL800 FLEX with AQURE connectivity Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, CEM, JGS, JFP, CGZ, CGA, KHP, CGL, CIG, MQM, KQI, GHS, GKR Dated: May 13, 2015 Received: May 20, 2015

Dear Lasse Moller:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For :

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142898

Device Name ABL800 FLEX with AQURE connectivity

Indications for Use (Describe)