The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

pH, pO2 and pCO2 pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cK+): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Sodium (cNa ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Calcium (cCa2): calcium measurements are used in the diagnosis and treatment of . parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Glucose (cClu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

Device Description

The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).

The change consists of an update to the Intralipid correction algorithm for Oxi parameters. The purpose of this update is to improve the suppression of Intralipid interference.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the ABL90 Flex with the improved Intralipid correction algorithm, extracted from the provided text:

Acceptance Criteria and Reported Device Performance

Issue	Acceptance Criteria	Reported Device Performance
Interference	Clinically relevant interferences must be known and specified in the labeling.	Interferences have been determined and specified in the Reference Manual. (Pass)
Method Comparison (overall)	Method comparison claims must be unchanged, i.e., 95% confidence intervals for the new algorithm must contain part of the predicted bias intervals for the old algorithm at the medical decision points as per EP9-A2.	95% confidence intervals for the new algorithm contain part of the predicted bias intervals for the old algorithm at the medical decision points. (Pass)
Method Comparison (Specifics per parameter)	Slope: 0.9-1.1; Intercept: < ±0.5 g/dL (for ctHb); < ±1% (for SO2, FCOHb, FMetHb, FO2Hb, FHHb); < ±5% (for FHbF); r: >0.975 (for ctHb, SO2, FCOHb, FMetHb, FO2Hb, FHHb); >0.85 (for FHbF)	All parameters met the slope, intercept, and r criteria (reported as 1.00 for slope, -0.10 to 0.28 for intercept, and 1.00 for r, except for FHbF which was 0.87 slope, -4.24% intercept, and 0.89 r). (Pass)
LOQ	LoQ claims must be unchanged.	LoQs fulfilled acceptance criteria and were not affected by the change. (Pass)
Bias and Imprecision (S₀ and CVₓ)	Claims for bias and imprecision obtained in-house must be unchanged, i.e., less than or equal to values specified in section 7 of the existing Reference Manual.	0.56% of measurements affected. In no case was the significance level α below 30% (typically >80%). The α acceptance level is ≥5%. This implies equal series mean for current and improved Intralipid algorithm for all the Oxi parameters. Recalculation verified that the acceptance criteria were met. (Pass)
Linearity	Linearity claims must be unchanged, i.e., the deviations from linearity must be less than or equal to existing claims.	Recalculation verified that the acceptance criteria were met. (Pass)

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: "between 76 and 282 samples per parameter spanning the measuring range."
- Data Provenance: "In-house method comparison study" and "existing performance verification data obtained in-house." This suggests the data was generated internally by Radiometer Medical ApS, likely in Denmark. The data is prospective in nature as it's a verification study against a new algorithm.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not explicitly stated. The study references "medical decision points" and "existing claims" but does not detail the involvement or qualifications of experts in establishing the ground truth for these.
Adjudication Method for the Test Set: Not explicitly stated. Given that the study compared the "new algorithm" against the "previous algorithm" and "existing claims," it implies a comparison to a established reference, but the method of adjudication (e.g., expert consensus) for that reference is not detailed.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The study focuses on the analytical performance of the device's algorithm.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: Yes, this appears to be a standalone (algorithm only) performance study. The focus is on the performance of the "Improved Intralipid correction algorithm for Oxi parameters" and its impact on measurements, without human interaction with the algorithm's output as part of the primary evaluation.
Type of Ground Truth Used: The ground truth used for performance evaluation was based on the "previous algorithm" (predicate device's algorithm) and "existing claims" for analytical performance (bias, imprecision, linearity, LOQ). This can be categorized as a comparative analytical truth against a previously validated method, rather than a clinical ground truth like pathology or patient outcomes.
Sample Size for the Training Set: Not explicitly stated. The document describes a "new correction" and an "improved Intralipid correction algorithm," implying development and training, but the sample size used for this training is not provided in this 510(k) summary.
How the Ground Truth for the Training Set Was Established: Not explicitly stated. The document describes the verification of the new algorithm against the old one and existing claims, but it does not detail how the ground truth was established for the training of the new algorithm itself.

Summary

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Special 510(k): ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters

Section 5. 510(k) Summary

1. Administrative

Device Information

Device Name: ABL90 Flex Common Name: Blood gases and blood pH test system Product Code: CHL (JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX) Registration Number: 21 CFR 862.1120 Classification: Class II Classification Panel: Clinical Chemistry

Submitter

Company Name: Radiometer Medical ApS ER Number: 3002807968 Address: Aakandevej 21 2700 Broenshoei Denmark +45 3827 3827 Phone: Fax: +45 3827 2727 Contact person: Soeren Boegestrand e-mail: soren.bogestrand@radiometer.dk

2. Description of Device Modification

The change consists of an update to the Intralipid correction algorithm for Oxi parameters. The purpose of this update is to improve the suppression of Intralipid interference.

3. Intended Use

The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinised whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order.

4. Substantial Equivalence

The ABL90 FLEX with the Improved Intralipid correction algorithm for Oxi parameters is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:

510(k) Number/Device Manufacturer: K111897 ABL90 Flex, Radiometer Medical ApS MAY 0 7 2013

K123748

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Special 510(k):

ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters

		Similarities
Issue	SE Device	Predicate Device (K111897)
Intended Use	Same	The ABL90 FLEX is a portable, automated analyzer thatmeasures pH, blood gases, electrolytes, glucose,lactate and oximetry in heparinised whole blood. TheABL90 FLEX is intended for use by trainedtechnologists, nurses, physicians and therapists. It isintended for use in a laboratory environment, nearpatient or point-of-care setting.
Blood GasMeasurement	Same	pH, pO2, pCO2 by potentiometry
ElectrolyteMeasurement	Same	cK+, cNa+, cCa2+, cCl- by potentiometry
MetaboliteMeasurement	Same	cGlu, cLac by amperometry
OximetryMeasurement	Same	ctHb, sO2, FO2Hb, FHHb, FCOHb, FMetHb, FHbF byspectrophotometry
PerformanceCharacteristics	Same	Identical Performance Characteristics
Calibration	Same	Two-Point liquid calibration
User Interface	Same	Menu driven touch screen
Software operatingsystem	Same	Microsoft XPE
Sample Introduction	Same	Aspiration
Dimensions (heightx width x depth)	Same	17.7 x 9.8 x 11.4 in
Weight	Same	11.1 kg
Ethernet	Same	1 x RJ45 connector,100Base-Tx Fast Ethernet
USB	Same	Three connectors for USB port

Differences
Issue	SE Device	Predicate Device(K111897)
Software version	Software version 2.6 MR4	Software version 2.5 MR2
Intralipid correctionalgorithm for Oxiparameters	Improved Intralipid correctionalgorithm for Oxi parametersimplemented in Softwareversion 2.6 MR4.	-

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Special 510(k):

ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters

5. Performance Data

No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply except the interference effect from intralipid to oximetry parameters was further reduced. The Reference Manual was updated to reflect the interference changes from intralipid to oximetry parameters.

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Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter

Summary of Design Control activiti '9

Risk Assessment

We conducted an FMEA risk and mitigated all identified hazards to As Low As Reasonaly Practicable (ALARP) per ISO
14971, and verified software mitigations by using test proto

Performance testin

Issue	Acceptancecriteria	Verificationmethod	Result and Pass/fail	Comments
Interference	Clinically relevant interferencesmust be known and specified inthe labeling.	Verification studyaccording to EP17-A2	Interferences have beendetermined and specified in theReference ManualPass
Methodcomparison	Method comparison claims mustbe unchanged, i.e. 95%confidence intervals for the newalgorithm must contain part ofthe predicted bias intervals forthe old algorithm at the medicaldecision points as per EP9-A2.	In-house methodcomparison study vs.previous algorithmaccording to EP9-A2with between 76 and282 samples perparameter spanningthe measuring range.Between 9 and 25% ofthe samples hadelevated intralipidindex values.	95% confidence intervals for thenew algorithm contain part ofthe predicted bias intervals forthe old algorithm at the medicaldecision points..Pass.	Existing methodcomparison claimsstill valid

RADIOMETER

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RADIOMETER Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter

面

Parameters for algorithmic correction of intraoperative Flexion/Extension aB190.

Issue	Acceptance criteria			Verification method	Result and Pass/fail			Comments
	Slope	Intercept	r		Slope	Intercept	r
Methodcomparison	0.9-1.1	$<$\pm$0.5g/dL$	>0.975	In-house methodcomparison study vs.previous algorithmaccording to EP9-A2with between 76 and282 samples perparameter spanningthe measuring range.	1.00	-0.10 g/dL	1.00	Existing methodcomparison claimsstill valid
	0.9-1.1	$<$\pm$1%$	>0.975		1.00	0.08%	1.00
	0.9-1.1	$<$\pm$1%$	>0.975		1.00	-0.35%	1.00
	0.9-1.1	$<$\pm$1%$	>0.975		1.00	-0.26%	1.00
	0.9-1.1	$<$\pm$1%$	>0.975		1.00	0.28%	1.00
	0.9-1.1	$<$\pm$1%$	>0.975		1.00	-0.02%	1.00
	0.85-1.15	$<$\pm$5%$	>0.85	Between 9 and 25% ofthe samples hadelevated intralipidindex values.	0.87	-4.24%	0.89
LOQ	LoQ claims must be unchanged.			Data analysis andrecalculation ofexisting LoQverification data.	LoQs fulfilled acceptance criteriaand were not affected by thechange.			Existing LoQclaims still valid
								Pass.
	ctHb	SO2	FCOHb	FMetHb	FO₂Hb	FHHb	FHbF

・・

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Special 510(K):
ABRI on FLEX - Improved Intralingual correction algorithm

Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter

RADIOMETER ®

Issue	Acceptancecriteria	Verificationmethod	Result and Pass/Fail	Comments
Bias andimprecision (S₀and CVₓ)	Claims for bias and imprecisionobtained in-house must beunchanged, i.e. less than or equalto values specified in section 7 ofthe existing Reference Manual.	Data analysis andrecalculation ofexisting performanceverification dataobtained in-house.Hypothesis H0:$μimproved = μcurrent$ wastested statistically.	0.56% of measurementsaffected. In no case was thesignificance level α below 30%(typically >80%). The αacceptance level is ≥5%. Thisimplies equal series mean forcurrent and improved Intralipidalgorithm for all the Oxiparameters.	Existing claims forbias andimprecisionobtained in-houseare still valid
		Values for samplesexceeding the indexvalue initiating thenew correction wererecalculated and biasand imprecision wererecalculated based onthis and comparedwith the existingclaims.	Recalculation verified that theacceptance criteria were met.Pass
Issue	Acceptancecriteria	Verificationmethod	Result and Pass/fail	Comments
Linearity	Linearity claims must beunchanged, ie. the deviationsfrom linearity must be less thanor equal to existing claims.	Values for samplesexceeding the indexvalue initiating thenew correction wererecalculated anddeviations fromlinearity wererecalculated based onthis and comparedwith the existingclaims.	Recalculation verified that theacceptance criteria were met.Pass	Existing linearityclaims still valid

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0 RADIOMETER

Special 510(k):
ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameter

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Image /page/7/Picture/0 description: The image shows the word "RADIOMETER" in bold, sans-serif font. To the right of the word is a circled "R" symbol, which is a registered trademark symbol. The text and symbol are in black against a white background.

Special 510(k):

ABL90 Flex - Improved Intralipid correction algorithm for Oxi parameters

7. Conclusion

The ABL90 FLEX with the improved Intralipid algorithm described above is substantially equivalent in Intended Use, fundamental scientific technology, and characteristics to the predicate ABL90 Flex (K111897). For the implementation of the change design control principles (risk management, verification and validation) have been applied which indicated that the change is of no impact to the performance of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is written in a sans-serif font.

Public Health Service

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

May 7, 2013

Radiometer Medical ApS C/O Søren Bøgestrand Akandevej 21 2700 Brønshøj DENMARK

Re: K123748

Trade/Device Name: ABL90 FLEX Analyzer Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Dated: April 04, 2013 Received: April 08, 2013

Dear Søren Bøgestrand:

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 Part 801); 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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Page 2- Søren Bøgestrand

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11:5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson - 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): K123748

Device Name: ABL90 FLEX Analyzer

Indications for Use:

The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-ofcare setting. These tests are only performed under a physician's order.

pH, pO2 and pCO2 pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cK+): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Calcium (cCa2): calcium measurements are used in the diagnosis and treatment of . parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung-W.Chan-S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K123748 510(k)

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Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.

FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OR)

YungWChan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K123748 510(k)

Regulation Number and Section

§ 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.