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 (cKT): 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 (cCart): 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 (cGlu): 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 hemoqlobin.

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, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).

The implementation of the WiFi option allows wireless functionality for establishing network connectivity; all of which is supported by wired LAN connection in the existing application.

AI/ML Overview

Here's an analysis of the provided text regarding the ABL90 Flex device modification for WiFi, structured to address your specific questions.

Acceptance Criteria and Study for ABL90 Flex - WiFi Modification

The submission pertains to a Special 510(k) for a device modification, specifically adding WiFi functionality to the existing ABL90 Flex. A key assertion in such submissions is that the modification does not affect the core performance characteristics of the previously cleared device. Therefore, the "acceptance criteria" and "device performance" in this context refer to the performance characteristics of the original ABL90 Flex, which the modified device is claimed to still meet.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a special 510(k) for a modification (WiFi functionality), the acceptance criteria are implicitly that the addition of WiFi does not degrade or alter the performance characteristics of the existing device's measurements. The reported device performance is that these performance characteristics remain unchanged.

Acceptance Criteria Category	Specific Acceptance Criteria (Implicit)	Reported Device Performance
Measurement Performance	No degradation in accuracy, precision, or other analytical performance for all measured parameters (pH, pO₂, pCO₂, K⁺, Na⁺, Ca²⁺, Cl⁻, Glu, Lac, ctHb, sO₂, FO₂Hb, FCOHb, FMetHb, FHHb, FHbF).	"No performance characteristics are affected by the change."
Device Functionality	Continued proper operation of all non-WiFi-related functions.	Implied by "No performance characteristics are affected by the change."
Safety and Effectiveness	The addition of WiFi does not introduce new safety concerns or compromise the device's effectiveness.	Addressed by risk management, verification, and validation.
Substantial Equivalence	Device with WiFi remains substantially equivalent to the predicate device (K092686).	Formally accepted as "substantially equivalent" by FDA.

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

The document explicitly states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply."

This indicates that no new performance studies were conducted specifically for the WiFi modification to generate a new "test set" for measurement performance. The evidence relies on the existing performance data of the predicate device (K092686).

Sample Size for Test Set: Not applicable for new performance data related to the WiFi modification, as existing data is referenced. The sample size for the original ABL90 Flex (K092686) performance studies would be relevant but is not provided in this submission summary.
Data Provenance: Not applicable for new performance data related to the WiFi modification. The provenance for the original ABL90 Flex performance data (K092686) is not detailed in this submission summary.

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

Again, because no new performance studies are detailed for the WiFi modification, this information is not provided in the submission. The ground truth for the original ABL90 Flex (K092686) performance studies would have been established, but details are not present here.

4. Adjudication Method for the Test Set

Not applicable, as no new performance studies with specific test sets requiring adjudication were conducted for the WiFi modification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is typically performed for diagnostic imaging devices where human interpretation plays a significant role. The ABL90 Flex is an automated analytical instrument where the output is numerical measurements, not subjective human interpretation.

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

Yes, in essence. The ABL90 Flex is an automated analytical device. Its performance, as referenced from the original 510(k) (K092686), is inherently "standalone" in that it performs measurements without real-time human intervention affecting the measurement process itself. The modification (WiFi) is a connectivity feature and does not alter the core analytical algorithm or measurement capabilities.

7. The type of Ground Truth Used

For the core analytical measurements of the ABL90 Flex (pH, pO₂, electrolytes, glucose, etc.), the ground truth would typically be established through:

Reference Methods: Highly accurate and precise laboratory methods considered the "gold standard" for specific analytes.
Calibrated Reference Materials: Using certified reference materials or calibrators with known concentrations.
Interlaboratory Comparison: Comparing results against other established and validated analytical devices or laboratories.

However, the specific details for the original ABL90 Flex (K092686) are not provided in this document.

8. The Sample Size for the Training Set

Not applicable. The ABL90 Flex is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the conventional sense. Its "training" or calibration involves using specific calibrant solutions according to established protocols.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of machine learning for this device. The calibration process involves using commercially available or internally prepared calibrants with known, traceable values (ground truth) to adjust the instrument's response.

Summary

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Special 510(k): Device Modification to ABL90 Flex - WiFi

RADIOMETER ®

K122642

Section 5. 510(k) Summary

OCT 2 6 2012

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 212700 BroenshoejDenkmark
Phone:	+45 3827 3827
Fax:	+45 3827 2727

2. Description of Device Modification

The implementation of the WiFi option allows wireless functionality for establishing network connectivity; all of which is supported by wired LAN connection in the existing application.

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.

4. Substantial Equivalence

The ABL90 FLEX with the implementation of the WiFi option is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:

510(k) Number/Device Manufacturer:

K092686 ABL90 Flex, Radiometer Medical ApS (subsequent submissions: K111897, K120197)

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Special 510(k): Device Modification to ABL90 Flex - WiFi

RADIOMETER IR

Predicate: ABL90 Flex (K092682)
Similarities	Differences
Intended UseThe ABL90 FLEX is a portable, automatedanalyzer that measures pH, blood gases,electrolytes, glucose, lactate and oximetry inheparinised whole blood. The ABL90 FLEX isintended for use by trained technologists,nurses, physicians and therapists. It isintended for use in a laboratory environment,near patient or point-of-care setting.	Wireless LAN network connectivity utilizingstandard technology and protocols providedand supported by the operating system(Windows XP Embedded). Currently this isprovided by establishing cabled LANconnections.
Blood Gas Measurement
pH, pO₂, pCO₂ by potentiometry
Electrolyte Measurement
cK⁺, cNa⁺, cCa²⁺, cCl⁻ by potentiometry
Metabolite Measurement
cGlu, cLac by amperometry
Oximetry Measurement
ctHb, sO₂ FO₂Hb, FHHb, FCOHb, FMetHb,FHbF
Hemoglobin Measurement
Spectrophotometry
Identical Performance Characteristics
Two-Point liquid calibration
Menu driven touch screen
Software operating system
Microsoft XPE
Sample Introduction
Aspiration
Dimensions (length x width x depth)
External Power Source
230/120 V mains

5. Performance Data

No performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply.

6. Conclusion

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

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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 eagle or bird-like symbol with three curved lines representing its body or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

10903 New Hampshire Avenue Silver Spring, MD 20993

Radiometer Medical ApS c/o Martin Gabler Aakandevej 21 Denmark DK-2700

OCT 26 2012

Re: K122642

Trade Name: ABL90 Flex Analyzer Regulation Number: 21 CFR §862.1120 Regulation Name: Blood gases and blood pH test system Regulatory Class: Class II Product Codes: CHL, CEM, CGA, CGZ, GHS, GKR, JFP, JGS, JIX, KHP, KQI, JJY Dated: October 1, 2012 Received: October 3, 2012

Dear Mr. Gabler:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you dealle specific at hitro Diagnostic Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH'S (21 CFA Part 001197) 1 or Galleric's (OSB's) Division of Postmarket Surveillance at (301) Office of Dal valiano and Drolling of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

OFF it For 805), preace aroblem/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 r ou may other of Small Manufacturers, International and Consumer Assistance at its toll-free number (800 638-2041 or (301) 796-5680 or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology 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): K122642

Device Name: ABL90 Flex Analyzer

Indications For Use:

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

Potassium (cKT): 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 (cCart): 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.

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 Diagnostic Device Evaluation and Safety (OIR)

Bustle Ch

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) &(2.2642

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Indications for Use

510(k) Number (if known): K122642

Device Name: ABL90 Flex Analyzer

Indications For Use:

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 hemoqlobin.

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.

And/Or Over the Counter Use Prescription Use X (21 CFR Part 801 Subpart D) (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 Diagnostic Device Evaluation and Safety (OIR)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K122642 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.