ABL90 FLEX

K123748 · Radiometer Medical Aps · CHL · May 7, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123748
• Device Name: ABL90 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: May 7, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended 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-of-care setting. These tests are only performed under a physician's order.

Device Story

ABL90 FLEX is a portable, automated analyzer for in vitro testing of heparinized whole blood. Device measures pH, blood gases (pO2, pCO2), electrolytes (K+, Na+, Ca2+, Cl-), metabolites (glucose, lactate), and co-oximetry parameters (ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF). System uses potentiometry for blood gases/electrolytes, amperometry for metabolites, and spectrophotometry for oximetry. Modification involves an updated Intralipid correction algorithm for oximetry parameters to improve interference suppression. Operated by trained healthcare professionals in labs or point-of-care settings. Output provided via menu-driven touchscreen; results assist clinicians in diagnosing/treating life-threatening conditions like acid-base disturbances, electrolyte imbalances, and metabolic disorders. Device connects via Ethernet/USB for data management.

Clinical Evidence

Bench testing only. In-house method comparison study performed according to EP9-A2 using 76-282 samples per parameter, with 9-25% of samples containing elevated Intralipid index values. Results showed 95% confidence intervals for the new algorithm contained predicted bias intervals for the old algorithm at medical decision points. Statistical analysis (H0: μimproved = μcurrent) confirmed equal series means for all oximetry parameters (significance level α > 30%). Linearity and LoQ claims remained unchanged and met acceptance criteria.

Technological Characteristics

Portable, automated analyzer. Measurement principles: potentiometry (pH, blood gases, electrolytes), amperometry (glucose, lactate), spectrophotometry (oximetry). Connectivity: 100Base-Tx Fast Ethernet (RJ45), 3 USB ports. Software: Microsoft XPE operating system. Algorithm: Intralipid correction for oximetry parameters.

Indications for Use

Indicated for use by trained clinicians (technologists, nurses, physicians, therapists) in laboratory or point-of-care settings to measure pH, blood gases, electrolytes, glucose, lactate, and oximetry parameters in heparinized whole blood for the diagnosis and treatment of acid-base, electrolyte, and metabolic disorders, anemia, and carbon monoxide poisoning.

Regulatory Classification

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.

Predicate Devices

• ABL90 Flex (K111897)

Submission Summary (Full Text)

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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 [phone] Phone: Fax: [phone] Contact person: Soeren Boegestrand e-mail: [e-mail]

### 2. Description of Device Modification

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.

### 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 that<br>measures pH, blood gases, electrolytes, glucose,<br>lactate and oximetry in heparinised whole blood. The<br>ABL90 FLEX is intended for use by trained<br>technologists, nurses, physicians and therapists. It is<br>intended for use in a laboratory environment, near<br>patient or point-of-care setting. |
| Blood Gas<br>Measurement | Same | pH, pO2, pCO2 by potentiometry |
| Electrolyte<br>Measurement | Same | cK+, cNa+, cCa2+, cCl- by potentiometry |
| Metabolite<br>Measurement | Same | cGlu, cLac by amperometry |
| Oximetry<br>Measurement | Same | ctHb, sO2, FO2Hb, FHHb, FCOHb, FMetHb, FHbF by<br>spectrophotometry |
| Performance<br>Characteristics | Same | Identical Performance Characteristics |
| Calibration | Same | Two-Point liquid calibration |
| User Interface | Same | Menu driven touch screen |
| Software operating<br>system | Same | Microsoft XPE |
| Sample Introduction | Same | Aspiration |
| Dimensions (height<br>x width x depth) | Same | 17.7 x 9.8 x 11.4 in |
| Weight | Same | 11.1 kg |
| Ethernet | Same | 1 x RJ45 connector,<br>100Base-Tx Fast Ethernet |
| USB | Same | Three connectors for USB port |

| Differences | | |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------|
| Issue | SE Device | Predicate Device<br>(K111897) |
| Software version | Software version 2.6 MR4 | Software version 2.5 MR2 |
| Intralipid correction<br>algorithm for Oxi<br>parameters | Improved Intralipid correction<br>algorithm for Oxi parameters<br>implemented in Software<br>version 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 | Acceptance<br>criteria | Verification<br>method | Result and Pass/fail | Comments |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Interference | Clinically relevant interferences<br>must be known and specified in<br>the labeling. | Verification study<br>according to EP17-A2 | Interferences have been<br>determined and specified in the<br>Reference Manual<br>Pass | |
| Method<br>comparison | Method comparison claims must<br>be unchanged, i.e. 95%<br>confidence intervals for the new<br>algorithm must contain part of<br>the predicted bias intervals for<br>the old algorithm at the medical<br>decision points as per EP9-A2. | In-house method<br>comparison study vs.<br>previous algorithm<br>according to EP9-A2<br>with between 76 and<br>282 samples per<br>parameter spanning<br>the measuring range.<br>Between 9 and 25% of<br>the samples had<br>elevated intralipid<br>index values. | 95% confidence intervals for the<br>new algorithm contain part of<br>the predicted bias intervals for<br>the old algorithm at the medical<br>decision points..<br>Pass. | Existing method<br>comparison claims<br>still 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 | |
| Method<br>comparison | 0.9-1.1 | $<$\pm$0.5g/dL$ | >0.975 | In-house method<br>comparison study vs.<br>previous algorithm<br>according to EP9-A2<br>with between 76 and<br>282 samples per<br>parameter spanning<br>the measuring range. | 1.00 | -0.10 g/dL | 1.00 | Existing method<br>comparison claims<br>still 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-<br>1.15 | $<$\pm$5%$ | >0.85 | Between 9 and 25% of<br>the samples had<br>elevated intralipid<br>index values. | 0.87 | -4.24% | 0.89 | |
| LOQ | LoQ claims must be unchanged. | | | Data analysis and<br>recalculation of<br>existing LoQ<br>verification data. | LoQs fulfilled acceptance criteria<br>and were not affected by the<br>change. | | | Existing LoQ<br>claims 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 | Acceptance<br>criteria | Verification<br>method | Result and Pass/Fail | Comments |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Bias and<br>imprecision (S₀<br>and CVₓ) | Claims for bias and imprecision<br>obtained in-house must be<br>unchanged, i.e. less than or equal<br>to values specified in section 7 of<br>the existing Reference Manual. | Data analysis and<br>recalculation of<br>existing performance<br>verification data<br>obtained in-house.<br>Hypothesis H0:<br>$μimproved = μcurrent$ was<br>tested statistically. | 0.56% of measurements<br>affected. In no case was the<br>significance level α below 30%<br>(typically >80%). The α<br>acceptance level is ≥5%. This<br>implies equal series mean for<br>current and improved Intralipid<br>algorithm for all the Oxi<br>parameters. | Existing claims for<br>bias and<br>imprecision<br>obtained in-house<br>are still valid |
| | | Values for samples<br>exceeding the index<br>value initiating the<br>new correction were<br>recalculated and bias<br>and imprecision were<br>recalculated based on<br>this and compared<br>with the existing<br>claims. | Recalculation verified that the<br>acceptance criteria were met.<br><br>Pass | |
| Issue | Acceptance<br>criteria | Verification<br>method | Result and Pass/fail | Comments |
| Linearity | Linearity claims must be<br>unchanged, ie. the deviations<br>from linearity must be less than<br>or equal to existing claims. | Values for samples<br>exceeding the index<br>value initiating the<br>new correction were<br>recalculated and<br>deviations from<br>linearity were<br>recalculated based on<br>this and compared<br>with the existing<br>claims. | Recalculation verified that the<br>acceptance criteria were met.<br>Pass | Existing linearity<br>claims 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 [phone] or [phone] 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.

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.

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.

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.

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)