(267 days)
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No
The summary describes a standard blood gas analyzer measuring pH and other parameters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on traditional analytical validation metrics like precision, method comparison, and linearity.
No
The device is an in vitro diagnostic (IVD) analyzer used for measuring the pH of pleural fluid samples and other parameters; it does not provide therapy.
Yes
The device measures the pH parameter in pleural fluid, and the pH measurement of pleural fluid is described as a "clinically useful tool in the management of patients with parapneumonic effusions," which indicates its use in aiding diagnosis or patient management.
No
The device description explicitly states it is an "analyzer" and a "member of the ABL800 FLEX blood gas analyzer family," which are hardware devices used for in vitro testing. The performance studies also describe precision, method comparison, and linearity studies conducted on the analyzer, indicating it is a physical instrument.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro testing of pleural fluid samples for the pH parameter". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVD devices.
- Sample Type: The device analyzes "pleural fluid samples," which are biological specimens taken from the body.
- Purpose: The pH measurement of pleural fluid is used as a "clinically useful tool in the management of patients," indicating its use for diagnostic or monitoring purposes.
- Device Description: The description confirms it's an "analyzer" for measuring various parameters in biological samples (whole blood and pleural fluid).
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The ABL837 FLEX analyzer is intended for:
- . in vitro testing of pleural fluid samples for the pH parameter
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
§ 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.
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Section 5
510(k) Summary
DEC 1 0 2010
1. Submitter Information
A. Establishment Registration: 3002807968
- B. Manufacturing Site: Radiometer Medical ApS
- C. Company Address: Aakandevej 21, DK-2700 Broenshoej, Denmark
D. Date Prepared: March 3, 2010
2. Contact Person
- A. Jana S. Hellmann
- B. Phone: (+45) 3827 3389
C. Fax: (+45) 3827 2727
- D. Address: Aakandevej 21, DK-2700 Broenshoej, Denmark
E. E-mail: jana.hellmann@radiometer.dk
3. Application Correspondent
A. Martin Gabler
- B. Phone: (+45) 3827 3114
- C. Fax: (+45) 3827 2727
- D. Address: Aakandevej 21, DK-2700 Broenshoej, Denmark
E. E-mail: martin.gabler@radiometer.dk
4. Device Identification
- A. Trade/Proprietary Name: ABL837 FLEX analyzer
- B. Classification: Class II (21CFR § 862.1120)
C. Product Code: 75CHL.
D. Subsequent Codes: CEM, JGS, JFP, CGZ, CGA, CGL, KHP, CIG, MQM, GHS, GKR, KQI, JIX, JJY
5. Device Description
The ABL837 FLEX analyzer is a member of the ABL800 FLEX blood gas analyzer family for the whole blood measurement of blood gas, pH (whole blood and pleural fluid), electrolyte, metabolite, co-oximetry, creatinine and expired air for the parameters pO2 and pCO2.
6. Intended Use (added with this submission)
In vitro testing of pleural fluid samples for the pH parameter.
7. Substantial Equivalence
Predicate:
A. Trade/Proprietary Name: Roche Omni C
B. Classification: Class II (21CFR § 862.1120)
C. Product Code: CHL.
- D. K-Number: 050423
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| Item | SE Device | Predicate Device |
|---|---|---|
| ABL837 FLEX analyzer with pleural | ||
| pH | Roche analyzer | |
| K050423 | ||
| Indications for use | New indication for measuring of pH in | |
| pleural fluids | Same | |
| Blood Gas Measurement | pH and pCO₂ by potentiometry | Same |
| Calibration Method | Two-Point liquid calibration | Same |
| User interface | Menu driven touch screen | Same |
| Sensors | Traditional, discrete amperometric and | |
| potentiometric sensors installed in the | ||
| analyzer | Same | |
| Calibration and QC | ||
| solutions | Discrete bottles and ampoules | Same |
The ABL837 FLEX analyzer is substantially equivalent to the predicate device Roche Omni C (K050423) regarding the measurement of pH in pleural fluid.
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8. Performance Characteristics:
Precision study:
Repeatability and Device/Method Precision is evaluated according to "NCCLS Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline - Second Edition, EP5-A2, Vol. 24, No. 25".
Performance Claims for Precision Performance, Repeatability (So) and Total Precision (SQ)
| pH | Number of
Observations | Mean | Repeatability (S₀) | Total Precision (Sₓ) |
|-----|---------------------------|-------|--------------------|----------------------|
| 7.1 | 244 | 7.153 | 0.012 | 0.029 |
| 7.3 | 256 | 7.294 | 0.009 | 0.020 |
| 7.5 | 244 | 7.517 | 0.006 | 0.028 |
The test verifies that the use of this new pleural fluid measuring mode produces pH results with acceptable precision.
Method Comparison:
Method comparison study has been conducted according to NCCLS quideline AP9-A2 "Method Comparison and Bias Estimation Using Patient Samples".
The slope of the linear fit to the data is 1.056 for the ABL837, and the intersection with the Yaxis is at -0.393. The linear fit intersects the identity line X = Y (and thus the Roche data) at pH 7.016. Furthermore, the graph clearly shows coherence between the ABL837 data and the Roche data in the sense that the X=Y line. representing the Roche data. Iies within the 95% confidence interval of the linear regression, in the entire pathological range from pH 7,0 to 7,5, and the difference in slope of 5.6% is well within the 10% acceptance.
At the critical decision interval fluid treatment, namely around pH 7.3, the ABL837 device measures 0.0159 above the Roche analyzer. This bias is considered acceptable, taking into account the nature of the sample material, and the fact that the clinical decision point is not defined more accurately than is the case. This means that the difference of 0.0159 pH could be contained in the rounding of the data. Finally, the placement of the critical decision point varies regionally; at some hospitals pH 7.2 is considered the critical decision point.
Summarizing our findings, we find that the results of this test clearly demonstrate that the ABL837 analyzer correctly measures pH in pleural fluid, since the measurements show a good agreement with those of the predicate device.
Linearity:
The data to proof the linear fit of the method has been taken from the method comparison study.
The data points from the 58 samples lie sufficiently distributed in the pathological range, and form a straight line, when plotting the ABL837 pH values against the Roche pH values. An R2 value of 0.993 is found when doing a linear regression on the data, plotting randomly selected single ABL837 measurements against the Roche average of two measurements.
Summarizing our findings, we find that the results of this test clearly demonstrate that the ABL837 analyzer correctly measures pH in pleural fluid, since the measurements show a good aqreement with those of the predicate device.
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Conclusion:
Taken the results from the performance studies and the comparison of the new device with the predicate devices into consideration, we believe that the ABL837 with pleural pH is as safe and effective as the predicate devices.
Calibration and Quality Control
Since the measuring technology for pH in pleural fluid is the same as in blood no new calibration or quality controls have been introduced for the new indication. The existing calibration and OC solutions are listed below.
Calibration
The following are the calibration solution relevant for the pH electrode.
S1827 Calibration Solution 1
Use: For calibration of the pH, electrolyte and metabolite electrodes in the ABL837 FLEX analyzer.
S1837 Calibration Solution 2
Use: For calibration of the pH, electrolyte and metabolite electrodes in the ABL837 FLEX analyzer,
Quality Controls
AutoCheck6+ and Cleaning Met II Solution
Use: This quality control system can be used for quality control of the ABL837 FLEX analyzer from Radiometer.
| Parameter | S7835
Level 1 | S7845
Level 2 | S7855
Level 3 | S7865
Level 4 |
|-----------|------------------|------------------|------------------|------------------|
| pH | 7.1 | 7.4 | 7.6 | 6.8 |
Range+ QUALICHECK
Use: Range+ QUALICHECK quality control systems can be used for quality control of the ABL77, ABL700 Series and ABL800/8x7 FLEX analyzers from Radiometer.
| Parameter | S7930
Level 1 | S7940
Level 2 | S7950
Level 3 |
|-----------|------------------|------------------|------------------|
| pH | 6.8 | 7.0 | 7.8 |
Technology
The technology has not been altered for the new indication of measuring pH in pleural fluids.
Potentiometric Method
The potential of an electrode chain is recorded using a voltmeter, and related to the concentration of the sample (the Nernst equation).
The electrode chain consisting of a sample, electrode, reference electrode, voltmeter, membranes and electrolyte solutions.
The reference electrode maintains a stable, fixed potential against which other potential differences can be measured. The potential is not altered by sample composition.
The pH electrode (E777) is a pH-sensitive glass electrode. The pH-sensitive glass membrane is located at the tip and seals the inner buffer solution with a constant and known pH
Modes of Operation
The instrument is an automated, random access, stat instrument. The specimens are withdrawn from a sampling device and drawn into the closed fluid transport system within the instrument for analysis.
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The FLEXQ allows the capability of automatic sampling from up to three blood samplers. Automatic measurements are accomplished via bar coding on the patient samples. The required tests for the identified sample are retrieved from a networked server. If required, manual introduction of a blood sample may be performed as well.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Radiometer Medical ApS c/o Martin Gabler Regulatory Affairs Specialist Akandevej 21 Bronshoj, Denmark DK-2700
DEC 1 0 2010
Re: K100777 Trade Name: Radiometer Medical ApS ABL837 FLEX analyzer Regulation Number: 21 CFR §862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system. Regulatory Class: Class II Product Code: CHL Dated: November 8, 2010 Received: November 15, 2010
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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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796. 5450. 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 Small Manufacturers, International and Consumer Assistance at its tolloffre no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100777
DEC 1 0 2010
Device Name: ABL837 FLEX analyzer
Intended Use:
The ABL837 FLEX analyzer is intended for:
- . in vitro testing of pleural fluid samples for the pH parameter
Indications for use:
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 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 (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k): K100777