The neonatal bilirubin test intended use on the Rapidlab 1245 and Rapidlab 1265 analyzers is an in vitro diagnostic test for the determination of total neonatal bilirubin (nBili) concentration in the whole blood of newborn infants. Measurement of nBili aids in assessing the risk of kernicterus.

Device Description

Neonatal Bilirubin (nBili) is a new parameter enabled on models 1245 and 1265 of the Rapidlab® 1200 blood gas family of instruments. It is intended as an in vitro diagnostic test for the determination of total neonatal Bilirubin (nBili) concentration in the whole blood of newborn infants. Enabling the nBill measurement is accomplished through software design changes introduced in Rapidlab Software Version 2.1. No hardware /mechanical changes were needed.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for Neonatal Bilirubin (nBili) on Rapidlab® 1200 Blood Gas Systems

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Coefficient of determination (r) > 0.90	For 2,241 samples, the coefficient of determination (r) values were "well within the acceptance criteria (>.90)" for all model, device, and mode combinations.

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

Sample Size: 2,241 samples.
Data Provenance: The samples were described as "unconjugated bilirubin in oxygenated whole blood (neonatal type samples)". The text does not explicitly state the country of origin or if the data was retrospective or prospective, but the nature of the samples suggests clinical relevance to neonates. It was an "internal evaluation study."

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

The document does not provide information on the number of experts, their qualifications, or their role in establishing the ground truth if a gold standard method was used. The study primarily compares the device's measurement against predicate devices, rather than an expert human interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The study involved instrumental measurements, not human interpretation that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The device measures a biochemical marker (bilirubin concentration) rather than interpreting medical images or clinical observations that would typically involve human readers. The study compared the device's performance against predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed. The "nBili internal evaluation study" assessed the performance of the Rapidlab 1245 and 1265 in measuring neonatal bilirubin concentrations. This device, being a diagnostic instrument (blood gas system), inherently operates in a standalone manner to provide quantitative results. The human involvement is in operating the device and interpreting its output, not in performing the measurement itself.

7. Type of Ground Truth Used:

The ground truth for the test set was established by comparing the Rapidlab 1200 systems' nBili measurements against "predicate devices" (Radiometer ABL735 and ABL800 FLEX). The study aimed to demonstrate "substantial equivalence" to these established devices across the reporting range. Therefore, the ground truth was effectively the measurements obtained from these predicate devices.

8. Sample Size for the Training Set:

The document does not provide information about a separate training set or its sample size. The focus is on the performance of the device's software, which "was enabled through software changes." The 2,241 samples appear to be for validation/testing, not for training a machine learning model. This suggests that the "software changes" were likely based on established physiological models or signal processing algorithms, rather than iterative machine learning training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no explicit training set for a machine learning model is mentioned. The device's measurement technology relies on "multiple wavelength spectrophotometry (CO-oximetry)" and "iterative least squares analysis" to determine bilirubin values, which are then "corrected for hematocrit." This description points to a deterministic algorithm based on scientific principles and calibration, rather than a system trained on data with established ground truth.

Summary

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This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter informationContact person:	Noor Malki, MS
	Manager, Regulatory Affairs & Compliance
Address:	Siemens Healthcare DiagnosticsPoint of Care (POC) Product Segment2 Edgewater DriveNorwood, MA 02062
Phone:	781-269-3401
Date summary prepared:	June 18, 2008
Device InformationProprietary Name:	Neonatal Bilirubin (nBili) on Rapidlab® 1200 Blood Gas Systems
Common name:	Neonate bilirubin on blood gas system
Classification name:	Bilirubin in the neonate test system
Classification number:	21 CFR 862.1113, Class I reserved
Classification panel:	Clinical Chemistry and Clinical Toxicology Devices

Predicate Devices

Element	Predicate I	Predicate II
Device Name	ABL800 FLEX	ABL735
Common name	Blood gas analyzer	Blood gas analyzer
510(k) Number	K043218	K991417
Manufacturer	Radiometer Medical ApS	Radiometer America

Device Description

Statement of Intended Use

The neonatal bilirubin test intended for use on the Rapidlab® 1245 and Rapidlab 1265 analyzers is an in vitro diagnostic test for the determination of total neonatal bilirubin (nBili) concentration in the whole blood of newborn infants. Measurement of nBili aids in assessing the risk of kernicterus.

Summary of Technological Characteristics

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The measurement technology used for the Rapidlab 1200 systems family (including models 1245 and 1265) remain unchanged. Ability to measure neonate Bilirubin was enabled through software changes.

The Rapidlab 1200 System uses multiple wavelength spectrophotometry (CO-oximetry) to measure the transmission of light through a sample of neonate whole blood to determine concentrations of hemoglobin derivatives and bilirubin. The Rapidlab 1200 System aspirates the whole blood sample at the sample port and then transfers the sample to the CO-ox module. As the sample flows through an optical chamber, the CO-ox module optics head directs light through the sample and to a polychromator that measures the intensity of transmitted light at different wavelengths. Iterative least squares analysis is used to determine raw bilirubin values. Raw values are then corrected for hematocrit to produce nBill results.

Assessment of Performance

Studies were conducted to demonstrate the performance of the Rapidlab 1245 and 1265 with (nBili) parameter and assess substantial equivalence against the radiometer ABL735 and ABL800 FLEX (predicate devices).

The nBili internal evaluation study entailed testing concentrations of unconjugated bilirubin in oxygenated whole blood (neonatal type samples) across the reporting ranges. For a total of 2,241 samples, the coefficient of determination (r ) values were well within the acceptance criteria (>.90) for all model, device, and mode combinations. Specimens were evaluated on both models (1245 and 1256) and against the predicate devices. Based on performance data analyzed it was concluded that the predetermined acceptance criteria was met.

In addition information on Software Development Life Cycle including software requirements specifications, risk management report, and overall verification and validation results were included to provide additional assurance of device performance.

Conclusion

In conclusion, the studies completed demonstrate that the Neonatal Bilirubin (nBili) on the Rapidlab 1245 and 1265 blood gas systems is similar to the predicate in both Technological Characteristics and Intended Use. The data presented in the submission is a summary of internal evaluation, external clinical evaluation, and software development information. This information provides assurance that the RapidLab 1200 analyzer (models 1245 and 1265) measuring neonate bilirubin has demonstrated substantial equivalence to the currently marketed radiometer predicate across the reporting range.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 7 2008

Siemens Healthcare Diagnostics Inc. Point of Care (POC) Product Segment c/o Noor Malki POC, Regulatory Affairs 2 Edgewater Drive Norwood, MA 02062

Re: K073537

Trade Name: Neonatal Bilirubin (nBili) on Rapiblab models 1245 and 1265 Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system. Regulatory Class: Class I reserved Product Code: MQM Dated: June 23, 2008 Received: June 24, 2008

Dear Noor Malki:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to Ivgally marketed predicate device results in a classification for your device and thus, perceits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-fre minber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Séan M. Cooper, M.S., D.V.M. 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):_073537

Device Name: Neonatal Bilirubin (nBili)

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

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Office of In Vitro Diagnostic Office of in the Evaluation and Safety

510(k) K073537

Regulation Number and Section

§ 862.1113 Bilirubin (total and unbound) in the neonate test system.

(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.