(193 days)
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No
The summary describes a software update to enable a new parameter (neonatal bilirubin) on existing blood gas analyzers. There is no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics. The evaluation focuses on standard analytical performance metrics like the coefficient of determination.
No
The device is described as an in vitro diagnostic test for determining neonatal bilirubin concentration, which aids in assessing risk but does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test 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." This directly indicates its role in diagnosing a condition or aiding in risk assessment for a condition.
No
The device description explicitly states that the software changes enable a new parameter on existing Rapidlab® 1200 blood gas family of instruments (models 1245 and 1265). These instruments are hardware devices. Therefore, the device is not software-only, but rather software that modifies the functionality of a hardware medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the neonatal bilirubin test is an "in vitro diagnostic test for the determination of total neonatal bilirubin (nBili) concentration in the whole blood of newborn infants."
- Device Description: The "Device Description" section reiterates that the nBili parameter is "intended as an in vitro diagnostic test."
- Sample Type: The test is performed on "whole blood," which is a biological specimen taken from the human body.
- Purpose: The test is used to "aid in assessing the risk of kernicterus," which is a medical condition.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transfused blood, organs or tissues, or to monitor therapeutic measures.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MQM
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
newborn infants
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
coefficient of determination (r ) values were well within the acceptance criteria (>.90)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter information
| Contact person: | Noor Malki, MS |
|---|---|
| Manager, Regulatory Affairs & Compliance | |
| Address: | Siemens Healthcare Diagnostics |
| Point of Care (POC) Product Segment | |
| 2 Edgewater Drive | |
| Norwood, MA 02062 | |
| Phone: | 781-269-3401 |
| Date summary prepared: | June 18, 2008 |
| Device Information | |
| Proprietary 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
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.
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
1
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
4
Indications for Use
510(k) Number (if known):_073537
Device Name: Neonatal Bilirubin (nBili)
Indications For Use:
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.
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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Lath Lctiv
Division Sign-Off
Office of In Vitro Diagnostic Office of in the Evaluation and Safety
510(k) K073537