(127 days)
Indications : The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids.
RADIANCE v2.5 is a Windows-based software application that runs on an independent server and, when added to ABL800 FLEX, enables remote data entry and control of compatible blood-gas analyzers connected to a laboratory information system (LIS) and/or a hospital information system (HIS).
This 510(k) summary (K050869) describes a software modification (RADIANCE v2.5) to an existing blood gas analyzer (ABL800 FLEX). The submission claims substantial equivalence to the predicate device (ABL800 FLEX K041874) based on having the "same intended use and the same fundamental scientific technology," with "Design control information" ensuring substantial equivalence.
This document package does not contain information about acceptance criteria or specific studies to prove that the device meets acceptance criteria. It is a software modification to an existing device, and the primary focus of the 510(k) notice is on functionality, rather than new performance claims that would require extensive clinical studies. The FDA's letter states: "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." This implies that the device is considered equivalent based on its technical specifications and intended use matching a previously cleared device, rather than new, independent performance studies demonstrating specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and detailed study information because that information is not present in the provided text.
Specifically, the following information is not present in the provided document:
- A table of acceptance criteria and the reported device performance: This document does not describe measurable acceptance criteria for the RADIANCE v2.5 software or present performance data against such criteria.
- Sample size used for the test set and the data provenance: Not applicable as a performance study for the software itself is not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a blood gas analyzer software, not an AI diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
The submission is for a software update that enables remote data entry and control of compatible blood-gas analyzers, expanding the functionality of an already cleared device. The "Design control information" is cited as the basis for ensuring substantial equivalence, suggesting that internal validation and verification activities, rather than large-scale clinical performance studies, were deemed sufficient for this type of modification.
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510(k) Summary As required by 807.92 For RADIANCE v2.5 modification to ABL800 FLEX (K041874) Prepared on March 30, 2005
Submitted by: Radiometer Medical ApS Akandevei 21 DK-2700 Bronshoj, Denmark
Tel. 45 38 27 38 27 Fax: 45 38 27 27 36
Contact Person: Kirsten Rono
Device Trade Name: RADIANCE 2.5 modification to ABL800 FLEX
Common Name: Blood Gas, Co-0ximetry, Electrolyte and Metabolite Analyzer
Classification: Blood gases and blood pH test system, Class II Sec. 21 CFR 862.1120
Predicate Device: ABL800 FLEX K041874
Manufactured by: Radiometer Medical ApS Akandevej 21 DK-2700 Bronshoj, Denmark
Description of the Device: RADIANCE v2.5 is a Windows-based software application that runs on an independent server and, when added to ABL800 FLEX, enables remote data entry and control of compatible blood-gas analyzers connected to a laboratory information system (LIS) and/or a hospital information system (HIS).
Intended Use for the Device: The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2 pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and cooximetry paramenters (total hemoglobin, ox ygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids
Substantial Equivalence to Predicate Device: ABL800 FLEX modified by the addition of RADIANCE v2.5 has many similarities to the predicate device which previously
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received 510(k) clearance. It has the same intended use and the same fundamental scientific technology. Design control information ensures substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.
Public Health Service
AUG 1 1 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kirsten Rønø Director of Quality and Regulatory Affairs Radiometer Medical ApS Åkandevej 21 Brønshøj Denmark DK-2700
Re: K050869
Trade/Device Name: ABL800 Flex modified by RADIANCE v2.5 Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (pCO2, pO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, CIG, GHS, KQI, KHP, MQM Dated: July 12, 2005 Received: July 12, 2005
Dear Ms. Rønø:
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 a legally marketed predicate device results in a classification for your device and thus, permits 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) 276-0484. 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson
Carol C. Benson, M.A. Acting 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 Statement
| 510(k) Number (if known) | K050869 |
|---|---|
| Device Name | ABL800 FLEX modified by RADIANCE v2.5 |
| Indications for Use | Indications : The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use ______ |
|---|---|---|
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(Per 21 CFR 801. 109)
(Division Sign-Off)
Division of Clinical Laboratory Devices ﺮ 186 KOSC 510(k) Number .
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.