ABL90 FLEX

K120197 · Radiometer Medical Aps · CHL · Mar 19, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120197
• Device Name: ABL90 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CHL · Clinical Chemistry
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for 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.

Device Story

Radiometer ABL 90 Flex Analyzer; blood gas/electrolyte/metabolite analyzer. Modification adds remote control capabilities via Netop host/client OTS software. Remote functions: perform calibrations, initiate replacement procedures, perform QC measurements, edit log file data (patient demographics, input parameters, sample notes), and approve patient results. Device used in clinical settings; operated by healthcare professionals. Remote access allows off-device management of analyzer functions; does not alter patient results. Fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data. Bench testing and design control verification/validation activities performed to assess the impact of the software modification.

Technological Characteristics

Portable, automated analyzer. Measurement principles: potentiometry (pH, blood gases, electrolytes), amperometry (glucose, lactate), spectrophotometry (hemoglobin). Software: Microsoft XPE operating system. Connectivity: Netop™ integration for remote access. Power: 230/120 V mains. Sample introduction: aspiration.

Indications for Use

Indicated for use by trained clinicians (technologists, nurses, physicians, therapists) in lab or point-of-care settings to measure pH, blood gases, electrolytes (K+, Na+, Ca2+, Cl-), glucose, lactate, and oximetry parameters (ctHb, sO2, FO2Hb, FCOHb, FMetHb, FHHb, FHbF) in heparinized whole blood for the diagnosis and treatment of acid-base, electrolyte, metabolic, and hemoglobin-related disorders.

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

• Radiometer ABL 90 Flex Analyzer (k092686)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k120197

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Radiometer ABL 90 Flex Analyzer-k092686
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

A software modification that adds remote control capabilities to some of the functions of the analyzer. Remote access to the analyzer by the Netop host/client OTS software supporting the following functions:

- Perform calibrations,
- Perform replacements (initiates specific replacement procedures only),
- Perform QC measurements,
- Edit data in the log files (edit patient demographics, input parameters and additional patient sample information (notes) in the log file only, no changes in any patient results), and
- Approve patient results.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.