GEM PREMIER 4000

K133407 · Instrumentation Laboratory CO · CHL · Jan 13, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133407
• Device Name: GEM PREMIER 4000
• Applicant: Instrumentation Laboratory CO
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jan 13, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GEM® Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus. Intelligent Quality Management (iQM) is used as the quality control and assessment system for the GEM Premier 4000 system. iQM is an active quality process control program designed to provide continuous monitoring of the analytical process with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external quality controls. Facilities should follow local, state and federal regulatory guidelines to ensure that a total quality management system is followed. As part of this program, GEM CVP (Calibration Valuation Product) with CO-Ox, GEM CVP tBili and GEM CVP Hematocrit are external solutions intended to complete the calibration process and final accuracy assessment of the iQM cartridge calibration following warm-up. The reported values for GEM CVP (two levels for pH, blood gases, electrolytes, total bilirubin, CO-Oximetry and hematocrit) must meet IL's specifications before the iQM cartridge can be used for patient sample measurements. Once the cartridge calibration is verified, the internal iQM program monitors the status of the system during the cartridge use life.

Device Story

Portable critical care analyzer for point-of-care or central lab use; operated by healthcare professionals. Inputs: whole blood or heparinized plasma samples. Principle: potentiometry (pH, pCO2, electrolytes), amperometry (pO2, glucose, lactate), conductivity (hematocrit), and spectrophotometry (CO-Oximetry, tBili). System utilizes Intelligent Quality Management (iQM) for continuous monitoring, automatic error detection, and correction, replacing traditional external controls. Output: quantitative measurements of blood parameters and derived values. Modification (V3.0.0) adds remote desktop sharing, remote software upgrades, remote diagnostics, and remote LIS tracing to facilitate service and support. Data transmitted for service/complaint review. Benefits: rapid diagnostic information for patient management.

Clinical Evidence

No clinical data; bench testing and design control verification/validation activities performed to confirm software modification safety and functionality.

Technological Characteristics

Portable analyzer; dimensions 18x12x15 inches; weight 44 lbs. Sensing: potentiometry, amperometry, conductivity, spectrophotometry. Software: Fedora Core 9 (Linux). Connectivity: remote desktop sharing, remote upgrades, remote diagnostics, remote LIS tracing. Quality control: iQM (Intelligent Quality Management) with external GEM CVP solutions.

Indications for Use

Indicated for use by healthcare professionals to analyze whole blood (or heparinized plasma for tBili/CO-Ox) for pH, blood gases, electrolytes, metabolites, hematocrit, total bilirubin, and CO-Oximetry. Used in clinical settings and central labs for diagnosis of acid/base status, electrolyte/metabolite balance, oxygen delivery capacity, biliary obstruction, liver disease, and hemolytic diseases. Includes neonates for kernicterus risk assessment.

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

• GEM® Premier 4000 (K112995)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k133407

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:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: GEM PREMIER 4000 (k112995).

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 the software modifications of the GEM® Premier 4000 analyzer, including introducing of the following functionality:

- Remote desktop sharing to allow real-time sharing of the analyzer screen with IL service
- Remote software upgrades to facilitate deployment of future software versions
- Remote diagnostics to capture data for service diagnostic and trending purposes
- Remote LIS tracing to facilitate service diagnostics
- Remote cartridge data transfer for service and complaints files for review
- Other non-analytical updates and improvements

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and 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

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recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.