(251 days)
The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized 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, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium heparinized whole blood. 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.
*s02 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.
- · pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances.
- · Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
- Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insividus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
- Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment
- of disease conditions characterized by low or high blood potassium levels.
- Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
- Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
- · Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
- · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism
- disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
- · Lactate (Lac) measurement is used:
- to evaluate the acid-base status of patients suspected of having lactic acidosis;
- to monitor tissue hypoxia and strenuous physical exertion;
- in the diagnosis of hyperlactatemia.
- · Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.
– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
-
COHo: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
-
MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
-
HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.
-
O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.
-
sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.
The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.
*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.
Key Components:
Instrument: It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
PAK (Cartridge): All required components for sample analysis are contained in the GEM PAK, including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, pump tubing, distribution valve, waste container and Process Control Solutions. The GEM PAK is an entirely closed analytical system. The operator cannot introduce changes to the analytical process before or during the GEM PAK's use-life on board the instrument. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. The setup of the instrument consists of inserting the GEM PAK into the instrument. The instrument will perform an automated GEM PAK start-up during which the following is performed: warm-up (15 minutes), sensor conditioning (10 minutes), Process Control Solution (PCS) performance (15 minutes), all of which take about 40 minutes. After GEM PAK start-up, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte (PC Solution D and E), are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. Note: GEM PAKs that include tBili analyte will require the successful performance of CVP 5 tBili. Includes all necessary components for hemolysis detection, such as an acoustofluidic flow cell, an LED light source and an optical detector, for appropriate flagging of potassium measurements in whole blood samples without additional sample volume or sample processing steps.
Intelligent Quality Management (iQM3): iQM3 is used as the quality control and assessment system for the GEM Premier 7000 system. iQM3 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external QC. iQM3 introduces hemolysis detection in whole blood samples, enhancing quality assessment in the pre-analytical phase of testing.
Based on the provided text, the device in question is the GEM Premier 7000 with iQM3, which is a portable critical care system for analyzing blood samples. The document describes its comparison to a predicate device, the GEM Premier 5000, and discusses its performance studies.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of specific numerical acceptance criteria for each analyte's performance (e.g., pH, pCO2, Na+, etc.) nor does it list the reported device performance in those exact terms. Instead, it states that "All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met."
The "Performance Summary" section lists the types of studies conducted to demonstrate that the modifications (specifically the new iQM quality check/Hemolysis detection module) do not impact the performance data represented in the Operators Manual, aligning with recognized guidelines. This implies the acceptance criteria are tied to maintaining performance comparable to the predicate device and being within acceptable ranges as defined by the mentioned CLSI guidelines.
Therefore, a table of explicit numerical acceptance criteria and reported performance values for each analyte is NOT AVAILABLE in the provided text. The document broadly states that the device met its acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions several types of performance studies:
- Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification)
- Shelf-life and Use-life studies
However, the specific sample sizes used for these test sets are NOT provided in the text. There is also no information about the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is NOT available in the provided text. The device is an in-vitro diagnostic (IVD) instrument that provides quantitative measurements of various blood parameters. The "ground truth" for such devices typically comes from reference methods, calibrated standards, or comparative analyses with established, highly accurate laboratory instruments, rather than human expert consensus on interpretations like with imaging.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Given that this is an IVD device for quantitative measurements of blood parameters, the concept of "adjudication" by multiple human readers (like in imaging studies) does not directly apply. Performance is assessed through analytical accuracy, precision, and interference studies against known standards or reference methods. Therefore, no adjudication method in the sense of expert consensus on interpretations is described or implied.
5. If a multi reader multi case (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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is part of the workflow. The GEM Premier 7000 with iQM3 is described as an analytical instrument providing direct quantitative measurements, not an AI system assisting human readers with interpretation. The "iQM3" refers to Intelligent Quality Management, which is an automated quality control system for the instrument itself, not an AI for human diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone analytical instrument. The performance studies described (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Verification, etc.) essentially represent "standalone" performance, as they evaluate the accuracy and precision of the instrument's measurements directly. The iQM3 system is an internal quality control mechanism for the device's measurements. Therefore, yes, a standalone performance evaluation of the device's analytical capabilities was implicitly done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device that provides quantitative measurements of blood parameters, the "ground truth" for the test set would typically be established using:
- Reference methods: Highly accurate and precise laboratory methods for measuring each analyte.
- Calibrated standards: Solutions with precisely known concentrations of the target analytes.
- Comparison to predicate device: As this is a 510(k) submission, a primary method of establishing "ground truth" performance for the new device is by comparing its measurements against those of a legally marketed predicate device (GEM Premier 5000), which itself would have been validated against reference methods and standards.
The text mentions "two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards" for "Auto PAK Validation (APV)". This strongly suggests that traceable standards and potentially CLSI-defined reference methods were used to establish the ground truth for performance evaluation.
8. The sample size for the training set
The document describes the GEM Premier 7000 with iQM3 as a medical device for quantitative measurements, not explicitly as a machine learning/AI model that requires a "training set" in the conventional sense (i.e., for supervised learning). The iQM3 is an "active quality process control program" with "Pattern Recognition (PR) software." While pattern recognition might involve some form of "training" or calibration, the document does not specify a separate "training set" in terms of data volume for such a process. It focuses on the validation of the device's analytical performance. Therefore, the concept of a "training set" sample size as applicable to AI/ML devices is not explicitly discussed or provided.
9. How the ground truth for the training set was established
As noted above, the primary function of GEM Premier 7000 with iQM3 is quantitative measurement. If the "iQM3" component involved training for its "Pattern Recognition (PR) software," the document does not detail how a specific ground truth for such training was established. It primarily discusses the use of "Process Control Solutions (PCS)" and "Calibration Valuation Product (CVP 5)" for system checks and validation ("Auto PAK Validation (APV) process"). These solutions, traceable to NIST or CLSI standards, function as internal reference points for the device's operational checks and quality control, which could be considered an ongoing form of "ground truth" to maintain analytical performance, rather than a one-time "training set" for model development.
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August 10, 2023
Instrumentation Laboratory Company Gabriella Erdosy Director of Regulatory Affairs 180 Hartwell Road Bedford, Massachusetts 01730
Re: K223608
Trade/Device Name: GEM Premier 7000 with iQM3 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, CGZ, JFP, CGA, KHP, MQM, GKF, GKR, GHS, GLY Dated: July 10, 2023 Received: July 11, 2023
Dear Gabriella Erdosy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223608
Device Name
GEM Premier 7000 with iQM3
Indications for Use (Describe)
The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized 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, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium heparinized whole blood. 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.
*s02 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.
- · pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances.
- · Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
- Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insividus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
- Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment
- of disease conditions characterized by low or high blood potassium levels.
- Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
- Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
- · Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
- · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism
- disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
- · Lactate (Lac) measurement is used:
- to evaluate the acid-base status of patients suspected of having lactic acidosis;
- to monitor tissue hypoxia and strenuous physical exertion;
- in the diagnosis of hyperlactatemia.
- · Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.
– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
- COHo: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human
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blood as an aid in the diagnosis of carbon monoxide poisoning.
-
MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
-
HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.
-
O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.
-
sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K223608: GEM Premier 7000 with IQM3
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory (IL) Co. |
|---|---|
| 180 Hartwell Road | |
| Bedford, MA 01730, USA |
| Gabriella Erdosy | |
|---|---|
| Contact Person | Director of Regulatory Affairs |
| Phone: 781-861-4571 | |
| Fax: 781-861-4207 | |
| Email: gerdosy@werfen.com |
| Preparation Date | August 10, 2023 |
|---|---|
| ------------------ | ----------------- |
| Device Trade Name | GEM Premier 7000 with iQM3 |
|---|---|
| ------------------- | ---------------------------- |
| Predicate Device | GEM Premier 5000 | K203790 |
|---|---|---|
| ------------------ | ------------------ | --------- |
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| Regulatory Information | |||||
|---|---|---|---|---|---|
| GEM Premier 7000 with iQM3 | |||||
| Analyte | RegulationSection | Regulatory Description | Class | ProductCode | Panel |
| pH, pCO2, pO2, | 862.1120 | Blood Gases (pCO2, pO2) and Blood pHsystem | II | CHL | |
| Sodium | 862.1665 | Sodium test system | II | JGS | |
| Potassium | 862.1600 | Potassium test system | II | CEM | 75 |
| Chloride | 862.1170 | Chloride test system | II | CGZ | |
| Ionized Calcium | 862.1145 | Calcium test system | II | JFP | |
| Glucose | 862.1345 | Glucose test system | II | CGA | |
| Lactate | 862.1450 | Lactic acid test system | I* | KHP | |
| Total Bilirubin | 862.1113 | Bilirubin (total and unbound)in the neonate test system | I(Reserved) | MQM | |
| Hematocrit | 864.5600 | Automated hematocrit instrument | II | GKF | |
| 864.7425 | Carboxyhemoglobin assay | II | GHS | ||
| CO-Oximetry | 864.5620 | Automated hemoglobin system | II | GKR | 81 |
| 864.7500 | Whole blood hemoglobin assays | II | GLY |
- Meets limitations of exemptions per 21 CFR 862.9(c)(9)
Special Conditions for Use Statement
- . For prescription use only.
- For clinical laboratory and point-of-care use. .
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Device Description
The GEM Premier 7000 with iQM3
The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.
*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.
| Key Components | Description |
|---|---|
| Instrument | It employs a unique touch-sensitive color screen and a simple set of menusand buttons for user interaction. The analyzer guides operators throughthe sampling process with simple, clear messages and prompts. |
| PAK (Cartridge) | All required components for sample analysis are contained in the GEM PAK,including sensors, optical cell for CO-Oximetry and total bilirubin, sampler,pump tubing, distribution valve, waste container and Process ControlSolutions. The GEM PAK is an entirely closed analytical system. The operatorcannot introduce changes to the analytical process before or during theGEM PAK's use-life on board the instrument. |
| The GEM PAK has flexible menus and test volume options to assist facilitiesin maximizing efficiency. The EEPROM on the GEM PAK includes all solutionvalues and controls the analyte menu and number of tests. | |
| The setup of the instrument consists of inserting the GEM PAK into theinstrument. The instrument will perform an automated GEM PAK start-upduring which the following is performed: warm-up (15 minutes), sensorconditioning (10 minutes), Process Control Solution (PCS) performance (15minutes), all of which take about 40 minutes. | |
| After GEM PAK start-up, Auto PAK Validation (APV) process is automaticallycompleted: two completely independent solutions traceable to NISTstandards, CLSI procedures or internal standards, containing two levels ofconcentration for each analyte (PC Solution D and E), are run by the analyzerto validate the integrity of the PC Solutions and the overall performance ofthe analytical system.Note: GEM PAKs that include tBili analyte will require the successfulperformance of CVP 5 tBili. | |
| Includes all necessary components for hemolysis detection, such as anacoustofluidic flow cell, an LED light source and an optical detector, forappropriate flagging of potassium measurements in whole blood sampleswithout additional sample volume or sample processing steps. | |
| Intelligent Quality Management(iQM3) | iQM3 is used as the quality control and assessment system for the GEMPremier 7000 system. iQM3 is an active quality process control programdesigned to provide continuous monitoring of the analytical processbefore, during and after sample measurement with real-time, automaticerror detection, automatic correction of the system and automaticdocumentation of all corrective actions, replacing the use of traditionalexternal QC. |
| iQM3 introduces hemolysis detection in whole blood samples, enhancingquality assessment in the pre-analytical phase of testing. |
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Indications for Use / Intended Use
The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized 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, MetHb, HHb, SO2-") parameters from arterial, venous, or capillary lithium heparinized whole blood. 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.
*sO2 = ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.
- . pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances.
- . Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
- l Sodium (Na*) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
- । Potassium (K*) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
- lonized calcium (Ca**) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
- -Chloride (Cl) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
- . Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
- . Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.
- Lactate (Lac) measurement is used: .
- ၊ to evaluate the acid-base status of patients suspected of having lactic acidosis;
- । to monitor tissue hypoxia and strenuous physical exertion;
- । in the diagnosis of hyperlactatemia.
- Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.
- . CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional hemoglobin species.
- Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
- COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
- Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
- HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.
- O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.
- sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.
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Comparison to Predicate
The GEM Premier 7000 with iQM3 system is substantially equivalent in function and intended use to the following predicate device:
Predicate Device: GEM Premier 5000 ●
| Item | Predicate Device | New Device | |
|---|---|---|---|
| Trade Names | GEM Premier 5000 | K203790 | GEM Premier 7000 with iQM3 |
| Manufacturers | Instrumentation Laboratory Co. | Instrumentation Laboratory Co. | |
| Indications for Use | The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized 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, sO2*) parameters from arterial, venous, or capillary heparinized whole blood. 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. *sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin. pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances. Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes: Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. | Same | |
| Indications for Use(Continued) | - | Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany. | |
| - | Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis. | ||
| • | Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). | ||
| • | Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. | ||
| • | Lactate (Lac) measurement is used: to evaluate the acid-base status of patients suspected of having lactic acidosis; to monitor tissue hypoxia and strenuous physical exertion; in the diagnosis of hyperlactatemia. | ||
| • | Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates. | ||
| • | CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species. | ||
| - Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. | |||
| - COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. | |||
| - MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia. |
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| - HHb: Deoxyhemoglobin, as a fraction | |
|---|---|
| of total hemoglobin, is used in | |
| combination with oxyhemoglobin to | |
| measure oxygen status. | |
| - O2Hb: Oxyhemoglobin, as a fraction of | |
| hemoglobin, is used intotal | |
| combination with deoxyhemoglobin to | |
| measure oxygen status. | |
| sO2: Oxygen saturation, morel | |
| specifically the ratio between the | |
| concentration of oxyhemoglobin and | |
| oxyhemoglobin plus | |
| deoxyhemoglobin, is used to measure | |
| oxygen status. |
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| Comparison to Predicate (Cont.) | ||
|---|---|---|
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000. | ||
| Item | Predicate Device | New Device |
| Trade Names | GEM Premier 5000K203790 | GEM Premier 7000 with iQM3 |
| Similarities | ||
| Intended User | Central Laboratory and Point-of-Care | Same |
| Blood Gas Measurement | Potentiometry: pH and pCO2Amperometry: pO2 | Same |
| Electrolyte Measurement | Potentiometry: Na+, K+, Cl-, Ca++ | Same |
| Metabolite Measurement | Amperometry: Glucose and Lactate | Same |
| Hemoglobin Measurement | Spectrophotometry: tHb, O2Hb, COHb, MetHb, HHb, sO2 | Same |
| Total Bilirubin | Spectrophotometry | Same |
| Hematocrit Measurement | Conductivity | Same |
| Sample Introduction | Aspiration | Same |
| Sampling ModesandSample Volumes | Normal Mode 150 μLMicro Mode 65 μLtBili/CO-Ox Mode 100 μL | Same |
| PAK Shelf-Life Stability | Up to 180 days | Same |
| PAK Storage Temperature | 15-25°C | Same |
| System Operating Temperature | 12-32°C | Same |
| Operating System Software | Linux-based | Same |
| Calibration | 2-point calibration | Same |
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| Comparison to Predicate (Cont.) | |||
|---|---|---|---|
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000. | |||
| Item | Predicate Device | New Device | |
| Trade Names | GEM Premier 5000K203790 | GEM Premier 7000 with iQM3 | |
| Similarities (Continued) | |||
| Sample Type | Heparinized whole blood (venous, arterial or capillary) | Same | |
| pH | 7.00 to 7.92 | Same | |
| pCO2 | 6 to 125 mmHg | Same | |
| pO2 | 6 to 690 mmHg | Same | |
| Na+ | 100 to 180 mmol/L | Same | |
| K+ | 1.0 to 19.0 mmol/L | Same | |
| Ca++ | 0.11 to 4.25 mmol/L | Same | |
| Cl- | 40 to 158 mmol/L | Same | |
| Reportable Range | Glucose | 4 to 685 mg/dL | Same |
| Lactate | 0.3 to 17.0 mmol/L | Same | |
| Hematocrit | 15 to 72% | Same | |
| tBili | 2.0 to 40.0 mg/dL | Same | |
| tHb | 3.0 to 23.0 g/dL | Same | |
| O2Hb | 0.7 to 100.0% | Same | |
| COHb | 0.3 to 75.0% | Same | |
| MetHb | 0.7 to 30.0% | Same | |
| HHb | 1.0 to 100.0% | Same | |
| SO2 | 0.7 to 100.0% | Same | |
| Comparison to Predicate (Cont.) | |||
| NOTE: The comparison on this page is to the predicate device, the GEM Premier 5000 | |||
| Item | Predicate Device | New Device | |
| Trade Names | GEM Premier 5000K203790 | GEM Premier 7000 with iQM3 | |
| Differences | |||
| Instrument Dimensions | GEM Premier 5000 Instrument:Height: 18.6 inchesWidth: 13.0 inchesDepth: 16.4 inchesWeight: 45.4 pounds | GEM Premier 7000 with iQM3 Instrument:Height: 18.9 inchesWidth: 12.9 inchesDepth: SameWeight: 45.3 pounds | |
| Cartridge (PAK) Dimensions | GEM Premier 5000 PAK (Cartridge):Height: 6.75 inchesWidth: 10 inchesDepth: 8 inchesWeight: 8.1 pounds | GEM Premier 7000 PAK with iQM3 (Cartridge):Height: 6.6 inchesWidth: 10.2 inchesDepth: 7.6 inchesWeight: Same | |
| Fluidic Pathway | The fluidic pathway directly connects Sensor Card and CO-Ox module | Addition of the new iQM quality check module between Sensor Card and CO-Ox module | |
| Sample Fluidic Process | Micro Mode (65 $ μ $ L) | Additional time (11s) for the new iQM quality check before analyte measurements | |
| PAK (Reagent) Bags | Process Control Solution Bag (PCS) B | Addition of Heparin | |
| Cartridge-Analyzer Interface | Cartridge fluidic components interface with hardware components on the analyzer | Modification to existing analyzer connection to support the iQM quality check module | |
| Instrument | An analyzer capable of supporting the GEM Premier 5000 Cartridge (PAK) | An analyzer capable of supporting the GEM Premier 7000 with iQM3 Cartridge (PAK) | |
| PAK Compatibility | GEM Premier 5000 only | GEM Premier 7000 with iQM3 only |
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| Comparison to Predicate (Cont.) | ||
|---|---|---|
| NOTE: The following table compares iQM2 on the GEM Premier 5000 to iQM3 on the GEM Premier 7000. | ||
| Item | Predicate Device | New Device |
| Trade Names | iQM2 (Intelligent Quality Management 2) | iQM3 (Intelligent Quality Management 3) |
| Instrument | GEM Premier 5000 | GEM Premier 7000 with iQM3 |
| 510(k) No. | K203790 | K223608 |
| Quality ControlPrinciple | Active quality process control program usinga combination of internal Auto PAKValidation (APV) and one level of externalCalibration Valuation Product (CVP 5), fiveinternal Process Control Solutions (PCSs)Pattern Recognition (PR) software andIntraSpect sample integrity quality checks,all of which are designed to provideimmediate error detection and automaticremedial action, replacing the use oftraditional external quality controls. | Same |
| ErrorDetectionScheme | Multi-level checks for detecting cartridgeerrors.• System checks• Sensor/CO-Oximetry checks• IntraSpect checks• Pattern Recognition (PR checks)• Process Control Solution (PCS) Stability | Same except addition of Hemolysisdetection.• Same, except addition ofHemolysis detectionfunctionality• Same except the addition ofHemolysis Module Checks• Same• Same• Same• Hemolysis detection |
| Error Mitigation | Automatic error handling:• Performing special rinse cycle afterdetecting micro-clots and verifying thecartridge function after clot removal.• Permanently disabling failed sensor ifits functionality could not berecovered.• Rejecting cartridge for process stabilityfailure.• Alerting the user if interferences aredetected in a sample.• Automatically documenting the failureand action taken.• IntraSpect | Same |
| Documentation | Automatic documentation:• Process Control Solutions delta charts.• Error reporting and corrective actionreport.• GEM CVP report. | Same |
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Comparison to Predicate (Cont.)
| NOTE: The following table compares internal Process Control (PC) Solutions in the GEM Premier 5000 PAK(cartridge) to internal Process Control (PC) Solutions in the GEM Premier 7000 with iQM3 PAK (cartridge). | ||
|---|---|---|
| Category | Predicate Device | New Device |
| Trade Names | Process Control (PC) Solutions | Process Control (PC) Solutions |
| Instrument | GEM Premier 5000 | GEM Premier 7000 with iQM3 |
| 510(k) No. | K203790 | K223608 |
| PC Solution B is the primary Process Control Solution measured at a minimum of every half hour or after every sample. Furthermore, Solution B is monitored every 30 seconds while residing in the sensor card between measurements. Further, PC Solution B is used as a reference blank for CO-Oximetry. PC Solution A is measured at a minimum of every 4 hours. All sensor slope values are also measured and checked. Slope, which is an indicator of sensor sensitivity and drift, must be within allowable limits. PC Solution A also contains dyes that are used for checking functionality of the optical cell and the CO-Oximetry. | PC Solution B – Same, except the addition of Heparin PC Solution A – Same | |
| PC Solutions | PC Solution C is measured at a minimum of once every 24 hours. PC Solution C is primarily used for measuring low-level oxygen; however, PC Solution C is also used to provide an additional measurement of pH, pCO2 and K+ sensor functionality. | PC Solution C – Same |
| PC Solution D is measured every 12 hours. PC Solution D provides additional measurement for all analytes including CO-Oximetry. Reference values for analytes in PC Solution D are assigned at time of manufacturing. The D sensor check starts after the successful completion of Auto PAK Validation (APV). | PC Solution D – Same | |
| PC Solution E is measured every 12 hours. PC Solution E provides additional measurement for all analytes including CO-Oximetry. Reference values for analytes in PC Solution E are assigned at time of manufacturing. The E sensor check starts after the successful completion of Auto PAK Validation (APV). | PC Solution E – Same |
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Performance Summary
Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification), Shelf-life and Use-life studies were performed to establish that the modifications introduced with the addition of the new iQM quality check (Hemolysis detection module) of the GEM Premier 7000 with IQMs do not impact the performance data represented in the Operators Manual. These studies followed recognized guidelines:
- . CLSI EP05-A3
- . CLSI EP07, 3rd Ed
- CLSI EP09c, 3rd Ed ●
- CLSI EP25-A
- . CLSI EP37, 1st Ed
All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met.
| Conclusion | The technological and functional characteristics of the new GEM Premier 7000with iQM3 as described above are substantially equivalent to that of the predicatedevice GEM Premier 5000. The analytical study results demonstrate that the GEMPremier 7000 with iQM3 is safe and effective for its intended purpose andequivalent in performance to the predicate device (K203790). |
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§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.