Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The description of "Intelligent Quality Management 2 (iQM2)" mentions "Pattern Recognition" as one of its checks. While "Pattern Recognition" can be a component of AI/ML, the description does not provide enough detail to definitively confirm the use of AI/ML algorithms. It could be a simpler statistical pattern detection method.

Therapeutic

No
This device is an in vitro diagnostic (IVD) device used for diagnostic purposes by measuring various parameters in blood samples to aid in the diagnosis and treatment of diseases. It does not provide any therapeutic function.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the measurements provided by the device "aid in the diagnosis of electrolyte balance." It further specifies that sodium, potassium, and chloride measurements "are used in the diagnosis and treatment" of various diseases involving electrolyte imbalance, and ionized calcium measurements "are used in the diagnosis and treatment" of parathyroid disease, bone diseases, renal disease, and tetany.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including an "Analyzer" with a touch screen, a "GEM Premier 5000 PAK" which houses sensors, optical cells, solutions, and other physical components, and mentions the analysis of whole blood samples, which requires physical interaction with the device. While it includes software (iQM2), it is an integral part of a larger hardware system.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is used to "rapidly analyze heparinized whole blood samples" and provides "quantitative measurements" of various analytes (sodium, potassium, chloride, ionized calcium). These measurements "aid in the diagnosis of electrolyte balance" and are used in the "diagnosis and treatment of disease conditions." This aligns directly with the definition of an in vitro diagnostic device, which is intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
Sample Type: The device analyzes "heparinized whole blood samples," which are specimens taken from the human body.
Analytes: The device measures specific analytes (electrolytes) in these samples.
Purpose: The measurements are used to "aid in the diagnosis" and "monitor electrolyte balance in the diagnosis and treatment of disease conditions."

The description of the quality control materials (GEM System Evaluator, GEM Hematocrit Evaluator, GEM CVP 5 tBili) also reinforces that this is an IVD system, as quality control materials are essential components of IVD testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 sodium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of electrolyte balance.

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.

Chloride (Cl-) measurements are used in the diagnosis and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

GEM System Evaluator is a three-level assayed quality control material for evaluating performance characteristics of pH, pCO2, pO2, Electrolytes, Metabolites, Total Bilirubin (tBili) and CO-Oximetry on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM Hematocrit Evaluator is a three-level assayed quality control material intended for evaluating performance characteristics of hematocrit on the GEM Premier 4000 and GEM Premier 5000 analyzers.

GEM CVP 5 tBili is an external Calibration Valuation Product used to complete the callbration process of the GEM Premier 4000 and GEM Premier 5000 analyzers prior to use with patient samples for total bilirubin (tBili) testing.

Product codes (comma separated list FDA assigned to the subject device)

JGS, CEM, CGZ, JFP, JJY, JJE, GLK

Device Description

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of sodium and ionized calcium from venous, arterial and capillary heparinized whole blood, as well as quantitative measurements of potassium and chloride from venous and arterial heparinized whole blood.
Key Components:
Analyzer: Employs a unique color touch 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.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox/tBili optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. Step 1: After inserting the GEM PAK, the instrument will perform an automated PAK warm-up during which the sensors are hydrated and a variety of checks occur, all of which take about 40 minutes. During warm-up, the instrument requires no user intervention. Step 2: After GEM PAK warmup, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions (PC Solution D and E) that are traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte, are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. NOTE: For total bilirubin, CVP 5 tBili (Calibration Valuation Product) must be run prior to performing tBili samples. Step 3: After successful performance of APV, iQM2 manages the quality control process, replacing external quality controls.
Intelligent Quality Management 2 (iQM2): iQM2 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. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System, Sensor, IntraSpect, Pattern Recognition and Stability Checks.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Health care professionals in a clinical setting and in a central laboratory.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Internal Precision Study – Aqueous Controls:

Study Type: Internal Precision Study
Sample Size: n=120 per analyte/level for each control level run on three (3) GEM Premier 5000 analyzers for twenty (20) days, with two (2) runs per day and one (1) replicate measured per run per level.
Key Results: All results were within specification.

Internal Precision Study – GEM PAK (Cartridge) Process Control Solutions D and E:

Study Type: Internal Precision Study
Sample Size: N=120 per analyte/per level for PCS D and E run on three (3) GEM Premier 5000 analyzers for twenty (20) days, with two (2) runs per day and one (1) replicate measured per run per level.
Key Results: All results were within specification.

Internal Precision Study – Whole Blood:

Study Type: Internal Precision Study
Sample Size: N=120 per analyte/per sample mode for five (5) different concentrations of whole blood per analyte, each run on three (3) GEM Premier 5000 analyzers per sample mode for five (5) days, with one (1) run per day and eight (8) replicates measured per run per level.
Key Results: All results were within specification.

Reproducibility Study with Aqueous Controls – Point-of-Care (POC) Setting:

Study Type: Reproducibility Study
Sample Size: 90 replicates per analyte from three (3) external clinical point-of-care (POC) sites, with three (3) operators on three (3) different GEM Premier 5000 instruments, using a single lot of GEM Premier 5000 PAKs. Each site ran each control level in triplicate, twice a day for 5 days.
Key Results: All results at all sites were within specification.

External Precision - Whole Blood:

Study Type: External Precision Study
Sample Size: Varied per analyte and site (e.g., Na+ (mmol/L) Normal Mode, POC All N=126; K+ (mmol/L) Normal Mode, POC All N=102). Conducted in 2 external central laboratories, 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations.
Key Results: Precision results were summarized, demonstrating performance within acceptable ranges.

LoB, LoD and LoQ:

Study Type: LoB, LoD, and LoQ establishment
Sample Size: Three (3) lots of GEM Premier 5000 PAKs (cartridges).
Key Results: LoB, LoD, and LoQ were established for Na+, K+, Ca++, and Cl-.

Linearity:

Study Type: Linearity Study
Sample Size: Nine (9) or ten (10) levels per analyte, each analyzed in triplicate on three (3) GEM Premier 5000 test analyzers.
Key Results: Linearity supported the claimed reportable range for each parameter. R² values were all 0.999 or 1.000, indicating strong linearity.

Analytical Specificity:

Study Type: Interference Study
Sample Size: Not specified, but various substances screened.
Key Results: Identified substances with no observed interference and substances that demonstrated interference, along with bias observed and direction.

Internal Method Comparison:

Study Type: Method Comparison Study
Sample Size: N=373 clinical samples for Na+, K+, Cl-, and Ca++.
Key Results: Compared performance of GEM Premier 5000 versus GEM Premier 4000. All parameter levels passed specification, with high R² values (0.995 to 0.999).

Whole Blood Performance at Medical Decision Levels:

Study Type: Performance Assessment at Medical Decision Levels (combining method comparison and precision data)
Sample Size: Not explicitly stated as a separate study, but built upon previous studies.
Key Results: Total Error Observed was computed based on bias and precision data at medical decision levels, and compared to specifications.

Clinical Testing (Method Comparison in POC setting):

Study Type: Clinical Testing / Method Comparison Study
Sample Size: N=486 for Na+, N=491 for K+, N=485 for Cl-, N=491 for Ca++ for pooled POC sites and CSL in Normal Mode. N=171 for native capillary samples, and N=201 for Na+, N=205 for Ca++ for pooled native and contrived capillary samples.
Key Results: Regression analysis results (slope, intercept, r) showed good correlation with the predicate device. Total error at medical decision levels for capillary samples was reported.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. Precision data provided in terms of SD and %CV, and bias data provided for method comparisons.

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.

GEM Premier 4000 K133407

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.

K112995, K093623

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).

Not Found

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus in the logo is composed of three intertwined figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2016

INSTRUMENTATION LABORATORY CO. CAROL MARBLE REGULATORY AFFAIRS DIRECTOR 180 HARTWELL ROAD BEDFORD MA 01730

Re: K160225

Trade/Device Name: GEM Premier 5000 (Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium), GEM System Evaluator, GEM Hematocrit Evaluator, GEM CVP 5 tBili Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: II Product Code: JGS, CEM, CGZ, JFP, JJY, JJE, GLK Dated: December 6, 2016 Received: December 7, 2016

Dear Ms. Marble:

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

1

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, PhD Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K160225

Device Name

GEM Premier 5000 (Measured Parameters: Sodium, Potassium, Chloride, Ionized Calcium) GEM System Evaluator, GEM Hematocrit Evaluator, GEM CVP 5 tBili

Indications for Use (Describe)