Search Results

The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use.

The OptiScanner® 5000 Glucose Monitoring System ("OptiScanner") is an automated, bedside glucose monitoring device that quantitatively measures the concentration of glucose in the blood of patients in the Surgical Intensive Care Unit (SICU). In contrast to Point of Care (POC) glucose measuring devices that measure glucose using enzymatic techniques, the OptiScanner uses a direct, reagent-free, spectrophotometer method to quantify glucose. The system is comprised of the following three primary components:

• OptiScanner Instrument
• OptiScanner Transport Cart
• OptiScanner Disposable Cartridge

The Instrument is the primary hardware component that houses all electrical, mechanical, analytical, and power subsystems. This includes the integrated pump, spectrometer, and the user interface. For mobility and easy access, the Instrument is mounted onto the chassis of a transport Cart. The Cart, in addition to holding the Instrument, holds batteries, IV pole(s) and bar code scanner. The Cartridge is a disposable, single patient use, sterile component containing the fluid pathway through which the blood is sampled, stored, processed, and analyzed. The Cartridge is the only component of the OptiScanner system that contacts patient blood. Integrated into the cartridge are tubing sets that are used to connect to the patient and to a saline bag. The Cartridge also includes a syringe that is intended to be pre-filled with heparin by the user for processing the blood samples. The Cartridge is inserted into the Instruments interface port that provides connections integrating the fluidic components of the Cartridge with the electro-mechanical subsystems of the Instrument.

This is a 510(k) summary for the OptiScanner® 5000 Glucose Monitoring System (K192785). The submission is for an update to the device labeling (User Manual) to include Peripherally Inserted Central Catheters (PICC) compatibility and clarifying language regarding central venous access catheter port placement. The physical device is unchanged from its predicate (K162042). Therefore, the performance criteria and study results presented here refer to the performance of the predicate device, K162042, which remains the same for K192785.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria (from the predicate device K162042) and Reported Device Performance (Table 1: Comparison of Subject Device to Predicate):

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for System Accuracy (Pivotal Trial from K162042): 160 SICU patients (resulting in 2,804 matched OptiScanner / YSI pairs).
• Data Provenance: The document does not explicitly state the country of origin but implies a clinical study environment, likely in the US, given the FDA submission. The study for K162042 was a prospective clinical trial as it involved patients in a SICU.
• Sample Size for PICC Compatibility (K192785): Not explicitly stated, but described as "in vitro design verification tests." This suggests a benchtop study with a set number of PICCs rather than a patient-based test set for this specific update.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• For the system accuracy reported as MARD 7.28%, the ground truth was established using the YSI analyzer. A YSI analyzer is a laboratory reference method, implying that the ground truth was established by certified laboratory personnel following standardized laboratory procedures. The number and specific qualifications of the technicians performing the YSI measurements are not provided in this summary.
• For the PICC compatibility testing, the ground truth was based on pre-defined technical specifications and performance criteria for blood draw and mechanical compatibility, not expert consensus on patient data.

4. Adjudication Method for the Test Set:

• For System Accuracy (K162042): Not applicable in the context of expert adjudication for diagnoses. The YSI analyzer served as the objective reference standard. Differences were quantified against this standard.
• For PICC Compatibility (K192785): Not applicable as it involved in vitro design verification tests against predefined engineering and performance specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device. The OptiScanner 5000 is an automated glucose monitoring system; it does not involve human readers interpreting results in a diagnostic imaging or similar context where MRMC studies are typically performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, this device is inherently a standalone algorithm/device performance study. The OptiScanner® 5000 Glucose Monitoring System is an automated device that measures plasma glucose concentration without direct human interpretation of the measurement result itself. Physicians use the numerical output from the device. The reported MARD value is a measure of the device's standalone accuracy against a reference method.

7. The Type of Ground Truth Used:

• The primary ground truth for the glucose measurements (system accuracy) was laboratory reference standard (YSI analyzer) for the predicate device's pivotal trial. This is considered a gold standard for glucose measurement.
• For the K192785 submission update regarding PICC compatibility, the ground truth was established by in vitro design verification tests against pre-defined performance specifications for blood draw and mechanical compatibility.

8. The Sample Size for the Training Set:

• The document does not explicitly state the sample size for a training set. However, for a Spectrophotometric detection method, the "training" would typically involve developing and refining the algorithms/models that convert the spectral data into glucose concentrations. This development and internal validation would likely occur using a substantial amount of diverse blood samples, but these are generally separate from the formal clinical validation study (like the 160 SICU patients). The summary focuses on the clinical performance, not the internal development data.

9. How the Ground Truth for the Training Set Was Established:

• Since the document does not specify a training set sample size, it does not detail how the ground truth for such a set was established. However, given the measurement technology (spectrophotometric), the ground truth for any development or internal validation would also be established by comparison to a highly accurate laboratory reference method (like YSI), similar to the method used for the clinical test set. This would ensure the Spectrophotometric model's accuracy against recognized standards.

Ask a specific question about this device

The OptiScanner® 5000 Glucose Monitoring System is an automated, bedside glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) in the surgical intensive care unit. The system collects a venous whole blood sample via connection to a central venous catheter, centrifuges the sample, and measures the plasma glucose concentration. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use.

The OptiScanner® 5000 Glucose Monitoring System ("OptiScanner") is an in-line, automated, bedside, frequent, automated glucose monitoring system that quantitatively measures the concentration of glucose in the blood of patients in a Surgical Intensive Care Unit (SICU). In contrast to Point of Care (POC) glucose measuring devices that measure glucose using enzymatic techniques, the OptiScanner uses a direct, reagent-free, spectrophotometer method to quantify glucose. The system is comprised of the following three (3) primary components:

• OptiScanner Instrument
• OptiScanner Transport Cart
• OptiScanner Disposable Cartridge

The Instrument is the primary hardware component that houses all electrical, mechanical, analytical, and power subsystems. This includes the integrated pump, spectrometer, and the user interface. For mobility and easy access, the Instrument is mounted onto the chassis of a transport Cart. The Cart, in addition to holding the Instrument, holds batteries, IV pole(s) and a bar code scanner. The Cartridge is a disposable, single patient use, sterile component containing the fluid pathway through which the blood is sampled, stored, processed, and analyzed. The Cartridge is the only component of the OptiScanner system that comes in contact with patient blood. Integrated into the cartridge are tubing sets that are used to connect to the patient and to a saline bag. The Cartridge also includes a syringe that is pre-filled with heparin by the user for processing the blood samples. The Cartridge is inserted into the Instruments interface port that provides connections integrating the fluidic components of the Cartridge with the electromechanical sub-systems of the Instrument.

The document K162042 for the OptiScanner 5000 Glucose Monitoring System provides information on its acceptance criteria and the study conducted to prove it meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for system accuracy is implicitly defined by the clinical study's primary endpoint, which the device met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): 160 Surgical Intensive Care Unit (SICU) subjects.
• Data Provenance: The study was a prospective, multi-center, non-randomized, observational study. While the specific countries are not explicitly stated, the context of an FDA submission typically implies data from within the United States or from sites compliant with FDA regulations. The data is prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not explicitly stated in the provided text. The ground truth was established by a "standard blood glucose reference control device, (Yellow Springs Instruments 2300, [YSI])". This suggests that the YSI 2300 itself, a laboratory-grade analyzer, provided the reference values, rather than human experts interpreting results to establish ground truth.

4. Adjudication Method for the Test Set

• This information is not explicitly stated. The ground truth was established by comparison to the YSI 2300. In a study comparing an automated device to a reference method like the YSI, adjudication by human experts is typically not the primary method for establishing ground truth for individual glucose readings. The "matched samples" nature implies direct comparison between the OptiScanner and YSI readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This study involved a device measuring glucose values against a reference device, not human readers interpreting results with or without AI assistance. Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance study was done. The OptiScanner 5000 Glucose Monitoring System is an automated device, and the clinical study (MANAGE IDE) evaluated its performance against a reference standard (YSI) without direct human intervention in the glucose measurement process or interpretation of the raw data by human readers for the purpose of the study's endpoints. The "reported blood glucose levels" from the OptiScanner are a direct output of its algorithm.

7. The Type of Ground Truth Used

• Reference Standard Device: The ground truth was established using a "standard blood glucose reference control device, (Yellow Springs Instruments 2300, [YSI])". The YSI is a laboratory instrument considered a "gold standard" for glucose measurement.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for the training set for the Partial Least Squares (PLS) regression algorithm. It describes the algorithm's use in calculating blood glucose levels but does not detail its development or training data.

9. How the Ground Truth for the Training Set Was Established

• The document does not explicitly state how the ground truth for the training set was established. It mentions that the system detects glucose by analyzing mid-infrared (MIR) light absorption spectra and calculates levels using a set of PLS regression algorithms. This implies that the algorithm would have been trained on reference glucose values (likely from a method similar to YSI or other lab analyzers) corresponding to MIR spectra. However, the specifics of this training process and ground truth establishment are not provided in the summary.

Ask a specific question about this device