OptiScanner 5000 Glucose Monitoring System
Device Facts
| Record ID | K162042 |
|---|---|
| Device Name | OptiScanner 5000 Glucose Monitoring System |
| Applicant | Optiscan Biomedical Corp. |
| Product Code | LZF · General Hospital |
| Decision Date | Oct 16, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | AI/ML |
AI Performance
| Output | Acceptance | Observed | Dev DS | Test DS |
|---|---|---|---|---|
| Blood Glucose Concentration | Not specified | MARD 7.28% (Upper one-sided 97.5% confidence limit 7.50%); Population CV 10.31% (Upper one-sided 97.5% confidence limit) | Not specified | MANAGE IDE Study (Prospective, multi-center, non-randomized, observational study): 160 Surgical Intensive Care Unit subjects with 2,804 matched OptiScanner-YSI pairs. |
Indications for Use
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, centrifyges 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.
Device Story
Automated, bedside glucose monitoring system for SICU patients; connects to central venous catheter (CVC) or multilumen access catheter (MAC). System draws ~3 mL venous blood; retains 0.17 mL for analysis; returns remainder to patient via saline flush. Processing involves heparinization and centrifugation to separate plasma. Glucose concentration measured via mid-infrared (MIR) spectrophotometry (7um-10um). Instrument houses pump, spectrometer, and user interface; mounted on transport cart. Healthcare providers monitor glucose levels via touchscreen display; system provides alarms for high/low glucose and line issues. Benefits include frequent, automated monitoring without chemical reagent drift; reduces manual sampling burden; provides stable, reproducible glucose tracking.
Clinical Evidence
Prospective, multi-center, non-randomized, observational MANAGE IDE study (n=160 SICU subjects; 2,804 matched pairs). Comparator: YSI 2300. Primary endpoints: accuracy and precision. Results: MARD 7.28% (upper 97.5% CI 7.50%); population CV 10.31%. No device-related adverse events reported.
Technological Characteristics
Spectrophotometric MIR (7-10um) absorption sensing. Components: Instrument, Transport Cart, single-use sterile disposable cartridge. Connectivity: Standalone with touchscreen display. Power: AC with 3-hour battery backup. Biocompatible materials. Sterilization: SAL 10^-6. Software: PLS regression algorithm.
Indications for Use
Indicated for surgical intensive care unit (SICU) patients aged 18 and older for glucose trend detection and pattern tracking. Contraindicated for patients <18 years, pregnant or nursing women, and patients undergoing MRI or CT scans.
Regulatory Classification
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Predicate Devices
- VIA Medical Pump/Blood Chemistry Monitor (K951739)
Related Devices
- K192785 — OptiScanner® 5000 Glucose Monitoring System · Optiscan Biomedical Corporation · Feb 5, 2020
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k162042
B. Purpose for Submission:
New device
C. Measurand:
Plasma glucose from central venous catheter blood draw
D. Type of Test:
Quantitative, mid-infrared (MIR) spectrophotometric assay
E. Applicant:
OptiScan Biomedical Corporation
F. Proprietary and Established Names:
OptiScanner 5000 Glucose Monitoring System
G. Regulatory Information:
| Product Code | Classification | Regulation | Panel |
| --- | --- | --- | --- |
| LZF
Pump, Infusion
Analytic Sampling | II | 21 CFR §880.5725
Infusion Pump | General Hospital
(80) |
| PYV
Hospital Continuous
Glucose Monitoring
System | | 21 CFR §862.1345
Glucose test system | Clinical Chemistry
(75) |
H. Intended Use:
1. Intended use(s):
See Indication(s) for use below.
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2. Indication(s) for use:
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.
3. Special conditions for use statement(s):
Prescription use only.
Contraindications:
- Patients that are <18 years of age
- Women who are pregnant or nursing
- Patients undergoing Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT)
Warnings:
- The OptiScanner disposable cartridge should be used only by medical personnel having specific training in, and understanding of, the techniques associated with such devices and procedures.
- The disposable cartridge is for single patient use only. Do not re-sterilize. Do not re-use. Re-use of the cartridge may pose infection to the patient due to non-sterile condition and cross contamination of blood.
- Do not use the cartridge if the packaging is received open or damaged.
- The OptiScanner has not been tested for use in the operating room.
- The OptiScanner should be connected to the most proximal port when using a Central Venous Catheter. If the most proximal port is not available, use next most proximal port for OptiScanner primary connection.
- Do not infuse anything above the OptiScanner enclosure.
- Do not rest containers of liquids on top of the OptiScanner enclosure.
- Avoid infusion of any glucose containing solutions adjacent to the OptiScanner port. Infuse these solutions in the most distal port available, as clinical research has shown glucose administered through the distal port does not affect OptiScanner accuracy.
- Be advised of possible complications associated with central venous catheterization. These include but are not limited to: vessel wall perforation, cardiac tamponade, air embolism, catheter embolism, thrombosis, bacteremia, septicemia.
- Due to the risk of further blood loss, do not use the OptiScanner in patients with low hematocrit (less than 15%).
- The OptiScanner should not be used concomitantly with the intravenous administration of high dose ascorbate (IVC) for the treatment of patients with cancer.
- Use caution when OptiScanner readings are below 60 and above 300 mg/dL as these concentrations have not been studied in the intended use population.
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- Use caution when OptiScanner is reading in the hypoglycemic range (<70 mg/dL). The comparator measurement check may not be sufficient to indicate instances of severe hypoglycemia, especially when the Low Glucose Alarm is set to 80 mg/dL.
- Though central line occlusions were not studied in the trial, it should be noted that the CVCs utilized with the OptiScanner may become occluded. In the event of a line occlusion, follow hospital protocol to clear the line.
- Certain substances should be used with caution with the OptiScanner. Refer to the Interfering Substance section in Chapter 7 for more information.
- Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding the daily reference check is imperative to screen for potential offsets.
- No additives of any kind are to be passed through or injected into the saline bag or saline flush line.
- Do not use the OptiScanner in patients that are being administered intravenous immunoglobulin therapies (IVIG). These therapies may generate false glucose measurements. Examples of IVIG therapies are Gamimune N, HepaGam B, Octagam, Vaccinia Immune Globulin, and WinRho SDF Liquid.
- Do not use the OptiScanner in patients that have used peritoneal dialysis solutions any time in the past week. These solutions may generate false glucose measurements.
- Do not inject heparin or any other substances into the saline bag.
- If moving the OptiScanner without disconnecting from the patient, always maintain the connection between the venous line and the OptiScanner patient line.
- Do not use stopcocks. Ensure catheter lines are not pinched off by clamps, hemostats or physically kinked.
- Use of stopcocks or catheters with valves (for example, Groshong catheters) that potentially alter, restrict or impede flow should never be used with the OptiScanner.
- Only use normal, 0.9% saline with the OptiScanner. Do not use saline with dextrose, ringers, or any other substance or additive to connect to the OptiScanner.
- The disposable cartridge must be primed before being connected to the patient. Do NOT connect to patient until priming is complete.
- Be sure there is no air in the catheter lumen when connecting the OptiScanner to the patient. If present, air could be returned to the patient. Ensure catheter is primed per manufacturer's instructions for use.
4. Special instrument requirements:
OptiScanner 5000 Instrument
I. Device Description:
The OptiScanner 5000 Glucose Monitoring System is comprised of the OptiScanner 5000 Instrument, a transportation cart, disposable OptiScanner cartridges (sold separately), and a barcode scanner with USB connectivity. The OptiScanner 5000 instrument houses the mechanisms that automatically draw and return blood to the patient, analyzes the sample and calculates the glucose value. The disposable cartridges are sterile, single use only, and designed for use on a single patient for up to 72 hours.
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J. Substantial Equivalence Information:
1. Predicate device name(s):
VIA Medical Corp Pump/Blood Chemistry Monitor
2. Predicate 510(k) number(s):
k951739
3. Comparison with predicate:
Due to an administrative error, the predicate device indications for use in the similarities table below erroneously stated 'same' and has now been corrected to 'similar'.
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device: OptiScanner 5000 Glucose Monitoring System | Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) |
| Indications for Use | Intended for hospital bedside glucose monitoring for detecting trends and tracking patterns in glucose | Similar |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device: OptiScanner 5000 Glucose Monitoring System | Predicate Device: VIA Medical Corp Pump/Blood Chemistry Monitor (k951739) |
| Patient use population | Patients in the surgical intensive care unit (SICU) | Hospitalized patient |
| Test Principle | Spectrophotometric | Enzymatic |
| Sample Type | Venous blood | Venous or arterial blood |
| Point of access for sample | Central venous catheter | Peripheral venous and arterial lines |
| Sampling Frequency | 15 minutes | 5 minutes |
K. Standard/Guidance Document Referenced (if applicable):
IEC 60601-1-2, Medical electrical equipment Part 1. General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic compatibility – Requirements and Tests Electromagnetic Compatibility - Requirements and Tests (2007).
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ISO 10993-1 (2009), Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 11137-1 (2010), Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)].
ISO 11137-2 (2013), Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.
ISO 11607-1 (2006), Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including: Amendment 1 (2014)].
ISO 11607-2 (2006), Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes [Including: Amendment 1 (2014)].
## L. Test Principle:
The OptiScanner 5000 Glucose Monitoring System samples and measure blood glucose levels every 15 minutes. Samples (~3 mL) are drawn from the patients central venous catheter (CVC) or multi-lumen access catheter. Of the withdrawn blood, 0.17 mL is retained for measurement and the remaining blood is returned to the patient. The retained volume is heparinized to prevent clotting while it is processed and is centrifuged to separate the red blood cells from the plasma. The plasma is evaluated and the glucose quantified by the spectrophotometer by analyzing mid-infrared (MIR) light (7 um – 10 um wavelength) absorption spectra through an array of optical filters. The OptiScanner 5000 Glucose Monitoring System is designed to display glucose values every 15 minutes along with a trend line with settable high and low alarms.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Due to an administrative error, it was previously unclear that the sponsor evaluated precision in two separate studies and the data presented was only for the second study. Also due to an administrative error, the description for the second study erroneously listed the number of days as 16 and is now corrected.
The sponsor evaluate precision in two studies. In the first study, the sponsor evaluated repeatability using pooled venous whole blood samples adjusted to five glucose levels (40, 80, 130, 200 and 400 mg/dL). Each glucose level was measured in replicates of ten on each of ten OptiScanner 5000 units using three cartridge lots for a total of 500
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tests (5 glucose levels, 10 units, 10 replicates per unit). Each sample was measured on the OptiScanner and the comparator method, Yellow Springs Instrument (YSI).
In a second study, the sponsor evaluated repeatability and intermediate precision using pooled plasma adjusted to five different glucose levels (40, 80, 130, 200 and 400 mg/dL). Each glucose level was run on ten OptiScanner 5000 units, using 5 lots of cartridges, for two runs per day over 20 days.
Results for the second study are summarized in the table below:
| | Mean Glucose (mg/dL) | 43 | 81 | 131 | 208 | 397 |
| --- | --- | --- | --- | --- | --- | --- |
| | N | 799 | 799 | 800 | 799 | 799 |
| Day | SD | 1.39 | 0.81 | 1.39 | 4.83 | 9.50 |
| | CV (%) | 3.22 | 1.00 | 1.06 | 2.32 | 2.39 |
| Run | SD | 1.31 | 3.58 | 4.14 | 5.70 | 7.34 |
| | CV (%) | 3.04 | 4.40 | 3.16 | 2.74 | 1.84 |
| Replicate (Repeatability) | SD | 1.73 | 1.48 | 1.81 | 1.31 | 2.84 |
| | CV (%) | 4.01 | 1.82 | 1.38 | 0.63 | 0.72 |
| Instrument | SD | 3.10 | 4.54 | 5.25 | 6.55 | 15.75 |
| | CV (%) | 7.19 | 5.58 | 4.01 | 3.16 | 3.97 |
| Combined/Total SD | | 4.03 | 6.02 | 7.07 | 10.02 | 20.01 |
| Combined/Total CV (%) | | 9.35 | 7.41 | 5.39 | 4.83 | 5.04 |
b. Linearity/assay reportable range:
The concentration range evaluated in the clinical study ranged from 64 mg/dL to 366 mg/dL. The OptiScanner 5000 will display results between 40 mg/dL and 400 mg/dL glucose.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability:
The clinical study was performed using the OptiScanner 5000 Glucose Monitoring System and YSI 2300 as the comparator method (see Section M.3.c.).
Stability:
The disposable cartridges and accessories (plasma separation chamber, OptiScanner Heparin Syringe and Adapter) are packaged together and are sterilized to an assurance level (SAL) of 10-6 using gamma irradiation. The other components of the
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system (the instrument, a transportation cart, and a barcode scanner) are provided as non-sterile.
The one year shelf-life of the disposable cartridges and accessories was validated, using accelerated and real-time testing, to be up to one year when stored at $5^{\circ}\mathrm{C}-35^{\circ}\mathrm{C}$ ( $41^{\circ}\mathrm{F}-95^{\circ}\mathrm{F}$ ) according to the requirements of ISO 11607: Packaging for Terminally Sterilized Medical Devices, and ASTM D 4169: Standard Practice for Performance Testing of Shipping Containers and Systems.
# d. Detection limit:
See linearity study in Section M.1.b. above.
# e. Analytical specificity:
Fifty-two endogenous and exogenous substances were evaluated in a bench study to determine the effect of potentially interfering compounds on device performance. Test samples were prepared by spiking potentially interfering substances into pooled heparinized plasma samples. A control sample without interferent was also prepared for each substance. Three concentrations of each substance and three glucose concentrations (60 mg/dL, 120 mg/dL and 250 mg/dL) were analyzed in replicates of three using three OptiScanner 5000 systems. The difference between the test sample and the control sample was calculated.
Substances that did not interfere at any concentration tested are listed in the table below.
| Potential Interfering Substance | Highest concentration tested with no significant interference (mg/dL) |
| --- | --- |
| Acetaminophen | 20 |
| Albumin | 4900 |
| Ascorbic Acid | 3 |
| Aztreonam | 24.2 |
| Bilirubin | 25 |
| Calcium Gluconate | 102.5 |
| Cholesterol | 309 |
| Creatinine | 10 |
| Dopamine | 20 |
| Ethylene Glycol | 20 |
| Galactose | 10 |
| Glutathione | 3.07 |
| Hemoglobin | 20,000 |
| Heparin | 5 IU/mL |
| Iohexol | 1.4 |
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| Potential Interfering Substance | Highest concentration tested with no significant interference (mg/dL) |
| --- | --- |
| Isomalt | 0.09 |
| Lactate | 125 |
| Lacititol | 0.09 |
| L-Dopa | 0.5 |
| Magnesium in Magnesium Sulfide | 6.02 |
| Maltitol | 0.09 |
| Pralidoximelodide | 1.3 |
| Sodium Citrate | 39.7 |
| Sorbitol | 0.09 |
| Tazabactam | 3.4 |
| Triglycerides | 557 |
| Uric Acid | 10 |
| Xylitol | 0.09 |
Substances that exhibited a greater than $5\mathrm{mg / mL}$ bias, compared to the control sample, at any of the concentrations tested during the initial interference screen underwent additional testing at five lower concentrations. The sponsor defined no significant interference to be $\leq 20\mathrm{mg / dL}$ bias compared to YSI.
Due to an administrative error, the paragraph below erroneously stated 'concentrations' instead of 'glucose readings' and is now corrected.
For substances that significantly interfere, the device is designed to not give a reading ('no read') when it detects certain interferents at certain concentrations (see table below). A No Read appears as ‘---’ on the screen. The table below provides the highest concentration tested at which no interference was observed and the concentration at which all glucose readings are No Reads. Tested concentrations between the two reported concentrations in the table below resulted in either a biased measurement or as a No Read. Substances that do not have a reported 'concentration at which all measurements are No Reads' (indicated by a ‘-’ below) resulted in either significant bias or a “No Read” (but did not result in a No Read $100\%$ of the time) for all concentrations evaluated greater than the concentration reported in column 2.
| Potential Interfering Substance | Highest concentration tested with no significant interference (mg/dL) | Concentration (mg/dL) at which all measurements are No reads (mg/dL) | Therapeutic Concentration (mg/dL) |
| --- | --- | --- | --- |
| Amino Acid, FreAmineIII | 0 | >525 | Not available. |
| Amino Acid, | 15 | - | Not available. |
| FreAmineIII | 25 | 15 | Not available. |
| Fluamid, | 0 | 15 | Not available. |
| Fluamid, | 25 | 25 | Not available. |
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| Potential Interfering Substance | Highest concentration tested with no significant interference (mg/dL) | Concentration (mg/dL) at which all measurements are No reads (mg/dL) | Therapeutic Concentration (mg/dL) |
| --- | --- | --- | --- |
| ProcalAmine | | | |
| Dextran | 0 | >450 | Not available. |
| EDTA | 25 | >100 | Not available. |
| Ethanol | 50 | >100 | 0-400^{1} |
| Gentisic Acid | 0 | >125 | 0.2-0.6^{2} |
| Glycerol | 0 | >106.5 | Not available. |
| Hetastarch | 175 | >700 | Not available. |
| Ibuprofen | 25 | - | 15-30^{2} |
| Icodextrin | 14 | >56 | Not available. |
| L-Arginine | 150 | >450 | Not available. |
| Maltose | 0 | >160 | Not available. |
| Mannitol | 306; interference of >20 mg/dL was observed at 50 mg/dL | - | Not available. |
| MethylDopa | 25 | >75 | 0.1-0.75^{2} |
| Piperacillin, Sodium | 19.5 | - | 0.1-0.5^{3} |
| Salicylate | 0 | - | 10-30^{2} |
| Sodium Chloride | 248.3 mEq/dL | - | Not available. |
| Sodium Thiosulfate | 5.5 | - | Not available. |
| Tolazamide | 0 | - | Not available. |
| Tolbutamide | 25 | >50 | 4.5-10^{3} |
| Voluven | 0 | >175 | Not available. |
| Xylose | 0 | >100 | Not available. |
1. Tietz Textbook of Clinical Chemistry. Chapter 49: Fourth Ediction. Edited by CA Butis, ER Ashwood, DE Bruns. Philadelphia, WB Saunders Company, 2006.
2. Clinical and Laboratory Standards Institute Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition (EP7-A2)
3. Schulz M, Iwersen-Bergmann S, Andresen H, Schmoldt A. Therapeutic and toxic blood concentrations of nearly 1000 drugs and other Xenobiotics. Critical Care 2012, 16(4): 136
The sponsor has included the following in the labeling:
- Not all substances which could potentially interfere with OptiScanner measurement accuracy have been identified. Following the instructions regarding
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the daily reference check is imperative to screen for potential offsets. The OptiScanner should not be used during the first 12 hours following the administration of a D-Xylose absorption test.
- Do not use the OptiScanner in patients who are being treated with Sodium Thiosulfate.
- Do not use the OptiScanner when glycerol is being infused intravenously for the treatment of brain edema.
- Substances containing maltose, or substances that can be metabolized into maltose, may generate falsely high blood glucose readings on the OptiScanner. Do not use the OptiScanner in patients that have are receiving any of these medications.
See also Section M.2.c. below for a list of medications that were present during the clinical study.
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
The performance of the OptiScanner in the intended use population is described below in Section M.2.c.
b. Matrix comparison:
Not applicable.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
The performance of the OptiScanner 5000 Glucose Monitoring System in surgical intensive care unit (SICU) patients was established in a non-randomized, observational clinical study conducted on 160 SICU patients. During the study
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venous blood was obtained from patients through central venous catheters (CVC). Blood was withdrawn for measurement on the OptiScanner 5000 every 15 minutes and results from the OptiScanner 5000 were compared to results obtained from comparative blood drawn taken 6 to 12 times per day for measurement of the plasma on the Yellow Springs Instruments Model 2300 (YSI 2300; comparator method). A total of 2,804 OptiScanner-comparator method paired samples with a glucose range of 64 to $366\mathrm{mg / dL}$ were collected during the study. Disposable cartridge use times ranged from 18 to 72 hours during the study.
Glucose results, patient conditions (see Patient Conditions table below for details), and medication information (see the Medications table below for details) were collected during the study. Adverse events that were not determined to be device related were not collected during the study.
The following table provides the analysis of OptiScanner 5000 (OS) values and the percent of data points that fell within $5\%$ , $10\%$ , $15\%$ , $20\%$ , $30\%$ , $40\%$ and $>40\%$ of specific glucose ranges on the YSI comparator method (CM).
Agreement $(\%)$ of OS-CM paired points stratified by different CM glucose ranges
| CM glucose ranges (mg/dL) | Number of paired OS- CM | Percent of OS within 5% of CM | Percent of OS within 10% of CM | Percent of OS within 15% of CM | Percent of OS within 20% of CM | Percent of OS within 30% of CM | Percent of OS within 40% of CM | Percent of OS greater than 40% of CM |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Overall | 2,804 | 46.9 | 75.5 | 91.1 | 96.8 | 99.6 | 99.9 | 0.1 |
| <40 | - | - | - | - | - | - | - | - |
| ≥40-60 | - | - | - | - | - | - | - | - |
| >61-80 | 23 | 17.4 | 47.8 | 78.3 | 87.0 | 95.7 | 95.7 | 4.3 |
| >80-180 | 2,427 | 46.2 | 75.2 | 90.6 | 96.7 | 99.7 | 100 | 0.0 |
| >180-300 | 352 | 53.4 | 79.3 | 95.7 | 97.7 | 99.7 | 100 | - |
| >300 | 2 | 50 | 100 | 100 | 100 | 100 | 100 | - |
The following tables show the percentage of concurring OS readings compared to CM values. With ideal performance the OS readings would match the CM values. For example, with perfect concurrence, the shaded boxes would be 100 percent.
Concurrence of CM values and the OS readings using the glucose ranges obtained on the CM.
| OS (mg/dL) | CM (mg/dL) | | | | | | | | | N (Number of OS - CM pair |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | <40 | 40-61 | 61-80 | 81-120 | 121-160 | 161-200 | 201-250 | 251-300 | >300 | |
| Overall | 2,804 | 46.9 | 75.5 | 91.1 | 96.8 | 99.6 | 99.9 | 0.1 | | |
| <40 | - | - | - | - | - | - | - | - | - | |
| ≥40-60 | - | - | - | - | - | - | - | - | - | |
| >61-80 | 23 | 17.4 | 47.8 | 78.3 | 87.0 | 95.7 | 95.7 | 4.3 | | |
| >80-180 | 2,427 | 46.2 | 75.2 | 90.6 | 96.7 | 99.7 | 100 | 0.0 | | |
| >180-300 | 352 | 53.4 | 79.3 | 95.7 | 97.7 | 99.7 | 100 | - | | |
| >300 | 2 | 50 | 100 | 100 | 100 | 100 | 100 | - | | |
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| | | | | | | | | | readings) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| <40 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 41-60 | 0 | 0 | 0 | 100% | 0 | 0 | 0 | 0 | 2 |
| 61-80 | 0 | 0 | 24.3% | 74.3% | 1.4% | 0 | 0 | 0 | 70 |
| 81-120 | 0 | 0 | 0.6% | 78.1% | 21.3% | 0 | 0 | 0 | 943 |
| 121-160 | 0 | 0 | 0 | 12.6% | 79.3% | 8.1% | 0.1% | 0 | 1128 |
| 161-200 | 0 | 0 | 0 | 0 | 27.3% | 65.7% | 6.9% | 0 | 458 |
| 201-250 | 0 | 0 | 0 | 0 | 0 | 32.3% | 60.5% | 7.2% | 167 |
| 251-300 | 0 | 0 | 0 | 0 | 0 | 0 | 20% | 77.1% | 35 |
| >300 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100% |
# Patient Conditions:
The study participants were diagnosed with the following medical conditions at admittance:
| Abdominal Aortic | CAD Mitral Stenosis | GI Bleed | Mitral Valve Replacement | Ruptured Abdominal Aortic Aneurysm |
| --- | --- | --- | --- | --- |
| Aneurysm | CAD s/p CABG (Coronary Artery Bypass Grafting) | Gunshot Wound | Multiple Trauma | S/p Right Hepatectomy Secondary to Hepatocellular Cancer |
| Abdominal Pain | Cardiogenic Shock | Heart Failure | MVA Trauma (Motor Vehicle Accident) | SDH (Succinate Dehydrogenase) |
| Abdominal Wall | Chest pain | Hepatic Mass Resection | Mx Pelvic Fracture | Sepsis |
| Reconstruction | Chest pain, Unstable Angina | Hyperparathyroidism s/p Parathyroidectomy | Myectomy | Septal Myectomy |
| Abscess of Neck | Chest Wound | Hypertrophic Cardiomyopathy | Myocardial Infarction | Septic Shock |
| Accidental Removal of J-Tube | Colon Cancer, Colectomy | Hypotension | Necrotizing Fasciitis | Severe Mitral Regurgitation |
| Acute Kidney Injury | Colonic Mass Obstruction | Hypotension, Sepsis | Neurogenic Shock due to Traumatic Injury | Small Bowel Obstruction |
| Acute Myocardial | Colovesical Fistula, | Ileus | NSTEMI, Non-St Segment | Spine Disorder |
| | Lung | | | |
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| Infarction | Postoperative | | Elevation Myocardial Infarction | |
| --- | --- | --- | --- | --- |
| Acute Respiratory Failure | Complex Hip Fracture s/p MCC | Intra-abdominal Sepsis | Orthotopic Liver Transplant with Kidney Transplant | Splenic Infarct |
| Alcoholic Cirrhosis | Coronary Artery Disease | Intracranial Hemorrhage | Ovarian Cancer | Stab Wound |
| Anastomotic Leak | Critical Left Leg Ischemia | Laceration of Brachial Artery | Pancreatic Cancer | Abdominal Hysterectomy and Ventral Hernia Repair |
| Aortic Dissection Repair | Decompensation of Cirrhosis of Liver, Post Liver Transplant | Leaky Mitral Valve | Pancreatitis | Cardiac and Respiratory Arrest |
| Aortic Stenosis | Dilated Ascending Aorta | Left Arm Cellulitis | Parastomal Hernia Repair | Revascularization of Left Lower Extremity |
| Aortic Stenosis, AVR | Diverticulitis of Colon | Left Femoral Artery Pseudoaneurysm | Perforated Diverticulitis | Splenectomy for Infarction hematoma |
| Aortic Valve Narrowing | End Stage Renal Disease | Left Knee Antibiotic spacer infection | Perforated Diverticulitis s/p Resection | Subclavian TAVR |
| Aortic Valve Replacement | Enterocutaneous Fistula | Left Ventricular Assist Device Insertion (LVAD) | Pneumonia | Succinate Dehydrogenase, tumor |
| Ascites, Severe Anemia | Esophageal Perforation | Liver Disease | Post Op TAH, BSO, Appendectomy | Superior Mesenteric Artery Thrombosis |
| Bowel Obstruction | Exploratory Laparotomy | Liver Transplant | Pseudomyxoma Peritoneal, HIPEC | Thoracabdominal Aneurysm |
| Bowel Perforation | Exploratory Laparotomy Tumor Debulk | Malignant Neoplasm of Pelvis | R common femoral artery occlusion s/p thrombectomy | Transapical TAVR |
| Burn Injury | Fall | Mitral Stenosis and | Redo TVR with | Tricuspid Valve |
| | | Laceration of Brachial Artery | Pancreatic Cancer | Abdominal Hysterectomy and Ventral Hernia Repair |
| Cervical Cancer | Cervical Cancer | Laceration of Brachial Artery | Pancreatic Cancer | Splenic Infarct |
| Cervical Cancer | Cervical Cancer | Laceration of Brachial Artery | Pancreatic Cancer | Splenic Infarct |
| Cervical Cancer | Cervical Cancer | Laceration of Brachial Artery | Pancreatic Cancer | Splenic Infarct |
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# Medications:
Study participants received the following medications in the SICU during the clinical study:
| Acetaminophen | Dextrose | Levofloxacin | Plasma-lyte |
| --- | --- | --- | --- |
| Acetaminophen with Codeine #3 (Tylenol with Codeine #3 | Diazepam | Levothyroxine | Polyethylene Glycol |
| Acetazolamide | Diclofenac | Lidocaine | Potassium Chloride |
| Acetazolamide (Diamox) | Digoxin | Linezolid | Potassium Phosphate; Potassium Sodium |
| Acetylcysteine 20% | Dilaudid | Lisinopril | Pravastatin |
| Acyclovir | Diltiazem | Lorazepam | Prednisolone |
| Adenosine | Diphenhydramine | Losartan | Prednisone |
| Albumin | Diphtheria/Pertussis, Acel/Tetanus adult | Lovenox | Pregabalin |
| Albuterol | Dobutamine | Maalox | Preparation-H Rectal ointment |
| Alprazolam | Docusate | Magnesium Hydroxide | Prismasate Prismasate Bag |
| Alteplase | Dolutegravir | Magnesium SO4 | Procainamide |
| Amantadine | Donepezil | Mannitol | Prochlorperazine |
| Amicar | Dopamine | Marcaine | Propofol |
| Amoxicillin | Doxorubicin | Methotrexate | Propofol |
| Amoxicillin | Doxorubicin | Methotrexate | Propofol |
| Benzam | Doxorubicin | Methotrexate | Propofol |
| Benzam | Doxorubicin | Methotrexate | Propofol |
| Citalopram | Doxorubicin | Methotrexate | Propofol |
| Citalopram | Doxorubicin | Methotrexate | Propofol |
| Citalopram | Doxorubicin | Methotrexate | Propofol |
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| Amiodarone | Dorzolamide | Melatonin | Propranolol |
| --- | --- | --- | --- |
| Amlodipine | Doxazosin Mesylate | Meperidine | Protamine |
| Amoxicillin | Duloxetine DR | Meropenem | Protonix |
| Ampicillin | Emollients | Mesalamine ER | Psyllium |
| Anti-inhibitor coagulant | Emtricitabine; Emtricitabine / Tenofovir | Methadone | Pyridostigmine |
| Aquaphor Healing Ointment | Enoxaparin | Methylene blue | Pyridoxine |
| Artificial Tears | Entecavir | Methylprednisolone | Quetiapine; Quetiapine Fumarate |
| Ascorbic Acid | Ephedrine | Metoclopramide | Ramelteon |
| Aspirin | Epinephrine | Metolazone (Zaroxolyn) | Ranitidine |
| Atenolol | Epoetin alfa | Metoprolol | Recombinant Factor VII |
| Atorvastatin | Epoprostenol | Metronidazole | Remifentanil |
| Atracurium | Eptifibatide | Mexiletine | Rifaximin |
| Atropine | Ergocalciferol liquid | Micafungin | Rocuronium |
| Atrovent nebulizer | Ertapenem | Miconazole 2% | Ropivacaine |
| Azathioprine | Erythromycin | Midazolam | Rosuvastatin; Rosuvastatin Calcium |
| Azithromycin | Escitalopram | Midodrine | Saline Flush |
| Bacitracin | Esmolol | Milk of Magnesia | Saliva Substitute |
| Baclofen | Esomeprazole | Milrinone | Sarna Lotion |
| Basiliximab | Etomidate | Mineral Oil | Scopolamine |
| Beclomethasone | Famotidine | Mirtazapine (Remeron) | Senna |
| Benadryl | Fat Emulsion | Montelukast | Sertraline |
| Bisacodyl | Fenofibrate | Morphine | Sildenafil Citrate |
| Brimonidine | Fentanyl | Multivitamin | Simvastatin |
| Brinzolamide | Ferrous Sulfate | Mupirocin | Sodium Bicarbonate |
| Budesonide | Fibrin sealant component | Mycophenolate | Sodium Chloride |
| Bumetanide | Finasteride | Mycophenolate Mofetil | Sodium Phosphate; Sodium Phosphate/ Potassium |
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| | | | Phosphate |
| --- | --- | --- | --- |
| Bupivacaine | Flecainide | Mycophenolic Acid | Spironolactone |
| Bupropion | Fluconazole | NaCHO3 | Sterile Water |
| Calcium | Fludrocortisone | NaCl | Succinylcholine |
| Calcium Carbonate; Calcium Carbonate/Vit D | | | |
| Calcium Chloride | Flumazenil | NaHCO3 8.4% | Sucralfate |
| Calcium Citrate | Fluoxetine | Naropin 0.2% | Sufentanil |
| Calcium Gluconate | Folic Acid | Neomycin
Polymyxin B | Sulfamethoxazole; Sulfamethoxazole/ Trimethoprim |
| Captopril | Fosphenytoin | Neostigmine | Tacrolimus |
| Carbidopa/Levodopa | Furosemide | Nephrocap | Tamsulosin |
| Carisoprodol | Furosemide | Nicardipine | Tetanus and Diphtheria Toxoid Vaccine |
| Carvedilol | Gabapentin | Nicotine | Theophylline tablet |
| Cefazolin | Gelatin absorbable | Nimodipine | Thiamine (Vitamin B-1) |
| Cefepime | Gentamicin | Nitroglycerin | Timolol |
| Cefoxitin | Glycopyrrolate | Nitroprusside | Tiotropium |
| Ceftaroline Fosamil (Teflaro) | Guaifenesin | Norepinephrine | Tizanidine |
| Ceftriaxone | Haloperidol | Normal Saline | Torsemide |
| Celecoxib | Heparin; Heparin Sodium | Nortriptyline | Total Parenteral Nutrition |
| Cell Saver | Hepatitis B Immunoglobulin | Normal Saline(NS) ½ NS | Tramadol |
| Cetirizine | Hydralazine | Nystatin | Tranexamic Acid |
| Chloraseptic | Hydrocodone-acetaminophen | Ocular lubricant | Trazodone |
| Chlorhexidine | Hydrocortisone | Ofloxacin | Triamcinolone Acet |
| Chlorothiazide | Hydromorphone | Olanzapine | Trimethoprim/Sulfa |
| Cholecalciferol | Ibuprofen | Omeprazole | Valganciclovir |
| Cilostazol | Imipenem-Cilastatin | Ondansetron | Valium |
| Ciprofloxacin | Human Insulin | Oseltamivir | Vancomycin |
| Cisatracurium | Insulin Lispro
Insulin Detemir
Insulin Glargine
Insulin (Humulin R) | Oxacillin | Vasolex |
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| | Insulin Regular | | |
| --- | --- | --- | --- |
| Citalopram | Iodixanol | Oxybutynin | Vasopressin |
| Clindamycin | Ipratropium
Ipratropium/Albuterol | Oxycodone | Vecuronium |
| Clonazepam | Iron Sucrose | Oxymetazoline | Vein Graft solution |
| Clonidine | Isoproterenol | Pancuronium | Venelex |
| Clopidogrel | Isosorbide Dinitrate | Pantoprazole | Versed |
| Colchicine | KCL | Papaverine | Vitamin K |
| Cosyntropin | Ketamine infusion | Paroxetine | Voriconazole |
| Cyanocobalamin (Vitamin B12) | Ketorolac | Pazopanib HCl (Votrient) | Warfarin |
| 5% dextrose (D5)/ ½ normal saline (NS); | Labetalol | Pepcid | White Petrolatum/Mineral Oil |
| D5/Lactate ringers (LR); D5 NS; D5W | Lactated Ringer | Peridex | Zantac |
| D5LR with 150 gm/L Dextrose | Lactulose | Phenylephrine | Zinc Sulfate |
| D5W with 150 mEq Sodium Bicarbonate | Lansoprazole | Phenytoin | Ziprasidone |
| Daptomycin (Cubicin) | Lasix | Phytonadione | Zofran |
| Desmopressin | Latanoprost | Piperacillin | Zolpidem |
| Dexamethasone Dexmedetomidine | Levetiracetam | | |
## Alarm Performance
Alarm performance was evaluated to calculate true alarm rates (sensitivity), false alarm rates, missed alarm rates and specificity. The descriptions of each assessment and the results for the alarm rate performance are in the tables below and have been included in the device labeling:
| Performance Metric | Definition |
| --- | --- |
| True Alarms (Sensitivity) | The OptiScanner 5000 alarmed when it should have.
This metric gives users confidence that the OptiScanner 5000 will alarm for hypoglycemia or hyperglycemia when it should. |
| False Alarms | The OptiScanner 5000 alarmed when it should not have.
This metric gives users an understanding of how frequently the OptiScanner 5000 will alarm for hypoglycemia or hyperglycemia when it should not be alarming. |
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| Missed Alarms | The OptiScanner 5000 should have alarmed but did not. This metric gives users an understanding of how frequently the OptiScanner 5000 should have alarmed for hypoglycemia or hyperglycemia but did not alarm. |
| --- | --- |
| Specificity | The OptiScanner 5000 did not alarm when it should not have alarmed. This metric gives users an understanding of how frequently the OptiScanner 5000 did not alarm for hypoglycemia or hyperglycemia when it should not have been alarming. |
Low Glucose Alarm Performance (±15 Minutes)
| | Alarm at 90, Comparator ≤70 mg/dL (hypoglycemia detection) | Alarm at 90, Comparator ≤90 mg/dL |
| --- | --- | --- |
| True Alarm Rate (Sensitivity) | 100% (3/3) | 84% (98/116) |
| False Alarm Rate | 98% (158/161) | 42% (72/170) |
| Missed Alarm | 0% (0/3) | 16% (18/116) |
| Specificity | 94% (2,643/2,801) | 97% (2,616/2,688) |
High Glucose Alarm Performance (±15 Minutes)
| | Alarm at 150, Comparator ≥180 (hyperglycemia detection) | Alarm at 150, Comparator ≥150 |
| --- | --- | --- |
| True Alarm Rate (Sensitivity) | 99% (357/360) | 92% (801/873) |
| False Alarm Rate | 60% (538/895) | 14% (135/936) |
| Missed Alarm | 1% (3/360) | 8% (72/873) |
| Specificity | 78% (1,906/2,444) | 93% (1,796/1,931) |
# Additional Alarms:
The sponsor includes descriptions of additional alarms in the labeling. These include alarms for saline bag occlusion, air in line to patient, patient line occlusion, and occlusion during blood return.
# Human factors study
A human factors-usability analysis was conducted according to EN62366-1:2015, Medical Devices - Application of Usability Engineering to Medical Devices.
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Usability studies were performed by intended operators of the device to assess tasks determined to be high-risk. Based on the results of the primary summative usability test results, specific design changes were made to the OptiScanner to address usability test findings. A follow-up supplemental usability test was conducted to evaluate the changes to determine the effectiveness in their ability to mitigate the risk associated with the original usability study findings. The usability evaluations performed demonstrated that users understood the instructions provided in the labeling and that they could use the device safely.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Instrument Name:
OptiScanner 5000 Instrument
O. System Descriptions:
1. Modes of Operation:
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☐ X or No ☐
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?
Yes ☐ or No ☐ X.
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
3. Specimen Identification:
The patient ID can be entered into the OptiScanner 5000 Glucose Monitoring System manually or by using the barcode scanner included with the system. The patient ID is displayed on the device screen along with the glucose measurement and glucose trend information.
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4. Specimen Sampling and Handling:
The venous blood drawn from the patient for measurement is immediately centrifuged in the disposable test cartridge to plasma and analyzed by the device.
5. Calibration:
The OptiScanner 5000 requires no calibration by the user.
6. Quality Control:
There is no quality control material for use with the OptiScanner 5000 Glucose Monitoring System.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
1. Hematocrit Study: The effect of different hematocrit levels on the performance of the OptiScanner 5000 was evaluated using donor blood samples with hematocrit levels adjusted to 15, 20, 25, 30, 35, 40, 45, 50, 55 and 60% spiked with glucose to achieve 5 concentrations ranging from 40 to 400 mg/dL (40, 100, 150, 250, 400 mg/dL). Results from the OptiScanner 5000 were compared with results obtained from the comparator, YSI-2300 analyzer. The % biases relative to YSI were acceptable and support the claimed hematocrit range of 15 to 60%.
2. Operating Conditions: The sponsor evaluated temperatures ranging from 20°C to 27°C (68°F - 80.6°F) and relative humidity (RH; non-condensing) ranging from 20% to 60%. OptiScanner 5000 results were compared to results obtained from the YSI-2300 analyzer using donor blood samples. Three temperature and humidity combinations were tested including low temperature/low humidity, average temperature and humidity (23°C/40% RH) humidity, and high temperature/high humidity. No significant effect (relative to YSI) was observed for the temperature and humidity combinations tested. The results support the claimed system operating conditions of a temperature range of 20°C to 27°C and relative humidity range of 32 to 60%.
3. Bubble Sensor: The device is designed to prevent air bubbles from reaching the patient. Two bubble sensors are incorporated into the patient line, which is part of the disposable cartridge, to detect bubbles and generate an alarm when bubbles are detected. Once bubbles are detected, the device stops the pump which prevents blood from being returned to the patient. The sponsor validated this feature and demonstrated that the bubble sensor functions as intended.
4. Biocompatibility
The sponsor provided acceptable biocompatibility testing on finished and sterilized disposable cartridges that included: cytotoxicity, sensitization, irritation, systemic toxicity (acute), systemic toxicity (sub-acute), pyrogenicity, hemocompatibility, genotoxicity
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(reverse mutation assay, chromosomal aberration, in vivo mouse micronucleus), and immunotoxicology tests.
5. Electromagnetic Compatibility and Electrical Safety:
The sponsor provided appropriate documentation certifying that electromagnetic testing (EMC) has been performed and the OptiScanner 5000 Glucose Monitoring System was found to be compliant. The labeling includes a warning against the use of the OptiScanner 5000 near Magnetic Resonance Imaging (MRI) equipment or Computerized Tomography (CT) equipment.
6. Cleaning and Disinfection:
The sponsor provided disinfection efficacy testing demonstrating the chosen wipes (Clorox Healthcare Bleach Germicidal Wipes; EPA registration number 67619-12) were effective against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella Pneumoniae, and Mycobacterium terrae when on the exterior surfaces of the device and cart.
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
R. Conclusion:
Due to an administrative error, additional conclusions were erroneously included and have now been removed.
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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