(448 days)
Not Found
No
The summary describes a spectrophotometer-based glucose monitoring system and its performance metrics (MARD, CV). There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No.
The OptiScanner® 5000 Glucose Monitoring System is indicated for detecting trends and tracking patterns in glucose levels and determining dysglycemia. It is an in vitro diagnostic device and does not provide or perform therapy.
Yes.
The device is explicitly stated to be for "in vitro diagnostic use" and is indicated for "detecting trends and tracking patterns" to determine "dysglycemia."
No
The device description explicitly lists hardware components (Instrument, Transport Cart, Disposable Cartridge) and describes their physical functions, indicating it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use."
- Method of Analysis: The device measures the concentration of glucose in a blood sample, which is a biological specimen taken from the body. This is a core characteristic of in vitro diagnostics.
- Purpose: The intended use is for "detecting trends and tracking patterns" and "determining dysglycemia" by analyzing the glucose concentration in the blood sample. This is a diagnostic purpose, even though it's not for initial screening or diagnosis of diabetes.
Therefore, based on the provided information, the OptiScanner® 5000 Glucose Monitoring System clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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.
Product codes
LZF, PYV
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
After obtaining the absorption spectrum for a specific sample, the system calculates blood glucose levels using a set of Partial Least Squares (PLS) regression algorithm.
Input Imaging Modality
Not Found
Anatomical Site
Central venous catheter (CVC) or multi-lumen access catheter (MAC) line; venous blood sample.
Indicated Patient Age Range
age 18 and older
Intended User / Care Setting
healthcare providers; surgical intensive care unit
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)
The Manual vs. Automated MoNitoring Accuracy of GlucosE IDE Study (MANAGE IDE) was a prospective, multi-center, non-randomized, observational study, with matched samples, comparing the blood glucose levels reported by the OptiScanner® 5000 Glucose Monitoring System (OptiScanner) with a standard blood glucose reference control device, (Yellow Springs Instruments 2300, [YSI]). Data were obtained from 160 Surgical Intensive Care Unit subjects with 2,804 matched OptiScanner-YSI pairs. There were no device-related adverse events and no unexpected device effects that occurred during the clinical study. There were two non-device related serious adverse events during the course of the trial. The OptiScanner also met both the primary and secondary endpoints for accuracy and precision.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
When compared to the gold standard YSI readings, the overall MARD for the OptiScanner was 7.28%. With an upper one-sided 97.5% confidence and accounting for variance due to subject and random error. MARD was 7.50%. The overall population CV was 10.31% with an upper one-sided 97.5% confidence limit.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 16, 2017
OPTISCAN BIOMEDICAL CORP. DON WEBBER CHIEF OPERATING OFFICER 24590 CLAWITER ROAD HAYWARD CA 94545
Re: K162042
Trade/Device Name: OptiScanner 5000 Glucose Monitoring System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: II Product Code: LZF, PYV Dated: September 15, 2017 Received: September 15, 2017
Dear Don Webber:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162042
Device Name
OptiScanner 5000 Glucose Monitoring System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | ❍ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
1. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| DATE PREPARED | October 9th, 2017 |
|---|---|
| APPLICANT | OptiScan Biomedical Corp. |
| 24590 Clawiter Road | |
| Hayward, CA 94545 | |
| OFFICIAL | |
| CORRESPONDENT | Don Webber |
| COO, OptiScan Biomedical Corporation | |
| phone: (510) 962 -6223 | |
| fax: (510) 342-5809 | |
| e-mail: dwebber@optiscancorp.com |
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| 510(k) Number | K162042 |
|---|---|
| TRADE NAME | OptiScanner 5000 Glucose Monitoring System |
| COMMON NAME | Automated, in-line, bedside, glucose monitoring system |
| MODEL NUMBERS | • OptiScanner Instrument - PN 2004234 |
| • OptiScanner Disposable Cartridge and Accessories - PN 2004756 | |
| • OptiScanner Transport Cart - PN 2002168 | |
| • OptiScanner Instrument Software and Algorithm - versions 2.12 and 3.0.5.0 respectively | |
| DEVICE CLASSIFICATION | Name: Infusion pump |
| Regulation No: 21 CFR §880.5725 | |
| Product Code: LZF – Pump, Infusion Analytic Sampling | |
| Class: II | |
| Name: Glucose test system | |
| Regulation No: 21 CFR §862.1345 | |
| Secondary Product Code: PYV – Hospital Continuous | |
| Glucose Monitoring System | |
| Class: II | |
| PREDICATE DEVICE | VIA Medical Pump/Blood Chemistry Monitor (K951739) |
SUBSTANTIALLY EQUIVALENT TO:
The OptiScanner is substantially equivalent in intended use and technological features to the Via Medical GlucoScout (K951739). Both devices are intended to be used to "… monitor blood glucose in an in-hospital setting ... "
SUMMARY OF SIMILARITIES / DIFFERENCES:
The OptiScanner acquires samples in an automated fashion at a patient's bedside in the same way as the predicate device, the GlucoScout. Both devices use a sterile closed system to connect to the patient. Both employ a single-use, single-patient disposable cartridge intended to be used for up to 72 hours of monitoring. In both systems, the blood samples are processed in cartridges. The cartridges in both systems are connected to durable medical equipment (comprised of a hardware and software system) that controls blood sampling, calculates the glucose value, and displays the blood glucose value after each sample. Both systems return of the blood not used for analysis back to the patient with a flushing solution of either saline (OptiScanner, 2.5 mL saline) or calibration solution (GlucoScout, 6 mL calibration solution).
Both systems alarm at clinician determined, preset high and low glucose values, and both systems have patient line alarms.
5
The biggest difference between the GlucoScout and the OptiScanner is the method used to determine the glucose level from the whole blood sample. The GlucoScout uses an enzymatically-based glucose oxidase method to detect and quantify blood glucose. The OptiScanner, on the other hand, uses a spectrophotometric method to detect and quantify glucose.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
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.
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, 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.
TECHNICAL CHARACTERISTICS:
To provide frequent, automated glucose monitoring, the OptiScanner samples and measures blood glucose levels every 15 minutes. Small blood samples (~3 mL) are drawn directly from the patient through a vascular access catheter [e.g., Central Venous Catheter (CVC) or Multilumen Access Catheter (MAC)]. Only 0.17 mL of the blood sample is retained for analysis and
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SECTION 2.
510(K) SUMMARY
glucose measurement, with the remaining blood returned to the patient propelled by a volumecontrolled saline flush through the catheter. The retained sample is heparinized (with no heparin returned to the patient) to prevent clotting while its processed, and is centrifuged to separate the red blood cells from the plasma is then evaluated by the spectrometer to determine the glucose concentration of the blood sample. The system detects glucose by analyzing midinfrared (MIR) light (7um - 10um wavelength) absorption spectra. The use of the MIR region was selected because the primary spectral peaks for glucose are in this region. After obtaining the absorption spectrum for a specific sample, the system calculates blood glucose levels using a set of Partial Least Squares (PLS) regression algorithm. For safety, if the system encounters an unknown interfering substance, it stores the spectral information, and may not provide a glucose measurement value. Blood glucose results are continuously displayed and plotted on a graphical user interface (touchscreen) for ease of monitoring by users (healthcare providers).
This quantitative method provides a robust, stable, and reproducible analytical method for glucose measurement. Because the sample analysis is based on the physical absorption properties of the glucose, readings from the OptiScanner are not subject to drift as they are with chemically-based systems.
PERFORMANCE STANDARDS:
No performance standards have been established by the Agency to date that apply to this device.
SUMMARY OF NONCLINICAL TESTING:
Comprehensive design verification and validation testing was performed on the OptiScanner 5000. Testing provided objective evidence that the OptiScanner 5000 is safe and effective for its intended use of automated glucose monitoring of patients in the Surgical Intensive Care Unit. Results from extensive bench testing demonstrated the function, performance, and safety of the device to meet its intended use. Bench testing included sub-system design verification testing, system function and performance testing, safety feature testing, and blood glucose measurement validation. In addition, in vivo safety testing in a large animal model demonstrated that the device can safely and reliably draw, analyze, and return blood to a patient.
Electrical safety and electromagnetic compatibility (EMC/EMI) testing was performed to verify that the device is in compliance with harmonized safety standards for medical electrical equipment (IEC 60601-1 and 60101-1-2). Biocompatibility testing confirmed that the materials of construction for the device in contact with patient blood are biocompatible and safe for its intended patient contact. Sterilization and packaging validation of the OptiScanner 5000 Disposable Cartridge confirmed the device is provided to the user sterile (SAL 10°0) and that package integrity is maintained for the duration of its shelf-life. Software verification/validation testing established the software for the device was thoroughly verified to meet its defined requirements and documented in accordance with FDA guidance documents. Summative usability testing established the system design met usability requirements and addressed potential use errors through inherent design or safety features. Overall, testing confirmed that the OptiScanner 5000 can be used according to its intended use and in an equivalent manner to the predicate device.
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SECTION 2.
SUMMARY OF CLINICAL TESTING:
The Manual vs. Automated MoNitoring Accuracy of GlucosE IDE Study (MANAGE IDE) was a prospective, multi-center, non-randomized, observational study, with matched samples,
comparing the blood glucose levels reported by the OptiScanner® 5000 Glucose Monitoring System (OptiScanner) with a standard blood glucose reference control device, (Yellow Springs Instruments 2300, [YSI]). Data were obtained from 160 Surgical Intensive Care Unit subjects with 2.804 matched OptiScanner-YSI pairs. There were no device-related adverse events and no unexpected device effects that occurred during the clinical study. There were two non-device related serious adverse events during the course of the trial. The OptiScanner also met both the primary and secondary endpoints for accuracy and precision. When compared to the gold standard YSI readings, the overall MARD for the OptiScanner was 7.28%. With an upper one-sided 97.5% confidence and accounting for variance due to subject and random error. MARD was 7.50%. The overall population CV was 10.31% with an upper one-sided 97.5% confidence limit.
SUBSTANTIAL EQUIVALENCE DISCUSSION:
Automated, in-line, bedside glucose monitoring has been commercially available in the US for 20 years (GlucoScout, K951739). The GlucoScout and the OptiScanner are both intended to be used in an in-hospital, point of care (POC) setting to monitor blood glucose at a patient's bedside in an automated fashion at preset time intervals. Both devices monitor only one patient at a time. A technological comparison suggests that the key features of the OptiScanner 5000 are the same as those for the GlucoScout. The OptiScanner acquires samples in an automated fashion at a patient's bedside in the same way as the GlucoScout. Both devices use a sterile closed system to connect to the patient. Both employ a single-patient disposable cartridge intended to be used for up to 72 hours of monitoring. In both systems, blood samples are processed in the cartridges in both systems are connected to durable medical equipment (a hardware and software system) that controls blood sampling, calculates the glucose value, and displays the blood glucose level after each sample. Both systems return the portion of the blood not used for analysis back to the patient with a flushing solution of either saline (OptiScanner) or calibration solution (GlucoScout). Both systems alarm at clinician determined, preset high and low glucose values, and both systems have patient line alarms. The extensive suite of bench, electrical, mechanical, biocompatibility, sterilization, software, animal and usability testing confirm that the OptiScanner can be used in an equivalent manner to the GlucoScout, namely, to automatically monitor blood glucose at patient bedside.
Bench, electrical, mechanical, biocompatibility, sterilization, software, animal, clinical and usability testing confirm that the OptiScanner has met all of its predetermined performance criteria without raising any new or untoward performance issues.
Based on the above, OptiScan believes that the substantial equivalence of the OptiScanner to the GlucoScout has been demonstrated, and that there is both a regulatory and scientific basis for market clearance.
8
| DEVICE FEATURE | OPTISCANNER 5000 GLUCOSE
MONITORING SYSTEM | VIA MEDICAL
GLUCOSCOUT |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | "...an automated, bedside, glucose monitoring system
designed for in-hospital use in patients in the surgical
intensive care unit" | "...bedside monitoring of blood glucose levels in whole
blood on a real-time basis by accessing an intravenous or
arterial site" |
| Target Patient population | Patients in the surgical intensive care unit | Not specified |
| Key Indication Modifying Statement(s) | "...not intended for the screening or diagnosis of diabetes
mellitus but is indicated for use in determining
dysglycemia" | None |
| Point of Care | In-Hospital | In-Hospital |
| Glucose quantification method | Spectrophotometric detection of glucose | Electrochemical biosensor, amperometric (glucose oxidase) |
| Single use Disposables? | Yes. Sampling cartridge | Yes. Sampling cartridge |
| Duration of single use for disposables | 72 hours | 72 hours |
| Source of sample | Venous blood | Venous or arterial blood |
| Point of access for sample | Central venous catheter (CVC) or multi-lumen access
catheter (MAC) | Venous and arterial lines |
| Invasive / indwelling components? | No. Connects to central venous catheter (CVC) or multi-
lumen access catheter (MAC) line | No. Connects to venous or arterial access lines |
| Sample acquisition method | Blood draw (3 mL) through connection to venous access.
0.17 mL retained, heparinized and analyzed. Rest of blood
returned to patient with 2.5 mL saline flush. | Pump reverses and draws sample through venous/arterial
access into sensor set. After analysis, sample is returned to
patient along with 6 mL calibration solution. |
| Sample size required for analysis | 0.17 mL | 0.5 mL - 1.2 mL |
| Average fluid infused into patient / hr
(excluding blood return) during
monitoring | 10 mL saline (assumes measurement every 15 minutes) | 77 mL saline + calibration solutions (assumes measurement
every 5 minutes + 5 mL saline KVO) |
| Sampling frequency | 15 minutes | 5 minutes |
| Measuring range | 40 - 400 mg/dL | 30 - 600 mg/dL |
| Hematocrit range | 15% - 60% | Unknown |
| Requires use of heparin | Yes, but discarded with portion of blood sample that is
analyzed (0.17 mL). Heparin is not infused into patient. | Yes, heparin is infused into patient in sample flush. |
| Physician determined high and low glucose
values? | Yes | Yes |
| Alarms | | |
| High / Low Glucose | Yes | Yes |
| Air in line / Occlusion | Yes | Yes |
| Calibration | At factory. None required under normal use. | Self-calibrating between readings. |
| DEVICE FEATURE | OPTISCANNER | VIA MEDICAL
GLUCOSCOUT |
| System Accuracy | MARD 7.28% Based on pivotal trial results with 160
SICU patients (2,804 matched OptiScanner / YSI pairs). | $\pm$ 10% based bench testing using standards and on a study
in diabetic subjects admitted to the metabolic ward (n=7). |
| Temperature sensitive | No | Yes |
| Data storage | Yes, 72 hours of data | Yes, 12 hours of data |
| Back-up battery power? | Yes, 3 hours of operation w/o AC power | Yes, 3 hours of operation w/o AC power |
| Single patient use disposables | Yes | Yes |
Comparison of Proposed Device to the Predicate
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