(128 days)
Not Found
No
The summary describes a spectrophotometer-based glucose monitoring system with no mention of AI or ML in its description, intended use, or performance studies.
No
The device is described as an "in vitro diagnostic use" system that measures glucose concentration to detect trends and track patterns, which falls under diagnostic purposes rather than direct therapeutic intervention.
Yes.
The "Intended Use / Indications for Use" section explicitly states, "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... 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." This clearly indicates its purpose is to diagnose (determine dysglycemia) and monitor medical conditions (glucose levels).
No
The device description explicitly lists hardware components: OptiScanner Instrument, OptiScanner Transport Cart, and OptiScanner Disposable Cartridge. The Instrument is described as the "primary hardware component."
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The OptiScanner® 5000 Glucose Monitoring System is for in vitro diagnostic use."
Furthermore, the device description and intended use clearly indicate that it analyzes a biological sample (venous whole blood) to provide information about a patient's health status (glucose concentration), which is 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 (comma separated list FDA assigned to the subject device)
LZF, PYV
Device Description
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.
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
age 18 and older
Intended User / Care Setting
Surgical intensive care unit; In-hospital
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
A comprehensive bench testing program was originally executed as reported in K162042 for the OptiScanner 5000 System to verify the function, performance, and safety of the device. This Traditional 510(k) seeks FDA clearance of revisions the product labeling (User Manual) to include Peripherally Inserted Central Catheters (PICC) for which compatibility has been demonstrated, and to add clarifying language to the User Manual regarding optimal placement of the central venous access catheter port. All other elements of the OptiScanner system are unchanged and as a result only a subset of the testing performed in the Original 510(k) filing was repeated to support the proposed change. The compatibility requirements of PICCs were assessed through in vitro design verification tests, evaluating the mechanical compatibility of the PICCs to the OptiScanner patient connector as well as blood draw performance relative to Central Venous Catheters (CVCs). Test results demonstrated that the PICCs evaluated performed adequately for their ability to draw blood within the acceptance criteria limits, and that the evaluated PICCs were mechanically compatible with the patient connector on the disposable cartridge.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data were required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MARD 7.28% Based on pivotal trial results with 160 SICU patients (2,804 matched OptiScanner / YSI pairs).
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.
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.
Not Found
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
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2020
Optiscan Biomedical Corporation Charles Zimliki Vice President of Regulatory, Quality, and Clinical Affairs 24590 Clawiter Road Hayward, California 94545
Re: K192785
Trade/Device Name: OptiScanner® 5000 Glucose Monitoring System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZF, PYV Dated: January 2, 2020 Received: January 2, 2020
Dear Charles Zimliki:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192785
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, 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.
| 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
This K192785 510(k) Summary was prepared in accordance with 21 CFR 807.92.
Submitter 1.
| Applicant: | OptiScan Biomedical Corporation
24590 Clawiter Road
Hayward, CA 94545 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Official
Correspondent: | Charles Zimliki
Vice President of Regulatory, Quality, and Clinical Affairs
Phone: (240) 350-6690
Email: czimliki@optiscancorp.com |
| Date Prepared: | 31 January 2020 |
2. Device Information
| Trade Name: | OptiScanner® 5000 Glucose Monitoring System |
|---|---|
| 510(k) Number: | K192785 |
| Common Name: | Automated, in-line, bedside, glucose monitoring system |
| 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 | |
| Product Code: PYV – Hospital Continuous Glucose Monitoring | |
| System | |
| Class: II |
3. Predicate Device Information
| Trade Name: | OptiScanner® 5000 Glucose Monitoring System (K162042) |
|---|---|
| 510(k) Number: | K162042 |
| Common Name: | Automated, in-line, bedside, glucose monitoring system |
| Device Classification: | Name: Infusion Pump |
| Regulation No.: 21 CFR 880.5725 | |
| Product Code: LZF – Pump, Infusion Analytic Sampling |
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| Class: II |
|---|
| Name: Glucose Test System |
| Regulation No.: 21 CFR §862.1345 |
| Product Code: PYV – Hospital Continuous Glucose Monitoring |
| System |
| Class: II |
Device Description 4.
The main features of the OptiScanner® 5000 Glucose Monitoring System are described below. There have been no changes to the OptiScanner Instrument, Cart, or Cartridge. They are identical to those cleared in K162042.
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.
5. 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
5
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.
Comparison of Technical Characteristics with the Predicate Device 6.
There are no differences in the technological characteristics between the proposed device and the predicate device (K162042). The purpose of this Traditional 510(k) is to seek an update to the device labeling (User Manual) to:
-
- Update the listing of central venous catheters in "IV Catheters" section that can be used with the OptiScanner 5000 when performing the patient blood draw
-
- Add clarification to "Catheter Placement" section regarding the description of the "proximal port" of the central venous catheter
The physical device remains unchanged from the predicate (K162042), with the only change being a revision to the device labeling. Table 1 provides a technological comparison between the proposed device and the predicate device.
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| Device Feature | Subject Device
OptiScanner 5000 | Predicate Device
OptiScanner 5000 (K162042) | Comments |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User Manual
(OptiScanner Instrument) | The OptiScanner® 5000 User's Manual | The OptiScanner® 5000 User's Manual | MODIFIED
Subject of this 510(k) filing:
Chapter 2:
"IV Catheters" (including Figure 41)
updated to include additional IV
catheters which have been successfully
evaluated for compatibility with the
OptiScanner system.
"Catheter Placement" updated to add
clarifying text.
No other revisions have been made to
the User Manual |
| Instructions for Use
(OptiScanner Disposable
Cartridge) | Instructions for Use, OptiScanner® 5000 | Instructions for Use, OptiScanner® 5000 | Unchanged |
| Product Labeling
(OptiScanner Disposable
Cartridge) | ● Disposable Cartridge, Tyvek/Box
● Disposable Cartridge, Shipper | ● Disposable Cartridge, Tyvek/Box
● Disposable Cartridge, Shipper | Unchanged |
| Device Feature | Subject Device
OptiScanner 5000 | Predicate Device
OptiScanner 5000 (K162042) | Comments |
| 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. | 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. | Unchanged |
| Intended Use | The OptiScanner® 5000 Glucose
Monitoring System is intended for in-
vitro diagnostic use | The OptiScanner® 5000 Glucose
Monitoring System is intended for in-
vitro diagnostic use | Unchanged |
| Target patient population | Patients in the surgical intensive care
unit | Patients in the surgical intensive care
unit | Unchanged |
| Key indication-modifying
statement | "…not intended for the screening or
diagnosis of diabetes mellitus but is
indicated for use in determining
dysglycemia" | "…not intended for the screening or
diagnosis of diabetes mellitus but is
indicated for use in determining
dysglycemia" | Unchanged |
| Point of care | In-hospital | In-hospital | Unchanged |
| Glucose quantification
method | Spectrophotometric detection of glucose | Spectrophotometric detection of glucose | Unchanged |
| Single use disposables? | Yes (sampling cartridge) | Yes (sampling cartridge) | Unchanged |
| Duration of single use
disposables | 72 hours | 72 hours | Unchanged |
| Device Feature | Subject Device
OptiScanner 5000 | Predicate Device
OptiScanner 5000 (K162042) | Comments |
| Source of sample | Venous blood | Venous blood | Unchanged |
| Point of access for sample | Central venous catheter (CVC),
Peripherally Inserted Central Catheters
(PICC) or multi-lumen access catheter
(MAC) | Central venous catheter (CVC) or multi-lumen access catheter (MAC) | Added access by Peripherally Inserted
Central Catheters (PICC) |
| Invasive / indwelling
components? | No. Connects to central venous catheter
(CVC), peripherally inserted central
catheters (PICC), or multi-lumen access
catheter (MAC) line. | No. Connects to central venous catheter
(CVC) or multi-lumen access catheter
(MAC) line. | Added Peripherally Inserted Central
Catheters (PICC) |
| 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. | 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. | Unchanged |
| Sample size required for
analysis | 0.17 mL | 0.17 mL | Unchanged |
| Average fluid infused into
patient during monitoring
(excluding blood return) | 10 mL saline / hour
(assumes measurement every 15 min) | 10 mL saline / hour
(assumes measurement every 15 min) | Unchanged |
| | | | |
| Sampling frequency | 15 min | 15 min | Unchanged |
| Measuring range | 40 - 400 mg/dL | 40 - 400 mg/dL | Unchanged |
| Hematocrit range | 15-60 % | 15-60 % | Unchanged |
| 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, but discarded with portion of blood
sample that is analyzed (0.17 mL).
Heparin is not infused into patient. | Unchanged |
| | | | |
| Physician-determined high
and low glucose values? | Yes | Yes | Unchanged |
| Alarms | | | |
| Device Feature | Subject Device
OptiScanner 5000 | Predicate Device
OptiScanner 5000 (K162042) | Comments |
| High / low glucose | Yes | Yes | Unchanged |
| Air in line / occlusion | Yes | Yes | Unchanged |
| Calibration | At factory
(None required under normal use) | At factory
(None required under normal use) | Unchanged |
| System accuracy | MARD 7.28% Based on pivotal trial
results with 160 SICU patients (2,804
matched OptiScanner / YSI pairs). | MARD 7.28% Based on pivotal trial
results with 160 SICU patients (2,804
matched OptiScanner / YSI pairs). | Unchanged |
| Temperature sensitive | No | No | Unchanged |
| Data storage | Yes
(72 hours of data) | Yes
(72 hours of data) | Unchanged |
| Back-up battery power | Yes
(3 hours of operation w/o AC power) | Yes
(3 hours of operation w/o AC power) | Unchanged |
| Single patient use
disposables | Yes | Yes | Unchanged |
Table 1: Comparison of Subject Device to Predicate
7
8
9
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7. Performance Standards
No performance standards have been established by the Agency to date that apply to this device.
Summary of Non-Clinical Testing 8.
A comprehensive bench testing program was originally executed as reported in K162042 for the OptiScanner 5000 System to verify the function, performance, and safety of the device. This Traditional 510(k) seeks FDA clearance of revisions the product labeling (User Manual) to include Peripherally Inserted Central Catheters (PICC) for which compatibility has been demonstrated, and to add clarifying language to the User Manual regarding optimal placement of the central venous access catheter port. All other elements of the OptiScanner system are unchanged and as a result only a subset of the testing performed in the Original 510(k) filing was repeated to support the proposed change. The compatibility requirements of PICCs were assessed through in vitro design verification tests, evaluating the mechanical compatibility of the PICCs to the OptiScanner patient connector as well as blood draw performance relative to Central Venous Catheters (CVCs). Test results demonstrated that the PICCs evaluated performed adequately for their ability to draw blood within the acceptance criteria limits, and that the evaluated PICCs were mechanically compatible with the patient connector on the disposable cartridge. Overall, the test results demonstrate that PICCs can be used with the OptiScanner system in accordance with its intended use and in an equivalent manor to its use with CVCs.
Summary of Clinical Testing 9.
No clinical data were required for this submission.
10. Conclusion
The revised labeling that OptiScan is requesting for the proposed OptiScanner® 5000 Glucose Monitoring System is to update the listing of central catheters to which compatibility with the OptiScanner system has been established. Additionally, the labeling updates provide clarification regarding the description of the "proximal port" of the central catheter. The submitted information demonstrate substantial equivalence to the predicate.