FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM by NOVA BIOMEDICAL CORPORATION

The FOCUS Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single patient and should not be shared. Intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. Alternative site testing on the forearm can be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to quantitatively measure whole blood glucose in fresh, human capillary whole blood taken from the fingertip or forearm.

FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters and Test Strips as a quality control check to verify that the meter and test strip are working together properly, and that the test is performing correctly.

The FOCUS PRO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multi-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with sing-use, auto-disabling lancing devices. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

FOCUS PRO Blood Glucose Test Strips are used only with FOCUS PRO Meters for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood taken from the fingertip or forearm.

Device Description

The FOCUS and FOCUS Pro Blood Glucose Monitoring Systems are comprised of glucose reagent test strips using glucose dehydrogenase flavin-adenine dinucleotide chemistry (GDH-FAD), a portable hand-held electronic meter and glucose control solutions.

The FOCUS and FOCUS Pro Blood Glucose Monitoring Systems are identical and include identical components (test strips, meter, control solutions), differing only in name to identify the intended user of the system. The FOCUS Blood Glucose Monitoring System is intended for single-patient use (self-testing) and the FOCUS Pro Blood Glucose Monitoring System is intended for multi-patient use (healthcare professional user).

When a user inserts a test strip into the meter, the meter turns on. While the test strip is in the meter, the user obtains a blood or glucose control sample, and then applies the sample to the test strip by touching the test strip to the sample. When an adequate amount of sample has been applied to the test strip, the meter emits an audible beep (when this feature is selected by the user) and the test begins. The meter's liquid crystal display (LCD) shows a test is in process by counting down from the number 4. When the test is complete, the meter displays the glucose result. Blood glucose results are plasma-calibrated to facilitate comparison to standard laboratory methods of blood glucose measurement.

The Blood Glucose Meter is a handheld device powered by one 3-volt nonrechargeable lithium battery. The meter includes a Test Port for insertion of a single test strip, an LCD display, a test strip release button, and buttons to navigate through menu choices. Meter operation is self-prompting using three user interface buttons. In addition to measuring glucose, the Meter also stores blood glucose and control solution results. The Meter offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. A "battery low" warning alerts the user to change the batteries. Battery charge information is available on the "Meter status screen". The user can select the auto shutoff option to conserve power when the Meter is not in use. Test data and Meter setup information will be stored in a non-volatile form to prevent data loss.

Meter Power Supply: The meter uses single volt (3V) lithium, non rechargeable battery (# CR2032). Theoretical battery life is approximately 1 year or 1000 tests, when testing is performed three times per day.

No-Coding System. The user is not required to enter a test strip lot-specific Calibration Code into the meter by pressing a button or by inserting a Code Key. FOCUS and FOCUS Pro test strips are assigned only one code and this single code is used for all strip lots.

Glucose Control Solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other nonreactive ingredients (dye). They contain no products of human origin. There are three leveis of controls, (Levels 1, 2 and 3).

When a control solution sample is applied to the FOCUS or FOCUS Pro test strip, the meter automatically detects and identifies the glucose control sample using an impedance measurement while performing the glucose measurement. After identifying the sample as control solution, the meter marks the result with the control solution icon and stores the marked result in the meter memory. All control results are excluded from the glucose patient result average calculations.

The FOCUS and FOCUS Pro Blood Glucose Monitors measure glucose electrochemically as described in the Nova One Glucose Monitor System (K122435). In the same manner, the magnitude of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.

AI/ML Overview

The provided text is a 510(k) summary for the FOCUS Blood Glucose Monitoring System and FOCUS Pro Blood Glucose Monitoring System. It describes the devices, their intended use, and compares them to a predicate device. However, it does not contain specific details about acceptance criteria, performance studies with detailed results, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The "Performance Studies" section only states: "The performance of the FOCUS and FOCUS Pro Blood Glucose Monitors was studied in the laboratory and in Human Factors testing by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements." This is a very high-level summary and doesn't provide the requested granular details.

Therefore, I cannot fully complete the table and answer all questions based on the provided text. I will fill in what can be inferred or explicitly stated.

Acceptance Criteria and Device Performance

Since specific acceptance criteria and detailed performance metrics (accuracy, precision, etc.) are not provided in the summary, this section cannot be fully completed. The summary only generally states that "lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements."

Acceptance Criteria (e.g., Accuracy, Precision)	Reported Device Performance
Not specified in provided text	Substantially equivalent to current methods for blood glucose measurements (general statement)

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The summary only mentions "laboratory and Human Factors testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not specified. This device measures glucose quantitatively, and the "ground truth" would typically refer to a reference laboratory method (e.g., YSI analyzer) rather than expert consensus on images. The summary does not provide details of the reference method used or the personnel operating it.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This concept is typically relevant for subjective interpretation tasks (like image review) where multiple experts might disagree. For a quantitative measurement device, the "adjudication" would be related to comparing device readings against a recognized reference method. No specific methodology for this comparison is detailed beyond the general statement of "substantially equivalent."
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is a blood glucose monitor, not an AI-assisted diagnostic imaging tool that would involve human readers interpreting cases.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone device in the sense that it measures glucose directly and provides a quantitative result. Its performance is measured as the accuracy and precision of these direct measurements. The summary states "performance of the FOCUS and FOCUS Pro Blood Glucose Monitors was studied in the laboratory," which implies standalone testing of the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Laboratory Method: For blood glucose monitors, the ground truth is typically established by comparative measurements against a highly accurate reference laboratory instrument, such as a YSI glucose analyzer. While not explicitly stated, this is the standard for such devices. The summary mentions "plasma-calibrated to facilitate comparison to standard laboratory methods of blood glucose measurement."
The sample size for the training set:
- This is not an AI/Machine Learning device that would have a distinct "training set." The system's calibration and development would be based on internal development data, but it's not described in terms of a machine learning training set.
How the ground truth for the training set was established:
- Not applicable, as it's not an AI/ML device with a separate training set in that context. The "ground truth" for calibrating and developing the device would likely be established using reference laboratory methods, similar to the test set, but specific details are not provided.

Summary

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KI3JOB

510(k) Summary

510(K) Owner:	Nova Biomedical Corporation
Address:	200 Prospect St.Waltham, MA 02454
Phone:	781-894-0800
Fax Number:	784-891-4806
RegistrationNumber:	1219029
Contact Person:	Paul W. MacDonald
Date Prepared:	01 April 2013
ProprietaryName:	FOCUS Blood Glucose Monitoring SystemFOCUS Pro Blood Glucose Monitoring System
Common OrUsual Name:	Glucose Test System (Glucose Meter, Test Strips, and Glucose Controls)
ClassificationName:	Glucose Dehydrogenase, Glucose
DeviceClassification:	II
RegulationNumber:	21 CFR § 862.1345
Product Codes:	NBW, LFR, JJX
PredicateDevice(s):	K122435: Nova Biomedical Corporation Nova One Glucose Monitor System
Intended Use:	The FOCUS Blood Glucose Monitoring System is intended for the quantitativemeasurement of glucose in fresh capillary whole blood obtained from the fingertipor forearm. Intended to be used by a single patient and should not be shared.Intended for self-testing outside the body by people with diabetes mellitus as anaid to monitor the effectiveness of diabetes control. Alternative site testing on theforearm can be used only during steady-state blood glucose conditions. Notintended for the diagnosis of or screening for diabetes, and not intended for useon neonates.FOCUS Blood Glucose Test Strips are used only with FOCUS Meters toquantitatively measure whole blood glucose in fresh, human capillary whole bloodtaken from the fingertip or forearm.FOCUS Control Solution is for use with FOCUS and FOCUS PRO Meters andTest Strips as a quality control check to verify that the meter and test strip areworking together properly, and that the test is performing correctly.

OCT 17 2013:

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The FOCUS PRO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multipatient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with sing-use, auto-disabling lancing devices. Alternative site testing on the forearm should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

Device Description:

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Summary of the Technological Characteristics: The FOCUS and FOCUS Pro Blood Glucose Monitors have the same fundamental scientific technology and the same intended use as the predicate Nova One Glucose Monitor System (K122435).

fundamental scientific technology and have the same intended use as the

The FOCUS and FOCUS Pro Biood Glucose Monitors use the same

predicate Nova One Glucose Monitor System (K122435).

Comparison to Predicate Devices:

Performance Studies:

The performance of the FOCUS and FOCUS Pro Blood Glucose Monitors was studied in the laboratory and in Human Factors testing by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements.

Conclusion: Results of laboratory and Human Factors testing demonstrate that the performance of the FOCUS and FOCUS Pro Blood Glucose Monitors have the same intended uses, with similar technological characteristics and can produce results that are substantially equivalent to results obtained on the predicate devices. The systems perform as intended and raise no new safety or effectiveness issues.

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CHARACTERISTIC	FOCUS Blood Glucose Monitoring System(Self-Monitoring)	FOCUS PRO Blood Glucose MonitoringSystem (Professional Monitoring)	Predicate DeviceK122435: Nova One System(Professional Monitoring)
Hematocrit Range (%)	25 - 60	25 - 60	25 - 60
Sample Type	Capillary whole blood from the fingertip, forearm	Venous, arterial whole blood and capillarywhole blood from the fingertip, forearm	Venous, arterial whole blood and capillarywhole blood from the fingertip, forearm
Sample Size	0.4µL	0.4µL	0.4µL
Glucose Units	mg/dL	mg/dL	mg/dL
Sample Application	Capillary action of test strip	Capillary action of test strip	Capillary action of test strip
Handheld Meter	Yes	Yes	Yes
Meter Data Storage	Up to 400 blood and control solution results	Up to 400 blood and control solution results	Up to 400 blood and control solution results
Analysis Time(seconds)	4	4	4
Insulin Tracking	No	No	No
Power Source	One 3-volt coin cell battery	One 3-volt coin cell battery	One 3-volt coin cell battery
Test Strip Ejector	Yes	Yes	Yes
Test Strip ActiveReagent (Enzyme)	Glucose Dehydrogenase - FAD	Glucose Dehydrogenase - FAD	Glucose Dehydrogenase - FAD
Test Strip CalibrationCoding	No coding. No user input of calibration coderequired	No coding. No user input of calibration coderequired	No coding. No user input of calibration coderequired
Controls	Liquid, 3 levels	Liquid, 3 levels	Liquid, 3 levels
Automatic ControlDetection	Yes, identifies Control sample as Control.	Yes, identifies Control sample as Control	N/A
Lancing Device	Reusable lancing device and sterile lancets	Single use disposable safety lancets (notsupplied)	Nova single use disposable safety lancets
Ketone Alert	Yes, when glucose value is above 240 mg/dL.Feature can be turned on/off by the userduring set up.	Yes, when glucose value is above 240 mg/dL.Feature can be turned on/off by the userduring set up.	N/A

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DEPARTMENT OF HEALTII & HUMAN SERVICES

Public Health Service

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

October 17, 2013

Nova Biomedical Corporation c/o Paul W. MacDonald, Ph.D. 200 Prospect St. WALTHAM MA 02454-9141

Re: K131013

Trade/Device Name: Focus Blood Glucose Monitoring System Focus Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: October 11, 2013 Received: October 15, 2013

Dear Dr. MacDonald:

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.

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Page 2-Dr. MacDonald

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDcvices/Salcty/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 Small Manufacturers, International and Consumer Assistance 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 vours.

Carol C. Benson -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 Form

510(k) Number (if known): K131013

FOCUS Blood Glucose Monitoring System Device Name:

Indications for Use:

The FOCUS Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or forearm. Intended to be used by a single patient and should not be shared. Intended for self-testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. Aitemative site testing on the forearm can be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

FOCUS Blood Glucose Test Strips are used only with FOCUS Meters to quantitatively measure whole blood glucose in fresh, human capillary whole blood taken from the fingertip or forearm.

Prescription Use

AND/OR

Over-The-Counter Use ×

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Stayce Beck

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) _

Page 1 of 1

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Indications for Use Form

510(k) Number (if known): K131013 FOCUS Pro Blood Glucose Monitoring System Device Name:

Indications for Use:

The FOCUS PRO Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in venous and arterial whole blood and in fresh capillary whole blood obtained from the fingertip or forearm. Intended for testing outside the body (in vitro diagnostic use) for multi-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with sing-use, auto-disabling lancing devices. Alternative site testing on the foream should be used only during steady-state blood glucose conditions. Not intended for the diagnosis of or screening for diabetes, and not intended for use on neonates.

Prescription Use ×

AND/OR

Over-The-Counter Use ×

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Stayce Beck

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k) .

Page 1 of 1

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.