The Nova Max One Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. It is intended for single-patient home use and should not be used for testing multiple patients. It is intended for self testing outside the body by people with diabetes mellitus as an aid to monitor the effectiveness of diabetes control. The Nova Max One Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in fresh whole blood capillary samples obtained from the fingertip or alternative site testing (AST) on the forearm. AST on the forearm can be used only during steady-state blood glucose conditions. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on newborns.

Nova Max One Glucose Test Strips are intended for use only with the Nova Max One Blood Glucose Monitor for quantitative tests. The Glucose Monitor is intended to quantitatively measure glucose (sugar) in fresh capillary whole blood obtained from the finger tip or alternative site testing (AST) on the forearm. AST can be used only during steady-state blood glucose conditions. The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods. Nova Max One Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). The Monitor should only be used by a single user in the home and should not be shared by users. It is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on newborns.

Nova Max Control Solutions are intended for use with the Nova Max Blood Glucose Monitoring Systems as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Levels 1, 2, 3).

Device Description

Nova Max One Blood Glucose Monitor
The monitor is a hand-held testing device that works in conjunction with Nova Max One glucose-test strips to measure glucose in a whole blood sample. Monitor operation is self-prompting using three user interface buttons. In addition to measuring glucose, the monitor also stores patient test and quality control test data.
The self-prompting menu system is navigated by means of a three-button keypad. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts.
A "battery low" warning will alert the user to change the batteries. Battery charge state information is available on the "monitor status screen". The user can select the auto shutoff option to conserve power when the monitor is not in use. Test data and monitor setup information will be stored in a non-volatile format to prevent data loss.

Nova Max One Blood Glucose Test Strips
The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator and will utilize glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) chemistry. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Ten test strips will be provided with the meter kit and will also be available separately in vials of 25 strips.
Historical data (on file at Nova Biomedical) shows minimal differences between lots of test strips produced over 2 years. As a result, test strips will now be manufactured to meet a single calibration code requirement, allowing for the elimination of a calibration step for the user when using the Nova Max One Blood Glucose Monitor.

Control Solutions
The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls (1, 2 and 3). One level of control (Level 2) will be supplied with the monitor kit and all three levels will be available for sale separately from the monitor. These controls are manufactured by Nova Biomedical and identical to those cleared for market with the predicate Nova Max Blood Glucose Monitor System (K070255).

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Nova Max One Blood Glucose Monitoring System (K112638) based on the provided document. It's important to note that the document contains very limited detail about the specifics of the performance studies, particularly regarding acceptance criteria and detailed study design.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for accuracy. It generally refers to demonstrating "substantially equivalent" results. The qualitative statement about performance is provided.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent to current methods for blood glucose measurements (qualitative)	"The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements." "Results of laboratory and clinical testing demonstrate that the performance of the Nova Max One Blood Glucose Monitor has the same intended uses, with similar technological characteristics and can produce results that are substantially equivalent to results obtained on the predicate devices."
Performs as intended (qualitative)	"The system performs as intended and raises no new safety or effectiveness issues."

Acceptance Criteria (Implied)

Reported Device Performance

Substantially equivalent to current methods for blood glucose measurements (qualitative)

"The studies demonstrated that lay users can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements." "Results of laboratory and clinical testing demonstrate that the performance of the Nova Max One Blood Glucose Monitor has the same intended uses, with similar technological characteristics and can produce results that are substantially equivalent to results obtained on the predicate devices."

Performs as intended (qualitative)

"The system performs as intended and raises no new safety or effectiveness issues."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "performance of the Nova Max One Blood Glucose Monitor was studied in the laboratory and in clinical settings by healthcare professionals and lay users," but does not provide specific numbers for the test set.
Data Provenance: Not explicitly stated, but the studies were conducted in "clinical settings," implying human subject data. The country of origin is not mentioned. It is implied to be prospective, as it involves human testing of the new device.

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

This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established by comparative measurements using a laboratory reference method. The document does not specify who performed these reference measurements or their qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Given that this device is a blood glucose monitor intended for self-testing by a single user, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers assisting an AI is not applicable. The device is an automated measurement system, not an AI diagnostic aid that assists human interpretation of images or other complex data. The performance studies likely focused on the device's accuracy compared to a reference method, and user performance in obtaining samples and operating the device correctly.

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

Yes, implicitly. The "performance studies" described involve the device itself (monitor and test strip system) measuring glucose. When the document states "lay users can obtain blood glucose results that are substantially equivalent," it refers to the device's output. The "standalone" performance here refers to the device's ability to accurately measure glucose from a blood sample, separate from human interpretation of the result itself (which is numerical).

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring studies is typically established by a laboratory reference method for glucose measurement (e.g., YSI glucose analyzer) performed on the same blood sample or a split sample. The document states: "The Glucose Monitor is calibrated to provide plasma equivalent results to laboratory methods," which strongly suggests a comparison to a laboratory reference method.

8. The Sample Size for the Training Set

This information is not provided in the document. The document describes a medical device (blood glucose monitor) using electrochemical sensing with GDH-FAD chemistry. Such devices typically have a pre-defined algorithm based on the chemical reaction, not a machine learning model that requires a "training set" in the conventional AI sense. Any "calibration" or optimization would be part of the device's manufacturing and engineering process rather than a data-driven machine learning training phase.

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

As noted in point 8, the concept of a "training set" and "ground truth for the training set" in the context of an electro-chemical blood glucose monitor is generally not applicable as it would be for an AI/machine learning device. The device's underlying chemistry and algorithm are designed and validated through engineering principles and comparison to reference methods, not typically "trained" on a dataset in the way an AI model is.

Summary

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K112638

MAR - 9 2012

510(k) Summary

510(K) Owner:	Nova Biomedical Corporation
RegistrationNumber:	1219029
Address:	200 Prospect St.Waltham, MA 02454 USA
Phone:	781-894-0800
Fax Number:	784-891-4806
Contact Person:	Paul W. MacDonald
Date Prepared:	12/19/2011
Proprietary Name:	Nova Max One Blood Glucose Monitoring System
Common Or UsualName:	Blood Glucose Monitor
ClassificationName:	System, Test, Blood Glucose, Over the Counter
Product Codes:	NBW, LFR, JJX
Predicate Device:	K070255 - Nova Max Blood Glucose Monitor SystemK051839 - FreeStyle Freedom Blood Glucose Monitoring SystemK092638 - FreeStyle Blood Glucose Test Strips
DeviceDescription:	Nova Max One Blood Glucose MonitorThe monitor is a hand-held testing device that works in conjunction with Nova MaxOne glucose-test strips to measure glucose in a whole blood sample. Monitoroperation is self-prompting using three user interface buttons. In addition tomeasuring glucose, the monitor also stores patient test and quality control testdata.The self-prompting menu system is navigated by means of a three-button keypad.It offers audible feedback for user inputs, and audible and/or visual feedback forprompts and user alerts.
	A "battery low" warning will alert the user to change the batteries. Battery chargestate information is available on the "monitor status screen". The user can selectthe auto shutoff option to conserve power when the monitor is not in use. Test dataand monitor setup information will be stored in a non-volatile format to prevent dataloss.Nova Max One Blood Glucose Test StripsThe test strips contain a reaction layer that contains a glucose-enzyme (greaterthan 1.0 IU) and ferricyanide as a mediator and will utilize glucose dehydrogenaseflavin-adenine dinucleotide (GDH-FAD) chemistry. The test strip is touched to adrop of blood to initiate the test process. The strip is designed such that when adrop of blood is touched to the end of the strip, the blood is drawn into the reactionspace via capillary action. A simple one-step process provides a blood glucoseresult. Ten test strips will be provided with the meter kit and will also be availableseparately in vials of 25 strips.Historical data (on file at Nova Biomedical) shows minimal differences between lotsof test strips produced over 2 years. As a result, test strips will now bemanufactured to meet a single calibration code requirement, allowing for theelimination of a calibration step for the user when using the Nova Max One BloodGlucose Monitor.Control SolutionsThe control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactiveingredients (dye). They contain no products of human origin. There are threelevels of controls (1, 2 and 3). One level of control (Level 2) will be supplied withthe monitor kit and all three levels will be available for sale separately from themonitor. These controls are manufactured by Nova Biomedical and identical tothose cleared for market with the predicate Nova Max Blood Glucose MonitorSystem (K070255).
Intended Use:	The Nova Max One Blood Glucose Monitor is intended to be used for thequantitative measurement of glucose in fresh capillary whole blood. It is intendedfor single-patient home use and should not be used for testing multiple patients. Itis intended for self testing outside the body by people with diabetes mellitus as anaid to monitor the effectiveness of diabetes control. The Nova Max One BloodGlucose Monitor is specifically indicated for the quantitative measurement ofglucose in fresh whole blood capillary samples obtained from the fingertip oralternative site testing (AST) on the forearm. AST on the forearm can be used onlyduring steady-state blood glucose conditions. It is not intended for the diagnosis ofor screening for diabetes, and it is not intended for use on newborns.Nova Max One Glucose Test Strips are intended for use only with the Nova MaxOne Blood Glucose Monitor for quantitative tests. The Glucose Monitor is intendedto quantitatively measure glucose (sugar) in fresh capillary whole blood obtainedfrom the finger tip or alternative site testing (AST) on the forearm. AST can be usedonly during steady-state blood glucose conditions. The Glucose Monitor iscalibrated to provide plasma equivalent results to laboratory methods. Nova MaxOne Glucose Test Strips are for testing outside the body (in vitro diagnostic useonly). The Monitor should only be used by a single user in the home and should notbe shared by users. It is not intended for the diagnosis of or screening for diabetes,and it is not intended for use on newborns.Nova Max Control Solutions are intended for use with the Nova Max Blood GlucoseMonitoring Systems as a quality control check to verify the accuracy of bloodglucose test results. There are three levels of controls, (Levels 1, 2, 3).

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Summary ofTechnologicalCharacteristics:	The Nova Max One Blood Glucose Monitor has the same fundamental scientifictechnology and the same intended use as the current on-market Nova Max BloodGlucose Monitor (K070255). The Nova Max One Blood Glucose Monitor issubstantially equivalent to the Nova Max Glucose Monitor System.The Nova Max One Blood Glucose Monitor measures glucose electrochemically asdescribed in K070255 (Nova Max Glucose Monitor System). In the same manner,the magnitude of the current is proportional to the amount of glucose present in thesample, providing a quantitative measure of glucose in whole blood and controlsolutions.
Comparison toPredicate Devices:	The Nova Max One Blood Glucose Monitor uses the same fundamental scientifictechnology and has the same intended use as the predicate Nova Max BloodGlucose Monitor (K070255).
PerformanceStudies:	The performance of the Nova Max One Blood Glucose Monitor was studied in thelaboratory and in clinical settings by healthcare professionals and lay users. Thestudies demonstrated that lay users can obtain blood glucose results that aresubstantially equivalent to the current methods for blood glucose measurements.
Conclusion:	Results of laboratory and clinical testing demonstrate that the performance of theNova Max One Blood Glucose Monitor has the same intended uses, with similartechnological characteristics and can produce results that are substantiallyequivalent to results obtained on the predicate devices. The system performs asintended and raises no new safety or effectiveness issues.

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Comparison of Predicate Devices and Proposed device

Characteristic	Measuring Range	Operating Principle	Intended Use	Characteristic	Hematocrit Range	Sample type	Sample size	Glucose Units	Sample application	Handheld meter?	Data storage	Analysis Time	Insulin Tracking	Power source	Controls:	Test Strips Active reagent:	Test Strip Calibration Coding
PredicateK070255 - Nova Max BloodGlucose Monitor System	20-600 mg/dL	Coulometric Electro-chemicalSensor	The Nova Max Blood GlucoseMonitor is intended to be used forthe quantitative measurement ofglucose in whole blood. It isintended for use by people withdiabetes mellitus in the home asan aid to monitor the effectivenessof diabetes control. it is notintended for use in the diagnosisof or screening for diabetesmellitus and is not intended foruse on neonates. The Nova MaxBlood Glucose Monitor isspecifically indicated for thequantitative measurement ofglucose in whole blood samplesobtained from the fingertip,forearm and palm.	PredicateK070255 - Nova Max BloodGlucose Monitor System	25% to 60%	Capillary blood: fingertip, forearm, palm	0.30 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose andcontrol solution tests	5 seconds	No	3 volt coin cell battery	Liquid	Glucose Oxidase	No User Input of Calibration code required
PredicateK051839- Abbott FreeStyleFreedom Blood GlucoseMonitoring System	20-500 mg/dL	Coulometric Electro-chemicalSensor	The FreeStyle Freedom BloodGlucose Monitoring System isintended for use in thequantitative measurement ofglucose in capillary wholeblood from the finger, upperarm and palm, and venouswhole blood. It is intended foruse by healthcareprofessionals and people withdiabetes mellitus at home asan aid in monitoring theeffectiveness of a diabetescontrol program. It is notintended for the diagnosis ofor screening for diabetesmellitus, and is not intendedfor use on neonates or arterialblood.	PredicateK051839 – Abbott FreeStyleFreedom Blood GlucoseMonitoring System	15% to 65%	Capillary blood: forearm,upper arm, hand, thigh, calf,or fingers	0.30 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose andcontrol solution tests	5 seconds	No	3 volt coin cell battery	Liquid	Glucose Dehydrogenase-PQQ	No User Input of Calibrationcoding required
PredicateK092638 - Abbott FreeStyleBlood Glucose Test Strips	20-500 mg/dL	Coulometric Electro-chemicalSensor	The FreeStyle Lite BloodGlucose Monitoring System isintended for use in thequantitative measurement ofglucose in capillary wholeblood from the finger, upperarm and palm, and venouswhole blood. It is intended foruse by healthcareprofessionals and people withdiabetes mellitus at home asan aid in monitoring theeffectiveness of a diabetescontrol program. It is notintended for the diagnosis ofor screening for diabetesmellitus, and is not intendedfor use on neonates orarterial blood.	PredicateK092638 – Abbott FreeStyleBlood Glucose Test Strips	15% to 65%	Capillary blood: forearm,upper arm, hand, thigh, calf,or fingers	0.30 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose andcontrol solution tests	4 seconds	No	3 volt coin cell battery	Liquid	Glucose Dehydrogenase -FAD	Calibration coding required
ProposedNova Max One Blood GlucoseMonitor System	20-600 mg/dL	Coulometric Electro-chemicalSensor	The Nova Max One BloodGlucose Monitor is intended tobe used for the quantitativemeasurement of glucose infresh capillary whole blood. It isintended for single-patienthome use and should not beused for testing multiplepatients. It is intended for selftesting outside the body bypeople with diabetes mellitusas an aid to monitor the'effectiveness of diabetescontrol. The Nova Max OneBlood Glucose Monitor isspecifically indicated for thequantitative measurement ofglucose in fresh whole bloodcapillary samples obtainedfrom the fingertip or alternativesite testing (AST) on theforearm. AST on the forearmcan be used only duringsteady-state blood glucoseconditions. It is not intended forthe diagnosis of or screeningfor diabetes, and it is notintended for use on newborns	ProposedNova Max One Blood GlucoseMonitor System	25% to 60%	Capillary blood: fingertip,forearm	0.40 uL	mg/dL	Test strip capillary draw	Yes	Up to 400 blood glucose andcontrol solution tests	4 seconds	No.	3 volt coin cell battery	Liquid	Glucose Dehydrogenase - FAD	No User Input of Calibrationcode required

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a human form or a bird in flight. The emblem is composed of several curved lines that create a sense of movement and dynamism.

10903 New Hampshire Avenue Silver Spring, MD 20993

Nova Biomedical Corporation c/o Paul W. MacDonald Chief Quality and Regulatory Affairs Officer 200 Prospect Street Waltham, MA 02454

MAR 0 9 2012

Re: K112638

Trade/Device Name: Nova Max One Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR, JJX Dated: January 30, 2012 Received: February 1, 2012

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); lan the Ace oregallerinents, medical device reporting (reporting of medical device-related laberse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112638

Device Name:

Nova Max One Blood Glucose Monitoring System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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 Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K112638

Page 1 of

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.