(182 days)
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).
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).
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." |
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.
§ 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.