(212 days)
The Nova Max Mini Blood Glucose and ß-Ketone Monitor System is intended to be used for the quantitative measurement of glucose or ß-hydroxybutyrate (ß-ketone) 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 Mini Blood Glucose and ß-Ketone Monitor System is specifically indicated for the quantitative measurement of glucose in fresh capillary whole blood obtained from the fingertip or alternative site testing on the forearm, or ß-ketone in whole blood capillary samples obtained from the fingertip only. Glucose AST on the forearm can be used only during steady-state blood glucose conditions.
The Nova Max Mini is not intended for the diagnosis of or screening for diabetes, and it is not intended for use on neonates.
The Nova Max Mini Blood Glucose Test Strips are intended for use only with the Nova Max Mini Blood Glucose Monitor System to quantitatively measure capillary blood glucose from the finger and forearm.
The Nova Max Mini Ketone Test Strips are intended for use only on the Nova Max Mini Blood Glucose and ß-Ketone Monitor System to quantitatively measure capillary β-hydroxybutyrate from the finger.
Nova Max Mini Glucose/Ketone Control Solutions are intended for use with the Nova Max Mini Glucose and ß-Ketone Monitor and test strips as a quality control check to verify the accuracy of test results. There are two levels of controls, (Level 2 and Level 3).
The monitor is a hand-held testing device that works in conjunction with Nova Max Mini glucose test strips to measure glucose or the Nova Max Mini β-Ketone test strips to measure ß-ketone in a whole blood sample. Monitor operation is self-prompting using three user interface buttons. In addition to measuring glucose and ketone, 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 Mini 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 (Aspergillis sp.). 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 50 strips. These test strips are manufactured by Nova Biomedical and identical to those cleared for market with the predicate Nova Max One Blood Glucose Monitor System (K112638).
Nova Max Mini ß-Ketone Test Strips: The Nova Max Mini β-Ketone test strips contain a reaction layer that contains the enzyme βhydroxybutyrate dehydrogenase (Alcaligenes fecalis) greater than or equal to 0.3 IU; mediator greater than or equal to 0.42 µg: coenzyme equal or greater than 0.28 µg and additional ingredients (polymers, buffers). 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. This simple one-step process provides a blood ß-Ketone result displayed on the monitor. Two ketone test strips will be provided with the meter kit and will also be available separately in cartons of 10 strips. Ketone strips are individually packaged in foil pouches. The ketone test strip is identical to the strip cleared for market with the predicate Nova Max Plus Blood Glucose and ß-Ketone Monitor (K091547).
Control Solutions: The control solutions are aqueous assayed solutions, containing buffered D-Glucose. B-Ketone, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are two levels of controls, (Level 2 and Level 3). One level of control (Level 2) will be provided with the monitor and both levels will be available for sale separately from the monitor. These controls are manufactured by Nova Biomedical and identical to those cleared for market as Nova Max Plus Glucose and β-Ketone Control Solution (Κ101633).
Here's an analysis of the provided text regarding the Nova Max Mini Blood Glucose and ß-Ketone Monitor System, focusing on acceptance criteria and study details:
Missing Information/Limitations of Provided Text:
It's crucial to note that the provided 510(k) summary (K122688) for the Nova Max Mini Blood Glucose and ß-Ketone Monitor System does not contain the detailed performance study results that would directly state specific acceptance criteria and the device's performance against them, nor does it describe the methodology of these studies in detail (e.g., sample sizes for test sets, ground truth establishment, expert involvement, training set details).
The document primarily focuses on demonstrating substantial equivalence to predicate devices (K091547 and K112638) by highlighting similarities in technology, intended use, and operational principles. It states, "The performance of the Nova Max Mini Blood Glucose and β-Ketone Monitor was studied in the laboratory settings. The studies demonstrated that the device can provide glucose or ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements obtained from capillary blood." However, it does not provide the quantitative results from these "laboratory settings" studies.
Therefore, the following sections will be filled based on inferences from the general language of the document and common regulatory expectations for such devices, but direct evidence for most points is not present in the provided text.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
Since specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated in the provided 510(k) summary, this table is constructed based on the implied equivalence claims and common expectations for blood glucose and ketone monitoring systems. The "Reported Device Performance" is drawn from the summary's general statements about substantial equivalence.
| Characteristic | Acceptance Criteria (Inferred/Typical for BGMS)* | Reported Device Performance (as per document) |
|---|---|---|
| Glucose Measurement | ||
| Accuracy | (e.g., within ±15 mg/dL or ±15% of reference for >95% of results, per ISO 15197) | "Glucose results that are substantially equivalent to the current methods." |
| Precision | (e.g., low CV%, repeatability) | Implied to be equivalent to predicate devices. |
| Measuring Range | 20-600 mg/dL | 20-600 mg/dL (Matched to predicate and proposed device specifications) |
| Hematocrit Range | 25% to 60% | 25% to 60% (Matched to predicate and proposed device specifications) |
| Sample Type | Capillary blood (fingertip, forearm) | Capillary blood from the fingertip or alternative site testing on the forearm. |
| Ketone Measurement | ||
| Accuracy | (e.g., within certain limits of reference method) | "Ketone results that are substantially equivalent to the current methods." |
| Precision | (e.g., low CV%, repeatability) | Implied to be equivalent to predicate devices. |
| Measuring Range | 0.1 – 8.0 mmol/L | 0.1 – 8.0 mmol/L (Matched to predicate and proposed device specifications) |
| Sample Type | Capillary blood (fingertip only) | Whole blood capillary samples obtained from the fingertip only. |
Note: The acceptance criteria listed are inferred or typical for blood glucose monitoring systems based on ISO 15197 and FDA guidance; they are not explicitly stated in the provided K122688 document. The document primarily asserts substantial equivalence rather than presenting detailed validation data against specific criteria.
Study Details
As highlighted, the provided 510(k) summary does not contain detailed study information beyond general statements.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: The document states "studied in the laboratory settings." This implies the data was collected under controlled laboratory conditions, likely in the country of manufacturing/submission (USA, given the 510(k) owner's address). The data would be prospective in nature, as it was generated to evaluate the performance of the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For in vitro diagnostic (IVD) devices like blood glucose and ketone monitors, ground truth is typically established using a reference laboratory method (e.g., YSI analyzer for glucose), not through expert consensus on qualitative assessment. The role of "experts" would be to perform the reference method and potentially collect samples. Their specific number or qualifications are not detailed.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., radiology image reading). For objective measurements from IVDs against a reference method, adjudication isn't typically part of the data analysis process itself, beyond ensuring correct operation of the reference assays.
5. 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. This is not relevant for an in vitro diagnostic (IVD) device like a blood glucose and ketone monitor. MRMC studies are typically performed for imaging devices or AI tools that assist human interpretation. This device provides a direct quantitative measurement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device. Blood glucose and ketone monitors are inherently standalone devices that produce quantitative results directly. The "algorithm" is embedded in the device's software to process the electrochemical signal from the test strip. The performance studies would evaluate the accuracy and precision of the device (algorithm + hardware + strip) in producing these results without human interpretative intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would be established by a highly accurate and precise reference laboratory method for glucose and ß-ketone. For glucose, this often involves methods like hexokinase or glucose oxidase on a laboratory analyzer (e.g., YSI). For ß-ketone, a laboratory reference method would also be used.
- The document states: "...can provide glucose or ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements obtained from capillary blood." This implicitly refers to comparison against such reference methods.
8. The sample size for the training set:
- Not applicable/Not specified. For electrochemical IVD devices like this, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed during the design phase using a range of samples as part of the product development and validation process, but it's not typically referred to as a "training set" in the same way as AI/ML models. The 510(k) summary focuses on the final validated performance.
9. How the ground truth for the training set was established:
- Not applicable. As explained above, there isn't a "training set" in the typical AI/ML context for this type of IVD device. The ground truth for the development and validation of the device would be established using reference laboratory methods as described in point 7.
§ 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.