(441 days)
The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens.
The StatStrip Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure Glucose in a whole blood sample. Meter operation is self-prompting using an illuminated color touch-screen Graphical User Interface (GUI). In addition to measuring Glucose, the meter also stores patient test data, quality control test data, and other information relating to the patient sample, operator, reagents, and meter. Meter setup options relating to authorized operators, reagent lots, QC preferences, and other operational settings are customizable. Data is transferred bidirectionally between the meter, data docking station, and separate data management system each time a meter is placed in to a data docking station.
Operator ID, patient ID, reagent lot number, test strip code, and sample accession number can be scanned into the meter using an optional built-in barcode scanner. The meter can store up to 1,000 patient test results and 200 quality control test results. The user can recall and sort or search the meter test results database to find specific test information. A rechargeable battery provides power to operate. A battery low warning will alert the user to recharge the battery. Battery charge state information is available on the "meter status screen". A System Manager selectable auto shutoff option is provided to conserve power when the meter is not in use. All test data is stored in a non-volatile form to prevent data loss.
The Test Strip is designed with an electrode that measures Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood.
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. Test strips will be sold in vials of 50 strips.
Control Solutions are aqueous solutions that contain no products of human origin. The controls solutions are for use with the StatStrip family of meters. There are three (3) levels of control solutions (1, 2, and 3)
The StatStrip Glucose Linearity Sclutions are aqueous materials with a known concentration of glucose intended to verify performance of the Nova Biomedical Analyzers. Assay values for expected ranges are included on every bottle of linearity standards. If the results obtained are outside the expected range. the system may not be performing correctly. The combined linearity solutions are for use with the StatStrip family of meters. There are five (5) Levels of Linearity Standards.
The meter Data Docking Station is a stationary accessory used to recharge the battery in the meter. The charging station has one slot for the meter to be placed for charging and additional slots for extra batteries to be charged.
The charging station is typically located central to the patient care area being served by the meter (e.g. a nursing station). The Data Docking Station must remain plugged in to a wall outlet for power.
The Data Docking Station is used to charge the meter and can be used with a USB cable to transfer data from the meter to a central workstation (i.e. Computer Database or a Data Capture System).
The provided text describes a 510(k) premarket notification for the StatStrip Glucose Hospital Meter System. The submission is for a correction to a previous letter and primarily focuses on an expanded indication for use for an already cleared device, K063821 (Nova StatStrip Glucose Hospital Meter System). The manufacturer states that the device itself has not changed, only the labeling to allow for its use with arterial or venous samples in all hospital and professional healthcare settings.
Given this context, the acceptance criteria and supporting study described are geared towards demonstrating that the existing device performs equivalently for these expanded indications as it did for its previous indications, and equally to central laboratory methods.
Here's the breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy percentages within certain glucose ranges) for this particular submission. Instead, it relies on the established performance of the predicate device and demonstrates that the current device, with expanded indications, performs substantially equivalently to central laboratory methods.
The "Comparison of Predicate and Proposed device" table (Pages 6-7) highlights the characteristics that are identical between the predicate and proposed device, implying that the established performance for these characteristics remains valid.
| Characteristic | Predicate - Nova StatStrip Glucose Hospital Meter System (K063821) | Proposed - StatStrip Glucose Hospital Meter System | Performance Assessment (Implicit from text) |
|---|---|---|---|
| Test Measured | Glucose | Glucose | Identical |
| Operating Principle | Coulometric Electro-chemical Sensor | Coulometric Electro-chemical Sensor | Identical |
| GLU Measuring Range | 10-600 mg/dL | 10-600 mg/dL | Identical |
| Hematocrit Range | 25% to 60% | 25% to 60% | Identical |
| GLU Sample Size | 1.2 µL | 1.2 µL | Identical |
| Glucose Units | mg/dL | mg/dL | Identical |
| Sample type (Expanded) | Whole Blood: Capillary, Venous Arterial and Neonate | Capillary whole blood (finger stick), venous whole blood, arterial whole blood, neonate heel stick, and neonate arterial whole blood specimens. | |
| Venous whole blood, arterial whole blood, neonatal heel stick, and neonatal arterial whole blood samples throughout all hospital and all professional healthcare settings. | Performance shown to be substantially equivalent to central laboratory methods for expanded types. | ||
| GLU Analysis Time | 6 seconds | 6 seconds | Identical |
| GLU Test Strips Active Reagent | Glucose Oxidase | Glucose Oxidase | Identical |
2. Sample size used for the test set and the data provenance:
The document states: "The laboratory and clinical performance data for the StatStrip Glucose Hospital Meter System supports the expanded use of the system for arterial and venous specimens in all hospital and all professional healthcare settings." However, specific sample sizes for the test set are not provided within the given text. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified.
3. 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):
The nature of the device (a blood glucose meter) suggests that ground truth would be established through a central laboratory reference method, not by expert clinicians or radiologists. The document states "Results of clinical performance and laboratory testing demonstrate that the StatStrip Glucose Hospital Meter System produces results that are substantially equivalent to central laboratory methods." Thus, the "experts" facilitating the ground truth would be the personnel operating the central laboratory equipment, but no specific number or qualifications of these individuals are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As the ground truth is established by a central laboratory reference method, adjudication by multiple experts is not applicable in this context.
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:
An MRMC study is not applicable here as this is a blood glucose meter, not an imaging device typically evaluated with human readers or AI assistance. The performance is assessed against a laboratory reference method.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone measurement system (the meter and test strips). Its performance is evaluated intrinsically against a reference method, so the concept of "standalone (algorithm only)" is applicable to the device itself. The clinical and laboratory performance data discussed in the document would represent this standalone performance, but without specific raw data, the exact standalone performance metrics aren't detailed beyond the statement of substantial equivalence.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for the performance studies was established by central laboratory methods for glucose determination.
8. The sample size for the training set:
The document explicitly states: "No changes have been made to the meter, the software, the test strips, the controls or the linearity solutions." This implies that the device software and algorithms were already developed and "trained" prior to this submission (likely for the predicate device K063821). The submission itself is not about developing a new algorithm or device, but extending the indication for an existing one. Therefore, no new training set information is provided or relevant to this specific submission.
9. How the ground truth for the training set was established:
Given that no new training set is described for this submission, this question is not applicable here. The ground truth for the original development of the predicate device's algorithms would similarly have been established by comparison to reference laboratory methods.
§ 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.