(90 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 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 System previously cleared under K060345, K063821, and K132121 is being modified to include a new ergonomic design and wireless (Wi-Fi) connectivity option. The new system, sold under a new ordering number with wireless option, contains the following:
- StatStrip Meter, with integrated Wi-Fi connection and antenna option
- Charging Station
- Vial of StatStrip Test Strips
- Battery (3.7 V Lithium)
- Quick Reference Guide
- Instructions for Use Manual
- StatStrip Log Book
Offered separately:
StatStrip Test Strips .
Quality Control solutions, Level 1, 2, 3 .
Linearity Solutions, Levels 1,2,3,4,5 ●
The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with Nova glucose-test strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated 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, patient sample, operator, reagents and meter.
The self-prompting menu system is navigated by means of a combination of touch-panel onscreen keys, on-screen soft keyboard. The operator can use a finger or a PDA style stylus to select options for the on-screen display. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. The Meter also has a barcode scanner that automates data entry.
The rechargeable batteries provide sufficient power to operate for 8 hours before requiring recharging. A "battery fuel gauge" bitmap constantly informs the user as to the current state of charge on the battery. Battery charge state information is available on the "meter Welcome screen". The meter will shutoff (Sleep) after 90 seconds of inactivity. Test data and meter setup information will be stored in a non-volatile form to prevent data loss.
The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed for charging and a slot for an extra battery to be charged.
The charging station should be located central to the patient care area being served by the meter (e.g. a nursing station). The data charging station must remain plugged in to a wall outlet for power.
The system still allows the charging station to be used to transfer data from the meter to a central workstation, and allow meter setup information to be downloaded from the central workstation to the meter.
The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. 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 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 25 strips.
The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosityadjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter.
There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system.
Replacement batteries will be offered separately.
The StatStrip Glucose Hospital Meter with Wi-Fi option provides an additional communication method with a healthcare facility's network system. This new Wi-Fi capability to transmit data results and other information using Radio Frequency is wholly unrelated to any of the existing technology and functionality, i.e., operations performed for the glucose measurement cycle are identical to the predicate device.
The design change of this new Wi-Fi communication method is offered on a new system as an option. i.e., the existing system without integrated Wi-Fi capability is still available. The primary difference between this new design and the cleared devices is an integrated Wi-Fi module using the IEEE 802.11 a/b/g communication protocol to transmit data.
The document provided describes a 510(k) premarket notification for a modified glucose meter, the StatStrip Glucose Hospital Meter System. The primary changes are an ergonomic redesign and the addition of Wi-Fi connectivity. The submission aims to demonstrate substantial equivalence to previously cleared versions of the device.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the changes and the supporting evidence:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format for performance metrics. Instead, it states that the bench testing and external testing "confirmed that the performance of the StatStrip Glucose Hospital Meter System with new ergonomic enhancements and Wi-Fi connectivity option is substantially equivalent to that of the StatStrip Glucose Hospital Meter System (predicate device)."
The comparative table (Table 1) focuses on technological characteristics, not performance metrics, stating the proposed device is "Same" for most entries. For the primary performance-related characteristics, such as Measuring Range, Hematocrit Range, Sample type, and Test time to result, the proposed device is declared "Same" as the predicate.
Therefore, the implicit acceptance criterion for performance appears to be demonstrating "substantial equivalence" to the predicate device for all relevant performance parameters. The reported performance is that this equivalence was confirmed by the studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in performance | Confirmed |
| Measuring Range: 10-600 mg/dL | Same as Predicate |
| Hematocrit Range: 20-65% | Same as Predicate |
| Test time to result: 6 seconds | Same as Predicate |
| Operating Principle: Electrochemical biosensor | Same as Predicate |
| Sample type: Capillary whole blood, venous whole blood, etc. | Same as Predicate |
| Sample size: 1.2 μL | Same as Predicate |
| Calibration: Automatic, no Calibration Code | Same as Predicate |
| Data Storage: 1,000 patient / 200 QC test results | Same as Predicate |
| Test Strips – Active reagent: Glucose Oxidase | Same as Predicate |
| Qualtiy Controls: Liquid, 3 levels | Same as Predicate |
| Linearity: Liquid, 5 levels | Same as Predicate |
| Safety and effectiveness for intended use and purpose | Confirmed |
| No new concerns for safety and effectiveness due to Wi-Fi/ergonomic design | Confirmed |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Bench testing was completed" and "Additional external testing was conducted in intended use environments." However, it does not provide specific sample sizes for the test sets used in the Method Comparison Studies, Precision Studies, or Cleaning and Disinfection studies.
The document also does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the mention of "external testing... in intended use environments," it leans towards prospective testing in a clinical or laboratory setting, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For glucose meters, ground truth is typically established by a reference laboratory method rather than expert interpretation of results.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method. Since the device measures quantitative glucose levels and comparison is likely against a reference method, an adjudication process involving multiple human experts is typically not part of the ground truth establishment for such devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other complex data. For a glucose meter, the output is a numerical value, and the performance is assessed by comparing these values to a reference method, not by how human readers interact with an AI output.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The performance studies described ("Method Comparison Studies," "Precision Studies") for a glucose meter are inherently standalone algorithm performance studies. The device (meter with its embedded algorithm) generates a glucose reading, which is then compared to a reference method. There is no "human-in-the-loop" aspect to the reading process itself for a glucose meter, only for the subsequent clinical decision-making. The document confirms these types of studies were performed to demonstrate substantial equivalence.
7. The Type of Ground Truth Used
While not explicitly stated in detail, for glucose meters, the ground truth for "Method Comparison Studies" and "Precision Studies" is almost invariably established by a reference laboratory method (e.g., hexokinase method on a laboratory analyzer) known for its accuracy and precision.
8. The Sample Size for the Training Set
The document is for a 510(k) submission, which focuses on demonstrating substantial equivalence of modifications to an existing device. It discusses sensor technology and measurement algorithms being "identical" to the predicate device. Therefore, the focus is on verification and validation of the modified device, not typically on the initial development and training of a novel algorithm.
The document does not provide information about a training set size because the fundamental glucose measurement algorithm and sensor technology are stated to be the same as the predicate device. If there were any "training" in the context of the meter's internal algorithms, it would have been for the original predicate device, not for the modifications (ergonomics, Wi-Fi) described in this submission.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, no information on a training set is provided or relevant for the modifications discussed in this 510(k). The core technology is unchanged from the predicate device.
§ 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.