(110 days)
The StatStrip Xpress 2 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 Xpress 2 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.
lt 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 Xpress Glucose Hospital Meter System previously cleared under K070960 and K150461 is being modified to include a 2.2 inch color graphics display and an updated ergonomic design. The new system will be sold as the StatStrip Xpress 2 Glucose Hospital Meter System.
The intended use of the modified StatStrip Xpress 2 Glucose Hospital Meter System has not changed as a result of the modifications.
The StatStrip Xpress 2 Glucose Hospital Meter utilizes a 2.2" color graphics display in place of the segmented display that is currently used in the predicate StatStrip Xpress Glucose Hospital Meter. The color screen allows for the user interface to be displayed in a more modern format; however the overall screen content of the meter will remain unchanged from the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter will utilize the same screen progressions and user workflow as the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same three button keypad design as the predicate to navigate the user interface.
To support the increased power requirements of the color display, the newly designed StatStrip Xpress 2 Glucose Hospital Meter will be powered by two AAA batteries in place of the single Li 2450 coin cell battery used in the predicate StatStrip Xpress Glucose Hospital Meter.
The StatStrip Xpress 2 Glucose Hospital Meter uses identical signal processing and results generating methods and stores test results in the same manner as the predicate device.
The StatStrip Xpress 2 Glucose Hospital Meter's new ergonomic design introduces a flat, top surface design that eliminates ridges, recessed corners and raised edges. The strip port has been moved to the bottom of StatStrip Xpress 2 Glucose Hospital Meter in order to increase customer satisfaction. The new location of the strip port reduces the chance of control material entering the strip port. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same strip port and electronics for making glucose measurements as the predicate device. The proposed device has the same performance characteristics as the predicate device.
The provided text describes modifications to an existing device, the StatStrip Xpress Glucose Hospital Meter System, to create the StatStrip Xpress 2 Glucose Hospital Meter System. The primary changes are an updated 2.2-inch color graphics display, an updated ergonomic design, and a change in battery type. The document explicitly states that the intended use, sensor technology, measurement electronics, measurement algorithms, test strip formulations, product manufacturing, and quality control remain the same as the predicate device. Therefore, the performance characteristics are expected to be identical to the predicate device.
Given that the current submission is for modifications to an already cleared device and not a de novo submission for a new device, the document does not contain new studies to establish acceptance criteria or device performance for the StatStrip Xpress 2 beyond what was previously established for its predicate. It relies on the substantial equivalence to the previously cleared device (K070960 and K150461).
As such, I cannot provide a table of acceptance criteria and reported device performance, nor details on new studies, as these were not conducted for this specific submission. The document's focus is on demonstrating that the modifications do not introduce new concerns for safety and effectiveness and that the new device maintains the performance characteristics of its predicate.
To answer your request, I will extract relevant information about the predicate device's characteristics as implied by the substantial equivalence claim.
Here's a breakdown based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a new table of acceptance criteria and reported device performance for the StatStrip Xpress 2 Glucose Hospital Meter System. It asserts that the proposed device has the same performance characteristics as the predicate device (StatStrip Xpress Glucose Hospital Meter System, K150461 and K070960), due to identical sensor technology, measurement electronics, measurement algorithms, and test strip/control/linearity solution formulations.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission. The claim is based on the previously established performance of the predicate device.
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)
Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical or performance studies are described for the StatStrip Xpress 2 in this submission.
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
Not applicable. This is an in vitro diagnostic device for glucose measurement, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone glucose meter. Its performance is evaluated intrinsically against laboratory reference methods. The document states: "It is intended to provide plasma equivalent results to laboratory methods." This implies that the standalone performance was established during the clearance of the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the predicate device, the implied ground truth for glucose measurement is a laboratory reference method. The statement "It is intended to provide plasma equivalent results to laboratory methods" supports this.
8. The sample size for the training set
Not applicable. This device relies on established electrochemical principles, not machine learning or AI models with training sets.
9. How the ground truth for the training set was established
Not applicable, as no training set (in the machine learning sense) is mentioned.
Summary based on the provided document:
The FDA 510(k) submission for the StatStrip Xpress 2 Glucose Hospital Meter System did not require new studies to prove acceptance criteria because the device is a modified version of a previously cleared predicate device. The core measurement technology, algorithms, and intended use remain unchanged. Therefore, the performance characteristics of the StatStrip Xpress 2 are considered substantially equivalent to its predicate. The document implicitly relies on the studies and performance data submitted for the clearance of the predicate devices (K070960 and K150461) to demonstrate the StatStrip Xpress 2's effectiveness and safety.
§ 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.