(115 days)
The FreeStyle Lite Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be used by a single person and should not be shared. Alternate site testing should be done only during steady state times (when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Lite Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, upper arm and palm.
The FreeStyle Lite Meter, in conjunction with the FreeStyle Lite Test Strips works on the principal of coulometric biosensor technology, measuring glucose by its reaction with Glucose Dehydrogenase (GDH) in blood samples or control solutions, through electrochemical mediation.
The FreeStyle Lite Meter consists of the following major features:
- Strip Port where the FreeStyle Lite Test Strip is inserted. ●
- . Buttons - used to turn the meter on/off and recall information stored in the meter.
- . Display Window - where test results, messages and information stored in the meter appear.
The device is prepared for use by inserting a glucose test strip in the test strip port. Upon strip insertion, the meter will turn on automatically and perform a display check. The meter will then display the time, month and day (if set). The 'apply blood' message is displayed for the user to apply blood to the test strip until the meter begins the test. Blood detect will occur when the meter detects trigger current from the test strip, initiated when enough blood has covered the strip electrodes. Following the blood detect, the meter performs the glucose assay measurement.
The provided document is a 510(k) summary for the FreeStyle Lite Blood Glucose Monitoring System. It outlines the device's indications for use, description, principles of operation, and a comparison to a predicate device.
However, the document does not contain specific acceptance criteria tables, reported device performance data, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case study results, standalone performance study results, or training set information.
The primary focus of this submission is to incorporate new cleaning and disinfection procedures. Therefore, the performance studies mentioned near the end of the document likely pertain to the stability and accuracy of the device after repeated cleaning and disinfection cycles, rather than a general performance evaluation of the glucose measurement accuracy itself.
Without the specific performance study report, I cannot fulfill all parts of your request. I can, however, extract what is available regarding the cleaning and disinfection aspects, which seem to be the core of this particular submission's changes.
Here's a summary of the information that is available in the provided text, related to the device's characteristics and the changes in cleaning/disinfection:
1. Acceptance Criteria and Reported Device Performance:
Based on the "Differences" section, the main change and associated performance pertains to the cleaning and disinfection procedures.
| Acceptance Criteria (Implied for Cleaning/Disinfection) | Reported Device Performance (Implied) |
|---|---|
| Meter Cleaning/Disinfection: | |
| Effectiveness and durability of the meter after extended cleaning and disinfection cycles. | The Modified FreeStyle Lite Blood Glucose Monitoring System (K150332) was tested for 522 cleaning and 522 disinfection cycles (stated as the equivalent of 2 cycles per week for 5 years) using Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12. |
Note: The document states "The results obtained from performance studies demonstrate that the FreeStyle Lite Blood Glucose Monitoring System is safe and effective for its intended use and technological characteristics, and therefore, substantially equivalent to the predicate device (K092602)." This implies the device maintained its intended performance after these cleaning/disinfection cycles, but specific accuracy data post-disinfection is not provided in this summary. |
| Lancing Device Cleaning/Disinfection:
Effectiveness and durability of the lancing device after extended cleaning and disinfection cycles. | The lancing device was tested for 210 cleaning and 210 disinfection cycles (stated as the equivalent of 2 cycles per week for 2 years) using Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12.
Note: Similar to the meter, the document implies the lancing device remained safe and effective after these cycles. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text. The number of cleaning/disinfection cycles (522 for meter, 210 for lancing device) refers to the duration/intensity of the test, not the number of individual devices or patients in a test set.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/not specified, as this document focuses on device cleaning/disinfection performance rather than diagnostic accuracy requiring expert ground truth in the typical sense.
4. Adjudication method for the test set:
- Not applicable/not specified.
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 device is a blood glucose monitoring system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, effectively. The "performance studies" mentioned would have evaluated the device's physical integrity and functional accuracy after the cleaning/disinfection procedures. This constitutes a standalone performance evaluation of the device itself under specific conditions. However, the specifics of how "performance" was measured (e.g., whether glucose accuracy remained within specifications) are not detailed in this summary.
7. The type of ground truth used:
- For the cleaning/disinfection changes, the "ground truth" would be the device's ability to maintain its specified performance and physical integrity (e.g., no degradation of materials, continued accurate glucose measurements) after the specified number of cleaning/disinfection cycles. The detailed technical reports for these studies (not included here) would have defined the pass/fail criteria for this performance.
- For the core glucose measurement function, the "ground truth" would typically be a reference method for glucose concentration, against which the device's readings are compared for accuracy. This information is usually detailed in the original 510(k) for the device's core functionality (K092602, the predicate).
8. The sample size for the training set:
- Not applicable/not specified, as this is not an AI/machine learning device requiring a training set in that context. If "training set" refers to data used to validate the core glucose measurement, that information is not in this document.
9. How the ground truth for the training set was established:
- Not applicable/not specified for the reasons above.
§ 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.