(134 days)
The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of ß-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous, arterial, and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, autodisabling lancing devices.
The system should not be used for the diagnosis of or screening for diabetes.
The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, and from venous, arterial. and neonatal whole blood. The Freestyle Precision Pro Blood B-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and B-Ketone Meter to quantitatively measure ß-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial, and neonatal whole blood.
Freestyle Precision Pro Blood Glucose and ß-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional). a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.
The Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System is a microprocessor-controlled devices that algorithmically process electrical current from a (biosensor) test strip to compute a diabetic patient's blood glucose reading. The meter is fabricated from standard electronic components housed in an injection molded plastic case that offers easy test strip alignment and insertion, and a custom graphic liquid crystal display (LCD). The LCD will display menu prompts, icons, results, and data. The meter also includes a function key for turning the unit on/off and to select functions.
The meter requires 2 user replaceable standard AA cell batteries. The Freestyle Precision Pro meter is calibrated by scanning the lot specific bar code on the test strip foil label. An assay cannot be performed until the barcode information has been recorded.
The meter automatically stores the last 2,500 test results, which may be a combination of blood glucose or glucose control results. These results can be recalled and displayed again. Additionally, the meters can store up to 6,000 Operator IDs or 1,000 Quality Control tests.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K132511) does not explicitly state numerical acceptance criteria for blood glucose or β-ketone measurement accuracy. It primarily focuses on demonstrating substantial equivalence to a predicate device by extending the hematocrit range. The key performance characteristic mentioned is the acceptable performance over the hematocrit range of 15%-65%.
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Not explicitly stated as numerical accuracy targets (e.g., ISO 15197:2003 accuracy percentages) | The FreeStyle Precision Pro System demonstrated acceptable performance for blood glucose and β-ketone testing over the hematocrit range of 15%-65%. |
| Substantial Equivalence to predicate device (K130094) for intended use and technological characteristics | The device is identical to the predicate device with the exception of the extended hematocrit range. |
Important Note: The document mentions ISO 15197:2003 as a referenced standard, which does specify accuracy criteria for blood glucose monitoring systems. However, these specific criteria and how the device met them are not detailed in this 510(k) summary. The summary focuses on the change from the predicate (hematocrit range) and that the performance is "acceptable."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The summary mentions "laboratory testing" and that "the performance of the meter and test strip was studied by healthcare professionals," but does not give a specific number of samples or patients.
- Data Provenance: Not explicitly stated. The document indicates "laboratory testing" and studies by "healthcare professionals," but does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned. The studies were conducted by "healthcare professionals," but their specific qualifications (e.g., specific medical specialty, years of experience) are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. The device is for quantitative blood glucose and β-ketone measurement, and the studies described focus on the analytical performance of the system itself against established methods (implied through substantial equivalence to the predicate) and across a new hematocrit range. There is no mention of human reader interpretation or AI assistance in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- Standalone Performance: Yes, this is inherently a standalone performance study. The FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System is a device designed to algorithmically process electrical current from a test strip to compute a blood glucose or β-ketone reading. The performance characteristics described are those of the device itself (meter and test strip) in measuring these analytes. There is no human interpretation component in the direct measurement of glucose/ketone levels by the device.
7. Type of Ground Truth Used
- Type of Ground Truth: Implied to be a reference method or predicate device comparison. The summary states, "The studies demonstrate that healthcare professionals can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurements, which include the predicate device listed above." This suggests that the device's readings were compared against accepted laboratory reference methods for glucose and β-ketone, or directly against the predicate device (K130094) which itself would have been validated against reference methods.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a separate "training set" in the conventional AI sense. The "algorithm" within this device refers to the microprocessor's programmed processing of electrical currents from the biosensor, which is based on electrochemical principles, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set in the AI sense for this device. The device's internal algorithms would be developed and calibrated based on chemical and electrical engineering principles, validated against known standards and reference methods during its design and development phases.
§ 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.