(233 days)
SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.
The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is not for use in neonates. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
SD GlucoNavii® Mentor BT Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoNavii® Mentor BT Multi Blood Glucose 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 diabetes control program. This system should only be used with auto-disabling, single-use lancing devices.
The SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The SD GlucoNavi® Mentor BT Multi Blood Glucose Monitoring System is not for use in neonates Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
SD GlucoNavii® Mentor BT Multi Blood Glucose Test Strips are for use with SD GlucoNavii® Mentor BT Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
SD GlucoNavii® Mentor BT and BT Multi Blood Glucose Monitoring Systems are OTC/ Rx blood glucose monitoring systems. The SD GlucoNavii® Mentor BT Blood Glucose Monitoring System is indicated for singlepatient use at home (over-the-counter; OTC) and should not be shared, while the SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System is for multi-patient use in a professional healthcare setting(over-thecounter; OTC and prescription; POC), in order to help monitor the effectiveness of diabetes control.
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The system can also set the pre-meal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
A Bluetooth unit for data transfer has been added to the subject devices in addition to NFC and USB cable communication features.
The following modifications were made on the subject device from the predicate device (K132929).
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- The addition of Bluetooth for wireless transmission of data to mobile device or PC, and which comprises the following modifications:
- i. Changed printed circuit board (PCB) layout.
- ii. Added Bluetooth module to PCB.
- iii. Added and deleted electronic components to support the Bluetooth Module.
- iv. Deleted USB communication circuit.
- Changed Firmware. V.
- Added Bluetooth icon to display. vi.
- Extended automatic meter shutoff times to allow enough time for data transfer via Bluetooth. vii.
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- Memory capacity for stored glucose test results decreased from 300 to 100 records.
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- The trade name of the systems has changed from SD GlucoNavii® Mentor NFC Blood Glucose Monitoring System and SD GlucoNavii® Mentor NFC Multi Blood Glucose Monitoring System to SD GlucoNavii® Mentor BT Blood Glucose Monitoring System and SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System.
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- The trade name of the test strips has changed from SD GlucoNavii® Mentor NFC Blood Glucose Test Strips and SD GlucoNavii® Mentor NFC Multi Blood Glucose Test Strips to SD GlucoNavii® Mentor BT Blood Glucose Test Strips and SD GlucoNavii® Mentor BT Multi Blood Glucose Test Strips.
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- Labeling was modified to reflect the changes to the device.
This document is a 510(k) Premarket Notification from the FDA regarding the SD GlucoNavii® Mentor BT Blood Glucose Monitoring System and SD GlucoNavii® Mentor BT Multi Blood Glucose Monitoring System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.
Therefore, much of the requested information, particularly regarding detailed study design, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not provided in this document as it pertains to clinical performance which the FDA states is "not applicable."
However, based on the provided text, we can extract the acceptance criteria (implicitly defined by the device's specifications and comparison to the predicate) and the reported device performance for certain aspects, primarily through the "Similarities and Differences" table.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or statistical format, but rather details the device's specifications, which act as de facto criteria. The reported device performance is largely presented by stating that the modified device's performance characteristics are "identical" to the predicate or within acceptable changes.
| Feature / Criteria (Implied Acceptance) | Reported Device Performance (SD GlucoNavii® Mentor BT) |
|---|---|
| Manufacturer | Identical (SD Biosensor, Inc.) |
| Product Code | Identical (CGA, NBW) |
| Indications for Use (Self-testing) | Identical (Quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, upper arm, or forearm; for self-testing by people with diabetes at home as an aid to monitor effectiveness of diabetes control; not for diagnosis/screening or neonates; alternative site testing only during steady-state) |
| Indications for Use (Multi-patient use) | Identical (Quantitative measurement of glucose in fresh capillary whole blood from fingertip, palm, upper arm, or forearm; for multiple-patient use in professional healthcare settings as an aid to monitor effectiveness of diabetes control program; to be used with auto-disabling, single-use lancing devices; not for diagnosis/screening or neonates; alternative site testing only during steady-state) |
| Test Time | Identical (5 seconds) |
| Measuring Range | Identical (20-600 mg/dL) |
| Operating Temperature | Identical (10-45°C (50-113°F) for blood sample / 18-30°C (64-86°F) for control solution) |
| Operating Humidity | Identical (15-95% RH) |
| Operating Altitude | Identical (up to 11,351ft.) |
| Hematocrit Range | 20-60% |
| Memory Capacity | 100 test results (Differs from predicate's 300, but deemed acceptable) |
| Coding | Identical (N/A) |
| Meter Dimensions | Identical (50mm x 93mm x 18mm) |
| Meter Weight | Identical (50g with battery) |
| Unit of Measure | Identical (mg/dL) |
| Sample Type | Identical (Fresh capillary whole blood) |
| Sample Sites | Identical (Fingertip, palm, forearm or upper arm) |
| Sample Volume | Identical (0.3 µL) |
| Monitor Type | Identical (LCD display) |
| Backlight | Identical (No) |
| Power Supply | Identical (3V CR2032 Battery x1, Replaceable) |
| Power Saving (Automatic Shut-off) | Identical (After 1 minute of inactivity without test strip / 3 minutes with test strip inserted) |
| Battery Life | Identical (Approximately 1,000 Tests) |
| Test Strip Technology | Identical (Glucose Oxidase (GOD)) |
| Test Principle | Identical (Electrochemical biosensor) |
| Sample Application | Identical (Test strip capillary draw) |
| Calibration | Identical (Plasma-calibrated) |
| Test Strip Storage Temperature | Identical (2-32°C (36-90°F)) |
| Test Strip Storage Humidity | Identical (10-95% RH) |
| PC Link Feature | Yes, NFC, or Bluetooth (Differs from predicate's USB Cable/NFC, but deemed acceptable) |
| Smart Device Link Feature | Yes, NFC or Bluetooth (Differs from predicate's NFC, but deemed acceptable) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical sensitivity and clinical specificity testing are not applicable." This implies that no clinical performance study involving a patient test set was conducted for this 510(k) submission, as the focus was on demonstrating substantial equivalence based on non-clinical tests (design control, risk analysis, verification & validation activities) due to the nature of the modifications (primarily adding Bluetooth connectivity). Therefore, sample size for a clinical test set and its provenance are not provided.
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 clinical test set was used for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used for 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 device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers and MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone blood glucose meter. Its performance is evaluated intrinsically, and the "study" demonstrating its performance relies on the device itself against a reference method (not detailed here, but expected for glucose meters). The document indicates "design control, risk analysis and verification & validation activities" were performed, which would include testing the device's accuracy and precision, but the specific details of these tests (e.g., sample size, reference method) are not included in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory-grade reference method for glucose measurement (e.g., YSI glucose analyzer), which is considered the gold standard. However, the document does not explicitly state the specific reference method used for the verification and validation activities.
8. The sample size for the training set
Not applicable in the context of an AI/algorithm training set. For a traditional medical device like a glucose meter, "training" might refer to calibration data, but the document does not provide details on the sample size for such data.
9. How the ground truth for the training set was established
Not applicable in the context of an AI/algorithm training set. For a glucose meter, the ground truth for calibration (if considered "training") would be established by measuring known glucose concentrations against a reference method.
§ 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.