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510(k) Data Aggregation
(151 days)
The CareSens S Fit Blood Glucose Monitoring System is intended for the surement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens S Fit Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens S Blood Glucose Test Strips are with the CareSens S Fit Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The CareSens S Fit BGMS is a derivation from the same design file as it predicate device, CareSens N Premier and CareSens N Premier BT Blood Glucose Monitoring System, utilizing a new test strip. This Premarket Notification (510(k) is intended to demonstrate that the candidate devices to be marketed is safe and effective as the predicate device.
The CareSens S Fit BGMS consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Level 1" and "Level 2" ranges). The CareSens S Fit BGMS is based on an electrochemical biosensor technology (electrochemical). The System measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The following items are included in the CareSens S Fit BGMS Blood Glucose Monitoring system:
- 1 CareSens S Fit Blood Glucose Meter
- 10 CareSens S Blood Glucose Test Strips
- 1 Lancing device
- 10 Lancets
- 1 Owner's Booklet
- 1 Quick Reference Guide
- 1 Battery (3.0V lithium battery)
The following items are compatible with the CareSens S Fit BGMS and are available separately.
- CareSens S Blood Glucose Test Strips
- CareSens S Glucose Control Solution
The provided text describes the performance testing and acceptance criteria for the CareSens S Fit Blood Glucose Monitoring System, particularly in the context of its 510(k) submission (K180866) to the FDA.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document frequently refers to "acceptance criteria" and "satisfying" or "meeting" them, particularly referencing the FDA SMBG Guidance (2016). While specific numerical acceptance criteria for each test (e.g., CV% for precision above a certain threshold) are often implied rather than explicitly stated in a single table, the key accuracy criteria from the Method Comparison/User Performance study are provided.
| Performance Metric | Acceptance Criteria (Implied/Referenced) | Reported Device Performance (CareSens S Fit BGMS) |
|---|---|---|
| Accuracy (Method Comparison/User Performance) | FDA SMBG Guidance (2016) criteria for accuracy:- For glucose concentrations < 100 mg/dL: 95% of results within ± 15 mg/dL of the reference.- For glucose concentrations ≥ 100 mg/dL: 95% of results within ± 15% of the reference. | In a study with 376 subjects: - 98.1% of data were within ± 15% bias relative to the reference measurement method.- 100% of data were within ± 20% bias relative to the reference measurement method. |
| Accuracy at Extreme Glucose Values | Accuracy criteria in the FDA guidance for method comparison analysis. | "The results satisfied the accuracy criteria in the FDA guidance for method comparison analysis." (Specifically evaluated performance for glucose > 250 mg/dL and < 80 mg/dL). |
| Intermediate Precision | Acceptance criteria of intermediate precision requirements of the FDA SMBG Guidance (2016). | Pooled SD of concentration interval 1 and 2 were 0.8 mg/dL and 1.5 mg/dL respectively. Pooled CV of interval 3, 4 and 5 were 2.8%, 3.2% and 4.0%. "The results have met the acceptance criteria." |
| Within-Run Precision | Not explicitly stated, but "meets the acceptance criteria". | Confirmed to meet the acceptance criteria. |
| Linearity | All three strip lots' results confirmed to be in linear relationship with the reference values. | All three strip lots' results were confirmed to be in linear relationship with the reference values. |
| Interfering Substances | No significant interference at FDA recommended test concentrations. | "Results obtained from the primary tests were sufficient to show non-significance of the presence of these interferents at all three blood glucose concentration intervals." (52 substances tested; except gentisic acid and maltose concentrations). Hemoglobin showed no effect up to 17.7 g/dL. |
| Hematocrit Effects | Bias within ±10 mg/dL for interval 1, and within ±8% on average (individual values within ±15%) for intervals 2-5. | For interval 1: bias within ±10 mg/dL. For intervals 2-5: bias within ±8% on average, all individual values within ±15% relative to the comparator method. "Confirmed that CareSens S Fit BGMS has no interference within 20% to 60% hematocrit level." |
| Accelerated Stability (Open Vial) | Predicted in-use stability of 5.5 months minimum. | All 3 lots of test strips are predicted to have an in-use stability of 5.5 months minimum. |
| Test Strip Stability (Before Opening) | SD and CV within acceptance criteria. Bias of meter measurement value against reference results within acceptance criteria. | SD and CV values were within the acceptance criteria for all three lots at all storage conditions. Bias of meter measurement value against reference results (YSI 2300 STAT Plus) was within the acceptance criteria for all 360 data points. |
| Test Strip Stability (After Opening) | Precision and accuracy within acceptance criteria for 1+ months of use. | "The strip performance with regard to precision and accuracy were within the acceptance criteria." (Tested for more than 1 month, grouped by use frequency). |
| Extended Open Vial Stability | Not explicitly stated as a pass/fail, but a recommendation derived from the test result. | At 96 hours (4 days) at 30°C - 80% RH, measurement results started to go off acceptance criteria from day 3 (72 hours). Precision also broadened from day 3. Recommendation: "strips that have been open in the air for more than 2 days should not be used especially at high temperature and humidity conditions." |
| Altitude Test | No systematic response or significant effect up to 10,000 feet. | "Confirmed that CareSens S Fit SMBG test systems have no systematic response to altitudes and is not significantly affected by lack of atmospheric oxygen up to 10,000 feet (3,048 m) above the sea level." (Tested at sea level and simulated 5,000 feet). |
| Operating Condition Test | System operates normally at claimed environmental conditions compared to YSI results. | "It is confirmed that CareSens S Fit SMBG test system operates normally at the claimed environmental conditions, compared to the YSI results." |
| Flex Study (Strip Properties) | Correct display of error messages for out-of-range measurements, or no effect on results. | Meters correctly displayed error messages when out of range measurements were taken, or did not affect the measurement results. (Included Samples outside Measuring Range, Short Sample Perturbation Study, and Intermittent Sampling). |
| Cleaning and Disinfection Study | Complete inactivation of HBV, no effect on performance or materials after 5 years of use simulation. | Demonstrated complete inactivation of live virus (HBV) on meter and lancing device surfaces. Demonstrated 5 years (260 cycles) of single-patient use (pre-cleaning and disinfection) has no effect on performance or external materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison/User Performance Study:
- Sample Size: At least 350 different subjects. The specific study conducted for CareSens S Fit had 376 subjects.
- Data Provenance: Not explicitly stated, but the submission is from Seoul, Korea (i-SENS, Inc.), suggesting the data is likely from Korea. The study is prospective as it involves subjects participating in a user evaluation of the device.
- Within-Run Precision Evaluation: 10 meters and 500 test strips (from 10 vials of 3 manufacturing lots) for each sample concentration.
- Intermediate Precision Evaluation: 10 meters and 500 test strips (from 10 vials of 3 manufacturing lots) for each sample concentration.
- Linearity Evaluation: 11 evenly spaced concentrations of blood samples.
- Hematocrit Effect Test: Five concentration levels of blood samples at nine hematocrit levels for three lots of test strips.
- Test Strip Stability (Before Opening): Three strip lots tested with 24 distinct samples at each testing point for 462 days. Total of 360 data points.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. Instead, it relies on a laboratory comparator method.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication was not described for establishing ground truth. The ground truth was established by a laboratory reference instrument.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study, in the sense of comparing human readers with and without AI assistance, was not explicitly done. This device is a Blood Glucose Monitoring System where the "reading" is performed by the device itself, not a human interpreter of images or complex data. The "user performance" study assesses the device's accuracy in the hands of intended users, and their ability to follow instructions, not their diagnostic performance with or without computational aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, numerous "standalone" tests were conducted where the device's performance was evaluated against a laboratory reference. These include:
- Within-Run Precision
- Intermediate Precision
- Linearity
- Additional Accuracy at Extreme Glucose Values
- Interfering Substance Evaluation
- Hematocrit Effect Test
- Various Stability Tests (Accelerated, Before Opening, After Opening, Extended Open Vial)
- Altitude Test
- Operating Condition Test
- Flex Study
- Cleaning and Disinfection Study
The Method Comparison/User Performance study combines both standalone device accuracy (in the hands of users) with usability aspects, but the core accuracy measurement is a standalone performance metric against a reference.
7. The Type of Ground Truth Used
The primary ground truth used for performance evaluation, particularly for accuracy, was:
- Laboratory Reference Instrument: The YSI 2300 STAT Plus glucose analyzer was consistently used as the reference equipment (comparator method) for measuring glucose levels in blood samples.
8. The Sample Size for the Training Set
The document does not specify a separate training set for an algorithm in the way that would typically be described for AI/machine learning models. The CareSens S Fit BGMS is an electrochemical biosensor system, implying its performance is largely governed by its hardware and electrochemical design, rather than a machine learning algorithm trained on a large dataset. The development and calibration of such a system would involve extensive testing and refinement, but this is not typically referred to as a "training set" in the context of this type of medical device's regulatory submission.
9. How the Ground Truth for the Training Set was Established
As no specific "training set" in the AI/ML sense is mentioned, this question is not directly applicable. The device's calibration and design would be based on established glucose measurement principles and validated against reference methods during its development phase.
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