(160 days)
CareSens N LINK Blood Glucose Monitoring System: The CareSens N LINK Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The 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 N Single Blood Glucose Test Strips are for use with the CareSens N LINK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
CareSens N LINK Multi Blood Glucose Monitoring System: The CareSens N LINK Multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes. The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N LINK Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The CareSens N LINK Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately). The CareSens N LINK Multi BGMS consists of a blood glucose meter, multi use test strips and the control solutions("Control A" and "Control B" ranges). The CareSens N LINK and CareSens N LINK Multi BGMS are based on an electrochemical biosensor technology (electrochemical). The Systems measure the glucose level in whole blood samples using a small electrical current generated in the test strips.
Here's an analysis of the acceptance criteria and study findings for the CareSens N LINK Blood Glucose Monitoring System, based on the provided 510(k) summary:
Key Takeaways:
- This submission focuses on demonstrating substantial equivalence to a predicate device (CareSens N Blood Glucose Monitoring System).
- The primary method for demonstrating this was analytical performance testing based on ISO 15197:2003(E) and a user performance evaluation.
- The document explicitly states that the wireless data transfer "demonstrates a 100% correlation to actual monitor data," which serves as an acceptance criterion for that specific feature.
- The provided document does not contain detailed acceptance criteria for the blood glucose measurement accuracy itself, nor the specific results alongside those criteria. It broadly states the device "performed similarly" and "All testing demonstrated safety and effectiveness."
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| System Accuracy (per ISO 15197:2003(E)) | "performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI)." | Specific numeric acceptance criteria (e.g., % within ±15 mg/dL or ±20%) and results are not provided in this summary. |
| Repeatability | "All testing demonstrated safety and effectiveness of the candidate device and substantial equivalence to the predicate device." | Specific numeric acceptance criteria and results are not provided. |
| Intermediate Precision | "All testing demonstrated safety and effectiveness of the candidate device and substantial equivalence to the predicate device." | Specific numeric acceptance criteria and results are not provided. |
| User Performance Evaluation | "assessed accuracy of results and usability of the device in the hands of intended users." Findings contributed to the conclusion of "safety and effectiveness." | Specific acceptance criteria for user performance (e.g., passing rate, error types) and results are not provided. |
| Wireless Data Transmission Accuracy | "demonstrates a 100% correlation to actual monitor data." | This is explicitly stated as an achieved performance metric for the new Bluetooth feature. |
| Disinfection Effectiveness | "complete inactivation of live virus inoculated on the materials of the meter and lancing device" (using CLOROX GERMICIDAL Wipes). | This shows the device meets the criterion for allowing effective disinfection for multi-patient use. |
| Disinfection Durability | "10,950 each of pre-cleaning and disinfection cycles for meter... has no effect on the performance or the external materials of the meter." | This demonstrates the device's durability for disinfection over its intended lifespan. |
Study Details
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided summary. The summary mentions "analytical performance testing" and "user performance evaluation" but does not give the number of samples or subjects used for each.
- Data Provenance: Not explicitly stated. However, given the submitter's address (Seoul, Korea), it can be inferred that the testing might have been conducted in South Korea or through contracted services. The document does not specify if the data was retrospective or prospective.
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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):
- For the system accuracy evaluation, the "Yellow Springs Instrument (YSI)" is mentioned as the laboratory reference method. The YSI is a highly accurate laboratory-grade glucose analyzer, effectively serving as the "expert" or gold standard for glucose measurement.
- No human experts were used to establish the ground truth for glucose values.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth for glucose values was established by a laboratory reference instrument (YSI), not through human expert adjudication.
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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 MRMC comparative effectiveness study was performed or is relevant to this type of device (blood glucose monitoring system). This is not an AI-assisted diagnostic imaging device that involves human readers interpreting cases.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the "analytical performance testing" including system accuracy, repeatability, and intermediate precision, assessed the device's performance standalone against the YSI reference method and its own internal consistency. The device itself is an algorithm (or electrochemical process) that measures glucose without human interpretation of the primary data.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Ground Truth: A laboratory reference method, specifically the Yellow Springs Instrument (YSI), was used as the ground truth for glucose concentration measurements.
- Disinfection Ground Truth: Inactivation of live Hepatitis B virus (HBV) was used as the ground truth for the effectiveness of the disinfectant.
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The sample size for the training set:
- Not applicable. Blood glucose meters typically do not use "training sets" in the same way machine learning models do. Their underlying technology (electrochemical biosensor) and algorithms are based on established chemical and electrical principles rather than learned patterns from data.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of this device's development as described. The device's calibration and performance are based on the electrochemical reaction and robust engineering, not on machine learning training data.
§ 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.