Search Results

The BaseSens I Blood Glucose Monitoring System is used for the quantitative measurement of glucose levels in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.

BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions.

BaseSens I Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.

The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N System. Rebranding here is intended to be understood as all components of the CareSens N System have been relabeled with the Hygieia name BaseSens I or BaseSens I Blood Glucose Monitoring System.

The System includes the BaseSens 1 blood glucose meter, test strips and controls.

The provided document describes the "BaseSens I Blood Glucose Monitoring System". However, it's a rebranding of an existing device, the i-Sens CareSens N Blood Glucose Monitoring System (FDA clearance K083468). The document explicitly states: "The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N System."

Therefore, this filing does not present a new study to prove "device meets the acceptance criteria". Instead, it argues for substantial equivalence based on the predicate device's existing clearance. The crucial statement in the document is: "The BaseSens I Blood Glucose Monitoring System does not raise any new safety and efficacy concerns when compared to the cleared CareSens N Blood Glucose Monitoring System." This implies that the acceptance criteria and performance were already met by the predicate device.

Since this is a re-branding application, it does not include a new study with specific acceptance criteria and performance data for the BaseSens I device. It relies on the previously submitted data and clearance of the i-Sens CareSens N.

Therefore, for the request, I will extract relevant information about the predicate device's characteristics and the basis for substantial equivalence, as no new study data is presented for the BaseSens I device itself.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate Device)

Given that the BaseSens I Blood Glucose Monitoring System is a rebranding and identical to the i-Sens CareSens N Blood Glucose Monitoring System, the acceptance criteria and reported performance would be those established for the i-Sens CareSens N Blood Glucose Monitoring System during its original FDA clearance (K083468). This document does not provide a table of acceptance criteria or specific performance data for the BaseSens I. It relies on the fact that its specifications are identical to the predicate.

Key specifications for both devices, implying the performance targets, are:

Note: This table details device characteristics that presumably met acceptance criteria in the predicate's original submission. This document does not contain specific numerical performance metrics (e.g., accuracy percentages, bias) or a direct comparison to predefined acceptance criteria for the BaseSens I.

Study Information (Based on Substantial Equivalence)

Since this is a rebranding, there is no new study performed or described in this document to prove the BaseSens I meets acceptance criteria. The claim of substantial equivalence is based on the predicate device (i-Sens CareSens N). Therefore, the following information is not applicable to this specific 510(k) submission but would have been part of the predicate device's original submission (K083468).

1. Sample size used for the test set and the data provenance: Not provided in this document, as no new study was conducted for the BaseSens I. This would have been part of the predicate's original submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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-based diagnostic imaging tool, and does not involve human readers interpreting cases.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone blood glucose meter. Its performance would be assessed as such, but no new standalone performance study is presented here.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods (e.g., YSI analyzer) for glucose concentration. This information is not explicitly stated in this document but would have been used for the predicate device's performance claims.
7. The sample size for the training set: Not applicable, as this is a physical medical device (blood glucose meter and strips), not a machine learning algorithm requiring a "training set" in the conventional sense. Its calibration and operational parameters are set during manufacturing and validation, which would correspond to a rigorous design and verification process, not a "training set" for AI.
8. How the ground truth for the training set was established: Not applicable for the same reasons as above.

In summary: The provided document is a 510(k) submission for a rebranded medical device. It asserts substantial equivalence to a legally marketed predicate device (i-Sens CareSens N) because the devices are identical. As such, it does not present new acceptance criteria or new study data. All performance claims and conformity to acceptance criteria for the BaseSens I are implicitly covered by the predicate device's prior FDA clearance.

Ask a specific question about this device