(56 days)
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II 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. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
No technological, material, performance, or design changes to the ACCU-CHEK Inform II System have been implemented since its clearance on K121679.
Thus, the Device Description for the ACCU-CHEK Inform II System remains the same as that presented and cleared in K121679.
This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the ACCU-CHEK Inform II System housing and components.
Please note that we intend to modify the ACCU-CHEK Inform II System labeling by adding the Super Sani-Cloth for cleaning and disinfection of the system, in addition to the Clorox Germicidal Wipes, which were previously cleared for this purpose on K121679. The Super Sani-Cloth will not replace the current Clorox Germicidal Wipe. Both wipes will be included in the product labeling.
This 510(k) submission (K130138) is a "Special 510(k)" for a claim extension to the existing ACCU-CHEK® Inform II System. The purpose is to add another cleaning and disinfecting product, Super Sani-Cloth® wipes, for use with the device. Therefore, the acceptance criteria and study described focus on the effectiveness of the Super Sani-Cloth wipes for cleaning and disinfection, not on the glucose monitoring performance of the ACCU-CHEK Inform II System itself.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| - Cleaning and disinfection test protocol followed for evaluating Super Sani-Cloth wipes for cleaning and disinfection of the six distinct components of the ACCU-CHEK Inform II System. |
- Meet performance requirements for intended use. | "All components passed the cleaning and disinfection test protocol, based on the defined criteria."
"The corresponding test results demonstrate that the Super Sani-Cloth wipes are effective for the cleaning and disinfection of the device..." |
| Substantial equivalence to the predicate device (ACCU-CHEK Inform II System with Clorox® Germicidal Wipes for cleaning and disinfection). | "The Super Sani-Cloth is substantially equivalent to the Clorox Germicidal Wipe when used on the ACCU-CHEK Inform II System."
"Overall, the data demonstrate that the ACCU-CHEK Inform II System operates in the same manner when cleaning and disinfecting occurs with the Super Sani-Cloth wipes." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document states the test was performed on "the same six distinct components of the ACCU-CHEK Inform II System," but it does not specify the number of individual devices or components tested, nor the number of cleaning/disinfection cycles.
- Data Provenance: The document implies this was a prospective study conducted by Roche Diagnostics Corporation, as they are submitting the results. The country of origin is not explicitly stated, but the company is based in Indianapolis, IN, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "ground truth" here would relate to the assessment of cleanliness and disinfection efficacy, which would typically be determined by laboratory methods (e.g., microbial cultures, visual inspection for cleanliness) rather than expert human interpretation in the context of device performance.
4. Adjudication method for the test set
This information is not provided in the document, as the evaluation likely involved quantitative laboratory measurements rather than human reader adjudication.
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
There was no MRMC comparative effectiveness study done. This submission is about the efficacy of a cleaning/disinfecting wipe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A "standalone" study in the typical sense of algorithm performance was not done. The study evaluated the standalone performance of the Super Sani-Cloth wipes in cleaning and disinfecting the device components, according to a defined protocol. There is no algorithm involved.
7. The type of ground truth used
The ground truth used would be based on laboratory standards and measurements for cleaning efficacy (e.g., visual cleanliness, gravimetric analysis if applicable) and disinfection efficacy (e.g., reduction in microbial load according to established disinfectant testing standards). While the specific methods aren't detailed, "All components passed the cleaning and disinfection test protocol, based on the defined criteria" indicates adherence to such objective measures.
8. The sample size for the training set
There is no training set in the context of this submission. This is a validation study for a cleaning product, not a machine learning model.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 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.