(99 days)
For single patient use
Easy Plus II Blood Glucose Monitoring System, Model 6276-S
The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared.
The Easy Plus II Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The Easy Plus II Blood Glucose Monitoring System Model 6276-S should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).
The Easy Plus II Test Strips are for use with the Easy Plus II Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Easy Plus II Control Solutions are for use with the Easy Plus II Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly.
Smartest Persona II Blood Glucose Monitoring System, Model 6276-S
The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared.
The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S should not be used for the diagnosis of or screening of diabetes or for neonatal use.
Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).
The Smartest Persona II Test Strips are for use with the Smartest Persona II Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Smartest Persona II Control Solutions are for use with the Smartest Persona II Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly.
For multiple patient use
Easy Plus II Multi Blood Glucose Monitoring System, Model 6276-M
The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).
The Easy Plus II Multi Test Strips are for use with the Easy Plus II Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Easy Plus II Multi Control Solutions are for use with the Easy Plus II Multi Blood Glucose Monitoring System Model 6276-M as a quality control check to verify that the meter and test strips are working together properly.
Smartest Persona II Multi Blood Glucose Monitoring System, Model 6276-M
The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose in not changing rapidly).
The Smartest Persona II Multi Test Strips are for use with the Smartest Persona II Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Smartest Persona II Multi Control Solutions are for use with the Smartest Persona II Multi Blood Glucose Monitoring System Model 6276-M as a quality control check to verify that the meter and test strips are working together properly.
The Easy Plus II Blood Glucose Monitoring System, Model 6276-5 (also applicable to: Easy Plus II Multi Blood Glucose Monitoring System, Model 6276-M; Smartest Persona II Blood Glucose Monitoring System, Model 6276-S; Smartest Persona II Multi Blood Glucose Monitoring System, Model 6276-M) is a product kit consisting of a blood glucose meter, test strips, control solutions, a lancing device, lancets, and instructions for use. The data download functionality is optionally available and sold separately.
To perform a test, a glucose test strip is inserted into the top of the device. When a small drop of blood is applied to the end of the test strip, glucose reacts with the reagents on the test strip, producing an electrical current that is proportional to the blood glucose concentration. The glucose concentration is calculated by the glucose meter and is based on the electrical current measured. The quantitative glucose concentration (in mg/dL or mmol/L) is displayed on the display screen.
The provided text is a 510(k) Summary for a blood glucose monitoring system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations.
The submission is for modifications to a previously cleared device, indicating that the core performance (accuracy of glucose measurement) was established by the predicate device (Easy Talk Blood Glucose Monitoring System, Model 6277, K100560). The changes are described as:
- Voice feature change: from talking to non-talking (removal of speaker and software module).
- Housing design modification: for style and market differentiation.
The document explicitly states: "Easy Plus II (6276-S) and Easy Plus II Multi (6276-M) Blood Glucose Monitoring Systems, in all functions and specifications are exactly same as Easy Talk Blood Glucose Monitoring System (Model 6277) except for the talking feature and housing design. The modifications in talking feature and housing design will not affect the intended use of the device, and it will not significantly affect safety or effectiveness." This implies that the performance in terms of glucose measurement accuracy is considered unchanged from the predicate device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness for glucose measurement accuracy is not directly detailed in this document for the new device. The performance studies mentioned focus on the safety aspects related to the modifications (disinfection, robustness, ease of use after modifications).
Below is a breakdown of the information that can be extracted or inferred based on the provided text, and where the information is not available as it relates to the modifications rather than re-evaluating the core performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
| :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Disinfection Efficacy | Not explicitly stated (implied to be complete inactivation) | "Clorox® Bleach Germicidal Wipes (EPA Reg No: 67619-12) was validated, demonstrating complete inactivation of live virus for use with the meters." (Specifically for Hepatitis B virus (HBV)). |
| Robustness (Cleaning/Disinfection Cycles) | Not explicitly stated (implied to withstand 3-year use life) | "demonstrated that there was no change in performance or in the external materials of the meters after 11,000 cycles of cleaning and 11,000 cycles of disinfection to simulate the claimed 3 year use life." |
| Lay User Ease of Use and Labeling Comprehension | Not explicitly stated (implied all users should find it "very easy to use" and manuals "easy to use") | "All users answered that Easy Plus II and Smartest Persona II Blood Glucose Monitoring Systems were very easy to use and the user manuals were written to make the devices easy to use." |
| Glucose Measurement Accuracy | Not provided in this document (Performance is claimed to be equivalent to the predicate device K100560) | "in all functions and specifications are exactly same as Easy Talk Blood Glucose Monitoring System (Model 6277)" |
2. Sample Size Used for the Test Set and Data Provenance
- Disinfection Studies: Sample size not specified. Data provenance is a "third party testing service."
- Robustness Studies: Sample size not specified (refers to "the meters").
- Lay User Questionnaire: 20 lay users. Data provenance is likely from the region where the study was conducted (not specified, but the submitter is in Taiwan). The study is prospective in nature for these lay users.
- Glucose Measurement Accuracy: Not applicable to this submission as it relies on the predicate's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Disinfection Studies: A third-party testing service was used. The specific number and qualifications of experts involved in establishing ground truth (i.e., verifying virus inactivation) are not provided.
- Robustness Studies: Not applicable.
- Lay User Questionnaire: The "ground truth" here is the user's subjective experience. No external experts are mentioned as establishing a ground truth for user-friendliness.
- Glucose Measurement Accuracy: Not applicable to this submission. For the predicate device, ground truth for blood glucose accuracy would typically be established by a laboratory reference method, not by experts adjudicating readings.
4. Adjudication Method for the Test Set
- Disinfection Studies: Not explicitly described, but typical for such studies involves laboratory methods to confirm virus inactivation.
- Robustness Studies: Not applicable.
- Lay User Questionnaire: "All users answered" implies a survey or direct questioning, not a formal adjudication process.
- Glucose Measurement Accuracy: Not applicable to this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a blood glucose monitoring system, not an AI/ML diagnostic interpretation tool that would typically involve multiple readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable in the context of this device. A blood glucose meter functions as a standalone device to measure glucose. Its performance (accuracy) is assessed inherently as a standalone system. The modifications outlined in this submission (voice feature, housing design) do not affect the "algorithm's" core function or performance.
7. The Type of Ground Truth Used
- Disinfection Studies: Laboratory testing for complete inactivation of live virus (e.g., HBV).
- Robustness Studies: Visual inspection and performance testing after cycles of cleaning/disinfection.
- Lay User Questionnaire: User feedback/self-reported ease of use.
- Glucose Measurement Accuracy (Implicit, from predicate): Laboratory reference methods (e.g., YSI analyzer) for blood glucose concentration.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the context of this 510(k) submission, which describes hardware and minor software modifications to a medical device, not an AI/ML algorithm requiring a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for this submission.
§ 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.