(47 days)
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
The iBGStar Blood Glucose Monitoring System (BGMS) consists of:
- iBGStar Blood Glucose Meter .
- . BGStar Test Strips
- BGStar Control Solution .
The iBGStar. Diabetes Manager Application (DMA) is an optional software accessory for the iBGStar Blood Glucose Monitoring System. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the DMA installed on an iPhone or iPod touch from the iBGStar meter.
Here's an analysis of the provided text regarding the AgaMatrix iBGStar Blood Glucose Monitoring System and iBGStar Diabetes Manager Application, focusing on acceptance criteria and supporting studies.
Based on the provided 510(k) summary, the device under review (K130535) is an update to an existing device (predicate K103544) to ensure compatibility with newer Apple devices (iPhone 5, iPod touch 5th generation) using a Lightning adapter. Crucially, the document states that there were no changes to the fundamental scientific technology of the Blood Glucose Monitoring System (meter, strips, controls) or the Diabetes Manager Application itself. The improvements are primarily related to connectivity and physical compatibility with new phone models.
Therefore, the performance data presented is focused on demonstrating that these new connectivity components (Lightning adapters) do not negatively impact the previously established performance, and that the updated system as a whole remains substantially equivalent to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (compatibility update, not a new sensing technology), the acceptance criteria mentioned are related to:
- Disinfection and Robustness of the new adapter hardware and associated Apple devices.
- Verification and Validation that the new adapters facilitate data transfer as intended.
- Human Factors to ensure users can correctly use the new adapters with the system.
The original performance characteristics for the blood glucose monitoring system (e.g., accuracy of glucose measurement) are assumed to be met as they were established for the predicate device, which remains unchanged in its core technology.
| Acceptance Criteria | Reported Device Performance (K130535) |
|---|---|
| Disinfection | Criterion: Ensure the new components (iPhone 5, iPod touch 5, Apple Lightning to 30-pin Adapter, and Apple Lightning to 30-pin Adapter (0.2m) cable) can be effectively disinfected without performance degradation. |
Performance: Disinfection testing with PDI® Super Sani-Cloth® Germicidal Disposable Wipes (EPA number 9480-4) demonstrated complete inactivation of live virus. |
| Robustness | Criterion: Ensure the new components maintain performance and material integrity after repeated cleaning/disinfection cycles.
Performance: Robustness testing involved 260 cleaning/disinfection cycles (simulating 5 years of use) with the PDI® Super Sani-Cloth® Germicidal Disposable Wipes. Results showed no change in performance or material of the tested devices. |
| Verification and Validation (of new adapters/connectivity) | Criterion: Demonstrate that the Apple Lightning to 30-pin Adapter and the Apple Lightning to 30-pin Adapter (0.2m) cable correctly enable the iBGStar DMA to function as intended (i.e., transfer glucose readings).
Performance: Verification and validation protocols were successfully executed, and results demonstrated "substantial equivalence to the predicate system" regarding the use of these adapters. |
| Human Factors | Criterion: Ensure users can successfully connect and transfer readings via the new Apple Lightning to 30-pin Adapter and cable.
Performance: A human factors study was conducted, and results demonstrated "substantial equivalence to the predicate system" in relation to users' ability to connect and transfer readings using the new adapters. |
| (Implied) Blood Glucose Measurement Accuracy/Performance | Criterion: (Inherited from predicate) The iBGStar BGMS performs quantitative measurements of blood glucose levels in fresh capillary whole blood with acceptable accuracy and precision.
Performance: The document explicitly states: "There have been no modifications to the iBGStar BGMS to allow it to operate with the iPhone 5 and iPod touch 5th generation. The Meter, Test Strips and Control Solution are identical to the previously cleared system. The iBGStar BGMS has all the same technological and performance characteristics as the predicate." Therefore, the previous performance data for K103544 is considered applicable and sufficient. No new studies on the core blood glucose measurement accuracy are reported here. |
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of this 510(k) submission being an update for compatibility with new accessories rather than a new core device, detailed sample sizes for the "test set" (in the typical sense of clinical performance) are not provided in this summary.
- Disinfection and Robustness Test Set: This involved the physical components: iPhone 5, iPod touch 5th generation, Apple Lightning to 30-pin Adapter, and Apple Lightning to 30-pin Adapter (0.2m) cable. The "sample size" here refers to the number of individual devices/adapters tested, which is not specified but implicitly sufficient for the tests performed (e.g., "the tested devices").
- Verification and Validation: The number of tests/data points for validating the data transfer via the new adapters is not specified.
- Human Factors Study: The sample size for the human factors study is not specified in this summary.
- Data Provenance: Not specified for these specific tests in this summary. The manufacturer is US-based. These tests are prospective, conducted for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable (N/A) for this submission.
The studies described (disinfection, robustness, verification/validation of connectivity, human factors for adapter connection) do not involve establishing a clinical "ground truth" using medical experts like radiologists. They are engineering and usability tests. The "ground truth" for the disinfection study was the complete inactivation of live virus, observed directly (laboratory result). For robustness, it was the maintenance of performance and material integrity. For verification/validation and human factors, it was the successful connection and data transfer by users, assessed against functional requirements.
4. Adjudication Method for the Test Set
This section is N/A for this submission.
The studies described do not involve a medical diagnosis or interpretation that would require an adjudication method (like 2+1 or 3+1 consensus). The outcomes are objective measurements or functional verifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This section is N/A for this submission.
An MRMC study is typically for evaluating the diagnostic performance of a system (often AI-based) and comparing human readers with and without AI assistance. This submission is for an updated blood glucose monitoring system and its associated data management app's compatibility with new phone accessories. It does not involve a diagnostic AI component in the sense of image interpretation or similar tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The "iBGStar Diabetes Manager Application" is a standalone software accessory in that it collects and displays data. This submission is about ensuring its connectivity with newer hardware accessories. The core 'standalone' performance (data logging, trend charting) of the application itself was likely established in the predicate 510(k) (K103544).
The described verification and validation protocols for K130535 specifically tested the standalone functionality of data transfer via the new adapters.
7. The Type of Ground Truth Used
- Disinfection Study: Laboratory-confirmed complete inactivation of live virus.
- Robustness Testing: Objective measurements of device performance and material integrity before and after simulated use cycles.
- Verification and Validation: Successful data transfer and system functionality, verified against predefined technical specifications.
- Human Factors Study: Observation and measurement of user success in connecting and transferring readings, likely against criteria for ease of use and error rates.
None of these studies utilized medical "gold standards" such as pathology, expert consensus on images, or long-term outcomes data, as they are not clinical performance studies for a new diagnostic capability.
8. The Sample Size for the Training Set
This section is N/A for this submission.
The device itself is a blood glucose monitor and a data management application. It is not described as an AI/Machine Learning device that requires a "training set" in the context of developing an algorithm for diagnostic or predictive tasks. The tests reported here are for hardware compatibility and usability, not algorithm development.
9. How the Ground Truth for the Training Set Was Established
This section is N/A for this submission, as there is no mention of an algorithm training set in the AI/ML sense.
§ 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.