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510(k) Data Aggregation
(197 days)
The Lingo Glucose System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, and display glucose values in people 18 years and older not on insulin. The Lingo Glucose System helps to detect euglycemic glucose levels. The Lingo Glucose System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
The Lingo Glucose System (also referred to as 'System') is Abbott's latest biowearable evolution in health technology for glucose measurement. This system encourages users 18 years and older not on insulin, to understand how glucose impacts their body. The Lingo Glucose System includes the Lingo Glucose Biosensor and the Lingo App.
Lingo Biosensor: The Lingo Glucose Biosensor hardware and technology is based on the FDA-cleared FreeStyle Libre 2 (FSL2) sensor (K222447). The Biosensor is a single use disposable on-body Biosensor that incorporates a subcutaneously implanted electrochemical glucose sensor and associated electronics. The Biosensor can be worn for up for 14 days and transmits data to the Lingo App via Bluetooth Low Energy (BLE). Similar to the predicate device, a disposable Biosensor insertion device, consisting of a Biosensor Applicator and Biosensor Pack is used to assemble and apply the Biosensor to the back of the user's upper arm.
Lingo App (iOS): When downloaded on a compatible smartphone running on iOS, the Lingo App uses Near-Field Communication (NFC) to start a new Biosensor and uses BLE to receive glucose data from the Biosensor. The user can view real-time glucose value, trend arrow, and glucose graph on the app through a glucose range of 55-200 mg/dL. The Lingo App contains on-boarding materials with a self-selection questionnaire that a user must consent prior to using the device. The App does not provide any glucose or system alerts.
The Lingo Glucose System (K233655) is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended for continuous measurement, recording, analysis, and display of glucose values in people 18 years and older not on insulin. It aims to help users detect euglycemic and dysglycemic glucose levels and understand the impact of lifestyle modifications on glucose excursions.
Here's an analysis of its acceptance criteria and the study used to demonstrate fulfillment:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance relies on the substantial equivalence of the Lingo Glucose System to its predicate device, the FreeStyle Libre 2 Flash Glucose Monitoring System (K222447). The clinical performance acceptance criteria for the Lingo Glucose System are tied to meeting the iCGM special controls requirements per 21 CFR 862.1355. While specific numerical acceptance criteria for accuracy (e.g., MARD percentage) are not explicitly stated in the provided text, the documentation states that the device demonstrated accuracy (clinical performance) meeting these iCGM special controls.
| Acceptance Criteria Category | Specific Criteria (Inferred from iCGM Special Controls & document) | Reported Device Performance (Lingo Glucose System) |
|---|---|---|
| Clinical Performance (Accuracy) | Meets iCGM special controls requirements per 21 CFR 862.1355 for glucose accuracy. | Statistical analysis confirmed the device met all specified criteria for glucose data accuracy, supporting compliance with iCGM special controls. (Leveraged clinical data from FSL2 study K222447). |
| Sterility | Meets ISO11137-1 and ISO 11137-2 for electron beam sterilization. | Applicable from predicate FSL2 sensor due to design similarities; predicate met these standards. |
| Shelf-Life, Packaging Integrity, Shipping | 9-month shelf life with storage temp 2°C - 28°C and humidity 10-90% RH non-condensing. | Same as predicate (9 months shelf life, same storage conditions). No additional testing required due to shared design and manufacturing. |
| Electrical Safety | Compliance with IEC 60601-1: 2005(r)2012, IEC 60601-1-6:2010+A1:2013, and IEC 60601-1-11:2015. | Demonstrated compliance for the Biosensor. |
| Electromagnetic Compatibility (EMC) | Withstands electromagnetic interference and emissions (IEC 60601-1-2, IEC CISPR 11). Wireless coexistence with other devices (FDA Guidance, AAMI TIR69, ANSI C63.27). Compliance with FCC Regulations and FAA Advisory Circular RTCA DO-160. | Testing performed; the system is able to withstand EMI/emissions, performs within limits with other devices, and demonstrated compliance with FCC and FAA regulations. |
| Mechanical Engineering | Mechanical, electrical, and functional testing meet acceptance criteria. | Test results showed that mechanical, electrical, and functional testing all met the acceptance criteria. |
| Biocompatibility | Evaluation in accordance with ISO10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." | Applicable from predicate device due to identical user-contacting materials. |
| Software Verification & Validation | Compliance with established specifications and IEC 62304; documentation per FDA Guidance. | Results met acceptance criteria, supporting that software is acceptable for intended use. |
| Cybersecurity | Risk management documentation per FDA Guidance, including analysis of confidentiality, integrity, availability; appropriate risk mitigation. | Cybersecurity risk management documentation provided; risk assessment performed; appropriate controls implemented and tested. |
| Human Factors | Risk analysis of design differences with predicate and Lingo App per ANSI/AAMI/IEC 62366, IEC 60601-1-6, and FDA Guidance. | User interface found to be adequately designed for intended users, uses, and environments. |
2. Sample Size Used for the Test Set and Data Provenance
The Lingo Glucose System leverages the clinical data from the FreeStyle Libre 2 (FSL2) study (K222447). The text states: "Abbott conducted a statistical analysis to confirm that the clinical data of the FSL2 System (submitted under K222447) can be leveraged to support the Lingo Glucose System."
- Sample Size for Test Set: Not explicitly stated for the FSL2 study in this document.
- Data Provenance: Not explicitly stated in this document. Based on typical FDA submissions for iCGM devices and considering the predicate device (FreeStyle Libre 2), these trials are generally prospective and multi-center, often involving participants from various healthcare systems or regions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For iCGM studies, ground truth is typically established by laboratory reference methods (e.g., YSI glucose analyzer) rather than expert consensus on images or clinical assessments.
4. Adjudication Method for the Test Set
This information is not provided in the given text. Again, for iCGM studies, the reference method provides the ground truth, so expert adjudication methods (like 2+1 or 3+1 used in imaging studies) are typically not applicable to the establishment of the ground truth itself.
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
An MRMC study is not applicable to this device. The Lingo Glucose System is a continuous glucose monitor (CGM) and does not involve human "readers" interpreting medical images or data in a way that would necessitate an MRMC analysis of AI assistance. Its primary function is direct glucose measurement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the clinical performance assessment of the Lingo Glucose System (by leveraging the FSL2 data) effectively represents a standalone algorithm performance study relative to the reference glucose measurements. The "system accuracy was demonstrated to meet the iCGM special controls requirements." The device continuously measures and reports glucose values, which is an algorithmic output compared against a reference standard. The user interacts with the app to view these values, but the core accuracy is an algorithmic function.
7. The Type of Ground Truth Used
The ground truth for iCGM devices is almost universally established by laboratory reference methods for glucose measurement, such as a YSI glucose analyzer, from blood samples drawn contemporaneously with the interstitial fluid measurements. The text refers to "clinical data" and "sensor performance," implying a comparison against such a gold standard.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for the training set. It mentions that "ADC Glucose Algorithm established for the predicate device" is used for the Lingo Glucose System. The development and training of such an algorithm would have involved a substantial dataset, but the specifics are not detailed here.
9. How the Ground Truth for the Training Set Was Established
The document states that the "ADC Glucose Algorithm established for the predicate device" is used. For this type of algorithm, the ground truth for its development (training) would have been established through a combination of:
- Laboratory reference glucose measurements: From blood samples.
- Contemporaneous interstitial fluid readings: From prototype or earlier versions of the sensor.
- Extensive data collection: From a diverse population under various physiological conditions (e.g., different glucose levels, meals, exercise).
This data would be used to develop and refine the algorithm that translates the electrochemical signals from the sensor into accurate glucose readings.
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