(469 days)
The t:slim X2 insulin pump with interoperable technology (the Pump) is intended for the subcutaneous delivery of insulin. at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.
The t:connect mobile app can be wirelessly paired to the t:slim X2 Insulin Pump with Interoperable Technology, for the purposes of allowing limited control of bolus insulin therapy. The t:connect mobile app is available on iOS and Android compatible smartphones via the Apple Store® and Google Play Store®. When successfully paired with The Pump, users have the ability to perform the following via the t:connect mobile app:
- View The Pump therapy data, trends, alerts, alarms, notifications, and reminders as a secondary display.
- Program Correction Boluses, Bolus Override, and Food (Standard) Boluses.
- Terminate (Cancel or stop) all bolus types regardless of origin of bolus request being made on the t:slim X2 Insulin Pump or the t:connect mobile app.
Outside of programming and terminating boluses, the t:connect mobile app will have no other controlling action on The Pump.
The provided document describes the FDA 510(k) clearance for the t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app). It focuses on the addition of the mobile app to allow limited control of bolus insulin therapy.
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
No specific quantitative acceptance criteria or detailed study results (like sensitivity, specificity, or specific error rates) are explicitly reported in this 510(k) summary for the t:connect mobile app. The submission primarily relies on non-clinical testing (human factors, software verification and validation, cybersecurity) and demonstrates substantial equivalence to a predicate device.
The clearance is for a medical device (insulin pump with a mobile app for control), not an AI/ML algorithm that predicts or diagnoses based on data. Therefore, many of the typical AI/ML study components (like expert ground truth establishment, MRMC studies, standalone algorithm performance, or specific performance metrics like AUC, sensitivity, specificity, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for this device.
The study aims to demonstrate that the mobile app addition is safe and effective and does not raise new questions of safety or effectiveness compared to the predicate device.
Acceptance Criteria and Reported Device Performance
Given the nature of this device (insulin pump with a mobile app for control), the "acceptance criteria" are more about functionality, safety, and human usability rather than diagnostic accuracy metrics.
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Summary from text) |
|---|---|---|
| Functionality | t:connect mobile app allows: |
- Viewing Pump therapy data, trends, alerts, alarms, notifications, and reminders as a secondary display.
- Programming Correction Boluses, Bolus Override, and Food (Standard) Boluses.
- Terminating (Cancelling or stopping) all bolus types regardless of origin of bolus request.
Pump functions independently from the mobile app.
Mobile app does not control or impact automated dosing algorithms (Basal-IQ, Control-IQ).
Bolus Calculator: Mobile app includes a built-in Bolus Calculator with the same purpose and function as the Pump's. Pump sends info to app for bolus calculation.
Display of Alerts/Notifications: Mobile app displays Pump Notifications, Alerts, Alarms, and Reminders. Specific alerts for "Pump Connection Lost" and "t:connect Mobile App Incomplete Bolus Alert." Specific notification for "Bolus in Progress on Pump." (Mobile app cannot clear/alter; requires Pump for that.)
Logging Critical Events: Pump logs bolus requests and terminations from the app. Mobile app logs actions of bolus initiation/termination. | The device (Pump with t:connect mobile app) met specified requirements and performed as intended. - The t:connect mobile app enables the listed functionalities for viewing data and controlling bolus insulin.
- The mobile app and pump retain independent functionality where appropriate.
- The bolus calculator functions as described.
- Alerts, alarms, and notifications are displayed on the app as intended.
- Critical events, including actions from the mobile app, are logged by the system. |
| Safety | Human Factors: Demonstrate intended users can effectively use the Subject Device for its intended purpose in expected use environments, ensuring safe use.
Software Verification & Validation (V&V): Ensure software conforms to patient needs and intended uses, implying absence of critical errors, accurate execution of commands, and data integrity.
Cybersecurity: Evaluate and ensure the device's resilience against cyber threats to prevent unauthorized access or manipulation.
Risk Management: Compliance with ISO 14971 implies a robust risk management process. | Human Factors: Results from the human factors study demonstrate users can safely and effectively use the features of the Subject Device.
Software V&V: Carried out activities (requirements linking, code inspection, static analysis, unit/system testing) to ensure specified conformity.
Cybersecurity: Evaluations were carried out.
Risk Management: Compliance with relevant standards (ISO 14971, IEC 62304) for risk management and software lifecycle processes implicitly ensures safety.
Overall: The device does not raise any new or different questions of safety or effectiveness. |
| Effectiveness | The device, with the mobile app, should continue to effectively manage diabetes mellitus in persons requiring insulin. The mobile app's role is to facilitate limited control of bolus insulin therapy. | The device functions as an alternate controller enabled infusion pump, providing the intended functionality for insulin delivery and bolus control via the app. |
Study Details
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Sample sizes used for the test set and data provenance:
This document focuses on non-clinical testing (human factors, software V&V, cybersecurity) and does not specify a "test set" in the context of a clinical trial or algorithm performance evaluation on a patient dataset.- Human Factors Validation Testing: While the document states "Human factors validation testing was conducted," it does not specify the sample size (number of participants) or data provenance (e.g., country of origin, retrospective/prospective).
- Software Verification and Validation: This testing involves internal software evaluations, code reviews, unit testing, and system-level testing. There isn't typically a "sample size" in the same way as a clinical dataset for these activities. The provenance relates to the software development process itself.
- No new clinical testing was required. This indicates no patient data was used for a new clinical study to support this specific 510(k) for the mobile app.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Specified in this context. For human factors, "ground truth" would be related to user performance outcomes and safety, assessed by usability engineers or similar experts rather than medical specialists establishing diagnostic ground truth from images or clinical data. The document does not specify the number or qualifications of experts for these assessments.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Specified. This type of adjudication is typically for establishing medical "ground truth" in diagnostic studies, which was not performed here.
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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:
- No. This type of study (MRMC for AI assistance) is not applicable to an insulin pump and its control app. This device does not involve "human readers" interpreting medical images or data with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable in the traditional AI/ML sense. The software itself undergoes comprehensive standalone verification and validation to ensure its functional correctness and safety, but this is distinct from "standalone performance" of a diagnostic AI algorithm. The device, including the app, is designed for human-in-the-loop use for insulin delivery.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For a device like an insulin pump and its control app, "ground truth" isn't established in the same way as for diagnostic AI. Instead, the "ground truth" for safety and effectiveness is established through:
- Functional Requirements: The expected, correct operation of the software and hardware.
- Usability Objectives: The desired safe and effective user interaction, verified through human factors testing.
- Regulatory Standards & Guidance: Adherence to established medical device software, cybersecurity, and risk management standards.
- Not Applicable. For a device like an insulin pump and its control app, "ground truth" isn't established in the same way as for diagnostic AI. Instead, the "ground truth" for safety and effectiveness is established through:
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The sample size for the training set:
- Not Applicable. This device is not described as using machine learning that has a "training set" in the context of data-driven model training. Its functionality is based on pre-defined algorithms for insulin delivery control.
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How the ground truth for the training set was established:
- Not Applicable. No training set for an AI/ML algorithm is mentioned.
§ 880.5730 Alternate controller enabled infusion pump.
(a)
Identification. An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
e.g., head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
e.g., occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
e.g., temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
e.g., battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
e.g., reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
e.g., establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is 250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.