(48 days)
The Tandem Mobi 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, 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 in individuals 2 years of age and greater.
The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the Tandem Mobi Mobile Application and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The Tandem Mobi Mobile Application ("Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications, and messages. The Tandem Mobi Mobile Application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem Mobi Mobile Application will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.
The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.
The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.
This document is a 510(k) summary for the Tandem Mobi insulin pump with interoperable technology, submitted to the FDA. It primarily focuses on demonstrating substantial equivalence to a predicate device (K233044).
Based on the provided text, the acceptance criteria and study proving the device meets them pertain to a diabetes management system (insulin pump), not an AI/ML-driven diagnostic or image-analysis device. Therefore, many of the requested points regarding AI/ML study design (e.g., ground truth establishment for a test set, expert consensus, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
The document discusses "Clinical Testing" but states that the same testing provided in a previous 510(k) (K232380) was used. This implies that the current submission (K240309) is not presenting a new, dedicated clinical study for its substantial equivalence claim, but rather leveraging prior clinical data from a related submission.
However, I can extract the relevant information from the provided text based on the nature of this device type and the 510(k) submission process.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table of specific acceptance criteria in the traditional sense of numerical thresholds for algorithm performance (like sensitivity/specificity for AI). Instead, it relies on demonstrating substantial equivalence to a predicate device (K233044). The "performance" is implicitly deemed acceptable if it performs the same function and does not raise new questions of safety or effectiveness compared to the predicate.
The key changes and comparisons are:
| Feature/Characteristic | Predicate Device (K233044) | Subject Device (Tandem Mobi insulin pump with interoperable technology) | Performance/Conclusion |
|---|---|---|---|
| Intended Use / Indications for Use | Subcutaneous delivery of insulin, at set and variable rates, for diabetes management in persons requiring insulin. Reliably and securely communicates with compatible, digitally connected devices (including automated insulin dosing software) to receive, execute, and confirm commands. Intended for single patient, home use, requires prescription. Indicated for individuals six years of age and greater. | Same, but indicated for individuals 2 years of age and greater. | DIFFERENT (widened age range). This is the primary difference identified. |
| Prescription Use | Required | SAME | SAME |
| Insulin Type | NovoLog or Humalog U-100 insulin | SAME | SAME |
| Infusion Set Type | Compatible, FDA cleared infusion sets with t:lock connectors manufactured for Tandem Diabetes Care. | SAME | SAME |
| Pump Type | Alternate Controller Enabled Infusion Pump (ACE) (21 CFR 880.5730) | SAME | SAME |
| Compatible Interoperable Devices | Dexcom G6 Continuous Glucose Monitoring System or other compatible iCGM; K200467: Control-IQ technology | SAME | SAME |
| Communication with Interoperable Devices | Bluetooth Low Energy (BLE) | SAME | SAME |
| Principles of Operation | Delivery of Insulin (Bolus and Basal) programmed by patient based on health care provider recommendations. | SAME | SAME |
| Pump Technological Characteristics | Ambulatory, battery operated, rate-programmable infusion pump for subcutaneous insulin delivery. Disposable cartridge (motor driven) for basal rates and boluses. | SAME | SAME |
| Alarm Type | Visual, audible, and vibratory | SAME | SAME |
| Bolus Calculator | Built-in | SAME | SAME |
| Bolus and Basal Insulin Control | Yes | SAME | SAME |
| Display of Primary Glucose and Therapy Information | Pump does not include a graphical user interface. Information displayed in the Tandem Mobi Mobile Application. | SAME | SAME |
| Use of Mobile Application | The t:connect mobile app (paired with Tandem Mobi Insulin Pump and iOS compatible smartphone) controls all aspects of pump therapy (view data, program boluses, terminate boluses, update historical data). Required and not optional. | DIFFERENT: t:connect Mobile App split into two apps (one for t:slim X2, one specific to Tandem Mobi - "Tandem Mobi Mobile Application"). | DIFFERENT (app structure change). |
| Sterilization | Pump: Non-sterile. Cartridge: Sterile via Ethylene Oxide Gas to SAL 10-6. | SAME | SAME |
| Cartridge Length of Use | Every 3 days for compatible insulins. | SAME | SAME |
The overall "performance" is that the Subject Device "serves the same function as the Predicate Device" and "performs insulin therapy functions that are the same as that of the Predicate Device." The key performance difference identified is the expanded age indication from 6 years of age and greater to 2 years of age and greater.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of a "test set" for performance evaluation of an algorithm. The filing mentions "Clinical Testing was provided to support this 510(k) Notification. The clinical testing provided was the same testing provided in 510(k) K232380." The details of sample size for that K232380 study are not in this document.
- Data Provenance: Not specified in this document (e.g., country of origin, retrospective/prospective). This information would be found in the K232380 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable to this type of device and submission. Ground truth for an insulin pump's functionality is typically established through engineering bench testing, simulated use, and clinical trials (for safety and efficacy in delivering insulin and managing blood glucose), rather than expert radiological review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. This is not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The device is an insulin pump that works with compatible interoperable technology, including automated insulin dosing software, but details on the performance validation of that software's algorithm are outside the scope of this specific 510(k) summary for the pump itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For an insulin pump, "ground truth" would relate to its ability to accurately and safely deliver insulin, receive and execute commands, and remain connected. This would be established through:
- Engineering specifications and bench testing (e.g., infusion accuracy, flow rates, alarm functionality).
- Software verification and validation (for reliable communication and command execution).
- Clinical data (likely outcomes data relating to glycemic control, safety, and adverse events if a study was performed in support of K232380).
- Usability/Human Factors testing (ensuring safe and effective interaction for the user).
The document states: "Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended." This testing included:
- Usability/Human Factors (comparative Use Related Risk Analysis only, no new testing)
- Software Verification and Validation (no new testing)
- Electrical Safety/EMC (no new testing)
- Insulin Compatibility and Biocompatibility (no new testing)
- Sterilization and Shipping (no new testing)
- Special Controls (adherence confirmed)
- Clinical Testing (same as K232380)
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that uses training sets in this context.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.