(88 days)
The Omnipod DASH Insulin Management System (the Pump) with interoperable technology is intended for 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 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, Humalog, Admelog, or Apidra U-100 insulin.
The Omnipod DASH™ Insulin Management System with interoperable technology provides for the management of insulin therapy by patients with diabetes mellitus. It is comprised of two primary components: the disposable insulin infusion pump (Pod), and an associated Bluetooth Low Energy (BLE) enabled remote controller. The Omnipod DASH System with interoperable technology is provided with the DASH Personal Diabetes Manager (PDM), but future alternate controllers may be established. The DASH PDM incorporates a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, programmable correction factor, insulin to carbohydrate ratio, target blood glucose value and Insulin on Board (IoB).
The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The DASH PDM is a handheld device that controls the Pod. The user interfaces with the device system through the DASH PDM using a touch screen, similar to a smartphone, where they control basal and bolus delivery and various insulin program settings and calculations. The DASH PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The device system is for prescription use only.
The remote control design of the Pod inherently enables connectivity to other interoperable controllers with new functionality. Capabilities can be built into compatible controllers to add functionality such as Automated Insulin Delivery (AID) systems. In this design, a controller may contain an algorithm and connect to an iCGM system. In such an integrated system, the AID controller would be responsible for coordinating the interoperable devices (Omnipod DASH and iCGM) in order to automate delivery. It would read the Pod for insulin delivery status, read the iCGM for the sensor value, compute an automated delivery amount and then command the Pod to deliver the required insulin amount. For this automated delivery to occur, the Controller is required to be in range of the Pod. The Pod is designed to the programmed basal rate in the case of extended loss of communication.
This document describes the Omnipod DASH™ Insulin Management System with interoperable technology. It is a 510(k) premarket notification for a Class II medical device, an alternate controller enabled infusion pump.
Key takeaway: This documentation confirms that the Omnipod DASH system is a medical device for insulin delivery, and the submission is for expanding its indications for use to include interoperable technology, allowing it to communicate with compatible digital devices. The FDA has determined it is substantially equivalent to existing devices.
Here's an analysis based on the provided text, focusing on the requested criteria for an AI/ML device, even though this document is for an infusion pump. It's important to note that the provided text is for an insulin pump, not an AI/ML diagnostic or assistive device. Therefore, many of the requested criteria (like ground truth, MRMC studies, expert adjudication) are not applicable in their typical sense for this type of medical device.
However, I will interpret the acceptance criteria in the context of a medical device submission, particularly for an infusion pump, and extract information where parallels can be drawn.
Acceptance Criteria for Omnipod DASH™ Insulin Management System with Interoperable Technology
The acceptance criteria for this device, as outlined in the "Special Control" section, predominantly focus on the safety and performance of the insulin pump itself, especially given its new interoperable functionality. The performance data presented demonstrates how the device meets these controls, often by stating that the subject device is identical to previous cleared versions (K182630 and K180045) and that previous testing is applicable, with some additional characterization.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Special Control) | Reported Device Performance and Evidence Provided |
|---|---|
| Infusion Delivery Accuracy: Device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions (includes specifications for ambient temp, pressure, fluid properties; testing met design input requirements for programmable range of rates/volumes, statistically valid number of devices). | All performance testing from K182630 and K180045 is applicable. Further characterization conducted and submitted in this 510(k). Delivery accuracy was specifically conducted for this submission (though specific results are not detailed in this summary). |
| Hazard Detection: Ability of the pump to detect relevant hazards (occlusions, air in line) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Appropriate performance validation under conditions of use. | The subject device is identical to DASH system in K182630/K180045. All testing (except delivery accuracy) was completed to demonstrate hazard detection in K182630 and K180045. Traceability of hazards to risk controls and verification evidence is included in the System Hazard Analysis. |
| Drug Compatibility: Compatibility with specified drugs, including assessment of drug stability under reasonably foreseeable use conditions (temp, light, etc.). | The subject device is identical to DASH system in K182630/K180045. All validation testing demonstrating compatibility with insulin was provided in K180045 and K182630. Device is only intended for U-100 insulin delivery. |
| Biocompatibility: Device parts directly or indirectly contacting the patient must be demonstrated to be biocompatible (chemical, particulate characterization, risk of harm from residues). | The subject device is identical to DASH system in K182630/K180045. Biocompatibility of patient-contacting parts (adhesive pad) demonstrated with cytotoxicity, sensitization, skin irritation studies (all passing). Biocompatibility of fluid-path parts demonstrated with cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility (all passing). |
| Reliability over Use Life: Evidence verifying and validating that the device is reliable over the ACE pump use life in terms of all device functions and pump performance. | The subject device is identical to DASH system in K182630/K180045. No additional shelf life testing was completed for Omnipod DASH with interoperable technology. |
| Electrical Safety, EMC, RF Wireless Safety: Designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements. | The subject device is identical to DASH system in K182630/K180045. No additional electrical safety and electromagnetic compatibility testing was completed for Omnipod DASH with interoperable technology. |
| Cross-channeling (for multi-drug devices): Risk of cross-channeling drugs must be adequately mitigated. | Omnipod DASH is only intended for U-100 insulin delivery. (Therefore, cross-channeling is not applicable). |
| Reprocessing (for multi-patient use): Validation of reprocessing procedures if intended for multiple patient use, demonstrating all functional and performance requirements are met after reprocessing. | Omnipod DASH with interoperable technology is intended only for single-patient use. The Pod is a single-use disposable. The PDM is a non-sterile single-use patient component. (Therefore, reprocessing is not applicable). |
| Interoperable Interface Specifications: Validated interface specifications for digitally connected devices (secure authentication, secure/accurate/reliable data transmission, sharing necessary state information, safe operation with out-of-bounds data, detailed process for sharing/validating protocol). | The interface between the Omnipod DASH controller (PDM) and pump (DASH Pod) has been specified and validated. Insulet has a detailed process for sharing the pump interface specification and validating correct implementation. |
| Critical Event Logging: Record of critical events stored and accessible for auditing of communications and sharing information with responsible parties. Minimum events: drug delivery, commands/confirmations, malfunctions, alarms/alerts, connectivity events. | Insulin delivery commands are logged in the PDM's memory. Execution of commands stored in Pod's memory (basal/bolus pulses) and confirmed with PDM. Pod/PDM logs allow auditing of failures (includes all special controls requirements). PDM stores 90 days of alarms/alerts/acknowledgements. PDM stores short duration (~3 days) of communication connectivity. Insulet ensures logging requirements met/verified for external controllers. |
| Human Factors Study: Design verification and validation includes human factors study demonstrating safe use by intended user. | Not explicitly detailed in this summary, but implied by the statement "No additional shelf life testing was completed for Omnipod DASH with interoperable technology" and the general nature of device clearance. The larger context of a 510(k) submission would typically include this or refer to previous submissions where it was performed. |
| Device Labeling: Labeling must include: compatible drugs/concentration, min/max basal/bolus rates/increments, pump accuracy description (bolus/basal at min/intermediate/max), hazard alarm perf (occlusion), wireless QoS, reprocessing instructions (if applicable). | Omnipod DASH User Guide updated to contain information from special controls. The performance testing provided in K182630 and K180045 are applicable to the subject device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for tests. It generally refers to previous clearances (K182630, K180045) for most testing, stating that the subject device is "identical" or that previous testing is "applicable," with "further characterization" or "delivery accuracy" specifically conducted for this submission.
- Sample Size: Not explicitly stated for specific tests in this summary. It mentions "statistically valid number of devices" as a requirement for delivery accuracy testing in the special control.
- Data Provenance: The data comes from the manufacturer's (Insulet Corporation) internal testing and previous FDA submissions (K182630, K180045). The country of origin for the data is not specified but is implied to be within Insulet's testing facilities (Acton, MA, USA is their address). The data would be prospective in nature, generated specifically for these regulatory submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable in the context of this device. The Omnipod DASH Insulin Management System is an infusion pump, not a diagnostic device that relies on human expert interpretation of data (like medical images) to establish ground truth. The "ground truth" for this device relates to its physical and functional performance (e.g., accurate insulin delivery, proper communication), which is established through engineering and performance testing against predefined specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting data or making diagnoses, and their initial assessments need to be reconciled to establish a consensus ground truth. For an infusion pump, performance is measured objectively via test equipment and quantitative outputs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done or applicable. MRMC studies compare the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging or similar fields. This device is an insulin pump, not a diagnostic tool where human interpretation is being augmented.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This concept is partially applicable but in a different context. The "algorithm" here is the pump's internal software controlling insulin delivery and communication. The "standalone" performance would be the pump's ability to deliver insulin accurately and communicate reliably based on pre-programmed settings or commands, independent of a human directly monitoring every millisecond. The performance tests (delivery accuracy, hazard detection, interoperability) are essentially evaluations of the pump's "standalone" (or automated) functional performance. The human (user) interacts with the PDM to initiate commands, but the core function (insulin delivery) is automated by the pump's internal algorithms.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications, established physical measurement methods, and regulatory standards for insulin pump function and safety.
Examples:
- For "infusion delivery accuracy," the ground truth is the precisely measured volume of fluid delivered compared to the commanded volume, determined using calibrated equipment.
- For "hazard detection," the ground truth is a simulated hazard (e.g., occlusion) and the objective measurement of the time taken for the pump to detect and alarm, compared against predefined safety limits.
- For "biocompatibility," the ground truth is the absence of adverse biological reactions, confirmed by standardized in-vitro and in-vivo tests according to ISO standards.
8. The Sample Size for the Training Set
This is not applicable in the AI/ML sense. This device is a traditional medical device (an infusion pump) with embedded software. It does not learn or get "trained" from data in the way a machine learning algorithm does. Its operation is based on deterministic algorithms and hardware.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" for an AI/ML model for this device. The ground truth for its development and validation (e.g., engineering specifications, performance requirements) is established through established medical device development processes, risk analysis, and compliance with national and international standards (e.g., ISO, FDA guidance).
§ 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.