(254 days)
The embecta Insulin Delivery System with interoperable technology (the Patch) is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch 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 patch is intended for single patient, home use and requires a prescription.
The embecta Insulin Delivery System is a prescription home use device intended to support insulin therapy for diabetes mellitus (DM) management. The embecta Insulin Delivery System is a disposable insulin delivery device (referred to as a Patch) that is operated by a Controller which consists of Controller software application provided on a locked down smartphone with Bluetooth Low Energy (BLE) and Wi-Fi capabilities. The embecta Insulin Delivery System performs the following functions: 1) Deliver user-set daily basal insulin 2) Deliver user-set or user-entered mealtime (prandial) or correction insulin doses 3) Generate system status and notifications. The Patch is a single use disposable patch pump device intended to be worn by the patient for a Patch Life period of up to 72 hours (3 Days). The Patch is adhered to the patient using a medical grade adhesive patch. The Patch features a syringe pump design that operates dose increment mechanism which controls the dose size. It stores and administers 300 U of user-filled U-100 insulin with variable basal and bolus dosage settings that are agreed upon between the user and their healthcare practitioner or provider. It is indicated for U-100 NovoLog® (insulin aspart) and U-100 Humaloq® (insulin lispro). The Controller App is a smartphone app running on a locked-down Android smartphone that is rechargeable with the provided charger. The Controller App will control the Patch. The embecta-provided smartphone will be non-sterile and is locked to run only the embecta Controller App to program the Patch discreetly. The Controller App will enable the user to pair, prime, and program basal and bolus dose via wireless transmission to the Patch as well as provide users with system alerts, including status information, and notifications. This includes, but is not limited to, controller battery life, total insulin delivered, calculation of a low insulin reservoir volume, occlusion, and other possible device faults. The Controller App is designed to program and display the patient's basal insulin delivery rate, delivered bolus doses, and insulin usage data on a color display touch screen.
The provided text is a 510(k) Summary for the embecta Insulin Delivery System. It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical performance data. There is no mention of a study involving AI/ML components or human reader performance. Therefore, I cannot provide information regarding:
- Number of experts used to establish ground truth
- Adjudication method
- Multi Reader Multi Case (MRMC) comparative effectiveness study
- Effect size of human readers improving with AI assistance
- Standalone (algorithm only) performance
- Sample size for the training set
- How the ground truth for the training set was established
However, based on the non-clinical performance data provided, I can construct a table of acceptance criteria (implicit from the reported performance) and the reported device performance for dose delivery accuracy and occlusion detection.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the reported performance data, which demonstrates the device's capability within specific tolerances.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (embecta Insulin Delivery System) |
|---|---|
| Basal Delivery Accuracy | |
| At rates ≥ 1U/hr | ±5% accuracy (e.g., 1.00 U/hr delivered 0.99 U, 30.00 U/hr delivered 30.13 U) |
| At 0.05U/hr | ±15% accuracy (e.g., 0.05 U/hr delivered 0.048 U) |
| Bolus Delivery Accuracy | |
| For amounts ≥ 1.0 U | ±5% accuracy (e.g., 6.00 U delivered 5.99 U; 30.00 U delivered 30.09 U) |
| For amounts |
§ 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.