(627 days)
The DEKA ACE Pump System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages 13 and above. 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 bolus calculator is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator-entered blood glucose, insulin to carbohydrate ratio, target glucose values, and current insulin on board.
The DEKA ACE Pump System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages 13 and above. 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 system as described in this submission is able to be integrated with a Dexcom G6 interoperable Continuous Glycemic Controller (iCGM). This submission also details the integration process that can be used to incorporate an iAGC.
The DEKA ACE Pump System consists of the following components:
- Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to an DEKA ACE Pump cassette, Remote Interface, iCGM, and iAGC. The pump is powered by a rechargeable lithium ion battery.
- Cassette: A single-use pumping cassette that combines microfluidic valves, a pump chamber, insulin reservoir, and Acoustic Volume Sensing (AVS) measurement chamber. The cassette interfaces to an DEKA ACE Pump and off-the-shelf infusion set.
- Remote Interface (Controller): A wireless controller that serves as the user interface to the DEKA ACE Pump system. This includes a large color touch display for ease of use.
The provided text describes the DEKA ACE Pump System, an insulin pump, and its comparison to a predicate device (Tandem t:Slim X2 insulin pump) for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence, primarily through non-clinical performance testing rather than clinical studies involving human patients.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document presents basal and bolus accuracy as performance metrics, comparing the subject device (DEKA ACE Pump) to the predicate device (Tandem t:Slim X2). The acceptance criteria for these accuracies are implicitly set by matching or improving upon the predicate device's performance, and by meeting the "Special Controls" requirements for this device type.
Basal Accuracy Comparison (Example for 0.1 U/hr)
| Interval | Predicate (Tandem DEN180058) - 0.1 U/hr Basal Accuracy | Subject Device (DEKA ACE Pump) - 0.1 U/hr Basal Accuracy | Acceptance Criteria (Implicit) |
|---|---|---|---|
| 1 hour | Average: 0.12 U, Min: 0.09 U, Max: 0.16 U | Average: 0.12 U, Min: 0.09 U, Max: 0.17 U | Comparable to or better than predicate; meets Special Controls. |
| 6 hours | Average: 0.67 U, Min: 0.56 U, Max: 0.76 U | Average: 0.62 U, Min: 0.57 U, Max: 0.66 U | Comparable to or better than predicate; meets Special Controls. |
| 12 hours | Average: 1.24 U, Min: 1.04 U, Max: 1.48 U | Average: 1.22 U, Min: 1.16 U, Max: 1.31 U | Comparable to or better than predicate; meets Special Controls. |
Bolus Accuracy Comparison (Example for 0.05U Bolus Accuracy - % of boluses within ranges)
| Range | Predicate (Tandem DEN180058) - 0.05U | Subject Device (DEKA ACE Pump) - 0.05U | Acceptance Criteria (Implicit) |
|---|---|---|---|
| 110%. | |||
| 25-90%) within 95-105% range.** | |||
| 105-250% | 0.0% | 0.0% | |
| Note: The subject device shows a higher percentage in some broader ranges (e.g., 75-90%, 90-95%) but crucially maintains a similar performance in the tightest 95-105% range and reduces extreme deviations. |
Other performance criteria mentioned in the "Non-Clinical/Performance Testing" section include:
- Worst Case Accuracy
- Occlusions
- Fault Insertion
- Sound Testing
- Incidental Delivery
- Reliability
- Drug Compatibility and Particulate Testing
- System Level Functionality
- Battery Performance
- Environmental Conditions
The acceptance criteria for these are generally that the device meets applicable standards (e.g., IEC 60601 series, ISO 10993, ISO 14971) and demonstrates performance "equivalent or better" or "meets all Special Controls requirements" compared to the predicate or established safety thresholds. Specific numerical acceptance criteria for these are not explicitly detailed in the provided text, but it states that the "subject device meets all Special Controls requirements."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text only discusses non-clinical, in-vitro performance testing.
- Sample Size for Basal Accuracy: The tables show data collected over intervals of 1, 6, and 12 hours. The number of individual test runs or devices included in these measurements is not explicitly stated.
- Sample Size for Bolus Accuracy:
- For 0.05U bolus accuracy: 800 boluses were analyzed for both predicate and subject device.
- For 2.5U bolus accuracy (predicate) and 5U bolus accuracy (subject): 800 boluses were analyzed.
- For 25U bolus accuracy: 256 boluses for predicate, 224 boluses for subject device.
- Data Provenance: The data is from non-clinical/performance testing (in vitro), not human patient data. Therefore, country of origin or retrospective/prospective classification in the context of human studies is not applicable. This data would have been generated in a lab setting by the manufacturer, DEKA Research & Development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as there was no clinical study involving human data, and thus no expert consensus or ground truth established in the traditional sense of medical image analysis or diagnostic studies. The performance testing was based on direct physical measurements of insulin delivery accuracy against engineered specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical study involving human data or expert review. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which did not occur here.
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
This is not applicable. The device is an insulin pump, not an AI-powered diagnostic tool requiring human interpretation. No MRMC study was conducted. The document explicitly states: "No clinical data was obtained in support of this premarket submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense, the non-clinical performance testing represents the standalone performance of the device (pump mechanism and associated components) in a controlled environment, without human intervention in the delivery process itself. The data presented for basal and bolus accuracy directly reflects the algorithmically controlled delivery mechanism's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing of an insulin pump is the physical delivery of insulin and adherence to predefined engineering specifications and regulatory standards for accuracy, flow rates, and safety features (e.g., occlusion alarms). This is established through highly precise laboratory instrumentation and metrology, not derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not explicitly stated in the document. As an insulin pump, it's a hardware device with embedded software for control. While the software might have been developed using iterative testing and tuning, the concept of a "training set" as understood in machine learning (e.g., for an AI algorithm) is generally not directly applicable or documented in this type of submission for a physical medical device's core functionality.
9. How the ground truth for the training set was established
This is not applicable in the context of this 510(k) submission for an insulin pump. The device's functionality is based on known physical principles and engineered control systems, not on learning from a "training set" with established ground truth labels in the AI sense. Development would involve extensive engineering verification and validation against performance requirements and regulatory standards rather than a machine learning training paradigm.
§ 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.