(89 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 six 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 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 a modification of the previously cleared DEKA ACE Pump System (K213536). The modified device is a wearable alternate controller enabled (ACE) insulin infusion pump (DEKA ACE Pump System) with the addition of an embedded iAGC (DEKA Loop). The user interface is an iOS app that can be downloaded to a user's iPhone.
The updated system is still intended to subcutaneously deliver 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 to receive, confirm, and execute commands. The Pump is intended for single patient, ambulatory use and requires a prescription. The Pump is indicated for use with Humalog U-100 insulin.
The DEKA ACE Pump System is indicated for the management of mellitus in persons six years of age and greater.
The system as described in this submission is able to be integrated with an integrated Continuous Glucose Monitor (iCGM). This submission also details the integration process that was used to incorporate the DEKA Loop iAGC Algorithm onto the DEKA ACE Pump.
The DEKA ACE Pump System consists of the following durable and disposable components:
- Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to a cassette, external wireless user interface, and iCGM. 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 a pump and off-the-shelf infusion sets.
- DEKA Loop App: An iOS mobile application that serves as the primary user face for the system. The DEKA Loop app can be downloaded onto the user's personal iPhone.
The provided text is a 510(k) summary for the DEKA ACE Pump System, focusing on demonstrating substantial equivalence to a previously cleared predicate device. It addresses modifications, primarily the addition of an embedded iAGC (DEKA Loop) and a change in the user interface to an iOS app, as well as a broadened age indication (from 13+ to 6+).
However, the document does not contain the specific information required to answer your request about acceptance criteria and study proving the device meets those criteria for aspects like deep learning model performance (e.g., accuracy, sensitivity, specificity, or AUC). The request is structured as if the document describes an AI/ML-based diagnostic device where performance metrics against a ground truth dataset would be evaluated.
Instead, this document describes a medical device (insulin pump) where the "performance testing" refers to engineering and quality assurance testing against technical standards and safety requirements (e.g., electrical safety, electromagnetic compatibility, biocompatibility, delivery accuracy of insulin). The "Acceptance Criteria" implicitly refer to meeting these established engineering and regulatory standards rather than statistical performance metrics of a diagnostic algorithm against a labeled test set.
Specifically:
- There is no mention of a deep learning model's performance metrics (accuracy, sensitivity, specificity, AUC) or related test set details (sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies).
- The "DEKA Loop iAGC Algorithm" is mentioned as being integrated, but there are no details on how its performance was evaluated, other than "Human Factors testing demonstrates equivalent safety and effectiveness for the indicated population" (page 7). This suggests focus on usability and safety in human interaction, not algorithmic diagnostic performance.
- The document explicitly states "No clinical data was obtained in support of this premarket submission" (page 13), reinforcing that the evaluation was primarily non-clinical and focused on substantial equivalence based on existing data and engineering tests.
Given the content of the provided document, I cannot fulfill your request for the specific details outlined for an AI/ML-based diagnostic device. The available information relates to the regulatory submission for an insulin pump, which is evaluated against different types of performance criteria.
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March 13, 2024
Deka Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K233952
Trade/Device Name: DEKA ACE Pump System Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate controller enabled infusion pump Regulatory Class: Class II Product Code: QFG, NDC Dated: December 14, 2023 Received: December 15, 2023
Dear Paul Smolenski:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233952
Device Name DEKA ACE Pump System
Indications for Use (Describe)
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 six 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 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K233952
Submitter Information
510(k) Sponsor: DEKA Research & Development 340 Commercial Street Manchester, NH 03101
Contact Person: Paul Smolenski Regulatory Affairs DEKA Research & Development Corporation Phone: (603) 669-5139 Fax: (603) 624-0573 psmolenski(@dekaresearch.com
Date Prepared: 2/29/2024
Proposed Device
Common/Usual Name: ACE Pump Trade/Proprietary Name: DEKA ACE Pump System Classification Name: Alternate Controller Enabled ACE Pump Device Classification: 880.5730 Product Code: QFG Class: II Device Panel: Clinical Chemistry
Predicate Device
The predicate device for this submission is the DEKA ACE Pump System cleared on 7/25/2023 under 510(k) K213536.
Device Description
The DEKA ACE Pump system is a modification of the previously cleared DEKA ACE Pump System (K213536). The modified device is a wearable alternate controller enabled (ACE) insulin infusion pump (DEKA ACE Pump System) with the addition of an embedded iAGC (DEKA Loop). The user interface is an iOS app that can be downloaded to a user's iPhone.
The updated system is still intended to subcutaneously deliver 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 to receive, confirm, and execute commands. The Pump is intended for single patient, ambulatory use and requires a prescription. The Pump is indicated for use with Humalog U-100 insulin.
The DEKA ACE Pump System is indicated for the management of mellitus in persons six years of age and greater.
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The system as described in this submission is able to be integrated with an integrated Continuous Glucose Monitor (iCGM). This submission also details the integration process that was used to incorporate the DEKA Loop iAGC Algorithm onto the DEKA ACE Pump.
The DEKA ACE Pump System consists of the following durable and disposable components:
- Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to a . cassette, external wireless user interface, and iCGM. 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 a pump and off-the-shelf infusion sets.
- DEKA Loop App: An iOS mobile application that serves as the primary user face for the ● system. The DEKA Loop app can be downloaded onto the user's personal iPhone.
The DEKA ACE Pump System is designed to be shipped to users in a kit that also includes infusion sets, needles, syringes, and other materials necessary for use.
Also consistent with the predicate, the DEKA ACE Pump system includes the following electronic interfaces:
- . Dexcom G6 iCGM: The DEKA ACE Pump System is compatible with Dexcom G6 iCGMs. Communication between the Dexcom G6 and DEKA ACE Pump is unchanged from the predicate device. The BLE central role on the ACE Pump radio processor connects directly to the Dexcom iCGM transmitter using the sensor's medical slot. The ACE Pump communicates with the iCGM transmitter at a regular interval to provide iCGM sensor data to the iAGC.
- . Halo Cloud: Halo Cloud is a digital platform that connects the DEKA ACE Pump System to a variety of cloud-related services. These services include:
- o Patient on-boarding and device pairing via secure key transfer
- Prescription setting downloads to the ACE Pump O
- Event log uploads from the ACE pump to the cloud O
- Remote (OTA) software updates O
Information is being supplied in this 510(k) premarket submission to demonstrate that the device is substantially equivalent in safety and effectiveness through comparison of indications for use and technological characteristics to the predicate DEKA ACE Pump System cleared on 7/25/2023 under K213536. As described throughout this submission, the subject DEKA ACE Pump System meets the product definition and all of the Special Controls defined in 21CFR 880.5730 for Alternate Controller Enabled Insulin Infusion Pumps, Product Code QFG.
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Substantial Equivalence Discussion
Intended Use Comparison
The table below compares the intended use of the subject device to that of the predicate device:
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Indications for Use | The DEKA ACE PumpSystem is intended for thesubcutaneous delivery ofinsulin, at set and variablerates, for the management ofdiabetes mellitus in personsrequiring insulin, ages 13 andabove. The pump is able toreliably and securelycommunicate withcompatible, digitallyconnected devices, includingautomated insulin dosingsoftware, to receive, execute,and confirm commands fromthese devices. The pump isintended for single patient,home use and requires aprescription.The bolus calculator isindicated for use for aidingthe user in determining thebolus insulin dosage formanagement of diabetesmellitus based on consumedcarbohydrates, operator-entered blood glucose, insulinsensitivity, insulin tocarbohydrate ratio, targetglucose values, and currentinsulin on board. | The DEKA ACE PumpSystem is intended for thesubcutaneous delivery ofinsulin, at set and variablerates, for the management ofdiabetes mellitus in personsrequiring insulin, ages six andabove. The pump is able toreliably and securelycommunicate withcompatible, digitallyconnected devices, includingautomated insulin dosingsoftware, to receive, execute,and confirm commands fromthese devices. The pump isintended for single patient,home use and requires aprescription.The bolus calculator isindicated for use for aidingthe user in determining thebolus insulin dosage formanagement of diabetesmellitus based on consumedcarbohydrates, operator-entered blood glucose, insulinsensitivity, insulin tocarbohydrate ratio, targetglucose values, and currentinsulin on board. |
| Prescription Use | Yes | Yes |
| Intended Population | Persons with DiabetesMellitus ages 13 and above | Persons with DiabetesMellitus ages 6 and above |
| Environment of Use | In professional healthcarefacilities and home healthcareenvironments | In professional healthcarefacilities and home healthcareenvironments |
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Discussion of differences in Indications of Use statements
The subject 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 6 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 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 sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.
The predicate's indications for use from K213536 are as follows:
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 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 sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.
Discussion of differences in intended populations
Both the predicate and subject device are intended for use in persons with Diabetes Mellitus. The predicate device is indicated for ages 13 and above and the subject device is indicated for ages 6 and above. The difference in the lower age limit does not impact the safety and effectiveness of the device for its indicated use. The risk management documentation has been updated to reflect this modification. Human Factors testing demonstrates equivalent safety and effectiveness for the indicated population.
Discussion of differences in environments of use
Both the predicate and subject devices are intended to be used in professional healthcare facilities and home healthcare environments. There are no differences in the environments of use.
Comparison of Technological Characteristics
The below table compares the technological characteristics of the subject device with those of the predicate. If a technological characteristic differs, an assessment of why the difference does not introduce new or different questions of safety or effectiveness is stated.
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Substantial Equivalence Table
The table below compares the intended use and technological characteristics of the subject device with that of the predicate device:
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| Characteristic | Predicate Device | Subject Device | Equivalence |
|---|---|---|---|
| DeviceClassificationRegulation andProduct Code | Alternate Controller EnabledInfusion Pump cleared under 21CFR 880.5730, Product CodeQFG | Alternate Controller EnabledInfusion Pump submitted under21 CFR 880.5730, Product CodeQFG | Same |
| Indications for Use | The DEKA ACE Pump System isintended for the subcutaneousdelivery of insulin, at set andvariable rates, for the managementof diabetes mellitus in personsrequiring insulin, ages 13 andabove. The pump is able toreliably and securely communicatewith compatible, digitallyconnected devices, includingautomated insulin dosing software,to receive, execute, and confirmcommands from these devices.The pump is intended for singlepatient, home use and requires aprescription.The bolus calculator is indicatedfor use for aiding the user indetermining the bolus insulindosage for management ofdiabetes mellitus based onconsumed carbohydrates, operator-entered blood glucose, insulinsensitivity, insulin to carbohydrateratio, target glucose values, andcurrent insulin on board | The DEKA ACE Pump System isintended for the subcutaneousdelivery of insulin, at set andvariable rates, for the managementof diabetes mellitus in personsrequiring insulin, ages six andabove. The pump is able toreliably and securely communicatewith compatible, digitallyconnected devices, includingautomated insulin dosing software,to receive, execute, and confirmcommands from these devices.The pump is intended for singlepatient, home use and requires aprescription.The bolus calculator is indicatedfor use for aiding the user indetermining the bolus insulindosage for management ofdiabetes mellitus based onconsumed carbohydrates, operator-entered blood glucose, insulinsensitivity, insulin to carbohydrateratio, target glucose values, andcurrent insulin on board. | The difference in the lower agelimit does not impact the safetyand effectiveness of the device forits indicated use. The riskmanagement documentation hasbeen updated to reflect thismodification. Human Factorstesting demonstrates equivalentsafety and effectiveness for theindicated population. |
| Characteristic | Predicate Device | Subject Device | Equivalence |
| Prescription Use | Yes | Yes | Same |
| Intended Population | 13 years and above | 6 years and above | The difference in the lower agelimit does not impact the safetyand effectiveness of the device forits indicated use. The riskmanagement documentation hasbeen updated to reflect thismodification. Human Factorstesting demonstrates equivalentsafety and effectiveness for theindicated population. |
| PatientEnvironment | On-body wearable ambulatorypump | On-body wearable ambulatorypump | Same |
| Environment of Use | In professional healthcare facilities and home environments | In professional healthcare facilities and home environments | Same |
| Primary UserInterface | Remote Interface hand-held controller | iOS app downloaded to a user's iPhone | The modifications to the userinterface do not impact safety oreffectiveness. Both controllersprovide the same level offunctionality and Human Factorstesting demonstrates equivalentsafety and effectiveness for theindicated population. |
| Delivery Method | Microprocessor controlled micro-dosing pump mechanism supplemented with Acoustic Volume Sensor (AVS) feedback for monitoring delivery accuracy | Microprocessor controlled micro-dosing pump mechanism supplemented with Acoustic Volume Sensor (AVS) feedback for monitoring delivery accuracy | Same |
| Insulin Basal RateDelivery Range | 0 Units/hour - 30 Units/hour | 0 Units/hour - 30 Units/hour | Same |
| Characteristic | Predicate Device | Subject Device | Equivalence |
| Insulin BolusDelivery Range | Programmable between 0.05 -25.00 Units in 0.01 Unitincrements | Programmable between 0.05 -25.00 Units in 0.01 Unitincrements | Same |
| Basal Accuracy | See “Delivery Accuracy” below | See “Delivery Accuracy” below | Same |
| Bolus Accuracy | See “Delivery Accuracy” below | See “Delivery Accuracy” below | Same |
| Bolus Volume afterOcclusion Release | No more than 0.74 Units | No more than 0.74 Units | Same |
| Time to OcclusionAlarm | 10 min (Bolus); 3 hours (Basal, 1U/hr); 6 hours (Basal, 0.1 U/hr) | 10 min (Bolus); 3 hours (Basal, 1U/hr); 6 hours (Basal, 0.1 U/hr) | Same |
| MaterialBiocompatibility | Compliant with ISO-10993 | Compliant with ISO-10993 | Same |
| Cartridge/CassetteShelf Life | 1 year | 1 year | Same |
| Ingress Protection | IP28, indicating protection fromcontinuous immersion in water.The pump can tolerate immersionto depths of up to 12 feet (3.7 m)for 1 hour. | IP28, indicating protection fromcontinuous immersion in water.The pump can tolerate immersionto depths of up to 12 feet (3.7 m)for 1 hour. | Same |
| Applicable SafetyStandards | • IEC 60601-1• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-1-8• IEC 60601-1-11• IEC 60601-2-24• ISO 11137-1 (Sterilized viaGamma Radiation)• ISO 10993-1• ISO 14971 | • IEC 60601-1• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-1-8• IEC 60601-1-10• IEC 60601-1-11• IEC 60601-2-24• ISO 11137-1 (Sterilized viaGamma Radiation)• ISO 10993-1• ISO 14971 | IEC 60601-1-10 evaluation wasincluded in the subject devicesubmission due to the integrationof DEKA Loop. |
| Power Source | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | Same |
| Characteristic | Predicate Device | Subject Device | Equivalence |
| Pump StorageConditions | Temperatures of -25 °C (-13 °F) to70 °C (158 °F)Non-condensing humidity of 15%to 90% | Temperatures of -25 °C (-13 °F) to70 °C (158 °F)Non-condensing humidity of 15%to 90% | Same |
| OperatingConditions | Temperatures of 5 °C (41 °F) to 40 °C (104 °F)Non-condensing humidity of 15%to 90% | Temperatures of 5 °C (41 °F) to 40 °C (104 °F)Non-condensing humidity of 15%to 90% | Same |
| System UserFeedback | Visual, audio, and vibratory | Visual, audio, and vibratory | Same |
| Battery OperatingTime | 72 hours | 72 hours | Same |
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The table below compares the intended use and technological characteristics of the subject bolus calculator with that of the predicate bolus calculator:
| Characteristic | Predicate Device (Bolus Calculator – K213536) | Subject Device (Bolus Calculator) | Equivalence |
|---|---|---|---|
| Intended Use | The bolus calculator aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, insulin sensitivity, insulin to carbohydrate ratio, target blood glucose values, and Insulin on Board (IOB). | The bolus calculator aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading, insulin sensitivity, insulin to carbohydrate ratio, target blood glucose values, and Insulin on Board (IOB). | Same |
| Normal and Extended Bolus | A Correction Bolus must be delivered as a Normal Bolus; Meal | A Correction Bolus must be delivered as a Normal Bolus; Meal | Same |
| Boluses can be delivered asnormal or extended | Boluses can be delivered asnormal or extended | ||
| Correction Bolus | Positive correction occurs if bloodglucose is higher than the "hightarget" and a negative correctionbolus occurs if blood glucose islower than the "low target" | Positive correction occurs if bloodglucose is higher than the "hightarget" and a negative correctionbolus occurs if blood glucose islower than the "low target" | Same |
| Preliminary MealBolus Calculation | Carb Intake/Insulin-to-Carb Ratio | Carb Intake/Insulin-to-Carb Ratio | Same |
| Suggested BolusRounded to | Nearest 0.01 U | Nearest 0.01 U | Same |
| Calculated IOBRounded to | Nearest 0.01 U | Nearest 0.01 U | Same |
| User Inputs inBolus Calculator | Blood Glucose level Carbs Insulin to Carbohydrate(IC) Ratio Insulin Sensitivity(Correction Factor) High Target (BG) Low Target (BG) | Blood Glucose level Carbs Insulin to Carbohydrate(IC) Ratio Insulin Sensitivity(Correction Factor) High Target (BG) Low Target (BG) | Same |
| Maximum BolusSize | Manually set by user | Manually set by user | Same |
| Primary UserInterface | Screen on Remote Interface | Screen on iPhone | Equivalent |
| User Inputs toCalculation (afterset-up) | Carbs, Blood Glucose Level | Carbs, Blood Glucose Level | Same |
| Calculator Outputs | Recommended Bolus Amount | Recommended Bolus Amount | Same |
| Labeling | User Interface Workflowdescribed in User Guide | User Interface Workflowdescribed in User Guide | Same |
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Non-Clinical / Performance Testing:
Performance testing was performed in order to establish substantial equivalence in terms of both safety and effectiveness, and to ensure the subject device met all applicable Special Controls. Performance testing from the predicate submission, K213536, is applicable to the subject submission.
Testing was performed utilizing the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-10, IEC 60601-1-11, IEC 60601-2-24, IEC 62304.
Human Factors was performed for the incorporation of DEKA Loop and the updated User Interface.
Clinical Study
No clinical data was obtained in support of this premarket submission.
Design Control
The DEKA ACE Pump System was specified and developed by DEKA. DEKA complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as ISO 13485.
Conclusion
The DEKA ACE Pump System Infusion Pump is substantially equivalent to the predicate cleared on 7/25/2023 in K213536. The differences, summarized in this submission, do not raise different questions of safety or effectiveness. The performance of the device is supported by DEKA's design control process which included non-clinical testing and risk management activities. The device meets all Special Controls for this product type as required by 21 CFR 880.5730 for Alternate Controller Enabled Insulin Infusion Pumps, Product Code QFG.
§ 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.