(25 days)
No
The document describes fluid delivery algorithms and a bolus calculator based on user input and pre-defined parameters, but does not mention AI or ML. The modification is solely for adding compatibility with a new insulin type.
Yes
The device is described as an insulin pump system intended for the management of diabetes mellitus, which is a medical condition. It delivers insulin to treat this condition, thus performing a therapeutic function.
No
This device is an insulin pump system intended for the delivery of insulin to manage diabetes. While it has a bolus calculator that aids in determining insulin dosage based on various inputs (including 'operator entered blood glucose'), its primary function is therapeutic delivery, not diagnostic information generation. The blood glucose input is used to calculate a treatment, not to diagnose a condition.
No
The device description explicitly lists hardware components such as the "Pump" (a durable pump with a rechargeable lithium ion battery) and the "Cassette" (a single-use pumping cassette with microfluidic valves, pump chamber, insulin reservoir, and Acoustic Volume Sensing measurement chamber). While it includes software (DEKA Loop App), it is part of a larger system that includes physical hardware for insulin delivery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The DEKA ACE Pump System is an insulin infusion pump. Its primary function is to deliver insulin subcutaneously to manage diabetes. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states "subcutaneous delivery of insulin" and "management of diabetes mellitus." It also mentions a bolus calculator for determining insulin dosage based on various factors, but this is a calculation based on user input and device data, not an in vitro test.
- Device Description: The description focuses on the components involved in insulin delivery (pump, cassette, app) and communication with other devices (iCGM, cloud). There is no mention of components or processes related to analyzing biological samples.
While the device interacts with data from an iCGM (which measures glucose levels in interstitial fluid), the pump itself is not performing the glucose measurement. It is receiving data from a separate device.
Therefore, the DEKA ACE Pump System falls under the category of a therapeutic device (delivering medication) rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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, 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.
Product codes (comma separated list FDA assigned to the subject device)
QFG, NDC
Device Description
The DEKA ACE Pump System described herein contains a modification of the labeling of the previously cleared DEKA ACE Pump System (K233952) to add Novolog U-100 (insulin aspart) as a compatible insulin. The device is a wearable alternate controller enabled (ACE) insulin infusion pump 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 DEKA ACE Pump System is intended for the management of diabetes mellitus in persons six years of age and greater.
The pump was previously cleared and is indicated for use with Humalog U-100 insulin. This Special 510(k) utilizes the same methodology and acceptance criteria used to obtain the clearance and indication for Humalog U-100 to add the indication for Novolog U-100.
The DEKA ACE Pump System, consistent with the predicate K233952, 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 interface for the system. The DEKA Loop app can be downloaded onto the user's personal iPhone.
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:
- Patient onboarding and device pairing via secure key transfer
- Prescription setting downloads to the ACE Pump
- Event log uploads from the ACE pump to the cloud
- Remote (OTA) software updates
No changes to the hardware or software of the system from that of the predicate are necessary to add the Novolog U-100 compatibility claim.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
ages six and above
Intended User / Care Setting
single patient, home use, professional healthcare facilities and home healthcare environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed in order to establish substantial equivalence for the compatibility claim of Novolog U-100 in comparison to the previously cleared compatibility claim for Humalog U-100 in terms of both safety and effectiveness, and to ensure the subject device met all applicable Special Controls. Performance testing from the predicate submission, K233952, is applicable to the subject submission. No clinical data was obtained in support of this premarket submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 24, 2024
DEKA Research and Development Paul Smolenski Director of Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K241178
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: April 26, 2024 Received: April 29, 2024
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).
1
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 OS 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 (OS) 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 medical devices and radiation-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 for Diabetes Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
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, 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
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: April 26, 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 3/13/2024 under 510(k) K233952.
Device Description
The DEKA ACE Pump System described herein contains a modification of the labeling of the previously cleared DEKA ACE Pump System (K233952) to add Novolog U-100 (insulin aspart) as a compatible insulin. The device is a wearable alternate controller enabled (ACE) insulin infusion pump 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 DEKA ACE Pump System is intended for the management of diabetes mellitus in persons six years of age and greater.
The pump was previously cleared and is indicated for use with Humalog U-100 insulin. This Special 510(k) utilizes the same methodology and acceptance criteria used to obtain the clearance and indication for Humalog U-100 to add the indication for Novolog U-100.
4
The DEKA ACE Pump System, consistent with the predicate K233952, 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 interface for the system. The DEKA Loop app can be downloaded onto the user's personal iPhone.
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:
- Patient onboarding and device pairing via secure key transfer o
- Prescription setting downloads to the ACE Pump o
- Event log uploads from the ACE pump to the cloud о
- Remote (OTA) software updates o
No changes to the hardware or software of the system from that of the predicate are necessary to add the Novolog U-100 compatibility claim.
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 3/13/2024 under K233952. 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.
Substantial Equivalence Discussion
Intended Use Comparison
The table below compares the intended use of the subject device to that of the predicate device:
5
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Indications for Use | 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 6 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 sensitivity, 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 6 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 sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board. |
| Prescription Use | Yes | Yes |
| Intended Population | Persons with Diabetes Mellitus ages 6 and above | Persons with Diabetes Mellitus ages 6 and above |
| Environment of Use | In professional healthcare facilities and home healthcare environments | In professional healthcare facilities and home healthcare environments |
Discussion of differences in Indications for Use statements
The indications for use are unchanged for this submission, and the statements for both the predicate and subject devices are identical.
6
The indications for use for the predicate and subject device 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 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.
7
Discussion of differences in intended populations
Both the predicate and subject device are intended for use in persons with Diabetes Mellitus ages 6 and above. There are no differences in the intended populations.
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 table below compares the intended use and technological characteristics of the subject device with that of the predicate device:
8
| Characteristic | Predicate Device | Subject Device | Equivalence |
|---|---|---|---|
| Device | |||
| Classification | |||
| Regulation and | |||
| Product Code | Alternate Controller Enabled | ||
| Infusion Pump cleared under 21 | |||
| CFR 880.5730, Procode QFG | Alternate Controller Enabled | ||
| Infusion Pump submitted under 21 | |||
| CFR 880.5730, Procode QFG | Same | ||
| Indications for Use | 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 DEKA ACE Pump System is Same | ||
| 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. | Same | ||
| Prescription Use | Yes | Yes | Same |
| Intended Population | Persons with Diabetes Mellitus | ||
| ages 6 and above | Persons with Diabetes Mellitus | ||
| ages 6 and above | Same | ||
| Patient | |||
| Environment | On-body wearable ambulatory | ||
| pump | On-body wearable ambulatory | ||
| pump | Same | ||
| Environment of | |||
| Use | In professional healthcare facilities | ||
| and home environments | In professional healthcare facilities | ||
| and home environments | Same | ||
| Delivery Method | Microprocessor controlled Micro- | ||
| dosing pump mechanism | |||
| supplemented with acoustic | Microprocessor controlled Micro- | ||
| dosing pump mechanism | |||
| supplemented with acoustic | Same | ||
| Characteristic | Predicate Device | Subject Device | Equivalence |
| Insulin Basal Rate | |||
| Delivery Range | volume sensor (AVS) feedback for | ||
| monitoring delivery accuracy. | |||
| 0 units/hour - 30 units/hour | volume sensor (AVS) feedback for | ||
| monitoring delivery accuracy. | |||
| 0 units/hour - 30 units/hour | Same | ||
| Insulin Bolus | |||
| Delivery Range | Programmable from 0.05 - 25.00 | ||
| Units in 0.01 Unit increments. | Programmable from 0.05 - 25.00 | ||
| Units in 0.01 Unit increments. | Same | ||
| Basal Accuracy | Unchanged from K213536 | Unchanged from K213536 | Same |
| Bolus Accuracy | Unchanged from K213536 | Unchanged from K213536 | Same |
| Bolus Volume after | |||
| Occlusion Release | No more than 0.74 units. | No more than 0.74 units. | Same |
| Time to occlusion | |||
| alarm | 10 min (Bolus); 3 hours (Basal, 1 | ||
| U/h); 6 hours (Basal, 0.1 U/hr) | 10 min (Bolus); 3 hours (Basal, 1 | ||
| U/h); 6 hours (Basal, 0.1 U/hr) | Same | ||
| Material | |||
| Biocompatibility | Compliant with ISO-10993 | Compliant with ISO-10993 | Same |
| Cartridge/Cassette | |||
| Shelf Life | 1 year | 1 year | Same |
| Ingress Protection | IP28, indicating protection from | ||
| continuous immersion in water. | |||
| The pump can tolerate immersion | |||
| to depths of up to 12 feet (3.7 m) | |||
| for 1 hour. | IP28, indicating protection from | ||
| continuous immersion in water. | |||
| The pump can tolerate immersion | |||
| to depths of up to 12 feet (3.7 m) | |||
| for 1 hour. | Same | ||
| Applicable Safety | |||
| 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 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 | Same | ||
| Characteristic | Predicate Device | Subject Device | Equivalence |
| • ISO 11137-1 (Sterilized via Gamma Radiation) | |||
| • ISO 10993-1 | |||
| • ISO 14971 | • ISO 11137-1 (Sterilized via Gamma Radiation) | ||
| • ISO 10993-1 | |||
| • ISO 14971 | |||
| Power Source | Rechargeable Lithium Ion Battery | Rechargeable Lithium Ion Battery | Same |
| Pump Storage Conditions | Temperatures of -25 °C (-13 °F) to 70 °C (158 °F) | ||
| Non-condensing humidity 15% to 90% | Temperatures of -25 °C (-13 °F) to 70 °C (158 °F) | ||
| Non-condensing humidity 15% to 90% | Same | ||
| Operating Conditions | 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 User Feedback | Visual, audible, and vibratory | Visual, audio, and vibratory | Same |
| Battery Operating Time | 72 hours | 72 hours | Same |
| Compatible Insulins | Humalog U-100 | Humalog U-100 | |
| Novolog U-100 | The addition of a Novolog U-100 compatibility claim to the labeling does not impact the safety and effectiveness of the device. | ||
| Testing and results performed with Novolog U-100 in this submission are equivalent to that performed with Humalog U-100 in the predicate clearance. No new or modified risks. |
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Non-Clinical / Performance Testing:
Performance testing was performed in order to establish substantial equivalence for the compatibility claim of Novolog U-100 in comparison to the previously cleared compatibility claim for Humalog U-100 in terms of both safety and effectiveness, and to ensure the subject device met all applicable Special Controls. Performance testing from the predicate submission, K233952, is applicable to the subject submission.
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 is substantially equivalent to the predicate cleared on 3/13/2024 in K233952. The addition of the claim for use with Novolog U-100 does 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.