(627 days)
Not Found
Unknown
The summary mentions "automated insulin dosing software" and "iAGC" (interoperable Automated Glycemic Controller), which are often associated with algorithms that could potentially incorporate AI/ML. However, the summary does not explicitly state that AI or ML is used in these components or the fluid delivery algorithms. The "Mentions AI, DNN, or ML" section is marked as "Not Found".
Yes
The device is intended for the management of diabetes mellitus by delivering insulin, which qualifies it as a therapeutic device.
No
The device is an insulin pump system intended for the delivery of insulin, not for diagnosing medical conditions. While it includes a bolus calculator that aids in determining insulin dosage based on various inputs, this is a therapeutic aid and not a diagnostic function.
No
The device description explicitly lists hardware components: a pump, a cassette, and a remote interface (controller).
No, 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 pump. Its primary function is to deliver insulin subcutaneously to manage diabetes. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states "subcutaneous delivery of insulin" and "aiding the user in determining the bolus insulin dosage." These are therapeutic and management functions, not diagnostic ones.
- Device Description: The components and description focus on the mechanics of insulin delivery, communication with other devices, and user interface. There is no mention of analyzing biological samples.
While the device interacts with data from an iCGM (which is a diagnostic device), the pump itself is not performing the diagnostic test. It is receiving and acting upon the results of the diagnostic test.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
QFG, NDC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
13 and above
Intended User / Care Setting
single patient, home use
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 in terms of both safety and effectiveness, and to ensure the subject device met all applicable special controls. Performance testing was organized into the categories described below:
- Nominal Basal Accuracy
- Nominal Bolus Accuracy
- Worst Case Accuracy
- Occlusions
- Fault Insertion
- Sound Testing
- Incidental Delivery
- Reliability
- Drug Compatibility and Particulate Testing
- System Level Functionality
- Battery Performance
- Environmental Conditions
Testing was performed utilizing the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, IEC 62304.
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.
Not Found
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 25, 2023
DEKA Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K213536
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: November 5, 2021 Received: November 5, 2021
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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
Enclosure
2
Indications for Use
510(k) Number (if known) K213536
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 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.
| 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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3
510(k) Summary: K213536
Submitter Information
510(k) Sponsor: DEKA Research & Development 340 Commercial Street Manchester, NH 03101
Contact Person: Paul Smolenski Regulatory Affairs DEKA Research & Development Phone: (603) 669-5139 Fax: (603) 624-0573 psmolenski@dekaresearch.com
Date Prepared: 07/24/2023
Proposed Device
Common/Usual Name: ACE Pump Trade/Proprietary Name: DEKA ACE Pump System Classification Name: Alternate Controller Enabled ACE Pump; Calculator, Drug Dose Device Classification: 880.5730 ; 868.1890 Product Code: QFG ; NDC Class: II Device Panel: Clinical Chemistry
Predicate Device
The predicate device for this submission is the Tandem t:Slim X2 insulin pump with interoperable technology granted under De Novo DEN180058.
Device Description
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.
4
-
- 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.
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 Tandem t:Slim X2 insulin pump with interoperable technology granted on 12/03/2019 under De Novo DEN180058. As described throughout this submission, the subject DEKA ACE Pump system meets the product definition and all of the Special Controls defined in DEN180058 and 21 CFR 880.5730 for Alternate Controller Enabled Insulin Infusion Pumps, Product Code QFG.
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 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.
5
Substantial Equivalence Discussion
Intended Use Comparison
The table below includes a summation matrix of the intended use between the new device and those of the current device:
| Characteristic | Predicate | Device |
|---|---|---|
| Indications for Use | The t:slim X2 insulin pump | |
| with interoperable technology | ||
| (the Pump) is intended for the | ||
| subcutaneous delivery of | ||
| insulin, at set and variable | ||
| rates, for the management of | ||
| diabetes mellitus in persons | ||
| requiring insulin. The Pump | ||
| is able to reliably and | ||
| securely 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 Pump is | ||
| indicated for use with | ||
| NovoLog or Humalog U-100 | ||
| insulin. The Pump is | ||
| indicated for use in | 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 |
6
| | individuals 6 years of age and
greater. | 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 Only or Over the
Counter | Prescription Only | Same |
| Intended Population | Persons with Diabetes
Mellitus Ages 6 and up | Persons with Diabetes
Mellitus Ages 13 and up |
| Environment of Use | In professional healthcare
facility and home healthcare
environments | Same |
Discussions of differences in Indications of Use statement
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.
The predicate's indications for use from DEN180058 are as follows:
The t:slim X2 insulin pump with interoperable technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely 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 Pump is indicated for use with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.
Discussions of differences in intended population
Both the predicate and subject device are intended for use in persons with Diabetes Mellitus. The predicate device is indicated for ages 6 and older and the subject device is indicated for ages 13 and older. The difference in the lower age limit does not impact the safety and effectiveness of the device for its indicated use. Testing demonstrates equivalent safety and effectiveness for the
7
indicated population.
Discussions of differences in environment of use
Both the predicate and subject devices are intended to be used in professional healthcare facility and home healthcare environments. There are no differences in the environments of use.
Comparison of Technological Characteristics with the Predicate Device
The below table compares the characteristics of the subject device to the predicate, t:slim X2 insulin infusion pump, and includes an assessment of differences between them and why the differences between the subject device and the predicate device do not introduce new or different questions of safety or effectiveness.
Substantial Equivalence Discussion
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 t:slim X2 insulin pump with | ||
| interoperable technology (the | |||
| Pump) is intended for the | |||
| subcutaneous delivery of insulin, | |||
| at set and variable rates, for the | |||
| management of diabetes mellitus | |||
| in persons requiring insulin. The | |||
| Pump is able to reliably and | |||
| securely 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 Pump is indicated for use with | |||
| NovoLog or Humalog U-100 | |||
| insulin. The Pump is indicated for | |||
| use in individuals 6 years of age | |||
| and greater. | 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- | Indications for use of the DEKA
ACE Pump System are equivalent
to the predicate.
Indications for use of the bolus
calculator are equivalent to other
devices with this product code. |
| Characteristic | Predicate Device | Subject Device | Equivalence |
| | | entered blood glucose, insulin
sensitivity, insulin to carbohydrate
ratio, target glucose values, and
current insulin on
board. | |
| Prescription Use | Yes | Yes | Same |
| Intended Population | 6 years and older | 13 years and older | The difference in the lower age
limit does not impact the safety
and effectiveness of the device for
its indicated use. Testing
demonstrates equivalent safety and
effectiveness for the indicated
population. |
| 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 | Micro-dosing threaded cartridge
pump | Microprocessor controlled Micro-
dosing pump mechanism
supplemented with acoustic
volume sensor (AVS) feedback for
monitoring delivery accuracy | No impact to safety or
effectiveness. Subject device
meets all Special Controls
requirements. Delivery method
has been found SE to ambulatory
pumps through clearance of
reference device. |
| Insulin Basal Rate
Delivery Range | 0 units /hour- 15units/hour | 0 units/hour - 30 units/hour | No impact on safety or
effectiveness. Subject device
meets all Special Controls
requirements across the entire
delivery rate range. |
| Insulin Bolus
Delivery Range | 0.01 U at volumes greater than
0.05 U units, Max Bolus Volume
25 U | Programmable from 0.05 - 25.00
Units in 0.01 Unit increments. | Same |
| Characteristic | Predicate Device | Subject Device | Equivalence |
| Basal Accuracy | See Delivery Accuracy
Comparison Below | See Delivery Accuracy
Comparison Below | No impact on safety or
effectiveness. Subject device
meets all Special Controls
requirements across the entire
delivery rate range. |
| Bolus Accuracy | See Delivery Accuracy
Comparison Below | See Delivery Accuracy
Comparison Below | No impact to safety or
effectiveness. Subject device
meets all Special Controls
requirements. |
| Bolus Volume after
Occlusion Release | Less than 3 Units | No more than 0.74 units | No impact to safety or
effectiveness. Subject device
meets all Special Controls
requirements. |
| Time to occlusion
alarm | 3 min (Bolus); 2 hours (Basal, 2
U/hr); 36 hours (Basal, 0.1 U/hr): | 10 min (Bolus); 3 hours (Basal, 1
U/h); 6 hours (Basal, 0.1 U/hr) | No impact to safety or
effectiveness. Subject device
meets all Special Controls
requirements. |
| Material
Biocompatibility | Compliant with ISO-10993 | Compliant with ISO-10993 | Same |
| Cartridge/Cassette
Shelf Life | 2 years | 1 year | Performance testing over the one
year shelf life of the cassette
indicates that the cassette remains
safe and effective. |
| Ingress Protection | IPX7: Watertight to a depth of 3
feet (0.91 meters) for up to 30
minutes | 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. | The higher level of ingress
protection than predicate meets
use model requirements. |
| Applicable Safety
Standards | • IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-8 | • IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-8 | Same |
| Characteristic | Predicate Device | Subject Device | Equivalence |
| | • IEC 60601-1-11
• IEC 60601-2-24
• ISO 11137-1 (Sterilized via Gamma Radiation)
• ISO 10993-1
• ISO 14971 | • IEC 60601-1-11
• IEC 60601-2-24
• ISO 11137-1 (Sterilized via Gamma Radiation)
• ISO 10993-1
• ISO 14971 | |
| Power Source | Rechargeable Lithium Polymer Battery | Rechargeable Lithium Ion Battery | Same |
| Storage Conditions | Temperature: -4°F (-20°C) to 140°F (60°C)
Humidity: 20% to 90% RH non-condensing | Temperatures of -25 °C (-13 °F) to 70 °C (158 °F)
Non-condensing humidity 15% to 90% | No impact to safety or effectiveness. Subject device meets all Special Controls requirements. |
| Operating Conditions | Temperature: 41°F (5°C) to 98.6°F (37°C)
Humidity: 20% to 90% RH non-condensing | Temperatures of 5 °C (41 °F) to 40 °C (104 °F)
Non-condensing humidity of 15% to 90% | No impact to safety or effectiveness. Subject device meets all Special Controls requirements. |
| System User Feedback | Visual, audible, and vibratory | Visual, audio, and vibratory | Same |
| Battery Operating Time | 4 – 7 days | 72 hours | No impact to safety or effectiveness. Subject device meets all Special Controls requirements. |
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Basal and Bolus Accuracy Comparison
Below is a comparison of the basal and bolus accuracies of the subject and predicate devices, as reported in their respective User Guides per the ACE Pump Special controls.
Tandem (DEN180058) Basal Accuracy:
0.1 U/hr Basal Accuracy
| Interval | Average Interval
(U) | Minimum (U) | Maximum (U) |
|----------|-------------------------|-------------|-------------|
| 1 hour | 0.12 | 0.09 | 0.16 |
| 6 hours | 0.67 | 0.56 | 0.76 |
| 12 hours | 1.24 | 1.04 | 1.48 |
2.0 U/hr Basal Accuracy
| Interval | Average Interval
(U) | Minimum (U) | Maximum (U) |
|----------|-------------------------|-------------|-------------|
| 1 hour | 2.1 | 2.1 | 2.2 |
| 6 hours | 12.4 | 12.0 | 12.8 |
| 12 hours | 24.3 | 22.0 | 24.9 |
15.0 U/hr Basal Accuracy
| Interval | Average Interval
(U) | Minimum (U) | Maximum (U) |
|----------|-------------------------|-------------|-------------|
| 1 hour | 15.4 | 14.7 | 15.7 |
| 6 hours | 90.4 | 86.6 | 93.0 |
| 12 hours | 181 | 175 | 187 |
DEKA ACE Pump Basal Accuracy:
0.1 U/hr Basal Accuracy
| Interval | Average Interval (U) | Minimum (U) | Maximum (U) |
|---|---|---|---|
| 1 hour | 0.12 | 0.09 | 0.17 |
| 6 hours | 0.62 | 0.57 | 0.66 |
| 12 hours | 1.22 | 1.16 | 1.31 |
1 U/hr Basal Accuracy
| Interval | Average Interval
(U) | Minimum (U) | Maximum (U) |
|----------|-------------------------|-------------|-------------|
| 1 hour | 1.02 | 0.98 | 1.09 |
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| Interval | Average Interval
(U) | Minimum (U) | Maximum (U) |
|----------|-------------------------|-------------|-------------|
| 6 hours | 6.05 | 5.84 | 6.22 |
| 12 hours | 12.07 | 11.73 | 12.33 |
30 U/hr Basal Accuracy
| Interval | Average Interval
(U) | Minimum (U) | Maximum (U) |
|----------|-------------------------|-------------|-------------|
| 1 hour | 30.16 | 29.80 | 30.61 |
| 6 hours | 181.05 | 178.94 | 184.46 |
Tandem (DEN180058) Bolus Accuracy:
| 0.05U bolus accuracy | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 250% | ||||||||||
| Number | ||||||||||
| of boluses | 21 / 800 | 79 / 800 | 63/ 800 | 34 / 800 | 272 / 800 | 180 / 800 | 105 / 800 | 29 / 800 | 17 / 800 | 0 / 800 |
| % of | ||||||||||
| boluses | 2.6% | 9.9% | 7.9% | 4.3% | 34.0% | 22.5% | 13.1% | 3.6% | 2.1% | 0.0% |
| 2.5U bolus accuracy | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 250% | ||||||||||
| Number | ||||||||||
| of boluses | 9 / 800 | 14 / 800 | 11 / 800 | 8 / 800 | 753 / 800 | 5 / 800 | 0 / 800 | 0 / 800 | 0 / 800 | 0 / 800 |
| % of | ||||||||||
| boluses | 1.1% | 1.8% | 1.4% | 1.0% | 94.1% | 0.6% | 0.0% | 0.0% | 0.0% | 0.0% |
| 25U bolus accuracy | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 250% | ||||||||||
| Number | ||||||||||
| of boluses | 0 / 256 | 0 / 256 | 1 / 256 | 3 / 256 | 252 / 256 | 0 / 256 | 0 / 256 | 0 / 256 | 0 / 256 | 0 / 256 |
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| 25U bolus accuracy | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| % of boluses | 0.0% | 0.0% | 0.4% | 1.2% | 98.4% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
DEKA ACE Pump Bolus Accuracy:
| 0.05U bolus accuracy | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 250% | ||||||||||
| Number | ||||||||||
| of | ||||||||||
| boluses | 0 / 800 | 53 / 800 | 202 / 800 | 107 / 800 | 278 / 800 | 80 / 800 | 69 / 800 | 11 / 800 | 0 / 800 | 0 / 800 |
| % of | ||||||||||
| boluses | 0.0% | 6.6% | 25.3% | 13.4% | 34.8% | 10.0% | 8.6% | 1.4% | 0.0% | 0.0% |
| 5U bolus accuracy | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 250% | ||||||||||
| Number of boluses | 0 / 800 | 0 / 800 | 0 / 800 | 0 / 800 | 800 / 800 | 0 / 800 | 0 / 800 | 0 / 800 | 0 / 800 | 0 / 800 |
| % of boluses | 0.0% | 0.0% | 0.0% | 0.0% | 100.0% | 0.0% | 0.0% | 0.0% | 0.0% | 0.0% |
| 25U bolus accuracy | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 250% | ||||||||||
| Number | ||||||||||
| of | ||||||||||
| boluses | 0 / | |||||||||
| 224 | 0 / | |||||||||
| 224 | 0 / | |||||||||
| 224 | 0 / | |||||||||
| 224 | 222 / | |||||||||
| 224 | 2 / | |||||||||
| 224 | 0 / | |||||||||
| 224 | 0 / | |||||||||
| 224 | 0 / | |||||||||
| 224 | 0 / | |||||||||
| 224 | ||||||||||
| % of | ||||||||||
| boluses | 0.0% | 0.0% | 0.0% | 0.0% | 99.1% | 0.9% | 0.0% | 0.0% | 0.0% | 0.0% |
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 was organized into the categories described below.
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| Nominal Basal Accuracy |
|---|
| Nominal Bolus Accuracy |
| Worst Case Accuracy |
| Occlusions |
| Fault Insertion |
| Sound Testing |
| Incidental Delivery |
| Reliability |
| Drug Compatibility and Particulate Testing |
| System Level Functionality |
| Battery Performance |
| Environmental Conditions |
Testing was performed utilizing the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, IEC 62304.
Clinical Study
No clinical data was obtained in support of this premarket submission.
Design Control
The DEKA ACE Pump was specified and developed by DEKA. DEKA complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as to ISO 13485.
Conclusion
The DEKA ACE Pump System is substantially equivalent to the t:slim X2 insulin pump with interoperable technology. The differences summarized in this submission do not raise different questions of safety and effectiveness. The performance of the device is supported by DEKA's design control process which included non-clinical testing and risk management activities. The DEKA ACE Pump System complies with the ACE Pump Special Controls as established in DEN180058.