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.

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.

AI/ML Overview

The provided text describes the DEKA ACE Pump System, an insulin pump, and its comparison to a predicate device (Tandem t:Slim X2 insulin pump) for FDA 510(k) clearance. The document focuses on demonstrating substantial equivalence, primarily through non-clinical performance testing rather than clinical studies involving human patients.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document presents basal and bolus accuracy as performance metrics, comparing the subject device (DEKA ACE Pump) to the predicate device (Tandem t:Slim X2). The acceptance criteria for these accuracies are implicitly set by matching or improving upon the predicate device's performance, and by meeting the "Special Controls" requirements for this device type.

Basal Accuracy Comparison (Example for 0.1 U/hr)

Interval	Predicate (Tandem DEN180058) - 0.1 U/hr Basal Accuracy	Subject Device (DEKA ACE Pump) - 0.1 U/hr Basal Accuracy	Acceptance Criteria (Implicit)
1 hour	Average: 0.12 U, Min: 0.09 U, Max: 0.16 U	Average: 0.12 U, Min: 0.09 U, Max: 0.17 U	Comparable to or better than predicate; meets Special Controls.
6 hours	Average: 0.67 U, Min: 0.56 U, Max: 0.76 U	Average: 0.62 U, Min: 0.57 U, Max: 0.66 U	Comparable to or better than predicate; meets Special Controls.
12 hours	Average: 1.24 U, Min: 1.04 U, Max: 1.48 U	Average: 1.22 U, Min: 1.16 U, Max: 1.31 U	Comparable to or better than predicate; meets Special Controls.

Bolus Accuracy Comparison (Example for 0.05U Bolus Accuracy - % of boluses within ranges)

Range	Predicate (Tandem DEN180058) - 0.05U	Subject Device (DEKA ACE Pump) - 0.05U	Acceptance Criteria (Implicit)
<25%	2.6%	0.0%	Lower percentage of boluses outside key ranges, especially <90% or >110%.
25-<75%	9.9%	6.6%
75-<90%	7.9%	25.3%
90-<95%	4.3%	13.4%
95-105%	34.0%	34.8%	High percentage (ideally >90%) within 95-105% range.
105-<110%	22.5%	10.0%
110-<125%	13.1%	8.6%
125-<175%	3.6%	1.4%
175-<250%	2.1%	0.0%
>250%	0.0%	0.0%
Note: The subject device shows a higher percentage in some broader ranges (e.g., 75-90%, 90-95%) but crucially maintains a similar performance in the tightest 95-105% range and reduces extreme deviations.

Other performance criteria mentioned in the "Non-Clinical/Performance Testing" section include:

Worst Case Accuracy
Occlusions
Fault Insertion
Sound Testing
Incidental Delivery
Reliability
Drug Compatibility and Particulate Testing
System Level Functionality
Battery Performance
Environmental Conditions
The acceptance criteria for these are generally that the device meets applicable standards (e.g., IEC 60601 series, ISO 10993, ISO 14971) and demonstrates performance "equivalent or better" or "meets all Special Controls requirements" compared to the predicate or established safety thresholds. Specific numerical acceptance criteria for these are not explicitly detailed in the provided text, but it states that the "subject device meets all Special Controls requirements."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided text only discusses non-clinical, in-vitro performance testing.

Sample Size for Basal Accuracy: The tables show data collected over intervals of 1, 6, and 12 hours. The number of individual test runs or devices included in these measurements is not explicitly stated.
Sample Size for Bolus Accuracy:
- For 0.05U bolus accuracy: 800 boluses were analyzed for both predicate and subject device.
- For 2.5U bolus accuracy (predicate) and 5U bolus accuracy (subject): 800 boluses were analyzed.
- For 25U bolus accuracy: 256 boluses for predicate, 224 boluses for subject device.
Data Provenance: The data is from non-clinical/performance testing (in vitro), not human patient data. Therefore, country of origin or retrospective/prospective classification in the context of human studies is not applicable. This data would have been generated in a lab setting by the manufacturer, DEKA Research & Development.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as there was no clinical study involving human data, and thus no expert consensus or ground truth established in the traditional sense of medical image analysis or diagnostic studies. The performance testing was based on direct physical measurements of insulin delivery accuracy against engineered specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there was no clinical study involving human data or expert review. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which did not occur here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an insulin pump, not an AI-powered diagnostic tool requiring human interpretation. No MRMC study was conducted. The document explicitly states: "No clinical data was obtained in support of this premarket submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense, the non-clinical performance testing represents the standalone performance of the device (pump mechanism and associated components) in a controlled environment, without human intervention in the delivery process itself. The data presented for basal and bolus accuracy directly reflects the algorithmically controlled delivery mechanism's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing of an insulin pump is the physical delivery of insulin and adherence to predefined engineering specifications and regulatory standards for accuracy, flow rates, and safety features (e.g., occlusion alarms). This is established through highly precise laboratory instrumentation and metrology, not derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not explicitly stated in the document. As an insulin pump, it's a hardware device with embedded software for control. While the software might have been developed using iterative testing and tuning, the concept of a "training set" as understood in machine learning (e.g., for an AI algorithm) is generally not directly applicable or documented in this type of submission for a physical medical device's core functionality.

9. How the ground truth for the training set was established

This is not applicable in the context of this 510(k) submission for an insulin pump. The device's functionality is based on known physical principles and engineered control systems, not on learning from a "training set" with established ground truth labels in the AI sense. Development would involve extensive engineering verification and validation against performance requirements and regulatory standards rather than a machine learning training paradigm.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K213536

Device Name DEKA ACE Pump System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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: 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 DEKA ACE Pump System consists of the following components:

1. 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.

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1. 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.
1. 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.

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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 pumpwith interoperable technology(the Pump) is intended for thesubcutaneous delivery ofinsulin, at set and variablerates, for the management ofdiabetes mellitus in personsrequiring insulin. The Pumpis able to reliably andsecurely communicate 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 Pump isindicated for use withNovoLog or Humalog U-100insulin. The Pump isindicated for use in	The DEKA ACE PumpSystem is intended for thesubcutaneous delivery ofinsulin, at set and variablerates, for the management ofdiabetes mellitus inpersons requiring insulin,ages 13 and above.The pump is able to reliablyand securely communicatewith compatible, 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 for

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	individuals 6 years of age andgreater.	management of diabetesmellitus based onconsumed carbohydrates,operator-entered bloodglucose, insulin sensitivity,insulin to carbohydrateratio, target glucose values,and current insulin onboard.
Prescription Only or Over theCounter	Prescription Only	Same
Intended Population	Persons with DiabetesMellitus Ages 6 and up	Persons with DiabetesMellitus Ages 13 and up
Environment of Use	In professional healthcarefacility and home healthcareenvironments	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

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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:

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Characteristic	Predicate Device	Subject Device	Equivalence
DeviceClassificationRegulation andProduct Code	Alternate Controller EnabledInfusion Pump cleared under 21 CFR 880.5730, Procode QFG	Alternate Controller EnabledInfusion Pump submitted under21 CFR 880.5730, Procode QFG	Same
Indications for Use	The t:slim X2 insulin pump withinteroperable technology (thePump) is intended for thesubcutaneous delivery of insulin,at set and variable rates, for themanagement of diabetes mellitusin persons requiring insulin. ThePump is able to reliably andsecurely communicate withcompatible, digitally connecteddevices, including automatedinsulin dosing software, to receive,execute, and confirm commandsfrom these devices. The Pump isintended for single patient, homeuse and requires a prescription.The Pump is indicated for use withNovoLog or Humalog U-100insulin. The Pump is indicated foruse in individuals 6 years of ageand greater.	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 to reliably andsecurely communicate withcompatible, digitally connecteddevices, including automatedinsulin dosing software, to receive,execute, and confirm commandsfrom these devices. The pump isintended for single patient, homeuse and requires a prescription.The bolus calculator is indicatedfor use for aiding the user indetermining the bolus insulindosage for management ofdiabetes mellitus based onconsumed carbohydrates,operator-	Indications for use of the DEKAACE Pump System are equivalentto the predicate.Indications for use of the boluscalculator are equivalent to otherdevices with this product code.
Characteristic	Predicate Device	Subject Device	Equivalence
		entered blood glucose, insulinsensitivity, insulin to carbohydrateratio, target glucose values, andcurrent insulin onboard.
Prescription Use	Yes	Yes	Same
Intended Population	6 years and older	13 years and older	The difference in the lower agelimit does not impact the safetyand effectiveness of the device forits indicated use. Testingdemonstrates equivalent safety andeffectiveness for the indicatedpopulation.
PatientEnvironment	On-body wearable ambulatorypump	On-body wearable ambulatorypump	Same
Environment ofUse	In professional healthcare facilitiesand home environments	In professional healthcare facilitiesand home environments	Same
Delivery Method	Micro-dosing threaded cartridgepump	Microprocessor controlled Micro-dosing pump mechanismsupplemented with acousticvolume sensor (AVS) feedback formonitoring delivery accuracy	No impact to safety oreffectiveness. Subject devicemeets all Special Controlsrequirements. Delivery methodhas been found SE to ambulatorypumps through clearance ofreference device.
Insulin Basal RateDelivery Range	0 units /hour- 15units/hour	0 units/hour - 30 units/hour	No impact on safety oreffectiveness. Subject devicemeets all Special Controlsrequirements across the entiredelivery rate range.
Insulin BolusDelivery Range	0.01 U at volumes greater than0.05 U units, Max Bolus Volume25 U	Programmable from 0.05 - 25.00Units in 0.01 Unit increments.	Same
Characteristic	Predicate Device	Subject Device	Equivalence
Basal Accuracy	See Delivery AccuracyComparison Below	See Delivery AccuracyComparison Below	No impact on safety oreffectiveness. Subject devicemeets all Special Controlsrequirements across the entiredelivery rate range.
Bolus Accuracy	See Delivery AccuracyComparison Below	See Delivery AccuracyComparison Below	No impact to safety oreffectiveness. Subject devicemeets all Special Controlsrequirements.
Bolus Volume afterOcclusion Release	Less than 3 Units	No more than 0.74 units	No impact to safety oreffectiveness. Subject devicemeets all Special Controlsrequirements.
Time to occlusionalarm	3 min (Bolus); 2 hours (Basal, 2U/hr); 36 hours (Basal, 0.1 U/hr):	10 min (Bolus); 3 hours (Basal, 1U/h); 6 hours (Basal, 0.1 U/hr)	No impact to safety oreffectiveness. Subject devicemeets all Special Controlsrequirements.
MaterialBiocompatibility	Compliant with ISO-10993	Compliant with ISO-10993	Same
Cartridge/CassetteShelf Life	2 years	1 year	Performance testing over the oneyear shelf life of the cassetteindicates that the cassette remainssafe and effective.
Ingress Protection	IPX7: Watertight to a depth of 3feet (0.91 meters) for up to 30minutes	IP28, indicating protection fromcontinuous immersion in water.The Pump can tolerate immersionto depths of up to 12 feet (3.7 m)for 1 hour.	The higher level of ingressprotection than predicate meetsuse model requirements.
Applicable SafetyStandards	• 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
	<25%	25-75%	75-90%	90-95%	95-105%	105-110%	110-125%	125-175%	175-250%	>250%
Numberof boluses	21 / 800	79 / 800	63/ 800	34 / 800	272 / 800	180 / 800	105 / 800	29 / 800	17 / 800	0 / 800
% ofboluses	2.6%	9.9%	7.9%	4.3%	34.0%	22.5%	13.1%	3.6%	2.1%	0.0%

	2.5U bolus accuracy
	<25%	25-75%	75-90%	90-95%	95-105%	105-110%	110-125%	125-175%	175-250%	>250%
Numberof boluses	9 / 800	14 / 800	11 / 800	8 / 800	753 / 800	5 / 800	0 / 800	0 / 800	0 / 800	0 / 800
% ofboluses	1.1%	1.8%	1.4%	1.0%	94.1%	0.6%	0.0%	0.0%	0.0%	0.0%

	25U bolus accuracy
	<25%	25-75%	75-90%	90-95%	95-105%	105-110%	110-125%	125-175%	175-250%	>250%
Numberof 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
	<25%	25-75%	75-90%	90-95%	95-105%	105-110%	110-125%	125-175%	175-250%	>250%
Numberofboluses	0 / 800	53 / 800	202 / 800	107 / 800	278 / 800	80 / 800	69 / 800	11 / 800	0 / 800	0 / 800
% ofboluses	0.0%	6.6%	25.3%	13.4%	34.8%	10.0%	8.6%	1.4%	0.0%	0.0%

	5U bolus accuracy
	<25%	25-75%	75-90%	90-95%	95-105%	105-110%	110-125%	125-175%	175-250%	>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
	<25%	25-75%	75-90%	90-95%	95-105%	105-110%	110-125%	125-175%	175-250%	>250%
Numberofboluses	0 /224	0 /224	0 /224	0 /224	222 /224	2 /224	0 /224	0 /224	0 /224	0 /224
% ofboluses	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.

Regulation Number and Section

§ 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.