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The twiist 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 twiist system 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 twiist system described herein contains a modification of the labeling of the previously cleared DEKA ACE Pump System (K233952) to add the ConvaTec contact™ detach 23" subcutaneous infusion set and the ConvaTec inset™ 23" and 32" subcutaneous infusions sets as compatible for use with the twiist system. The twiist system 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 twiist system is intended for the management of diabetes mellitus in persons six years of age and greater. The twiist system, consistent with the predicate K233952, consists of the following durable and disposable components: 1. **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. 2. **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. 3. **Sequel twiist App:** An iOS mobile application that serves as the primary user interface for the system. The twiist app can be downloaded onto the user's personal iPhone.

The embecta Insulin Delivery System with interoperable technology (the Patch) is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and older. The Patch 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 patch is intended for single patient, home use and requires a prescription.

The embecta Insulin Delivery System is a prescription home use device intended to support insulin therapy for diabetes mellitus (DM) management. The embecta Insulin Delivery System is a disposable insulin delivery device (referred to as a Patch) that is operated by a Controller which consists of Controller software application provided on a locked down smartphone with Bluetooth Low Energy (BLE) and Wi-Fi capabilities. The embecta Insulin Delivery System performs the following functions: 1) Deliver user-set daily basal insulin 2) Deliver user-set or user-entered mealtime (prandial) or correction insulin doses 3) Generate system status and notifications. The Patch is a single use disposable patch pump device intended to be worn by the patient for a Patch Life period of up to 72 hours (3 Days). The Patch is adhered to the patient using a medical grade adhesive patch. The Patch features a syringe pump design that operates dose increment mechanism which controls the dose size. It stores and administers 300 U of user-filled U-100 insulin with variable basal and bolus dosage settings that are agreed upon between the user and their healthcare practitioner or provider. It is indicated for U-100 NovoLog® (insulin aspart) and U-100 Humaloq® (insulin lispro). The Controller App is a smartphone app running on a locked-down Android smartphone that is rechargeable with the provided charger. The Controller App will control the Patch. The embecta-provided smartphone will be non-sterile and is locked to run only the embecta Controller App to program the Patch discreetly. The Controller App will enable the user to pair, prime, and program basal and bolus dose via wireless transmission to the Patch as well as provide users with system alerts, including status information, and notifications. This includes, but is not limited to, controller battery life, total insulin delivered, calculation of a low insulin reservoir volume, occlusion, and other possible device faults. The Controller App is designed to program and display the patient's basal insulin delivery rate, delivered bolus doses, and insulin usage data on a color display touch screen.

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.

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: 1. 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. 2. 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. 3. 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.

The Tandem Mobi 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, 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 in individuals 2 years of age and greater.

The Subject Device, Tandem Mobi insulin pump with interoperable technology ("Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ("pump") is screenless and includes visual LED, sound, and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the Tandem Mobi Mobile Application and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The Tandem Mobi Mobile Application ("Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications, and messages. The Tandem Mobi Mobile Application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem Mobi Mobile Application will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump. The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm. The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.

The DEKA ACE Pump System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages six and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is intended for single patient, home use and requires a prescription. The bolus calculator is indicated for use for aiding the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator entered blood glucose, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

The DEKA ACE Pump system is a modification of the previously cleared DEKA ACE Pump System (K213536). The modified device is a wearable alternate controller enabled (ACE) insulin infusion pump (DEKA ACE Pump System) with the addition of an embedded iAGC (DEKA Loop). The user interface is an iOS app that can be downloaded to a user's iPhone. The updated system is still intended to subcutaneously deliver insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices to receive, confirm, and execute commands. The Pump is intended for single patient, ambulatory use and requires a prescription. The Pump is indicated for use with Humalog U-100 insulin. The DEKA ACE Pump System is indicated for the management of mellitus in persons six years of age and greater. The system as described in this submission is able to be integrated with an integrated Continuous Glucose Monitor (iCGM). This submission also details the integration process that was used to incorporate the DEKA Loop iAGC Algorithm onto the DEKA ACE Pump. The DEKA ACE Pump System consists of the following durable and disposable components: - Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to a cassette, external wireless user interface, and iCGM. The pump is powered by a rechargeable lithium ion battery. - Cassette: A single-use pumping cassette that combines microfluidic valves, a pump chamber, insulin reservoir, and Acoustic Volume Sensing (AVS) measurement chamber. The cassette interfaces to a pump and off-the-shelf infusion sets. - DEKA Loop App: An iOS mobile application that serves as the primary user face for the system. The DEKA Loop app can be downloaded onto the user's personal iPhone.

The Inessa System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Inessa System 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 Inessa System is intended for single patient, home use and requires a prescription. The Inessa System is indicated for use in individuals 6 years of age and greater.

The Inessa System ("System") is intended for subcutaneous delivery of insulin at set and variable rates, bolus or basal. The Inessa System includes a skin-adhered Patch Pump that is programmed and controlled wirelessly by a handheld Controller. The System main components include: Patch Pump: a skin adhered, syringe pump type, designed for insulin delivery at set and variable basal and/or bolus doses. The Patch Pump includes two parts: Pump: a reusable part that includes motor, electronics, drive mechanism, and o rechargeable battery. Two Pumps are provided, one is charged (P2) while the other is in use (P1). Cartridge: a sterile disposable part that includes insulin Reservoir. o Controller: The System user interface is a handheld, Alternate Controller Enabled (ACE), providing instructions to the Pump and receiving information from the Pump using wireless Bluetooth Low Energy (BLE) communication. The System includes the following accessories: Inserter: disposable, for insertion of Soft Cannula and retraction of Insertion needle. Filling kit: disposable, for filling of the Cartridge. It includes Filling needle, Filling syringe and Vial adaptor . Charger: reusable, for charging the Pump and the Controller. Docker: reusable, docking station for pumps for charging and protecting the Pump when not in use. The System also includes a Bolus Calculator, accessible through the System Controller. Based on user inputs of blood glucose (current and targeted), carbohydrate intake (meals), patient's insulin characteristics (i.e., Insulin Duration of Action, Insulin Correction Factor, Insulin-to-Carbs Ratio), this feature calculates suggested and estimated values for: Correction Bolus (amount of insulin needed to correct elevated blood glucose (BG) ● level): . Meal Bolus (amount of insulin needed to cover carbohydrates in an upcoming meal); and "Insulin on Board" or "Bolus on Board" (estimation of how much Active Insulin (Al) . remains in the body from previous boluses).

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 melliting 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 in individuals 2 years of age and greater.

The t:slim X2 Insulin Pump with Interoperable Technology is an ambulatory, battery operated, rate-programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim X2 insulin pump includes a disposable cartridge with a 300 unit reservoir which is filled with insulin by the user with the use of the syringe and needle. The cartridge needs to be changed every 48-72 hours depending on the type of insulin used. The pump is motor driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue. The desired timing and quantity of insulin delivery (bolus or basal) is programmed by the patient based on their healthcare provider's recommendations. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, execute, and confirm commands from these devices. The t:connect mobile app enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The t:connect mobile app can transmit pump and therapy data from the pump to the cloud as long as the user's smartphone is connected to the internet. The pump is designed to be able to receive and display alerts and alarms to users based on information received from other interoperable devices. The pump is compatible with Interoperable Automated Glycemic Controllers, such as Basal-IQ Technology (K193483) and Control IQ Technology (K200467) to aid in diabetes management. The latter is being submitted concurrently. In addition, the Subject Device is compatible with iCGM systems cleared under K223931 21 CFR 862.1355.

The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE 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 Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.

The Omnipod 5 ACE Pump is intended to deliver insulin via a tubeless insulin pump (the Pod) that wirelessly connects to and receives insulin delivery commands from the Omnipod 5 App, which is installed on a locked-down Android controller device or a user's personal smartphone device. The predicate device allowed the user to download the Omnipod 5 App to an Android compatible phone. This submission includes an iOS compatible Omnipod 5 App to allow users to download it to a compatible iPhone. The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes SmartAdjust Technology (iAGC), and the SmartBolus Calculator. SmartAdjust Technology and the SmartBolus Calculator functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to a third party iCGM, SmartAdjust Technology, and the SmartBolus Calculator. The Omnipod 5 ACE Pump can operate in Manual Mode, delivering insulin based on userprogrammed basal rates, or in Automated Mode, where insulin is automatically delivered based on the calculations and command of a compatible iAGC. Currently, the Omnipod 5 ACE Pump is compatible with SmartAdjust Technology, the software which is pre-installed on the Pod and the App. Future alternate controllers may be established for use with the Pod, in which case the software modules of the SmartAdjust Technology would be disabled. The Pod is a bodywearable insulin pump that affixes to the user on the back of the arm, the lower back, the abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The Omnipod 5 App is a software application installed on a handheld touchscreen device (Android and iOS) that connects to the Pod via Bluetooth Low Energy (BLE) and serves as the user interface of the system. In addition to programmed basal delivery and automated insulin delivery, the Omnipod 5 ACE Pump allows users to deliver bolus doses at values that are either inputted manually or calculated by the SmartBolus Calculator based on the user's settings and user-entered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with SmartAdiust Technology and the SmartBolus Calculator. The Omnipod 5 App has the ability to wirelessly connect to the Insulet Cloud which it utilizes for registering new devices, authenticating users, ensuring hardware devices and host operating systems are compatible, and completing over the air software (OTA) and firmware (FOTA) updates.