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The Remunity® 2.0 Pump for Remodulin® (treprostinil) Injection (the Remunity 2.0 System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.

The Remunity 2.0 System is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for the treatment of pulmonary arterial hypertension (PAH). Remodulin® was FDA-approved under NDA 021272. The system consists of several components: a wearable pump assembly, a remote interface, and accessories (e.g., rechargeable batteries, battery charger, charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard luer connector for the delivery of Remodulin® from the system to the patient. The Remunity 2.0 System is prescription use only. The pump assembly is composed of a durable pump and a disposable, single-use cassette with a user-filled drug reservoir. The pump infuses Remodulin® subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The subject system utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.

The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician. The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products. The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

The subject device is a modified version of the predicate DEKA Infusion System. Updates have been made to the predicate device software to increase the maximum programmable flow rate (from 300 to 600 mL/h), update the labeling to reflect the increased maximum programmable flow rate and update the performance of tilt angle detection. The administration set is unchanged. The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention. The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.

The HemoCare® Hemodialysis System is indicated for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare Hemodialysis System is indicated for use in chronic dialysis facilities, self-care dialysis facilities, and the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed with the assistance or observation of an individual who has been trained and is considered competent in the use of the device. The HemoCare Hemodialysis System is not indicated for solo hemodialysis in the home setting.

The HemoCare® Hemodialysis System is a self-contained, software-controlled device that provides hemodialysis treatments, including short daily and nocturnal hemodialysis, for patients with renal failure. The device is intended for use by a single patient in chronic dialysis facilities, self-care dialysis facilities, and the home setting. The HemoCare® Hemodialysis System is composed of the following components: - The HemoCare® Treatment Device is a hemodialysis delivery system. When provided a source of water for dialysis, it produces infusion grade dialysate using liquid acid and powder bicarbonate concentrates. The Treatment Device provides secure, 2-way communication with the cloud for transmitting patient registration, physician-prescribed dialysis treatments, patient monitoring, and device status information. - The HemoCare® Water Device is a water purification system that produces water for dialysis through distillation of EPA drinking water. The Water Device interfaces with the Treatment Device. - The Blood Treatment Set connects to the patient access site and interfaces with the Treatment Device to provide extracorporeal blood flow through a dialyzer for dialysis treatment. The Blood Treatment Set is terminally sterilized and includes displacement blood pumps, a heparin delivery system, and an access disconnect sensor. The Blood Treatment set can be used for up to 16 treatments.

The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.

The HemoCare Bicarbonate Concentrate Set (BCS) is the Subject Device of this submission. It consists of powdered sodium bicarbonate in a single use cartridge with an integrated tubing assembly for interfacing with hemodialysis systems with compatible three-stream proportioning connector ports such as the HemoCare Hemodialysis System. The HemoCare System uses the bicarbonate concentrate in 3-stream, 45x proportioning to generate dialysate for bicarbonate hemodialysis therapy.

The Remunity® Pump for Remodulin® (treprosimil) Injection (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years old).

The Remunity Subcutaneous Delivery System for Remodulin® (Remunity System) is a wearable infusion pump designed to deliver Remodulin® for the treatment of pulmonary arterial hypertension (PAH). It is intended for continuous subcutaneous delivery of FDA-approved Remodulin® (treprostinil) (hereinafter referred to as 'Remodulin®' or 'Remodulin® (treprostinil)'), NDA 021272. The Remunity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery charger, charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard luer connector for the delivery of Remodulin® from the Remunity System to the patient. The pump assembly is composed of a reusable pump and a disposable single-use cassette with a pharmacy-filled or user-filled drug reservoir, which infuses Remodulin® subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The Remunity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy. The device is prescription use only. The modified device utilizes a touchscreen remote controller.

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 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.

DEKA Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and the DEKA alternate controller enabled (ACE) insulin infusion pump to automatically increase, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. DEKA Loop is intended for the management of Type 1 diabetes mellitus in persons six years of age and greater. DEKA Loop is intended for single patient use and requires a prescription.

DEKA Loop is an interoperable Alternate Glycemic Controller (iAGC) and works to control an ACE (Alternate Controller Enabled) insulin pump to automatically increase, decrease, and suspend delivery of basal insulin based on readings from an iCGM (integrated continuous glucose monitor) and glucose values predicted by DEKA Loop. DEKA Loop can also recommend, and with the user's confirmation, control the delivery of correction boluses when glucose values are predicted to exceed user configurable thresholds. It is controlled by an iOS app that is downloaded to a user's iPhone.

The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician. The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products. The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.

The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a Camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention. The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.

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.

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: 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. 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 an DEKA ACE Pump and off-the-shelf infusion set. 3. 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.