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The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.

The Byonyks X-1 APD Cycler System includes an Automated Peritoneal Dialysis Cycler and a disposable tubing set. The Byonyks X-1 APD Cycler is intended for acute and chronic peritoneal dialysis. Byonyks X-1 APD Cycler is an automated peritoneal dialysis system that uses a peristaltic pumping mechanism to infuse the dialysate (Dialyzing Solution) into the peritoneal cavity and drain it after the dialysate has dwelled within a patient's peritoneal cavity for a specified amount of time. Byonyks X-1 APD Cycler is a prescription-use-only device and the therapies administered using Byonyks X-1 APD Cycler are prescribed by a physician. The device operates according to a therapy prescription provided by the patient's physician. The device is designed to be used in dialysis clinics, outpatient care areas, and home treatment settings with dialyzing solutions approved for peritoneal dialysis. Dialysate is infused into the patient's peritoneal cavity from a dialysate bag through a surgically implanted catheter which provides a fluid connection to the device's disposable tubing set. The dialysate remains in the peritoneal cavity for the dwell time which is a programmed length of time prescribed by the patient's physician. After the dwell time has elapsed, the fluid is drained from the patient using the device's peristaltic pumping system to extract the fluid from the patient's peritoneal cavity. Peristaltic pumping mechanism of the Byonyks X-1 APD cycler assist the dialysate flow at pre- programmed flowrate up to the volume prescribed by the patient's physicians, device continuously monitors volume of dialysate exchanges along with the fluid pressure external to the cassette of disposable set, fluid pressure detects resistance in dialysate exchanges at which pumping regulates the overall flow. The Byonyks X-1 APD Cycler System consists of the (i) main control unit (Cycler) and the (ii) disposable set.

Intelligent Dialysis Assistant (IDA) is intended for automatic single exchange of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Intelligent Dialysis Assistant (IDA) must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. The patient prescription may include single or multiple exchanges, depending on the patient's need. The IDA Cartridge is a single-use, sterile cartridge exclusively for use with the IDA. It is intended to interface the IDA with the Twin Bag Set (patient dialysis prescription) and the patient's peritoneal catheter. The Medical Supervision Portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This Medical Supervision Portal is not intended to be a substitute for good clinical management practices, nor does its operation creatment pathways. The IDA Smartphone App is a software medical application intended for patients to review their treatment and review and approve their dialysis prescription provided by the healthcare professional through the Medical Supervision Portal. The user is not intended to take clinical action based on the application of a qualified healthcare professional.

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The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

The Liberty Select Cycler is a software-controlled electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Cycler is designed as a table-top unit that can be used to perform peritoneal dialysis (PD) in hospitals, dialysis clinics, and at home. The software has been updated from version 2.9.2 to introduce the Remote Therapy Programming feature. This feature allows the Cycler to securely receive prescription settings remotely from a Fresenius server.

The Lilliput™ APD System is indicated for adult chronic peritoneal dialysis in home and clinical settings.

The Lilliput APD System is available in one (1) configuration that includes an electromechanical cycler (hereinafter referred to as "Cycler"), disposable set (hereinafter referred to as "Disposable Set''), USB key, and Kinexus Gateway. The Disposable Sets are available in three (3) configurations: - . Lilliput Disposable Set, One Patient Connector (Low feature) - Lilliput Disposable Set, One Patient Connector with Extended Drain and Patient Lines (Medium Feature) - . Lilliput Disposable Set, Two Patient Connectors with Extended Drain and Patient Lines (High Feature) The Cycler is a software-controlled electromechanical device. The Disposable Sets are single-use Class II devices designed to operate with the Cycler to perform Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Disposable Sets are provided sterile and non-pyrogenic and are sterilized using ethylene oxide (EO).

The CloudCath System is intended for patients undergoing acute and chronic peritoneal dialysis. The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use by patients undergoing continuous cycling peritoneal dialysis (CCPD) in a healthcare facility or at home. The optical sensor has associated hardware and software components to allow for data transmission to a healthcare professional. This system is not intended to provide diagnostic information and is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

The CloudCath Peritoneal Dialysis Drain Set Monitoring System (CloudCath System) is a tabletop passive drainage system used as an attachment during a peritoneal dialysis (PD) treatment and indicated for use by patients with acute and chronic end-stage renal disease undergoing PD. The CloudCath System connects directly to the end of the cycler tubing set drain line in order to enable draining and contains an optical sensor that measures turbidity, reported as a turbidity score, in peritoneal dialysate effluent as a supplement to visual examination of cloudiness in dialysate drain lines. The system is indicated for use with validated peritoneal dialysis cyclers in healthcare facilities or home use environments. The optical sensor has associated hardware and software components to allow for remote data transmission by healthcare providers. The CloudCath System is comprised of three main components: Sensor, Drain Set and Patient Monitoring Software. The Drain Set and the Sensor are components used by the patient. The Patient Monitoring Software is a cloud-based system used by a healthcare professional to view the results from the patient's use of the CloudCath System.

Homechoice Claria APD System: Baxter's Homechoice Claria APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the HOME HEALTHCARE ENVIRONMENT including comparable use in professional healthcare facilities. Sharesource Connectivity Platform for use with the Homechoice Claria APD System: The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

The Homechoice Claria APD System (Claria) is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. The system automatically cycles peritoneal dialysis solution in the amounts and at the times prescribed by a clinician familiar with and well informed about peritoneal dialysis. The clinician may use the Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (Sharesource) to remotely communicate with the Claria cycler. Sharesource allows the transfer of treatment data originating from the treatment device to the clinician for review of historical treatment results. It also allows the clinician to adjust the device settings of the Claria cycler remotely. Changes to the device program by the clinician require the patient to review and accept the changes prior to the implementation of those changes. If the patient does not accept the changes, the Claria cycler will not accept the modified program. Sharesource does not include any real-time monitoring or real-time programming capabilities.

The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

The Liberty Select Cycler is an electro-mechanical medical device. Software controls the functions of the machine during peritoneal dialysis treatment, including fluid flow, heating, and alarms. Like the predicate device, the modified Liberty Select Cycler is a software-controlled electromechanical medical device designed as a table-top unit to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Select Cycler is used to perform continuous and intermittent peritoneal dialysis therapies. Treatment settings are programmed based on a physician's prescription.

The Liberty Cycler Sets are designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis.

The Cycler Sets are sterile, single-use devices designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis. Each Cycler Set contains a cassette portion and seven (7) fluid lines. The cassette is composed of a rigid molded plastic body covered with a flexible film (membrane). The cassette contains molded features, such as fluid channels, valve domes, and pumping chambers. There are 7 fluid lines connected to the cassette body: - One (1) drain line (yellow clamp) - One (1) patient connection line with two (2) stay •safe® patient connectors (blue clamp) - Five (5) Dialysate Solution Lines (with Safe-Lock® connectors): - One (1) heater bag (red clamp) - One (1) last dialysate bag/'last fill option' (green clamp) - Three (3) additional solution bags (white clamps) The flow of peritoneal dialysate solution to and from the patient's peritoneal cavity is directed by interaction between the Liberty Cycler and the cassette.

The Fresenius Liberty Select Cycler is indicated for acute and chronic peritoneal dialysis.

The Liberty Select Cycler is an electro-mechanical medical device. Software controls the functions of the machine during peritoneal dialysis treatment, including fluid flow, heating, and alarms. The Liberty Select Cycler is designed as a table-top unit and is prescribed for use in both professional and home treatment settings. The Liberty Select Cycler is a software-controlled electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Select Cycler is used to perform continuous and intermittent peritoneal dialysis therapies. Treatment settings are programmed based on a physician's prescription. The Liberty Select Cycler accommodates three (3) accessory devices: Cassette and tubing set, IQdrive, Optional wireless modem.

Amia Automated PD System: The Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Amia Automated PD System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis. Sharesource: The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.

The Amia Automated PD System with Sharesource (hereafter "Amia/Sharesource System") device is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The system automatically cycles peritoneal dialysis fluid in the amounts and at the times prescribed by a clinician familiar and well informed about peritoneal dialysis. The clinician may use the optional Sharesource software accessory to remotely communicate with the Amia Automated PD System. Sharesource will allow the transfer of treatment data originating from the treatment device to the clinician for review of patient historical treatment results. It will also allow the clinician to adjust the device settings of the Amia Automated PD System remotely. Changes to device program by the physician require the patient to review and accept the changes prior to the change of the device program on the cycler. If the patient does not accept the changes, the device will not accept the modified program. The Amia Automated PD System with Sharesource does not include any real-time remote monitoring or real-time remote programming capabilities.