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510(k) Data Aggregation
K Number
K212658Device Name
CloudCath Peritoneal Dialysis Drain Set Monitoring System
Manufacturer
CloudCath
Date Cleared
2022-02-09
(170 days)
Product Code
FKX
Regulation Number
876.5630Why did this record match?
Applicant Name (Manufacturer) :
CloudCath
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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