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SC+ Hemodialysis Machine/ SC+ Dialysate Cartridge

The SC+ Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. Treatments must be administered under physician's prescription, by a trained person who is competent in the use of the device.

Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED), Prolonged Intermittent Renal Replacement Therapy (PIRRT), Isolated Ultration including Slow Continuous Ultrafiltration (SCUF) and Continuous Venovenous Hemodialysis (CVVHD).

SC+ Blood Tube Set

The SC+ Blood Tube Set is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The Blood Tube Set is compatible only with the SC+ Hemodialysis System.

The SC+ is a haemodialysis delivery system intended for the provision of acute and chronic dialysis therapy, with or without ultrafiltration. The SC+ system utilises incoming Dialysis Water from an external source, with industry standard dialysis concentrate consumables, to manufacture the dialysis fluid used to deliver the treatment. The SC+ system is for use in patients with arteriovenous (AV) fistulas or central venous catheter access.

The SC+ system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

SC+ Hemodialysis System 5.4.1

The SC+ Hemodialysis System is intended for acute and chronic dialysis therapy, with or without ultrafiltration, utilizing Dialysis Water (from standalone Reverse Osmosis (RO) units or a central RO ring main) to produce dialysate. The SC+ Hemodialysis system is for use in patients with arteriovenous (AV) fistula or central venous catheter access.

The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

The SC+ Machine consists of a water circuit (heater, de-aeration module, etc) blood leak detector, air in blood detector, a pneumatic interface for the dialysate cartridges, a peristaltic blood pump and various other sensors. The dialysate cartridge contains the following; conductivity monitors, interfaces for pressure and temperature measurement, membrane pumps to perform mixing/proportioning in order to produce dialysis fluid and the controlled removal of fluid from a patient with acute and/or chronic renal failure based on a physician's prescription. The dialysate fluid is manufactured using dialysis water purified externally by reverse osmosis that is heated to approximately 37°C and subsequently deaerated within the machine before entering the cartridge.

The SC+ Blood Tubeset is a single use, sterile device consisting of an arterial line, a venous line, connections to a standard dialyzer, a saline line, three pressure transducer pods integrated into a single unit, a venous drip chamber, and a line for heparin infusion.

This document describes the regulatory submission for the SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, and SC+ Blood Tube Set (K222067). It indicates that the device has been found substantially equivalent to a legally marketed predicate device (K210661).

The provided text does not contain detailed acceptance criteria or results from a study that explicitly compares the device's performance against numerical acceptance criteria in a table format. Nor does it include information about sample sizes for test sets, data provenance, expert involvement in ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set details.

Instead, the document focuses on device modifications and a summary of Verification & Validation (V&V) activities. The V&V section lists the types of performance testing performed to support the determination of substantial equivalence, which implies that the device met internal criteria derived from these tests. These tests include:

• Essential Performance testing for dialysate composition
• Essential Performance testing for dialysate flow rate
• Essential Performance testing for Blood Flow Rate
• Essential Performance testing for Net Fluid Removal
• Essential Performance testing for Treatment Time
• Essential Performance testing for Consumables duration testing
• Blood Loss to Dialysate protective system testing
• Net Fluid Removal Protective system testing
• Patient Leakage Current testing
• Hemolysis testing
• Software verification

The conclusion states that the modifications provide "reasonable assurance of safety and effectiveness to demonstrate it is at least as safe and effective as the predicate device and therefore is substantially equivalent." This suggests that the V&V activities confirmed that the modified device's performance, across the listed essential performance and safety aspects, was comparable or superior to the predicate device, within acceptable safety margins.

Without further documentation, it's not possible to populate the requested detailed information regarding specific acceptance criteria, reported performance values, study design specifics, or expert involvement. The provided text is a regulatory summary, not a detailed study report.

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