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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 considered competent in the use of the device.

SC+ Blood Tubeset

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

The SC+ is a hemodialysis delivery system intended for acute and chronic dialysis therapy with or without ultrafiltration in an acute of chronic care facility. The system consists of the SC+ Machine, a single use disposable Dialysate Cartridge, and a sterile, single use, disposable Blood Tubeset.

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℃ 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 Quanta Dialysis Technologies Ltd SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, and SC+ Blood Tubeset, which received FDA clearance K210661. This device is not an AI/ML device, and thus the requested information regarding acceptance criteria, study details, and AI/ML-specific performance metrics is not applicable.

The submission is for modifications to an existing device (SC+ Hemodialysis System, K193670). The modifications include adding two-way wireless transmission capability for machine data and updated user workflows/interface for the machine, and for the blood tubeset, a luer activated valve on the venous bloodline and replacement of a saline spike with a recirculation luer.

The 510(k) summary concludes substantial equivalence based on performance testing to verify electrical safety and electromagnetic compatibility profiles, software verification, human factors validation testing, and biological safety testing. Precise details of these tests (e.g., specific acceptance criteria, sample sizes, and detailed results) are not provided in this summary document.

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