(290 days)
The Solution Delivery System Local and Solution Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.
The Osmonics Solution Distribution System (SDS) provides semi-automatic mixing of bicarb concentrate and the distribution of bicarb and acid concentrates from storage to hemodialysis patient stations. The mixed bicarb solution is automatically transferred to an elevated reservoir (head tank). The SDS, depending on the model purchased, can transfer up to three different acid concentrates to elevated head tanks from 55-gallon drums or larger bulk acid storage tanks. Bicarb and acid then flow via gravity from the head tanks to the dispensing stations.
The provided document describes the Osmonics Medical Systems Solution Delivery System (SDS) and its 510(k) premarket notification (K023011). However, the document does not contain information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study designs (like MRMC or standalone performance evaluations) as typically found in detailed performance studies.
Instead, the document states:
- Performance: "The Solution Delivery Systems have been manufactured and tested to meet the safety requirements of CSA and UL. The SDS systems comply with CAN/CSA C22.2 no. 601-1-M90: Safety of Medical Electrical Equipment, Part I, General Requirements for Safety and UL std No. 2601-1: Safety of Medical Electrical Equipment, Part I: General Requirements for Safety as certified by Canadian Standards Association."
This indicates that the device's performance was evaluated against safety standards for electrical and medical equipment, rather than clinical performance metrics or accuracy in specific measurements (which would be more relevant for an AI/CAD device). The document focuses on regulatory compliance based on safety and substantial equivalence to a predicate device, not on diagnostic performance or AI model evaluation.
Therefore, I cannot populate the requested table or answer the detailed questions about acceptance criteria, study design, and performance metrics as they are not present in the provided text. The document pertains to a medical device's safety compliance and regulatory clearance, not the performance evaluation of an AI-driven, diagnostic, or image analysis device.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.