(70 days)
The NxStage PureFlow SL module is an optional accessory to the NxStage System One™ that prepares dialysate for use during hemodialysis, as prescribed by the physician.
The NxStage PureFlow SL module is an optional accessory to the NxStage System One used to prepare water for hemodialysis that meets ANSI/AAMI/ISO 13959:2009 and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI/ISO 11663:2009. The PureFlow SL consists of the Control Unit (CU), the water Pre-Treatment Unit, the optional OPTA Kit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided document is a 510(k) Summary for a device modification, not a comprehensive study report with detailed performance data. Therefore, many of the requested details about specific acceptance criteria, study sizes, ground truth establishment, and MRMC effectiveness are not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device based on design control requirements and general performance verification.
Here's a breakdown of the available information structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance results. Instead, it makes a general statement about meeting design specifications and being suitable for its intended use.
However, based on the Technological Characteristics Comparison Table (Table 1) and the description, we can infer some qualitative "acceptance criteria" through comparison with the predicate device and relevant standards:
| Feature/Criteria (Inferred) | Reported Device Performance |
|---|---|
| Indication for Use | Same as predicate device (NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician). |
| Water purification technology | Same as predicate device (Deionization). |
| Ultrafiltration | Same as predicate device (Redundant ultrafiltration replaced within 12 weeks). |
| Water Quality | Meets or exceeds requirements per ANSI/AAMI/ISO 26722:2009 (Water treatment equipment for hemodialysis applications). |
| Proportioning method | Same as predicate device (Mixed to use Batch via volumetric dosing of purified water with specified amount of electrolyte concentrate). |
| Conductivity Measurement | Same as predicate device (System measures final batch conductivity prior to each treatment per ANSI/AAMI/ISO 26722:2009). |
| Dialysate Concentrate | Same as predicate device (Standard hemodialysis concentrate per ANSI/AAMI/ISO 13958:2009). |
| Packaging | Same as predicate device (Packaged in flexible LLDPE bags with standard luer lock connector, ranging in size from 20L to 60L). |
| Buffer | Same as predicate device (Lactate). |
| Mix-to-Use Time | Same as predicate device (96-hours). |
| Bioburden | Same as predicate device (AAMI/ANSI/ISO 11663: |
§ 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.