(34 days)
The NxStage Pureflow Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
The NxStage PureFlow Solutions are sterile, non-pyrogenic dialysis solutions provided in single use flexible PVC bags varying in sizes from 1000 to 5000ml. The dialysis solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.
The provided document describes a 510(k) submission for a medical device called "NxStage PureFlow Solution," which is a pre-mixed dialysate. This submission is a "Special 510(k) Device Modification" and relies on demonstrating substantial equivalence to a previously cleared predicate device (K022913), rather than conducting a new clinical study with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance against those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.
Instead, the submission for K033386 states the following:
1. Acceptance Criteria and Reported Device Performance:
- The fundamental acceptance criterion is that the modified device "meets design specifications" and is "substantially equivalent" to the baseline device (K022913).
- The document states: "Design validation testing has been performed to ensure that the modified device meets design specifications. The modified NxStage PureFlow Solution has been compared to the baseline as cleared in K022913 and found to be substantial equivalent."
- No specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity values) or detailed performance metrics are reported in this document.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. The document refers to "Design validation testing" but does not specify the sample size of any test sets used or the provenance of the data. Given it's a device modification, the validation likely focused on engineering specifications, material compatibility, and chemical properties, rather than patient-level or expert-reviewed performance data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable / Not provided. The concept of "ground truth" established by experts for a specific test set, as would be relevant for an AI/diagnostic device, is not discussed in this submission for a dialysate solution.
4. Adjudication Method:
- Not applicable / Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is not relevant for a dialysate solution and was not conducted or mentioned.
6. If a Standalone Performance Study Was Done:
- Not applicable / Not provided. "Standalone performance" in the context of an AI algorithm is not relevant for a dialysate product. The "Design validation testing" is a form of standalone testing for the device's physical and chemical properties, but not in the sense of an algorithm's diagnostic performance.
7. The Type of Ground Truth Used:
- Not explicitly stated in this context. For a dialysate, "ground truth" would relate to its chemical composition, sterility, stability, and functional performance (e.g., pH, electrolyte concentrations, osmolarity) rather than expert consensus on diagnostic images or pathology. The "design specifications" are the de facto ground truth used for validation.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. This document does not describe the development or training of an AI algorithm; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided.
Summary of the Study:
The "study" referenced in this document is the "Design validation testing" performed by NxStage Medical, Inc. This testing was carried out to "ensure that the modified device meets design specifications" and to demonstrate its "substantial equivalence" to the predicate device K022913. As a Special 510(k) for a device modification, the focus is on compliance with design controls (21 CFR 820.30) and engineering/performance validation against established specifications of the original device, rather than a new clinical performance study with human readers or AI.
§ 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.