(28 days)
NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
The NxStage PureFlow Solution with bicarbonate (NxStage PureFlow-B Solution) is a non-pyrogenic dialysis solution provided in single use flexible bags. The PureFlow-B Solution is intended for use with renal replacement therapy systems that utilize sterile premixed dialysate.
This is a 510(k) summary for the NxStage PureFlow-B Solution, a premixed dialysate for hemodialysis. This device is classified as a Class II medical device under 21 CFR 876.5820. The submission is a Special 510(k) Device Modification, indicating that the device has undergone modifications from a previously cleared device (K033386) and seeks to demonstrate substantial equivalence to it.
Here's an analysis of the provided information concerning acceptance criteria and the supporting study, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary and associated documents do not include a table of acceptance criteria nor specific reported device performance metrics in numerical form.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (K033386) through compliance with design control requirements and design validation testing. The conclusion states that the modified device "has been shown to meet the minimum requirements that are considered acceptable for its intended use" based on:
- Device indications for use
- Comparison of descriptive and technological characteristics
- Design control certification
This typically means that the acceptance criteria are implicitly met by demonstrating that the modified device performs similarly to the predicate device, especially considering it's a device modification where the fundamental intended use remains the same. The "acceptance criteria" here therefore refer to the device's ability to maintain the safety and effectiveness profile established by the predicate device after modifications.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set. It mentions "Design validation testing has been performed to ensure that the modified device meets design specifications." However, it doesn't detail the nature of this validation testing, whether it involved clinical data, bench testing, or a combination, nor does it provide sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since clinical data or a "test set" requiring expert ground truth is not explicitly described, this information is not provided in the document. For a fluid solution like a dialysate, "ground truth" would more likely relate to chemical composition, efficacy in solute removal (measured in-vitro or in-vivo), and safety (pyrogenicity, sterility), rather than expert consensus on image interpretation, for example.
4. Adjudication Method for the Test Set
As there is no mention of a test set requiring adjudication from experts, this information is not applicable/provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance to measure improvement in accuracy or efficiency. A dialysate solution does not typically involve human interpretation of outputs in the same way.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop) Was Done
No, a standalone performance study in the context of an algorithm or AI without human-in-the-loop performance is not applicable here. The device is a physical solution (dialysate), not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for a dialysate would primarily be based on:
- Chemical/Physical Specifications: Meeting established purity, concentration, pH, and electrolyte balance standards (e.g., USP monographs, ISO standards, internal specifications).
- Sterility and Endotoxin Testing: Ensuring the solution is non-pyrogenic and sterile.
- Performance in Dialysis Systems: Demonstrating effectiveness in removing waste products and maintaining fluid/electrolyte balance when used with compatible renal replacement therapy systems.
While the document doesn't explicitly state "type of ground truth," the concept of "design specifications" and compliance to "21 CFR 820.30 Design Control requirements" implies that the device was validated against pre-defined, measurable specifications. This would involve laboratory testing and performance evaluations against established chemical and biological criteria.
8. The Sample Size for the Training Set
As this is a physical medical device (a dialysate solution) and not an AI/ML algorithm that requires a "training set" of data, the concept of a training set sample size is not applicable and therefore not provided in the document.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set," this information is not applicable and not provided.
Summary of Key Takeaways from the document:
- The submission is for a device modification of a previously cleared dialysate.
- The primary method of demonstrating acceptability is through substantial equivalence to the predicate device (K033386), compliance with design control requirements (21 CFR 820.30), and performance of design validation testing.
- Specific quantitative acceptance criteria or detailed results of performance testing are not included in this summary document, which is typical for a 510(k) summary relying on substantial equivalence and design control certification for a non-AI/diagnostic device.
- The concepts of "test set," "expert ground truth," "adjudication," "MRMC studies," "standalone algorithm performance," and "training set" are not relevant or applicable to this type of device and submission as presented.
§ 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.