(27 days)
NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
The NxStage PureFlow-B Solutions (with bicarbonate buffer) are non-pyrogenic dialysis solutions provided in single use flexible bags. The PureFlow-B Solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. The range of constituents allows the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients.
Acceptance Criteria and Study for NxStage PureFlow-B Solution
This document details the acceptance criteria and the study that "proves" the NxStage PureFlow-B Solution device meets those criteria, based on the provided 510(k) summary.
Note: The provided document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a previously cleared device. It does not contain an "acceptance criteria" table in the traditional sense of a clinical trial or performance study with numerical targets and measured performance. Instead, the "acceptance criteria" for a 510(k) are met by demonstrating the modified device is as safe and effective as a predicate device.
Therefore, the interpretation of "acceptance criteria" here refers to the requirements for demonstrating substantial equivalence, and "reported device performance" refers to the manufacturer's assertion of meeting those requirements through comparison to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| I. Device Modification Documentation: Compliance with 21 CFR 820.30 Design Control requirements (as per FDA's guidance document for Special 510(k)s). | NxStage has provided certification of compliance to 21 CFR 820.30 Design Control requirements. This implies the modification process followed established quality system procedures and documented controls were in place to ensure the safety and effectiveness of the changes. |
| II. Design Validation: Validation of the modified device to confirm it meets design specifications. | The submission states that the modified device "meets Design validations." This indicates that the manufacturer performed testing and verification to ensure the modified device performs as intended and meets its design requirements. The specific validation methods are not detailed in this summary. |
| III. Substantial Equivalence to Predicate Device (K042045): The modified device is as safe and effective as the predicate device. | The modified NxStage PureFlow-B Solution has been compared to the baseline (predicate device, K042045) and found to be "substantially equivalent." This is the core conclusion of the 510(k) submission, indicating that any changes made do not raise new questions of safety or effectiveness and that the device performs similarly to one already legally marketed. |
| IV. Meets Minimum Requirements: The device fulfills all applicable regulatory and safety requirements. | "The modified NxStage PureFlow-B Solution has been shown to meet the minimum requirements that are considered applicable." This general statement covers compliance with relevant standards, regulations, and generally accepted principles for medical devices of this type. The specific "minimum requirements" are not itemized but would include aspects like sterility, biocompatibility, chemical composition, etc. |
Study Information & Details:
Regarding a "study" that proves the device meets (aforementioned) acceptance criteria:
The provided 510(k) summary describes a Special 510(k) Device Modification. For this type of submission, the "study" is primarily a demonstration of adherence to design control principles and a comparison to a predicate device, rather than a traditional clinical study with patient outcomes or a statistical analysis of a "test set."
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a traditional performance "test set" with patient data or a specific number of instances. The "test set" here refers to the comparisons and validations performed during the design control process. No specific sample sizes for laboratory tests, stability tests, or other verification activities are mentioned in this summary.
- Data Provenance: Not explicitly stated as "country of origin" for data, but the submission is from NxStage Medical, Inc. based in Lawrence, MA, USA, and is submitted to the US FDA. The "study" here is a regulatory affirmation based on design controls.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of expert review of images or clinical cases for ground truth. This is a technical and regulatory comparison, not a diagnostic device evaluation. The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at NxStage Medical, Inc., who are responsible for ensuring compliance and technical validity.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or reader studies where expert consensus is needed for ambiguous or subjective evaluations, common in diagnostic imaging. This 510(k) is for a manufacturing modification to a dialysate solution.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a premixed dialysate for hemodialysis, not an AI-powered diagnostic device or an imaging product. MRMC studies are specific to evaluating diagnostic accuracy, often in imaging.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemical solution, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this Special 510(k) is the predicate device (K042045). The modified device's performance, safety profile, and efficacy are compared against the known characteristics and performance of the predicate. The "truth" is that the modified device should meet the same specifications and perform comparably to the predicate. The basis for this "truth" would come from physicochemical testing, stability testing, and potentially limited biocompatibility testing if new materials were involved (though not explicitly detailed in the summary).
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of medical device submission.
§ 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.