(48 days)
NxStage Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
The NxStage Premixed Dialysate Solutions are a family of premixed dialysate solutions which are sterile, non-pvrogenic solutions to be provided in single use flexible PVC bags varying in sizes from 1000 to 5000ml. The premixed dialysate solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. A family of dialysate solutions will allow the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients.
The provided document is a 510(k) premarket notification for a medical device (NxStage Premixed Dialysate) and does not contain the level of detail typically found in a clinical study report that would include acceptance criteria and specific performance metrics in the format requested.
This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparing indications for use and technological (chemical) characteristics, and confirming the ability to manufacture a solution meeting end-product specifications. It is not an AI/software device, so many of the requested fields are not applicable.
Here's an analysis of what can be extracted or inferred from the document regarding the "study" that proves the device meets the "acceptance criteria":
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of quantitative acceptance criteria and corresponding reported device performance values in the way one would expect for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence and the successful production of a validation batch meeting "end-product specifications."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| For Substantial Equivalence: | Demonstrated: |
| Same Indication Statement as predicate devices | YES - "The indication for use for the NxStage Premixed Dialysate Solutions is equivalent to that of the predicate devices." (NxStage Dialysate Concentrate (K013655), Baxter Premixed Dialysate for Hemodiafiltration (K910270), PrismaSate Dialysis Solutions (K013448)) |
| Same technological characteristics (design, materials, etc.) | YES - "The chemical composition ranges, for the common constituents, of the NxStage Premixed Dialysate are identical to that of the PrismaSate Dialysis Solutions, K013448 and therefore raise no new types of safety or effectiveness issues." |
| Descriptive characteristics precise enough to ensure equivalence | NO (but not a failure) - "However, variations in product formulations and sterilization methods may impact final characteristics of the product." (This indicates the need for performance data). |
| Performance data available to assess equivalence | YES - "NxStage Medical, Inc. has provided data for a validation batch of the NxStage Premixed Dialysate Solutions produced under controlled manufacturing conditions..." |
| Performance data demonstrates equivalence | YES - "Results of the batch validation assays have demonstrated that the dialysate manufacturer is capable of producing a solution meeting all endproduct specifications." |
| For Manufacturing Quality: | Demonstrated: |
| Meets "all end-product specifications" | A validation batch was produced under controlled manufacturing conditions, and its results "demonstrated that the dialysate manufacturer is capable of producing a solution meeting all end-product specifications." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document refers to "data for a validation batch." The exact number of units or measurements within this batch is not specified. It is likely a single manufacturing batch was tested for chemical and physical properties.
- Data Provenance: The manufacturing location is "Glandorf, Germany." The study itself is an internal validation of a manufacturing batch, not a clinical trial with patient data. It is a prospective test of a newly manufactured batch.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Experts: Not applicable. This is not a study requiring expert consensus for ground truth as it relates to chemical and manufacturing specifications, not diagnostic interpretation. The "ground truth" would be established by validated analytical methods against pre-defined specifications.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This is a chemical/manufacturing validation, not a study requiring human adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, this type of study was not done. This device is a premixed dialysate, not an imaging or diagnostic device requiring human interpretation assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a medical solution, not an algorithm. The "performance" refers to its chemical composition and sterility.
7. The Type of Ground Truth Used:
- Ground Truth: The ground truth for this validation would be the pre-defined chemical and physical "end-product specifications" for the dialysate solution (e.g., specific concentrations of electrolytes, pH, sterility, endotoxin levels). These specifications would be derived from medical literature, regulatory guidelines, and the composition of the predicate devices.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This is a manufactured product validation, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As mentioned, there is no training set in this context.
In summary:
This 510(k) submission details the substantial equivalence of a premixed dialysate to existing predicate devices. The "study" mentioned refers to internal manufacturing validation of "a validation batch" to ensure it meets pre-defined "end-product specifications." The nature of the device (a chemical solution) means most of the questions pertaining to AI/diagnostic device studies are not applicable.
§ 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.