(90 days)
NxStage Dialysate Concentrate, after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
NxStage Dialysate Concentrate is a clear, sterile, non-pyrogenic concentrate, provided in 150 ml unit-dose vials, which, when diluted with sterile water in the required proportions, creates a dialysate for use in renal replacement therapy. When diluted, NxStage Dialysate Concentrate yields a dialysate with the following composition:
- Sodium 140.0 mEq/L;
- Calcium 3.0 mEq/L;
- Potassium 2.0 mEq/L ;
- Magnesium 1,0 mEq/L;
- Chloride 111.0 mEq/L;
- L-Lactate 35.0 mEq/L.
This document describes the 510(k) Premarket Notification for the NxStage Dialysate Concentrate. It's important to note that this is a submission for a dialysate concentrate, which is a medical device (a substance used for dialysis), not a diagnostic algorithm or AI software, therefore many of the standard questions regarding AI/ML studies are not applicable.
Here's an analysis of the provided information in the context of the requested categories, highlighting where information is not applicable due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are primarily based on achieving substantial equivalence to existing predicate devices in terms of intended use and technological characteristics, particularly its chemical composition and method of preparation. The performance discussed is about meeting these equivalence criteria rather than quantified performance metrics typically seen in AI/ML studies (like accuracy, sensitivity, specificity).
| Acceptance Criteria (from 510(k) Substantial Equivalence Decision Making Process) | Reported Device Performance (as claimed by NxStage Medical, Inc.) |
|---|---|
| Is the product a device? (Per 21 CFR §201 [321] (h)) | YES - NxStage Dialysate Concentrate is a device. |
| Does the new device have the same intended use as the predicate devices? | YES - The intended use for the NxStage Dialysate Concentrate ("after dilution, is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate") is considered equivalent to those for the predicate devices (NormoCarb Sterile Bicarbonate Concentrate and Baxter Premixed Dialysate for Hemodiafiltration), despite slight variations in wording. |
| Does the device have technological characteristics that raise new types of safety or effectiveness questions? | NO - "The composition of the NxStage Dialysate Concentrate is equivalent to that of other commercially available hemodialysis concentrates and raises no new types of safety or effectiveness questions. In addition, the packaging, sterility status and method of preparation are equivalent to those of the NormoCarb Sterile Bicarbonate Concentrate." Specifically, the composition is: Sodium 140.0 mEq/L, Calcium 3.0 mEq/L, Potassium 2.0 mEq/L, Magnesium 1.0 mEq/L, Chloride 111.0 mEq/L, L-Lactate 35.0 mEq/L. |
| Does descriptive or performance information demonstrate equivalence? | YES - NxStage Medical, Inc. "believes that the information provided in this submission clearly describes the NxStage Dialysate Concentrate and demonstrates that it is substantially equivalent to other commercially available hemodialysis concentrates." (Specific performance data beyond composition is not detailed in this summary for comparison, but is implied to be part of the full submission). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this describes a chemical concentrate, not a data-driven AI/ML device. No test set of data (e.g., medical images, patient records) was used in the manner of an AI/ML study. The "testing" involved chemical analysis and manufacturing process validation to demonstrate composition and sterility, which are not typically described with sample sizes or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. There was no "ground truth" to establish through expert consensus as this is a chemical product. The ground truth for a chemical concentrate would be its verified chemical composition, purity, and sterility according to established analytical methods and quality control standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. No adjudication method was used for a "test set" in the context of expert review, as this is a chemical product rather than a diagnostic interpretation.
5. 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
This is not applicable. This is not an AI-assisted device, so no MRMC study involving human readers and AI was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm; it's a dialysate concentrate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, if one were to loosely apply the term, would be the established chemical composition standards, sterility requirements, and manufacturing specifications for dialysate concentrates. Equivalence was demonstrated by showing the NxStage product meets these standards and is comparable to existing legally marketed devices.
8. The sample size for the training set
This is not applicable. There is no software algorithm or AI model that requires a training set for this device.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set, there is no ground truth for a training set to be established.
In summary, the provided document describes a 510(k) Premarket Notification for a Dialysate Concentrate, a chemical medical device. The "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices, primarily through matching chemical composition, intended use, and manufacturing processes, rather than performance metrics typically associated with AI/ML systems. Therefore, most of the questions relating to AI/ML study designs are not relevant to this specific 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.