(63 days)
B. Braun Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate.
The B. Braun Premixed Dialysate Solutions are a family of premixed dialysate solutions which are sterile, non-pyrogenic solutions to be provided in single use flexible PVC bags varying in sizes from 1000 mL to 5000 mL. 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.
This document is a 510(k) premarket notification for the B. Braun Premixed Dialysate. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a medical device clinical trial.
Therefore, many of the requested sections (2-7, and 9) are not applicable or cannot be answered from the provided text, as this type of submission relies on comparative analysis to existing devices, not new clinical performance data.
Here's the information that can be extracted or deduced:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" for substantial equivalence are met when the new device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, these do not raise new questions of safety and effectiveness.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as claimed for Substantial Equivalence) |
|---|---|
| Same Intended Use as Predicate Devices | B. Braun Premixed Dialysate is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate. This matches the intended use of the predicate devices. |
| Same Technological Characteristics as Predicate Devices (or different characteristics that do not raise new questions of safety and effectiveness) | Chemical Composition: The B. Braun Premixed Dialysate includes the same chemical composition range as the predicate NxStage Premixed Dialysate (K022913). It is also similar in composition to Gambro PrismaSate Solutions (K013448) and Baxter Premixed Dialysate (K910270). |
Manufacturing, Packaging, and Sterilization Process: The new device has the same manufacturing, packaging, and sterilization process as the predicate NxStage Premixed Dialysate (K022913). It is also similar in sterility and packaging to Gambro PrismaSate Solutions (K013448) and Baxter Premixed Dialysate (K910270).
Sterile and Non-Pyrogenic: The solutions are described as sterile and non-pyrogenic, aligning with the expected characteristics of dialysate solutions. |
| Compliance with General Controls (e.g., labeling, GMP) | The FDA letter explicitly states that the device is subject to the general controls provisions of the Act, including requirements for annual registration, listing, manufacturing practice, labeling, and prohibitions against misbranding and adulteration. (No specific study data is presented in the 510(k) summary for this, but it's an overarching requirement for acceptance). |
| Does not raise new questions of safety and effectiveness (implicitly by demonstrating equivalence in composition, process, and intended use as safe predicates) | The FDA's clearance implies that the provided information did not raise new questions of safety and effectiveness, leading to the substantial equivalence determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a performance study with a test set of patient data. It is a comparison of product specifications and processes to predicate devices.
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)
Not applicable. There was no test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring adjudication.
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
Not applicable. This device is a medical solution (premixed dialysate), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the sense of clinical diagnostic accuracy was established or used, as this is a physicochemical and process-based equivalence claim for a solution. The "ground truth" for this submission is whether the product's characteristics (composition, manufacturing, etc.) are sufficiently similar to legally marketed predicate devices to assure safety and effectiveness.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied as this is a premarket notification for a medical product, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set and no ground truth for a training set in this context.
§ 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.