Search Results

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.

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.

Ask a specific question about this device