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The HF Junior Hemoconcentrator is intended for use in prevention or relief of fluid overload, electrolyte and acid imbalances in cases of acute renal failure with oliguria or anuria. Also, it is used to remove excess fluid in cases of congestive heart failure, pulmonary and cerebral edema, anasarca, ascites, septic shock, burns, etc. In hypervolemic patients requiring parenteral nutrition and/or large volume of medications, the hemofilter may be used to reduce fluid overload. In hypercatabolic patients requiring more intensive solute removal, a sterile dialysate fluid may be made to flow around the fibers via the dialysate ports in order to increase the clearance of small molecules. It is indicated for patients (including pediatric patients) according to physician assessment of the patient and the instructions for use.

The HF Junior Hemofilter consists of many individual polysulfone hollow fibers encapsulated into a polycarbonate case. The device has arterial and venous ports on opposite ends of the device. As the patient's blood enters the device through the arterial blood port, it passes through the fiber bundle and then exits the device through the venous blood port and is returned to the patient. As the blood passes through the fiber bundle, ultrafiltration occurs as a result of a hydrostatic pressure gradient that exists across the semipermeable membrane. The resulting hemofiltration removes large quantities of plasma water, and small and medium sized solutes (such as IL .- 6, C3a and C5a) are removed from the vascular space thereby concentrating the red cell mass and the plasma proteins.

This 510(k) summary for the HF™ Junior Hemofilter focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel acceptance criteria through a clinical study. Therefore, many of the requested data points related to clinical study design (sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, ground truth establishment) are not applicable or explicitly stated in this document. The provided text describes bench testing to confirm performance equivalence.

Here's a breakdown of the available information:

HF™ Junior Hemofilter Acceptance Criteria and Performance (Based on Equivalence Testing)

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a numerical sample size for the test set (number of devices tested). It refers to "extensive testing" performed on "both the HF Junior and the HF Mini for comparison purposes."
   • Data Provenance: The testing was conducted by Minntech Corporation, the manufacturer. The data is retrospective in the sense that it evaluates manufactured devices against established predicate performance. The country of origin for the data is implicitly the United States, given the manufacturer's address.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was not a clinical study involving expert interpretation of data or images. The "ground truth" for this substantial equivalence submission is the established performance characteristics and safety profile of the predicate devices, as defined by FDA guidances and ISO standards for hemofilters.

3. Adjudication method for the test set: Not applicable. There was no clinical data requiring expert adjudication.

4. 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 document describes the 510(k) submission for a physical medical device (hemofilter), not an AI/software device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device. The performance data presented is "standalone" in the sense of the physical device's function, but it's not an algorithm's standalone performance.

6. The type of ground truth used: For this substantial equivalence submission, the "ground truth" or reference standard for comparison is the established performance and safety characteristics of the predicate devices. These characteristics are defined by:

   • Previously cleared Minntech hemofilters (HF Minifilter Plus Hemofilter, K962707, and HPH Junior, K050952).
   • Relevant FDA guidances.
   • International standards, specifically ISO 8637:2004E, "Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators."

7. The sample size for the training set: Not applicable. There was no machine learning or AI model involved, so no "training set."

8. How the ground truth for the training set was established: Not applicable, as there was no training set. The "ground truth" or reference for evaluating the HF Junior was the performance of the predicate devices as per regulatory standards.

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