(91 days)
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)
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance (Relative to Predicate) |
|---|---|---|
| Physical Characteristics | Materials | All materials used in the HF Junior are currently used in Minntech's other HF family of devices. No new materials or manufacturing methods are used compared to predicate devices. |
| Fiber Composition | The fiber used in the HF Junior has the same composition as other HF Hemofilter products (including the HF Minifilter, which differs only in internal diameter). It is exactly the same as the fiber used in the HPH Junior. | |
| Configuration, Size | Identical to the HPH Junior (K050952). | |
| Functional Performance | Static Prime Volume | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges are not provided, only that equivalence was shown. |
| Ultrafiltration Performance | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges are not provided, only that equivalence was shown. | |
| Blood Path Pressure Drop | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges are not provided, only that equivalence was shown. | |
| Protein Sieving (Albumin, Myoglobin, Inulin) | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges for sieving coefficients are not provided, only that equivalence was shown. | |
| Aqueous Sieving | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific quantitative values or acceptance ranges for sieving coefficients are not provided, only that equivalence was shown. | |
| Safety and Integrity | Structural Integrity | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific test methods or quantitative results are not provided, only that equivalence was shown. |
| Membrane Integrity | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific test methods or quantitative results are not provided, only that equivalence was shown. | |
| Hemolysis (Biocompatibility) | Tested to show substantial equivalence to the predicate device (HF Minifilter Plus and HPH Junior). Specific test methods (e.g., ISO 10993-4) or quantitative results (e.g., % hemolysis) are not provided, only that equivalence was shown. | |
| Regulatory Compliance | Compliance with relevant FDA guidances and ISO standards (e.g., ISO 8637:2004E: Cardiovascular Implants and Artificial Organs - Haemodialysers, Haemodiafilters, Haemofilters and Haemoconcentrators). | This is the overarching "acceptance criterion" for the study – demonstrating compliance with these standards and guidances to prove substantial equivalence to predicates. The testing performed (listed above) satisfies these requirements. |
Study Details:
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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.
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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.
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Adjudication method for the test set: Not applicable. There was no clinical data requiring expert adjudication.
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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.
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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.
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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."
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The sample size for the training set: Not applicable. There was no machine learning or AI model involved, so no "training set."
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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.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”