(441 days)
The HDF Assist Module is indicated for use, with the Fresenius 2008K2, and 2008T dialysis machines, for treatment of adult patients with acute or chronic renal failure or whenever hemodiafiltration is physician.
The HDF Assist Module works in conjunction with a qualified host high permeability (UF controlled) hemodialysis machine and its accessories (i.e., bloodlines, dialysate, concentrates, etc.), the HDF Assist Module accessories (HDF Infusion Set and Substitution Filter), appropriately purified water and ultrapure dialysate for hemodialysis, and a high permeability hemodialyzer / hemodiafilter (i.e., the OLPür™ MD 220 Hemodiafilter).
The HDF Assist Module is a software controlled; electro-mechanical medical device designed to work in combination with a sterile single use HDF Infusion Set (an accessory included in this submission) and a qualified host high permeability (UF controlled) hemodialysis machine, which produces ultrapure dialysis fluid. Upon installation the HDF Assist Module is connected to the host dialysis machine's IV Pole and plugged into a Standard 120VAC electrical mains power source.
To perform a hemodiafiltration treatment with the HDF Assist Module, the device is used in unison with the accessory sterile, single-use HDF Infusion Set to generate and control the online substitution fluid for hemodiafiltration from the ultrapure dialysis fluid of the host dialysis machine. The sterile HDF Infusion Set consists of an 0.25 m² ultrafilter, tubing including a peristatic pump segment, pressure sensor pods, and check valves.
The HDF Infusion Set is primed prior to treatment to remove air from the Set. The HDF Infusion Set is placed on the unit in preparation for each HDF treatment. A peristatic pump in the HDF Assist Module pumps a preset amount of ultrapure dialysis fluid produced by the host dialysis machine via the peristatic pump segment in the HDF Infusion Set. The dialysis fluid is drawn from an input dialysate Hansen T-connector and pumped through a sterile single use 0.25 m² ultrafilter in the HDF Infusion Set. The rest of the dialysis fluid flows outside of the fiber in the OLPūr™ MD 220 Hemodiafilter as in conventional hemodialysis.
During priming and treatment, the ultrafilter in the HDF Infusion Set removes bacteria and endotoxins from the ultrapure dialysis fluid, thereby generating an injectable quality substitution (replacement) fluid of correct electrolyte composition. The ultrafiltered substitution fluid flows through tubing connected to the extracorporeal circuit where it is infused as part of the hemodiafiltration treatment at the MD220 Mid-Dilution port. The ultrafilter is 100% tested in a production integrity check during manufacture.
This document is a 510(k) Premarket Notification for the Nephros, Inc. HDF Assist Module, HDF Infusion Set, and Substitution Filter. The acceptance criteria and the study that proves the device meets them are primarily described within the "Assessment of Non-Clinical Performance Data/Substantial Equivalence" section.
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Key Takeaway: This 510(k) submission is for modifications to an existing cleared device (K112314, OLPūr™ H2H Hemodiafiltration Module). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the modified device remains substantially equivalent (safe and effective) to the predicate device, rather than proving a de novo device's initial safety and effectiveness. No clinical studies were performed for this submission.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a modification submission, the "acceptance criteria" are generally compliance with relevant standards and demonstration of continued substantial equivalence. The "reported device performance" refers to the successful completion of various tests.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit from text) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and FDA Guidance "Use of International Standard ISO 10993-1" for Externally Communicating Device; Blood Path, indirect; Prolonged (Category B). | "Testing was performed according to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 and FDA Guidance..." (Implies successful completion and meeting of criteria). |
| Electrical Safety | Compliance with AAMI ES60601-1:2005 +A1, CSA C22.2#60601-1:2014 Ed.3, IEC 60601-1-8, and IEC 60601-2-16:2018 (Applicable Clauses). | "The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for Electrical Safety and other applicable standards by an independent ANSI Certified Testing Service company Interek Testing Services N.A. Inc." (Implies successful compliance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 ed 4.0 (2014-02) (with EMC deviations per IEC 60601-2-16:2018). | "The HDF Assist Module has been evaluated against the requirements of FDA Consensus and International Standards for EMC Compatibility by an independent ANSI Certified Testing Service company (Interek Testing Services N.A. Inc.)" (Implies successful compliance). |
| Microbiological Quality of Substitution Fluid | Conformance with ANSI AAMI ISO 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies. Specifically, generation of injectable quality substitution fluid through a multistage redundant system: | "The microbiological quality... is in conformance with ANSI AAMI ISO 23500:2014 Guidance..." (Explicitly states conformance). The multistage system (water treatment, Diasafe filters, and 0.25 m² ultrafilter in HDF Infusion Set) assures this quality. The mention of Log10 reduction for endotoxins and bacteria indicates performance metrics for the filter. |
| - Output from water treatment system: |
§ 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.”