Search Results

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.

Here's an analysis based on the provided text:

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.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify sample sizes for the non-clinical performance tests (e.g., how many units were tested for electrical safety, how many filters for integrity, etc.). The testing mentioned is primarily laboratory-based engineering and microbiological testing, not human subject testing.
• Data Provenance: The data provenance is generally from laboratory testing (e.g., independent ANSI Certified Testing Services like Interek Testing Services N.A. Inc.). There is no mention of specific countries of origin for the data or whether the data was retrospective or prospective in the context of clinical studies, as no clinical studies were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

• This information is not provided in the document. For non-clinical (engineering, software, microbiology) testing, "ground truth" is typically established by compliance with industry standards and validated test methods, rather than expert consensus on a dataset.

4. Adjudication Method for the Test Set

• This is not applicable to the type of non-clinical testing described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. The document explicitly states: "Clinical Studies: Not applicable. No clinical studies were performed in support of the modifications." This means there's no comparison of human readers with or without AI assistance. The device is a physical medical device (hemodiafiltration module), not an AI/software-as-a-medical-device (SaMD) that assists human interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable/done in this context. The device is not an algorithm that performs a diagnostic or interpretive function without human intervention. Its performance is evaluated through its physical and functional specifications (e.g., safety, fluid quality, software function). The "standalone" performance here refers to the device's ability to meet its design specifications independently, which is covered by the system performance testing and compliance with various standards.

7. The Type of Ground Truth Used

• For the non-clinical performance tests, "ground truth" is defined by:
  • Validated test methods and established engineering specifications/standards: For electrical safety, EMC, software V&V, and system performance. These are objective measurements against predefined limits.
  • International standards and guidance documents: For biocompatibility (ISO 10993 series) and microbiological quality (ANSI AAMI ISO 23500:2014). The "truth" is the device's ability to meet the defined limits and requirements within these standards.
  • Predicate device characteristics: The ultimate "ground truth" for this 510(k) submission is showing substantial equivalence to the OLPūr™ H2H Hemodiafiltration (HDF) Module (K112314), meaning the modified device performs comparably and remains safe and effective for its intended use.

8. The Sample Size for the Training Set

• Not applicable. This submission describes a physical medical device and its modifications, not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As no training set was used (see point 8).

Ask a specific question about this device