(256 days)
The dialyzer is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. There are no known contraindications.
The proposed device is a single use high flux (permeability) hollow-fiber dialyzer.
The provided text is a 510(k) Premarket Notification Submission for the NxStage® 1.6m² Dialyzer. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria through a study involving human subjects or AI algorithms.
Therefore, many of the requested categories in your prompt are not applicable to this type of submission. This document details non-clinical bench testing to demonstrate that the device functions comparably to existing, legally marketed devices.
Here's an attempt to answer your questions based only on the provided text, indicating where information is not present:
1. Table of acceptance criteria and the reported device performance
The document states: "Performance, verification and validation testing was conducted to characterize performance of the proposed device, consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, dated August 7, 1998, and the predetermined acceptance criteria was met."
However, the specific acceptance criteria for each test parameter (e.g., clearance rates, ultrafiltration coefficients) and the detailed results demonstrating that these criteria were met are not explicitly listed in the provided text. The submission focuses on a comparative table of technological characteristics, asserting substantial equivalence.
| Parameter | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Implied as meeting criteria) |
|---|---|---|
| Performance Testing (General) | Consistent with FDA Guidance, Predetermined Acceptance Criteria Met | Met |
| Verification & Validation Test | Consistent with FDA Guidance, Predetermined Acceptance Criteria Met | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "Performance, verification and validation testing" but does not detail the number of devices tested.
- Data Provenance: Not explicitly stated, given it's a bench test. The manufacturer address is in Lawrence, MA, USA, and the sterilization site is Ontario, CA, USA. The manufacturer is NxStage GmbH & Co. KG in Germany.
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. This submission is for a medical device (dialyzer) and involves non-clinical bench testing, not an AI algorithm or clinical study requiring expert ground truth for interpretation of images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, no expert adjudication for ground truth is described.
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 is a medical device (dialyzer) submission, not an AI diagnostic or assistive device. No human reader studies are described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dialyzer, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" refers to established engineering specifications and performance standards (e.g., clearance rates for various solutes) as outlined in FDA guidance for dialyzers. The document states that testing was "consistent with FDA's Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers." The "ground truth" would be the expected physical and chemical performance characteristics of a high-permeability hemodialyzer.
8. The sample size for the training set
Not applicable. This submission is for a medical device (dialyzer), not an AI algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or AI algorithm is described.
§ 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.”