(28 days)
The dialyzer is intended for use in hemodialysis for the treatment of chronic and acute renal failure.
This device is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The membrane used in this device is a blend of polyarylethersulfone (PAES) and polyviny)pyrrolidone(PVP). Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.
The provided document is a 510(k) summary for the Gambro Polyflux HD-C4 SMALL Dialyzer for Single Use. This document outlines the premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria study with the specifics requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance metrics like sensitivity/specificity).
Here's an analysis of what is available in the document related to your request:
Acceptance Criteria and Study Details for Gambro Polyflux HD-C4 SMALL Dialyzer for Single Use
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics with specific thresholds (e.g., "urea reduction ratio must be > X%" or "clearance must be > Y ml/min"). Instead, the acceptance criterion is implicitly tied to demonstrating substantial equivalence to the predicate device, the Polyflux HD-C4 (BIG) Hemodialyzer (K060195).
The device performance is reported as meeting this equivalence through "in vitro testing."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technological Characteristics: The proposed device configurations must have the same technological characteristics and be similar in design, function, composition, and operation to the currently marketed predicate configurations. | Summary of Non-Clinical Tests: "In vitro testing was conducted to compare the performance of the configurations to the predicate configurations." |
| Safety and Effectiveness: The device must be safe, effective, and perform as well as the predicate devices when used in accordance with instructions for use. | Conclusion: "Testing performed on the Gambro Polyflux Dialyzers indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instructions for use." |
The document explicitly states that the device's membrane (a blend of polyarylethersulfone (PAES) and polyvinylpyrrolidone (PVP)) is "equivalent to the membrane utilized in the Gambro Polyflux HD-C4 (BIG) single use hemodialyzers." This implies that the critical component responsible for filtration performance is considered equivalent, leading to equivalent overall performance. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "In vitro testing was conducted." No details regarding the number of units tested or specific experimental conditions are provided.
- Data Provenance: Not specified, but given the nature of in vitro testing, it would be laboratory-generated data rather than patient-derived data from a specific geographical region. It would be prospective in the sense that the tests were conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. For a device like a hemodialyzer, ground truth is established through physical and chemical performance measurements (e.g., clearance rates, ultrafiltration rates, membrane integrity, biocompatibility) rather than expert interpretation of images or clinical assessments. The comparison is against established performance benchmarks of the predicate device, typically measured by laboratory instruments.
4. Adjudication Method
- Not Applicable. As ground truth is established by objective physical and chemical measurements of device performance, there is no human adjudication process involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images. This device is a treatment device, and its performance is assessed through in vitro and potentially in vivo (though not detailed here) functional metrics, not reader interpretation. The document explicitly states "Summary of Clinical Tests: N/A."
6. Standalone Performance Study
- Yes, implicitly. The "in vitro testing" mentioned is a standalone performance study in the sense it evaluates the device's performance characteristics (e.g., clearance, ultrafiltration) in a laboratory setting, independent of human interaction or a "human-in-the-loop" application. However, detailed results (e.g., specific clearance values, ultrafiltration rates) are not provided in this summary. The results are summarized as being "safe, effective and perform as well as the predicate devices."
7. Type of Ground Truth Used
- Objective Performance Metrics (derived from laboratory testing) of the Predicate Device. The "ground truth" for the new device's performance is essentially the established performance profile and safety of the predicate device (Polyflux HD-C4 (BIG)). The goal is to demonstrate that the small version performs equivalently.
8. Sample Size for the Training Set
- Not Applicable. This is a hardware medical device (dialyzer), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
- Not Applicable. Again, this is not an AI/ML device, so no training set or its associated ground truth establishment process applies.
In summary, this 510(k) application focuses on demonstrating substantial equivalence through non-clinical (in vitro) testing of the physical and functional characteristics of the hemodialyzer, comparing it to an already cleared predicate device. The detailed statistical and expert-driven study elements you requested are typically found in submissions for diagnostic AI/ML software or other complex diagnostic tools, not for a device of this nature.
§ 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.”