(87 days)
The capillary dialyzer/filter is intended for use in hemodiafiltration and hemofiltration for the treatments of chronic or acute renal failure.
The Gambro POLYFLUX 140H, 170H and 210H Capillary Dialyzers/Filters labeled for single use have the same design, materials, intended use and function as other hemodialyzers/filters currently marketed in the United States. These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is polyarylethersulfone (PES) which is identical to the membrane utilized in the Gambro POLYFLUX 14S, 17S and 21S Hemodialyzers /filters labeled for single use which have been previously cleared for marketing in the United States under 510K Notifications (K982414). Blood enters a blood inlet port where it is distributed to the hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns (hollow fiber internal diameter) and a wall thickness of 50 microns. The number of hollow fibers in each hemodialyzer / filter is 7,500 for the POLYFLUX 140H, 9,300 for the POLYFLUX 170H, and 12,000 for the POLYFLUX 210H. This effective membrane length is 270 mm for the POLYFLUX 140H, 170H and 210H. The effective membrane surface area is 1.4 square meters for the POLYFLUX 140H, 1.7 square meters for the 170H and 2.1 square meters for the 210H. The housing and end caps of this hemodialyzer / filter are made of polycarbonate. The design and incorporation of the silicone header gasket is the same as previously approved for the Gambro GFS Plus Hemodialyzers / Filters(K902481). The fibers used in the Gambro POLYFLUX 140H, 170H and 210H are of the same composition as those previously approved for the Gambro POLYFLUX S Hemodialyzers / Filters labeled for single use (K982414). 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, a 510(k) Notification Supplement for Gambro POLYFLUX 140H, 170H & 210H Capillary Dialyzers/Filters, describes the device and its claimed substantial equivalence to predicate devices. However, the document does not contain the level of detail requested for a comprehensive acceptance criteria and study description, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods typically found in studies proving device performance for AI/imaging devices.
The document focuses on demonstrating substantial equivalence to previously cleared devices (Gambro POLYFLUX 14S, 17S & 21S and Gambro GFS PLUS 20) based on similarities in design, materials, intended use, and functioning.
Here's an attempt to answer your questions based only on the provided text, acknowledging where information is not present:
Acceptance Criteria and Device Performance Study for Gambro POLYFLUX 140H, 170H & 210H Capillary Dialyzers/Filters
The provided 510(k) Notification Supplement outlines the intent to market the Gambro POLYFLUX 140H, 170H, and 210H Capillary Dialyzers/Filters by demonstrating substantial equivalence to predicate devices (Gambro POLYFLUX 14S, 17S & 21S and Gambro GFS PLUS 20). The primary method used to establish this equivalence and thus "prove" the device meets acceptance criteria appears to be through comparison of design, materials, intended use, and in vitro performance testing against these predicate devices. Specific quantitative acceptance criteria or detailed study methodologies that would typically be found for an AI/imaging device are not provided in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with corresponding performance values for the new devices. Instead, the "acceptance criteria" are implicitly demonstrated through the claim of substantial equivalence to predicate devices by:
- Identical design, materials, intended use, and function.
- Identical membrane material (polyarylethersulfone (PES)).
- Similar component parts.
- Similar manufacturing processes (e.g., steam sterilization).
- In vitro performance testing indicating performance "as well as" the predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Safety and Effectiveness (as predicate devices) | "safe, effective, and perform as well as the predicate devices" |
| Design (similar to predicate devices) | Same design as other hemodialyzers/filters currently marketed; specifics mentioned include hollow fiber dimensions, number of fibers, membrane length, surface area, housing materials. |
| Material Composition (identical/similar to predicate devices) | Main membrane (PES) identical to POLYFLUX S series; other blood and non-blood contact materials and silicone O-Ring similar/identical to predicate devices. |
| Intended Use (identical to predicate devices) | Polyflux H indications: hemodiafiltration and hemofiltration for chronic or acute renal failure. Identical to predicate device indications. |
| Function (similar to predicate devices) | "perform as well as the predicate devices" in removing uremic toxins and waste products by diffusion and convection. |
| In vitro Performance (comparable to predicate devices) | "In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices." Data included in labeling. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "in vitro performance testing," but does not specify the sample size for these tests, the type of data, or its provenance (e.g., country of origin, retrospective/prospective). Given that the testing is in vitro, typical human-subject data provenance (like country of origin or retrospective/prospective) would not apply in the same way.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided. The "ground truth" for a medical device like a dialyzer would typically be established through direct physical and chemical measurements during in vitro performance testing against established standards or predicate device performance, not through expert consensus on qualitative observations.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. As the "test set" refers to in vitro performance data, adjudication methods like 2+1 or 3+1 (common in image interpretation studies) are not relevant here. Performance is measured directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or is not described. This type of study is relevant for evaluating the impact of AI systems on human reader performance, typically in diagnostic imaging. The device is a physical medical device (dialyzer), not an AI diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable in the context of this device. A dialyzer is a physical device, and its performance is assessed directly through in vitro measurements, not as a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth used for assessing the performance of the dialyzers would be based on physical and chemical measurements of their performance characteristics in vitro. This would include metrics like clearance rates for various solutes (e.g., urea, creatinine), ultrafiltration rates, and potentially biocompatibility assessments, comparing these values to established norms or the performance of the predicate devices. The document implies that "in vitro performance data are included in the labeling."
8. The Sample Size for the Training Set
This information is not provided and is not applicable for this type of device and submission. "Training set" is a concept used in machine learning and AI development. This document describes a traditional medical device, not an AI system.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for this type of device and submission.
§ 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.”