(514 days)
Altra Fluxed 200 Heinodialyzers are intended for acule or chronic Hemodialysis. Hemodiatysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.
The Altra Flux® 200 multiple use hemodialyzer is the Altra Flux® 200 single use device with reuse labeling. Like the Altra Flux® 200 single use device, it is used as an artificial kidney in a hemodialysis system to treat patients with acute or chronic renal failure. The blood from a patient flows through the arterial tubing of the extracorporeal blood circuit to the blood compartment of the hemodialyzer, then returns through the venous tubing of the extracorporeal blood system to the patient. The hemodialyzer has semipermeable hollow fibers which divide the device into two compartments. When the blood passes through the hollow fibers, water and toxic waste products from the blood pass through the semipermeable membrane into the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the hemodialyzer. A high permeability hemodialyzer has a semipermeable membrane that is more permeable to water than that of the conventional dialyzer. This device must be used in conjunction with a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood. This highly permeable, semipermeable membrane may also permit greater loss of high molecular weight substances from the blood, compared with the conventional hemodialyzer.
The provided text describes the Altra Flux® 200 Hemodialyzer with multiple use labeling, focusing on its substantial equivalence to an already marketed single-use device and its validation for reuse. However, it does not explicitly detail specific quantitative acceptance criteria or the full study design with all the requested information for a device performance study.
Based on the information provided, here's what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
The document states that "Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer." This implies the acceptance criterion was "as safe and effective as the predicate device" after reprocessing.
However, specific quantitative metrics (e.g., clearance rates, ultrafiltration rates, fiber bundle volume integrity) and their acceptable ranges are not provided in this summary. Therefore, a table cannot be fully completed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness after reprocessing "as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer" | "Testing performed on reprocessed devices demonstrate that the Altra Nova® 200 multiple use hemodialyzer is as safe and effective as the currently marketed Altra Nova® 200 single use hemodialyzer." (Specific quantitative metrics or comparison results are not provided in this document.) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the "testing performed on reprocessed devices." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring ground truth established by experts. The "ground truth" for a hemodialyzer's performance would be objective measurements of its function.
4. Adjudication method for the test set
This information is not applicable and hence not provided, as the study described is a performance validation of a medical device, not an AI or diagnostic tool requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or AI tools evaluated by multiple human readers. The Altra Flux® 200 Hemodialyzer is a therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a hemodialyzer. The device itself performs its function (filtration), and its performance is measured directly, not through an algorithm or human interpretation.
7. The type of ground truth used
The "ground truth" for the performance of a hemodialyzer would be direct measurements of its functional parameters (e.g., clearance of waste products, ultrafiltration rates, integrity of the membrane). While not explicitly stated, these are typically measured in laboratory settings or in simulated clinical conditions. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this context.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical medical device.
§ 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.”