(28 days)
Hemodialysis with EXELTRA™ Plus dialyzers is indicated for patients with renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Models EXELTRA™ Plus 210 Single Use Dialyzer
The provided document is a 510(k) summary for the EXELTRA™ Plus Dialyzer, a medical device for hemodialysis. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data for acceptance criteria based on performance metrics.
Therefore, much of the requested information regarding acceptance criteria and detailed study designs for a device's performance against those criteria is not present in this document. This is typical for 510(k) submissions, especially for devices where the underlying technology is well-established and the new device is a modification or equivalent to an existing cleared device.
Specifically, the document states: "Clinical Data: N/A"
However, I can extract the information that is available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria for device performance (e.g., clearance rates, ultrafiltration rates) nor corresponding performance data from a specific study designed to meet these criteria. Instead, it relies on demonstrating equivalence to predicate devices and adherence to relevant standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biological requirements of ISO 10993-1 | Components of the EXELTRA™ Plus dialyzers have met the biological requirements of ISO 10993-1: Biological Evaluation of Medical devices - Part: Guidance on selection of tests. |
| Validation of gamma sterilization cycle (AAMI/ISO 11137:1994) | The validation of the gamma sterilization cycle for the EXELTRA™ Plus dialyzer is based upon the AAMI/ISO 11137:1994 "Sterilization of Healthcare Products – Requirements for Validation and Routine Control – Radiation Sterilization". |
| Blood side integrity and manufacturing specifications conformance | Functional testing for blood side integrity and conformance to manufacturing specifications are performed as in-process and/or final inspections prior to product release to ensure a quality product. |
| Substantial Equivalence to Predicate Devices (Baxter CT Dialyzers) | "The general design and material of the EXELTRA™ Plus 210 is similar to the CT 110 and CT190G dialyzers cleared under K890315, K926568 and K970663, and do not raise any new types of safety and effectiveness issues, when compared to the predicate product." The FDA's letter states: "We have... determined the device is substantially equivalent... to legally marketed predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission states "Clinical Data: N/A," indicating no human clinical trials were conducted specifically for this 510(k) submission to demonstrate performance in a test set. The functional testing mentioned is likely internal quality control or engineering testing, not a formal clinical test set with patient data.
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)
This information is not applicable/not provided. As "Clinical Data: N/A," there was no clinical test set for which ground truth would be established by external experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. No clinical test set.
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
This information is not applicable/not provided. The device is a medical device (dialyzer), not an AI diagnostic or assistance tool. Therefore, MRMC effectiveness studies with human readers and AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a dialyzer, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the biological and sterilization testing, the "ground truth" would be established by the standards themselves (ISO 10993-1, AAMI/ISO 11137:1994) through accredited laboratory testing following those standards. For manufacturing specifications, the ground truth is the defined engineering specifications of the product. No clinical ground truth (e.g., pathology, outcomes data) from a new study is referenced.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of this device and submission type (no AI or machine learning model involved).
9. How the ground truth for the training set was established
This information is not applicable/not provided. No training set.
§ 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.”