(28 days)
Hemodialysis with EXELTRA™ 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.
Model EXELTRA™ 150 and 170 Single Use Dialyzers
This is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial for a novel AI algorithm would.
Based on the provided text, the device is the EXELTRA™ Dialyzer, Single Use (Models 150 and 170). The document states that no clinical data was required or provided for this 510(k) submission because the device is considered "substantially equivalent" to predicate devices and "do not raise any new types of safety and effectiveness issues."
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert ground truth, and AI performance metrics are not applicable (N/A) in this context.
Here's an attempt to answer the questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" and "reported device performance" in the context of a clinical study are provided because no clinical data was submitted. The acceptance for this 510(k) relies on substantial equivalence to predicate devices and meeting established manufacturing and biological standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biological Safety | Met biological requirements of ISO 10993-1. |
| Sterilization Efficacy | Validation of gamma sterilization cycle based on AAMI/ISO 11137:1994. |
| Manufacturing Quality | Functional testing for blood side integrity and conformance to manufacturing specifications performed as in-process and/or final inspections prior to product release. |
| Substantial Equivalence | General design and material similar to predicate devices (Baxter CT Dialyzers, K890315, K926568, K970663); does not raise new safety/effectiveness issues. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical "test set" data was submitted or required. The "testing" mentioned refers to manufacturing quality control and sterilization validation.
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. No clinical "ground truth" was established with experts for a test set. The validation relies on established international and industry standards for biological evaluation, sterilization, and manufacturing processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical "test set" requiring adjudication.
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 device is a dialyzer, not an AI-assisted diagnostic or therapeutic tool, and no MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device (dialyzer), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biological safety, the "ground truth" is adherence to ISO 10993-1. For sterilization, it's conformance to AAMI/ISO 11137:1994. For manufacturing, it's conformance to "manufacturing specifications." These are regulatory and engineering standards, not clinical ground truth.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical medical device, not an AI algorithm requiring a 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.”