(109 days)
The Prismaflex M150 Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
The Prismatlex disposable sets are sterile disposable extracomoreal circuits containing an AN69 hemofilter/dialyzer and fluid circuit for use with the Prismatlex control Unit. These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed:
- . SCUF: Slow Continuous Ultrafiltration
- CVVH: Continuous Veno-Venous Hemofiltration .
- Continuous Veno-Venous Hemodialysis CVVHD:
- CVVHDF: Continuous Veno-Venous Hemodiafiltration .
The provided text describes a 510(k) premarket notification for the "Prismaflex M150 Set," which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel effectiveness through studies that would typically involve acceptance criteria for artificial intelligence or image processing algorithms.
Therefore, many of the requested points are not applicable to this document as it pertains to a physical medical device (hemofilter and blood tubing set) and not a software algorithm or AI-powered diagnostic tool. The document explicitly states "Summary of Clinical Tests: Not applicable."
Here's a breakdown based on the provided text and the nature of a 510(k) for a physical device:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable as described for AI/algorithm performance. The submission focuses on demonstrating substantial equivalence to a predicate device (Prismaflex M100 Set). The "acceptance criteria" here relate to the non-clinical testing performed to show that the modified device performs as well as the predicate.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Summary from Submission) |
|---|---|
| Design, Function, Composition, and Operation equivalence | "substantially equivalent in design, function, composition, and operation, to the predicate device" |
| Performance equivalence through in vitro testing | "demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended used." |
| Safety and Effectiveness | "demonstrates that it is safe, effective and performs as well as the predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The "test set" and "data provenance" concepts are typically used for evaluating algorithms on specific datasets. For this physical device, "in vitro testing" was conducted to compare performance to the predicate device. The document does not specify sample sizes for these in vitro tests, nor does it refer to data provenance in the context of patient data for an algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. Ground truth establishment by experts is relevant for diagnostic algorithms. This is a physical device, and its performance was assessed through in vitro and manufacturing controls, rather than expert consensus on diagnostic outputs.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements in expert interpretations for establishing ground truth for algorithmic evaluation. This process is not relevant to the 510(k) submission for this physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states, "Summary of Clinical Tests: Not applicable." MRMC studies are used to evaluate the impact of a diagnostic aid on human reader performance. This device is a hemofilter and blood tubing set, not a diagnostic aid, and no clinical studies were deemed necessary for this 510(k) submission.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical medical product, not an algorithm, so the concept of standalone algorithmic performance is irrelevant.
7. The Type of Ground Truth Used
Not applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) is for evaluating the accuracy of a diagnostic or predictive system against a gold standard. For this physical device, the "ground truth" relates to its physical and functional specifications and its performance metrics (e.g., fluid management, filtration efficacy) which are assessed through engineering and bench testing.
8. The Sample Size for the Training Set
Not applicable. Training sets are used for machine learning algorithms. This document describes a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, training sets and their ground truth are for machine learning.
§ 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.”