(73 days)
The Prismaflex Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
The Prismaflex disposable sets are sterile disposable extracorporeal circuits containing a PAES hemofilter/dialyzer and fluid circuit for use with the Prismaflex control Unit. These Prismaflex disposable sets allow the following fluid management and renal replacement therapies to be performed:
- SCUF : Slow Continuous Ultrafiltration .
- CVVH : Continous Veno-Venous Hemofiltartion .
- CVVHD : Continous Veno-Venous Hemodialysis .
- CVVHDF : Continuous Veno-Venous Hemodiafiltartion .
The provided text describes a Special 510(k) Notification for the Gambro Prismaflex™ HF 1000 Set and HF 1400 Set. This type of submission generally relies on demonstrating substantial equivalence to existing predicate devices through non-clinical (in vitro) testing, rather than extensive new clinical studies with detailed acceptance criteria as one might find for novel high-risk devices.
Based on the provided text, here's the information:
Acceptance Criteria and Study Findings for Gambro Prismaflex™ HF 1000 Set / HF 1400 Set (K042938)
Overview:
The submission for the Prismaflex™ HF 1000 Set and HF 1400 Set is a Special 510(k) notification, which sought to demonstrate substantial equivalence to legally marketed predicate devices (Gambro Prisma HF1000 Set and Prismaflex M60/M100 Set). The modifications were considered substantially equivalent in design, function, composition, and operation.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of specific acceptance criteria in terms of numerical performance thresholds for the new devices. Instead, the "acceptance criterion" is implicitly demonstrating substantial equivalence to the predicate devices through non-clinical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence in design, function, composition, and operation to predicate devices (K011221, K041005) | Non-clinical (in vitro) testing was conducted to compare the performance of the proposed device configurations to the predicate configurations. The results demonstrated that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify the sample size (e.g., number of devices, number of runs) used for the in vitro testing.
- Data Provenance: The study was "in vitro testing," meaning it was conducted in a laboratory setting. The country of origin of the data is not specified, but the submitter is based in Lakewood, CO, USA. The testing was prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device relies on "in vitro" non-clinical testing to demonstrate performance equivalence, not clinical data requiring expert review of patient cases.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical test set requiring expert adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. The submission is based on non-clinical (in vitro) testing for substantial equivalence, not a clinical study comparing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. This is a medical device (hemofilter and blood tubing set) for physical use in therapies, not a software algorithm that performs diagnostic interpretation.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission was established by the performance specifications and characteristics of the legally marketed predicate devices. The new devices were deemed acceptable if their in vitro performance matched that of the predicates, indicating substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is a traditional medical device submission based on non-clinical comparative testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there was 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.”