(259 days)
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane.
The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered).
All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment.
If patients suffer from acute kidney injury and / or volume overload, the Prismatlex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as:
- · Slow Continuous UltraFiltration (SCUF)
- · Continuous Veno-Venous Hemofiltration (CVVH)
- · Continuous Veno-Venous HemoDialysis (CVVHD)
- Continuous Veno-Venous HemoDiaFiltration (CVVHDF)
to perform fluid management and reduction of uremic toxins.
The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (661b) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).
The Prismaflex ST60/ST100/ST150 set is a disposable, extracorporeal circuit for use with the PrismaFlex system, or with the PrisMax system. The Prismaflex ST60/ST100/ST150 set consists of an AN69 ST hollow fiber haemofilter/dialyser and tubing system.
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
- CVVHD: Continuous Veno-Venous Hemodialysis
- CVVHDF: Continuous Veno-Venous Hemodiafiltration
The fluid pathways of the Prismaflex set are guaranteed sterile and pyrogen-free. The Prismaflex set is sterilized by ethylene oxide (EO).
The shelf life of the Prismaflex ST60/ST100/ST150 sets is 24 months from the date of sterilization. The device is intended for single use.
The provided text describes a 510(k) premarket notification for the "Prismaflex ST set" (ST60/ST100/ST150 sets), a high permeability hemodialysis system. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The document focuses on non-clinical testing to support this claim.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance values like a clinical trial report would for specific endpoints (e.g., sensitivity, specificity for diagnostic devices, or specific measurable outcomes for therapeutic devices).
Instead, it states that the device was evaluated against established international standards and internal performance requirements. The "reported device performance" is described qualitatively as meeting these standards and requirements.
Here's a synthesized representation based on the information provided, inferring "acceptance criteria" from the standards and tests mentioned:
| Acceptance Criteria Category | Reported Device Performance (as stated) |
|---|---|
| Structural Integrity | Successfully verified and validated. Complies with ISO 8637-1 (mechanical characteristics). |
| Membrane Integrity | Successfully verified and validated. Complies with ISO 8637-1 (mechanical characteristics). |
| Ultrafiltration Rate | Successfully verified and validated. Complies with ISO 8637-1 (performance characteristics - ultrafiltration coefficient). |
| Clearances | Successfully verified and validated. Complies with ISO 8637-1 (performance characteristics - solute clearances). |
| Sieving Coefficients | Successfully verified and validated. Complies with ISO 8637-1 (performance characteristics - sieving coefficients). |
| Blood Pressure Drop | Successfully verified and validated. Complies with ISO 8637-1 (volume and pressure drop of blood compartment). |
| Total Volume of Blood | Successfully verified and validated. Complies with ISO 8637-1 (volume and pressure drop of blood compartment). |
| Priming Efficacy | Successfully verified and validated. |
| Shelf Life | Successfully verified and validated. 24 months from sterilization date. Complies with ISO 8637-1 (expiry date) and ISO 8638 (expiry date). |
| Sterilization Validation | Successfully verified and validated. EO sterilization. Complies with ISO 8637-1 (sterility) and ISO 8638 (sterility). |
| Pyrogenicity / LAL | Successfully verified and validated. Complies with ISO 8637-1 (non-pyrogenicity) and ISO 8638 (non-pyrogenicity). |
| EO Residuals | Successfully verified and validated. |
| Biocompatibility | Successfully verified through a battery of tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogen, Subacute/Subchronic Toxicity, Hemolysis) in accordance with ISO 10993-1, -4, -5, -10, -11. |
| Design Validation | The Prismaflex ST set design validation meets user needs and intended use, and is substantially equivalent to the predicate. |
| Tubing Compliance | Complies with ISO 8638 (tubing compliance). |
| Risk Assessment | Risk analysis confirms the device is appropriately designed, performs as expected, and in a safe manner. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes non-clinical bench and pre-clinical testing. These are laboratory-based tests of the device's physical and chemical properties, as well as its interaction with biological models (e.g., blood, cell cultures).
- Sample Size for Test Set: The document does not specify the exact number of units/sets tested for each performance characteristic. In bench testing for medical devices, this often involves a pre-defined number of samples per batch or according to a statistical sampling plan to ensure reliability and representativeness for the specific test (e.g., n=3, n=5, n=10 per test condition). However, these specific numbers are not disclosed in this summary.
- Data Provenance: The data provenance is from non-clinical (bench and pre-clinical) laboratory testing. There is no mention of human subject data, retrospective, or prospective studies involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to the type of study described. "Ground truth" established by experts (like radiologists for image analysis) is relevant for clinical studies, especially those involving human interpretation or diagnostic accuracy. The studies detailed here are non-clinical, focusing on the device's physical and chemical performance, where "ground truth" is typically defined by objective measurements against established engineering specifications and international standards, not expert consensus.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to procedures for resolving disagreements among multiple human readers/experts in clinical studies, particularly in diagnostic accuracy assessments. As this is a non-clinical device performance study, such a method would not be used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states that the safety and performance were evaluated through non-clinical testing. There is no mention of human readers, AI assistance, or comparative effectiveness studies involving human-in-the-loop performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. The device described, the "Prismaflex ST set," is a medical device for blood purification (hemodialysis/hemofiltration), not an AI algorithm or a diagnostic tool that would typically have a "standalone" algorithmic performance. The "performance" here refers to its physical and functional operation.
7. Type of Ground Truth Used
The "ground truth" for these non-clinical tests is established by:
- Objective Measurements: Directly measuring physical and chemical properties (e.g., ultrafiltration rate, clearances, pressure drop) using calibrated equipment.
- International Standards: Compliance with recognized international standards (ISO 8637-1, ISO 8638, ISO 10993 series) which define acceptable ranges and methodologies.
- Device Specifications: Meeting internal design specifications for the device.
There is no use of expert consensus, pathology, or outcomes data as "ground truth" in these non-clinical tests.
8. Sample Size for the Training Set
This question is not applicable. The Prismaflex ST set is a hardware medical device; its development and validation do not involve "training sets" in the context of machine learning or AI algorithms. The "training" that occurs is in the manufacturing and quality control processes to ensure consistency and adherence to specifications.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this 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.”