(239 days)
The Phoenix® Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit.
Phoenix® is a self-contained, microprocessor-controlled device that provides hemodialysis and ultrafiltration-only therapies. The system consists of the Hemodialysis Machine in use with a blood tubing set designed for the machine, a dialyzer, a heparin-filled syringe, a BiCart® column (sodium bicarbonate powder), and other appropriate dialysate concentrates. The machine has many built-in features which are intended to enhance the ease of providing patient dialysis treatments. Phoenix® has a modular structure.
The provided text describes a 510(k) submission for the Phoenix® Hemodialysis Delivery System 3.35. This document focuses on demonstrating substantial equivalence to a predicate device and includes information about nonclinical testing.
Here's an analysis to extract the requested information:
1. A table of acceptance criteria and the reported device performance
The document uses the predicate device (Phoenix® Hemodialysis Delivery System Version 3.00) as a benchmark for acceptance criteria and performance. The performance metrics for the modified device (Version 3.35) are compared directly against those of the predicate. The "Accuracy" values for the modified device represent the reported device performance.
| Parameter | Acceptance Criteria (Predicate V3.00) | Reported Device Performance (Modified Device V3.35) |
|---|---|---|
| Anticoagulation (Heparin Pump) | Range: 0.5 - 10 ml/hr | |
| Accuracy: ± 5% or ± 0.2 ml/h | Range: 0/0.5 - 10 ml/hr | |
| Accuracy: ± 5% or ± 0.2 ml/h | ||
| Blood Flow Rate | Range: 10 - 500 ml/min | |
| Accuracy: ± 10% | Range: 10 - 580 ml/min | |
| Accuracy: ± 10% if pressure before the pump is not lower (more negative) than – 150 mmHg | ||
| Fluid Removal Rate from Patient | Range: 0 - 4 Kg/h | |
| Accuracy: ± 2.5 % of actual value or ± 50 ml/h, whichever is greater | Range: 0 - 4 Kg/h | |
| Dialysate flow rate at 350 ml/min: Accuracy (on total Weight removed): ±(2% UF rate + 35 g/hr) | ||
| Dialysate flow rate at 500 ml/min: Accuracy (on total Weight removed): ±(2% UF rate + 50 g/hr) | ||
| Dialysate flow rate at 800 ml/min: Accuracy (on total Weight removed): ±(2% UF rate + 80 g/hr) | ||
| Dialysate Flow Rate | Range: 350 - 1000 ml/min | |
| Accuracy: ± 5% | Range: 350 - 800 ml/min | |
| Accuracy: ± 5% | ||
| Transmembrane Pressure | Range: -200 to +500 mmHg | Range: -100 to +450 mmHg |
| Ultrafiltration Rate | Range: 0 - 4 Kg/h | |
| Accuracy: ± 2.5 % of actual value or ± 50 ml/h, whichever is greater | Range: 0 - 4 Kg/h | |
| Accuracy: ± 2 % of actual value. | ||
| Dialysate Temperature | Range: 34 - 40 °C | Range: 34 - 39.5 °C |
| Dialysate Conductivity | Range: 13-17 mS/cm | Range: 13-17 mS/cm |
| Arterial Pressure | Range: -400 to +150 mmHg | Range: -400 to +150 mmHg |
| Venous Pressure | Range: 100 to +450 mmHg | Range: 0 to +450 mmHg |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "component level hardware testing," "static and dynamic software testing (e.g., unit testing, code inspections, testing targeted to the changes implemented in software version 3.35, regression testing)," and "human factors evaluations." However, it does not specify sample sizes for these tests, nor the country of origin or whether the data was retrospective or prospective. The information points to internally conducted engineering and software verification and validation activities.
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)
The document states that testing was performed by "internal and external independent personnel with the appropriate skills" for the nonclinical testing and human factors evaluations. However, it does not specify the number of experts, their qualifications, or their role in establishing a ground truth for a test set. The context is about engineering and system performance validation, not clinical image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set. This type of method is typically associated with studies involving human interpretation (e.g., radiology reads) where discrepancies need resolution. The testing described is primarily technical performance validation.
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
No MRMC comparative effectiveness study was done or mentioned. This submission is for a medical device (hemodialysis system), not an AI-powered diagnostic tool, and therefore, the concept of "human readers improving with AI assistance" is not applicable to the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the "algorithm only" in this context refers to the device's automated functions). The entire nonclinical testing section, which evaluated parameters like flow rates, accuracies, and pressures, represents standalone performance testing of the Phoenix® System 3.35. The tables directly report these standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the nonclinical testing, the "ground truth" would be established by controlled engineering measurements against known standards and specifications. For example, a calibrated flow meter would provide the "ground truth" for blood flow rate accuracy, or a calibrated pressure sensor for pressure measurements. These are physical and electrical measurements, not expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
The document does not mention a training set sample size. This is not an AI/machine learning device that typically requires a large training dataset. The development and testing revolve around hardware and software engineering principles.
9. How the ground truth for the training set was established
Since there is no mention of a training set, there is no information on how its "ground truth" was established.
§ 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.”