(141 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, hemofiltration and ultrafiltration 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. The Phoenix Hemodialysis Machine pumps blood from the patient, in a blood tubing set properly designed for the machine, through the dialyzer where purification takes place, and back to the patient. In the dialyzer, the blood and the dialysate fluid flow on opposite surfaces of a thin Semipermeable membrane. As the blood passes through the filter, the desired treatment processes take place. Depending upon the therapy in use, the treatment processes can include fluid removal and/or solute clearance. Phoenix has a modular structure. It is made up of five modules that carry out independent functions: Master Module, Hydraulic Module, Blood Module, Protection Module and Bio Module. The unit consisting of the Master, Hydraulic and Blood Modules is called the Control System. The Control System manages the implementation of the physical functions.
The provided document describes a Special 510(k) submission for the Phoenix® Hemodialysis Delivery System - version 3.40. This type of submission is used when the modification to a previously cleared device (the predicate device, in this case, Phoenix® version 3.35) does not affect the intended use or fundamental scientific technology. Therefore, the acceptance criteria and the study performed focus on demonstrating that the updated software (version 3.40) maintains equivalence and does not degrade the safety or effectiveness of the device compared to the predicate.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this Special 510(k) are primarily based on maintaining the performance parameters of the predicate device (Phoenix® version 3.35) and ensuring that the new software version (3.40) does not negatively impact these. The "reported device performance" is essentially that the updated device meets or exceeds the specifications of the predicate.
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | Intended to provide high flux and low flux hemodialysis, hemofiltration, and ultrafiltration on patients ≥ 15 Kg. To be used with high or low permeability dialyzers by trained operators as prescribed by a physician in chronic/acute care facilities. | Identical to predicate. Software 3.40 facilitates correct display of actual values for low weight - low volume sets, eliminating prior mathematical calculations. |
| Dedicated Disposable Sets | Gambro Cartridge™ Blood Set: 003410-510, 003410-710, 003414-500, 003414-510 (Double Needle); 003409-410, 003429-500 (Single Needle); 003412-500 (75 ml volume); 003422-520 (LOW WEIGHT - LOW VOLUME) | Identical to predicate, with clarification for 003412-500 (75 ml volume) instead of (20-40 Kg weight) and inclusion of 003422-520. |
| Anticoagulation | Heparin Syringe Pump: 0/0.5 - 9.9 ml/hr; Accuracy: ± 5% or ± 0.2 ml/h | Identical. |
| Blood Flow Rate | 10 - 580 ml/min; Accuracy ± 10% if pressure before pump not lower than -150 mmHg | 10 - 580 ml/min (10 - 140 ml/min in LW-LV mode*); Accuracy ± 10% if pressure before pump not lower than -150 mmHg. *The LW-LV mode is an enhancement. |
| Fluid Removal Rate from Patient | 0 – 4 Kg/h; Accuracy: Dialysate flow rate at 350 ml/min: ±(2% UF rate + 35 g/hr); 500 ml/min: ±(2% UF rate + 50 g/hr); 800 ml/min: ±(2% UF rate + 80 g/hr) | Identical. |
| Ultrafiltration Rate | 0 - 4 Kg/h; Accuracy: ±2 % of actual value | Identical. |
| Dialysate Flow Rate | 350 - 800 ml/min; Accuracy: ± 5% | Identical. |
| Transmembrane Pressure | -100 to +450 mmHg | Identical. |
| Dialysate Temperature | 34 - 39.5 °C | Identical. |
| Dialysate Conductivity | 13-17 mS/cm | Identical. |
| Arterial and Venous Pressure | Arterial: -400 to +150 mmHg; Venous: 0 to +450 mmHg | Identical. |
The key "performance improvement" highlighted in relation to the acceptance criteria is the elimination of manual calculations for low weight - low volume sets with software version 3.40. Previously, users had to divide displayed blood flow, liters processed, and pump speed by 4 to get actual values. The new software directly displays the actual values, which is a usability and safety enhancement.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in the conventional sense (e.g., number of patients or cases) for a test set. This is because no clinical studies were performed for this software modification (Page 4). The testing performed was non-clinical performance data, consisting of verification and validation activities for the software and the system.
The data provenance is internal to the manufacturer's development and testing processes; there's no mention of external data sources or country of origin for a specific "test set" in the context of clinical data. It falls under "retrospective" in the sense that the testing was based on the existing device design and specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical studies were performed and the testing was non-clinical, there isn't a "ground truth" derived from expert clinical opinion in the traditional sense for a test set of patient data.
Instead, the "ground truth" for the non-clinical testing was established by:
- System and software requirements and specifications.
- International safety standards (IEC 60601-1-2, 60601-2-16, 60601-1-4, 60601-1-6, 62366).
- The performance of the legally marketed predicate device (version 3.35).
The experts involved would be the manufacturer's software engineers, quality assurance personnel, regulatory affairs specialists, and potentially clinical representatives who defined and verified these requirements and standards. Their qualifications would be in their respective technical and domain expertise.
4. Adjudication Method for the Test Set
Again, given the non-clinical nature of the testing, there was no "adjudication method" in the sense of multiple experts reviewing and reaching a consensus on clinical outcomes or images.
The verification and validation activities inherently involve review and approval processes by qualified personnel. These would include:
- Static activities: impact analysis, final phase reviews, code inspections.
- Dynamic tasks: baseline verification, system and software test protocols execution, regression testing, Graphical User Interface and Use Cases test execution.
These processes ensure that the software performs as intended and meets specifications, which is a form of "adjudication" through technical review and testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed for the software modification." Therefore, there is no effect size reported for human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hemodialysis delivery system, which is a piece of medical equipment, not an AI algorithm in the contemporary sense. It is microprocessor-controlled and performs automated functions, but it always operates with a human-in-the-loop (trained operators). The "standalone" performance thus encompasses the device's ability to execute its programmed functions accurately and safely on its own, but within the context of human use and oversight.
The non-clinical performance data focuses on this "standalone" (device-only) functionality through:
- Static activities (code reviews, impact analysis).
- System and software functional tests.
- Regression testing.
- Graphical User Interface and Use Cases test execution.
These tests verify the algorithm's (software's) internal logic and its interaction with the hardware.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Technical specifications and performance requirements defined by the manufacturer.
- Compliance with international safety standards (relevant IEC standards listed).
- Functional equivalence to the legally marketed predicate device (Phoenix® version 3.35).
- Usability requirements verified through formative and summative usability validation.
It is not based on expert consensus for clinical diagnosis, pathology, or patient outcomes data, as no clinical studies were performed.
8. The Sample Size for the Training Set
This question is not applicable in the context of this device and submission. The Phoenix® Hemodialysis Delivery System is a hardware/software medical device that performs defined physiological functions, it is not an AI/Machine Learning algorithm that undergoes a "training phase" with a "training set" of data in the manner typically associated with such terms.
The software development would involve stages of coding, unit testing, integration testing, and system testing, which are forms of continuous verification and validation, but not "training" with a distinct "training set" of data for learning purposes.
9. How the Ground Truth for the Training Set Was Established
As established in point 8, there is no "training set" in the context of this device. Therefore, the ground truth for a training set was not 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.”