(266 days)
The 2008K Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
The 2008K@home Hemodialysis Machine is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home Hemodialysis Machine is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
The bibag System is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
The Wireless Wetness Detector is indicated for use with the 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.
The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient experiencing the common complications of dialysis which include nausea, cramping and vomiting
The 2008K Hemodialysis Machine, the 2008K@home Hemodialysis Machine, and the 2008T Hemodialysis Machine are variations of the same basic mechanisms and design concepts, having different user interfaces and/or mechanical sub-systems. These machines are medical electrical systems controlled by software. They are used for performing dialysis therapy by pumping blood through an extracorporeal circuit with a semipermeable membrane to remove toxins and excess water. The extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming and outgoing flow of dialysate fluid during ultrafiltration. The hydraulic systems are composed of various plastic/rubber, metal, and glass materials that have indirect, prolonged contact, externally communicating with the dialysate circuit, which has prolonged, indirect blood contact.
This document is a 510(k) Pre-market Notification for updates to the Fresenius Medical Care 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, and 2008T Hemodialysis Machine. It does not describe a study involving an AI (Algorithm Only) or MRMC (Multi-Reader Multi-Case) comparative effectiveness study, nor does it detail acceptance criteria related to diagnostic accuracy or clinical outcomes that would typify such studies for most AI/medical imaging devices.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through verification and validation of modifications made to the existing hemodialysis machines. The "acceptance criteria" and "device performance" described are related to the engineering and functionality of the devices rather than AI performance metrics like sensitivity or specificity.
Here's an interpretation based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Device Performance as Reported |
|---|---|
| Hardware Testing | |
| Electronic Functional Testing (e.g., dialysate air detection circuit effectiveness) | Demonstrated effectiveness of the dialysate air detection circuit. |
| Mechanical Functional Testing (e.g., hydraulic system effectiveness) | Demonstrated effectiveness of the hydraulic system. |
| Mechanical Reliability Testing (e.g., repeated function) | Demonstrated appropriate repeated function. |
| Mechanical Regression Testing (e.g., system functional performance) | Demonstrated system functional performance of the machines. |
| Software Verification and Validation | |
| Software Unit Testing (e.g., unit level performance meets design specifications) | Demonstrated unit level software performance met software design specifications. |
| Software Integration Testing (e.g., unit level software interaction meets design specifications) | Demonstrated the unit level software interacted as specified in software design specifications. |
| System Level Software Verification Testing (e.g., effectiveness of software modifications, confirmation of machine operation) | Demonstrated the effectiveness of the software modifications and confirmed operation of the machines. |
| Overall Conclusion | Test results demonstrated that the modified devices function as intended and met the acceptance criteria. Results of performance testing do not raise any new concerns with regard to safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of patient data or images. The testing described is engineering verification and validation of the hardware and software components of the hemodialysis machines themselves. Therefore, information regarding "country of origin of the data" or "retrospective/prospective" is not applicable. The sample size would be the number of modified devices or components tested. This number is not explicitly stated but is implied to be sufficient for demonstrating the functionality and reliability of the modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The "ground truth" here is the expected functional behavior and performance of the machines based on engineering specifications and safety standards, not a medical diagnosis or interpretation by experts. The "experts" involved would be the engineers, quality assurance personnel, and regulatory specialists conducting and reviewing the tests.
4. Adjudication Method for the Test Set:
Not applicable, as the evaluation involves engineering tests against predefined specifications, not human interpretation requiring adjudication.
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. This submission is for modifications to a hemodialysis machine, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance study was done in the typical sense of AI devices. The "software verification and validation testing" evaluates the machine's control software, which operates the machine automatically but is not an "AI algorithm" in the diagnostic sense.
7. The Type of Ground Truth Used:
The ground truth used in this context is the engineering specifications, design requirements, and established performance standards for the hemodialysis machines. These define what constitutes correct and safe operation of the device and its components.
8. The Sample Size for the Training Set:
Not applicable. This document describes the testing of physical devices and their control software, not the training of an AI model using a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no AI training set discussed in this document.
§ 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.”