(130 days)
The modified Fresenius 2008T Hemodialysis Machine has the same indications for use as the unmodified device. It is indicated for acute and chronic dialysis therapy.
The Fresenius 2008T Hemodialysis Machine (K093902) is indicated for acute and chronic dialysis therapy. It is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, the blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane before being returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood. In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient.
The provided application describes the integration of several modifications to the Fresenius 2008T Hemodialysis Machine (K093902), focusing on ergonomic enhancements and reliability for the user/operator interface. These modifications include a touch screen user interface (activation of existing functionality), a dialysate sample port, a modified shunt interlock system and Hansen connectors, a larger wheel lock pedal, and a reset board.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it describes various tests conducted to ensure the safety and effectiveness of the modified device and confirms that the device "met pre-determined acceptance criteria." For each modification, a set of tests was performed to verify its functionality, safety, and compatibility with the existing system. The "performance" column below summarizes the type of testing described.
| Component Modified | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Touch Screen | Ensure functional accuracy, software reliability, and user-friendliness of the activated touch screen interface. | Functional Verification: Performed to confirm the touch screen operates as intended. |
| Software Validation: Conducted to ensure the software driving the touch interface is reliable and correct. | ||
| Usability Testing: Performed to assess user interaction and ease of use. | ||
| Dialysate Sample Port | Verify chemical compatibility, structural integrity under pressure, absence of residual chemicals, and biocompatibility. | Fluid Path Chemical Testing: Ensured no adverse chemical interactions with the dialysate. |
| Surface Disinfect Chemical Testing: Verified compatibility with disinfectants. | ||
| Pressure Holding Testing: Confirmed the port maintains integrity under pressure. | ||
| Residual Chemical Testing: Demonstrated no harmful residues. | ||
| Aging Test: Assessed long-term durability. | ||
| Biocompatibility: Confirmed material safety for patient contact. | ||
| Usability Testing: Assessed ease of sample collection. | ||
| Modified Shunt Interlock System & Hansen Connectors | Ensure chemical compatibility, structural integrity, cycle durability, shipping resilience, electrical safety, and biocompatibility. | Fluid Path Chemical Testing: Ensured no adverse chemical interactions. |
| Surface Disinfect Chemical Testing: Verified compatibility with disinfectants. | ||
| Cycle Testing: Evaluated durability over repeated connections/disconnections. | ||
| Strength Testing: Assessed mechanical robustness. | ||
| Shipping Testing: Verified integrity after transportation. | ||
| Safety Testing: Ensured overall safe operation. | ||
| Pressure Holding Testing: Confirmed integrity under pressure. | ||
| Residual Chemical Testing: Demonstrated no harmful residues. | ||
| Shunt Electrical Testing: Verified proper electrical function. | ||
| Aging Test: Assessed long-term durability. | ||
| Biocompatibility: Confirmed material safety. | ||
| Usability Testing: Assessed ease of use and connection. | ||
| Wheel Lock Pedal | Verify durability, mechanical strength, and user-friendliness of the enlarged pedal. | Cycle Testing: Evaluated durability over repeated locking/unlocking. |
| Strength Testing: Assessed mechanical robustness. | ||
| Usability Testing: Performed to assess ease of use for locking/unlocking. | ||
| Safety Testing: Ensured reliable and safe operation. | ||
| Reset Board | Ensure functional correctness, reliable communication, and mitigation of static discharge issues. | Functional Validation: Confirmed the board performs its intended reset function. |
| Simulated Dialysis Treatment: Tested the board's function during a typical treatment. | ||
| Unstructured Testing (foreseeable misuse): Evaluated behavior under non-standard conditions. | ||
| Production Testing: Ensured quality in manufacturing. | ||
| Regression Testing: Confirmed existing functionalities were not negatively impacted. | ||
| ESD (Electrostatic Discharge) Testing: Verified protection against static discharge to mitigate the "missing cursor" error. |
Summary Conclusion on Performance: "Test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for the test sets used for each of the performance tests. It broadly mentions "Design verification and validation testing" and lists the types of tests conducted.
The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modifications, these tests would typically be performed internally by the manufacturer (Fresenius Medical Care North America, located in Waltham, MA, USA), likely in a controlled, prospective manner using newly manufactured or modified device components.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. Usability testing is mentioned for several components (Touch Screen, Dialysate Sample Port, Modified Shunt Interlock System & Hansen Connectors, Wheel Lock Pedal), which implies user feedback was gathered to assess ease of use and functional design from the perspective of intended users (e.g., nurses, technicians operating the machine). However, the details of these "experts" (users) are not provided. Other tests, such as chemical testing, strength testing, and electrical testing, would have been conducted by engineers and laboratory personnel with relevant expertise.
4. Adjudication Method for the Test Set:
The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The nature of the tests (functional, chemical, mechanical, electrical, software validation) suggests that results were determined by objective measurement and verification against predetermined specifications, rather than subjective interpretation requiring multi-expert adjudication. Usability testing would involve collecting feedback, but the method for resolving conflicting feedback or formal adjudication is not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The modifications are primarily ergonomic and reliability-focused for device operation, not related to interpretive diagnostic tasks that would typically involve human readers and require such a study (e.g., medical imaging AI). Therefore, there is no information about the effect size of human readers improving with or without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
The device is a hemodialysis machine, which is a life-support system with direct physical interaction and monitoring by human operators. The changes described are enhancements to the user interface and mechanical components. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI-driven diagnostic tools is not directly relevant here. The device's operation inherently involves human interaction for setup, monitoring, and intervention. Software validation and functional verification were performed on the embedded software for the touch screen and reset board, which can be considered "standalone" in verifying the code's function, but this is within the context of hardware interaction rather than an independent diagnostic algorithm.
7. Type of Ground Truth Used:
The ground truth for the various tests would be based on:
- Engineering specifications and design requirements: For functional, mechanical, and electrical tests (e.g., pressure holding, cycle testing, strength, electrical testing for the shunt, software validation).
- Chemical and biological standards: For fluid path chemical testing, surface disinfectant chemical testing, residual chemical testing, and biocompatibility.
- User expectations/standards: For usability testing (e.g., ease of use, intuitive navigation).
- Industry standards: Such as ISO 8637;2004 mentioned for the Hansen connector.
- Regulatory requirements: For safety testing and risk analysis.
Ultimately, the goal was to ensure the modified device maintained "essential performance" and "functioned as intended," aligning with the predicate device's established performance and safety profile.
8. Sample Size for the Training Set:
The document does not describe any machine learning or AI components that would require a distinct "training set" in the conventional sense. The "software validation" and "functional verification" tests are for embedded software that controls the device's operation, not for adaptive learning algorithms. Therefore, there is no mention of a training set sample size.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The software was validated against pre-defined functional specifications and performance requirements established through engineering design, risk analysis, and regulatory standards.
§ 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.”