(14 days)
Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
The Fresenius 2008T Hemodialysis Machine (K113427) 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, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and 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.
The display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running the third party MDDS (Medical Device Data Systems) program. The blue CDX Key located on the fold-down keyboard allows switching between the Dialysis Screen and the MDDS screen. The user interface of the 2008T machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.
Modifications to the previously cleared 2008T Hemodialysis Machine include:
- . Heparin and Sodium Variation System (SVS) Status: Addition of visual indication (display) on the home screen and dialysate screen.
- . Dialysate Flow Button: Addition of Dialysate Flow ON-OFF button in the Dialysate Screen.
- Applications Installed Display: Addition of text identifying which applications . (Apps) have been loaded is added to the machine's opening screen.
- Configurator: Software modification to support the transfer of machine . configuration information between machines during installation or upgrade in service mode.
- . Sodium Variation System (SVS) as an Optional Feature: Addition of SVS selection in service mode to make the existing SVS feature optional.
The following modification was implemented following a regulatory assessment that the change did not affect the fundamental scientific technology or intended use of the device. Based on FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", Fresenius Medical Care North America determined that this modification did not necessitate a 510(k) submission:
- Wireless Adapter: A dual band (i.e. 2.5Ghz and 5Ghz) wireless adapter provides the . wireless network link for the CDX PC, and supports 802.11a/b/g/n. This new wireless adapter replaces the obsolete wireless adapter (unmodified device) and maintains the latest wireless technology.
Additionally, this submission includes minor maintenance modifications made to the Functional Board Software (V.2.34) of the 2008T Hemodialysis Machine since the last clearance (K113427).
Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K113427):
The 2008T Hemodialysis Machine is a hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemo-concentration. The 2008T Hemodialysis Machine will accommodate the use of both low flux and high permeability, high flux dialyzers.
The provided text describes a 510(k) submission for modifications to the Fresenius 2008T Hemodialysis Machine. This submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device and that the modifications do not negatively impact its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria with specific quantitative targets for each performance aspect. Instead, it states that "Test results demonstrated that the modified 2008T Hemodialysis Machine functions as intended and met pre-determined acceptance criteria." It also mentions "functional validation," "summative usability testing," and "risk analysis" as evidence.
Based on the information provided, we can infer the reported performance as meeting these general criteria:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | Functions as intended, no impact on essential performance |
| Safety | Safety systems verified, all potential risks deemed acceptable |
| Effectiveness | No change in performance or intended use/indications for use |
| Usability | Passed summative usability testing |
| Substantial Equivalence | Substantially equivalent to the named predicate device |
| Risk Mitigation | All potential hazards identified and mitigated appropriately |
| Software Integrity | Software verified (functional tests, regression, safety systems) |
| Manufacturing Process | Manufacturing location and processes remain unchanged |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any test sets. It mentions "Software Verification and Validation Testing" and "Summative Usability Testing" without detailing how many test cases, iterations, or users were involved.
The provenance of this data is internal to Fresenius Medical Care North America ("according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820)"). It is implicitly retrospective in the sense that the testing was conducted on a device that had undergone modifications, and the data was collected to support the 510(k) submission. No country of origin for specific test subjects or users is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for a test set in the context of the device's technical or software performance. For "Summative Usability Testing," it is plausible that a group of representative users (e.g., dialysis technicians, nurses, or clinicians) would have been involved, but their number and specific qualifications are not provided. The types of tests conducted (e.g., software verification, regression) typically rely on predefined specifications and expected outputs rather than expert interpretation of results.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Given the nature of the modifications (software updates, feature additions, component replacements) and the testing performed (functional, safety, usability), it's unlikely that a traditional expert adjudication process (like 2+1, 3+1) would be necessary as seen in diagnostic device evaluations. The testing appears to follow a pass/fail criteria based on predefined specifications and risk analysis outcomes.
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
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a hemodialysis machine, not an AI-powered diagnostic or interpretive system that would involve human "readers" or AI assistance in a clinical interpretation task. The modifications are to the machine's software, display, and optional features.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself (hemodialysis machine) operates primarily as a standalone system to deliver therapy, albeit with human operators. The "Software Verification and Validation Testing" can be considered a form of standalone evaluation for the modified software components, ensuring they perform as programmed without human intervention beyond initiating tests and observing results. However, this is not an "algorithm-only" performance in the sense of an AI diagnostic tool. There is no mention of an "algorithm" being evaluated separately from the device's integrated function.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed would be based on:
- Design Specifications: The documented requirements and expected behavior of the software and hardware functions.
- Risk Analysis Outcomes: Identifying and verifying the mitigation of potential hazards.
- Predicate Device Performance: The unmodified 2008T Hemodialysis Machine served as the benchmark, implicitly providing the "ground truth" for expected performance, safety, and effectiveness. The testing aimed to confirm that the modified device's functions aligned with the predicate and its specifications.
8. The Sample Size for the Training Set
No training set is mentioned in the document. This is not an AI/ML device that requires training data. The modifications are software and component updates for an existing medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
§ 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.”