(285 days)
The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
The Fresenius 2008T represents the next genesis of the Fresenius 2008K model hemodialysis machine. Hemodialysis is prescribed by physicians for patients with acute or chronic renal failure, when conservative therapy is judged inadequate. Dialysis therapy may be intermittent or continuous. The 2008T has the same indications for use and same intended use as the predicate device the 2008K (K994267). The Fresenius modified 2008T hemodialysis machine incorporates changes with regards to the user interface only and all water requirements, module options. functional options, performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device, the 2008K (K994267).
This 510(k) submission for the Fresenius 2008T Hemodialysis Machine primarily focuses on demonstrating substantial equivalence to a predicate device (Fresenius 2008K) due to user interface modifications only. As such, it does not involve a clinical study to establish acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are related to safety and effectiveness through the lens of equivalence to the predicate device, especially regarding the modified user interface.
Therefore, many of the typical elements requested for a device that relies on clinical performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not present in this document because they are not relevant to this specific type of submission.
Here's a breakdown of the information that is applicable or can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from Submission) |
|---|---|
| Safety and Effectiveness Equivalence: The modified device should raise no new types of safety or effectiveness questions compared to the predicate device. | "The performance and technological characteristics of the Fresenius 2008T are equivalent to those of the Fresenius 2008K Dialysate Delivery System and raise no new types of safety or effectiveness questions." This is supported by: The 2008T having the same indications for use and same intended use as the 2008K.The modifications being limited to the user interface only.All other critical parameters (water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options) remaining unchanged.Completion of a Risk Analysis where potential hazards associated with modifications were identified, mitigated, and verified as acceptable. |
| Intended Use Equivalence: The device must have the same intended use as the predicate. | "The intended use for the Fresenius 2008T is equivalent to that for the Fresenius 2008K Dialysate Delivery System and is as follows: Fresenius 2008T is indicated for acute and chronic dialysis therapy." (This is identical to the 2008K's intended use.) |
| Technological Equivalence: The technological characteristics should not introduce new safety or effectiveness concerns. | "The Fresenius 2008T is a modified version of the Fresenius 2008K Dialysate Delivery System. The performance and technological characteristics of the Fresenius 2008T are equivalent... and raise no new types of safety or effectiveness questions." This is primarily asserted by the limited scope of change (user interface) and unchanged core functionalities and performance limits. |
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable as this submission is for a device modification primarily concerning the user interface of an already cleared device, not a novel device requiring a clinical performance study with a test set of patient data/samples. The assessment relies on engineering principles, risk analysis, and comparison to existing validated performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "ground truth" established in the context of diagnostic accuracy for this submission, as it's not a diagnostic device and the changes are limited to the user interface.
4. Adjudication Method for the Test Set
Not applicable.
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
Not applicable. This device is a hemodialysis machine, not an AI-assisted diagnostic tool, and no MRMC study was performed or required for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI/algorithm performance, which is not relevant to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the traditional sense of a clinical diagnostic study. The "ground truth" in this context is the established safety and effectiveness of the predicate device (2008K), against which the modified 2008T is compared. The assessment hinges on demonstrating that the user interface changes do not negatively impact the device's function or safety, which is inherently tied to the predicate's proven track record. This is assessed through:
- Engineering analysis
- Risk assessment
- Verification activities (implied by "mitigations have been verified")
8. The Sample Size for the Training Set
Not applicable. This term is used for AI/machine learning models. This submission does not involve such models.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of the Study that Proves the Device Meets the (Implicit) Acceptance Criteria:
The study proving the device meets the acceptance criteria is not a clinical trial involving patient data or diagnostic performance metrics. Instead, it is a comprehensive engineering assessment and risk analysis comparing the modified Fresenius 2008T to its predicate device, the Fresenius 2008K.
The key points of this "study" or justification are:
- Nature of Modification: The only changes in the 2008T from the 2008K are in the user interface.
- Unchanged Features: All critical operational and functional aspects remain identical to the predicate: water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options.
- Risk Analysis: A "Risk Analysis has been completed and potential hazards associated with the modifications have been identified, mitigated and where applicable mitigations have been verified. All potential risks were deemed acceptable after mitigation." This is the primary method for demonstrating safety and effectiveness for a change of this nature.
- Indications for Use: The 2008T retains the exact same Indications for Use as the 2008K, "indicated for acute and chronic dialysis therapy."
- Conclusion of Equivalence: Fresenius Medical Care North America "believes that the information provided in this submission clearly describes the Fresenius 2008T and demonstrates that it is substantially equivalent to the Fresenius 2008K Dialysate Delivery system."
In essence, the "study" is the entire 510(k) submission itself, which articulates the limited nature of the changes and provides documentation (e.g., risk analysis results, engineering specifications – though not fully detailed in this summary) to support the claim that these user interface modifications do not introduce new safety or effectiveness concerns, thus maintaining equivalence to the predicate device.
§ 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.”