(107 days)
2008T Hemodialysis Machine: The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.
bibag System (Optional): The bibag system is used with Fresenius three stream proportioning hemodialysis systems 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.
Crit-Line Clip Monitor (CLiC) (Optional): 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 without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.
The 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy. 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. In the dialysate circuit, the dialysate concentrates are mixed with purified water, 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 display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running third party MDDS (Medical Device Data Systems). 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 Hemodialysis Machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.
Bibag System (Optional): The bibag system is intended for use with Fresenius three stream proportioning hemodialysis systems 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 2008T Hemodialysis Machine with bibag System allows operators the option of preparing a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008T Hemodialysis Machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be performed using a specially modified 2008T Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution.
Modifications to the previously cleared 2008T Hemodialysis Machine (K121341) include:
Crit-Line Clip Monitor (CLiC) (Optional): Hardware, software and labeling t modifications to integrate the Crit-Line Clip Monitor (CLiC; K121599) and expansion of the Indications for Use for use of the CLiC with the 2008T Hemodialysis Machine. When integrated with the 2008T Hemodialysis Machine, the CLiC will use the same technology cleared under K121599, except the CLiC will now be hosted by the 2008T Hemodialysis Machine instead of the medical grade computer. When installed, the Crit-Line monitoring feature/user interface will be optional, selectable in Service Mode.
The intended use of the CLiC is as a continuous real-time monitor for non-invasive hematocrit, oxygen saturation, and percent change in blood volume measurement during hemodialysis treatment. The CLiC uses the principle of light absorption and scattering through the blood under test to measure oxygen saturation (O2 Sat) and hematocrit (Hct). The Hct values are then used to calculate the Blood Volume (BV) percentage change relative to the starting BV based on the beginning Hct.
Software Maintenance: Software maintenance modifications were made to the . 2008T Hemodialysis Machine since the last clearance (K121341).
. Additional Labeling Modifications: The 2008T Hemodialysis Machine Operator's Manual contains modifications to warnings concerning Total Buffer which were implemented as part of a Class I recall for Naturalyte/Granuflo Prescribing Information (Recall number Z-1826/Z-1827-2012).
The device description information included in the submission conforms to the applicable requirements of 21 CFR Section 876.5860(b).
This document describes the 510(k) summary for the Fresenius Medical Care 2008T Hemodialysis Machine with optional Crit-Line Clip Monitor (CLiC) and bibag System. However, it does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and a specific study proving it meets those criteria, especially in the context of an AI/human-in-the-loop study.
Based on the provided text, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "Test results demonstrated that the modified 2008T Hemodialysis Machine with optional CLiC functions as intended and met pre-determined acceptance criteria." It lists categories of tests but does not provide specific numerical acceptance criteria or detailed reported device performance values for each criterion.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Verification | Met pre-determined criteria |
| Software Verification | Met pre-determined criteria |
| Regression Testing | Met pre-determined criteria |
| Safety Systems Verification | Met pre-determined criteria |
| Simulated Dialysis Treatment | Met pre-determined criteria |
| Production Test Procedure | Met pre-determined criteria |
| Unstructured & Static Code Verification | Met pre-determined criteria |
| System Performance | Met pre-determined criteria |
| System Safety | Met pre-determined criteria |
| Electromagnetic Compatibility | Met pre-determined criteria |
| Usability (Formative & Summative) | Met pre-determined criteria |
| Risk Analysis (ISO 14971) | Potential risks deemed acceptable after mitigation |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for any of the verifications or validations. The document mentions "Simulated Dialysis Treatment" but doesn't quantify the number of simulations or "test cases."
- Data Provenance: Not specified. It's internal testing by Fresenius Medical Care Renal Therapies Group, LLC ("FMC-RTG"), suggesting it's likely conducted at their facilities or approved testing sites, but no details on country of origin are given. The studies are design verification and validation tests, which are typically prospective for the modifications being tested.
3. Number of experts used to establish the ground truth for the test set and their qualifications
- This information is not provided in the document. The tests described are primarily engineering and software verification/validation, and usability testing. "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant to the type of testing described here for a hemodialysis machine. For Usability testing, there would have been users (e.g., clinicians, nurses), but their number or specific qualifications are not stated.
4. Adjudication method for the test set
- This information is not provided. Adjudication methods (like 2+1 or 3+1) are typically used for clinical studies involving multiple readers or assessors determining ground truth, which is not the type of study detailed here. The tests are focused on device function, safety, and performance against engineering specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable and not provided. The device is a hemodialysis machine with an optional monitor (CLiC). It is not an AI-powered diagnostic or assistive tool for human readers/clinicians that would typically undergo an MRMC study comparing human performance with and without AI assistance. The CLiC provides real-time measurements, and the clinician "intervenes" based on this data, but this is data display, not AI assistance in interpretation or decision-making in the sense of a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable in the context of an "algorithm only" performance study typically seen with AI devices. The CLiC has algorithms for measuring hematocrit, oxygen saturation, and percent change in blood volume. The document states "Performance Specifications (monitoring parameters)" for CLiC are similar to the predicate, implying these algorithms' outputs were verified, but details on a "standalone" algorithm performance study and its metrics are not provided. The device itself is a complex electro-mechanical system where human interaction is inherent to its operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the functional and safety tests, the "ground truth" would be the engineering specifications, design requirements, and recognized industry standards (e.g., IEC standards for safety, ISO 14971 for risk management). For the measurement capabilities of the CLiC (Hct, O2 Sat, BV%), the ground truth would be established reference methods or calibrated instruments against which the CLiC's measurements were compared during verification, but these details are not provided.
8. The sample size for the training set
- This information is not applicable and not provided. This device is a traditional hemodialysis machine, not one that employs machine learning or AI that would require a "training set" in the computational sense.
9. How the ground truth for the training set was established
- This information is not applicable and not provided for the reasons stated in point 8.
§ 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.”