(186 days)
The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibaq 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 Fresenius 2008T Hemodialysis Machine with bibag System is the cleared 2008T Hemodialysis Machine that has been modified to enable use of a specialized, single use, sealed bag (the "bibaq") containing USP grade dry sodium bicarbonate powder to produce a saturated solution of sodium bicarbonate. The addition of the bibag system to the hemodialysis machine allows operators the option of producing a saturated sodium bicarbonate solution on-line through automated mixing of AAMI grade water and dry sodium bicarbonate powder within the bibag source disposable rather than with liquid bicarbonate concentrates. The bibag system is comprised of: (1) the bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium carbonate concentrate. A specialized bibag connector (is attached? to the hemodialysis machine.] The bibag disposable hangs on two nozzles located in the bibag connector.
The provided document describes the Fresenius 2008T Hemodialysis Machine with bibag™ system. The primary goal of the submission is to demonstrate that the modified hemodialysis machine, incorporating the bibag system, is substantially equivalent to predicate devices and functions as intended.
Here's an analysis of the acceptance criteria and the study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| System Functionality & Software | Ensure all modifications function as intended. | "The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria." |
| Essential performance of the 2008T is not impacted. | "The essential performance of the hemodialysis machine has not been impacted by the modifications." | |
| Software validation & regression testing passed. | "Software validation and regression testing" were performed, implying they passed based on the overall conclusion that "all modifications functioned as intended and met pre-determined acceptance criteria." | |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (2007) Class A. | "The modified 2008T hemodialysis machine with bibag system met the requirements of IEC 60601-1-2 (2007)." |
| Electrical Safety | Compliance with UL 60601-1 (1st Ed., 2006-04-26). | "The modified 2008T hemodialysis machine with was found to comply with the above standards." |
| Compliance with CAN/CSA-C22.2 No. 601.1-M90 (2005). | "The modified 2008T hemodialysis machine with was found to comply with the above standards." | |
| bibag Disposable Testing (Dry Sodium Bicarbonate) | Dissolution testing per USP requirements. | "Dissolution testing per USP requirements" was performed, indicating compliance as part of the overall conclusion that the bibag system functioned as intended and met acceptance criteria. |
| Bioburden & Endotoxin testing per USP & AAMI RD61:2006. | "Bioburden & Endotoxin testing per USP & AAMI RD61:2006" was performed, indicating compliance as part of the overall conclusion that the bibag system functioned as intended and met acceptance criteria. | |
| Biocompatibility testing per USP 32-NF26 biological tests . | "Biocompatibility testing of the bibag materials per USP 32-NF26 biological tests " was performed, indicating compliance as part of the overall conclusion that the bibag system functioned as intended and met acceptance criteria. | |
| System Performance (with bibag dry bicarbonate) | Ensure proper function with dry bicarbonate concentrate. | "System performance testing using bibag dry bicarbonate concentrate" was performed, and the overall conclusion states that "the bibag system... and the modified 2008T hemodialysis machine functioned as intended and met pre-determined acceptance criteria." This implies successful performance in producing a saturated solution. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the individual tests. It states that "Verification and validation testing were performed," but details on the number of units or test cycles are not provided. The data provenance is implied to be from internal lab testing conducted by Fresenius Medical Care North America. There is no information regarding country of origin for data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modification, the testing would typically be prospective, controlled laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The tests performed are objective engineering and performance validations (e.g., electrical safety, EMC, software validation, material biocompatibility, dissolution). These tests rely on predefined engineering standards and specifications, not on expert consensus or interpretation of medical images or outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. The tests described are objective and pass/fail based on meeting predefined thresholds and standards. There is no mention of subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed and is not applicable to this type of device modification. This is a technical modification to a hemodialysis machine, not a diagnostic or AI-assisted interpretation tool that would benefit from such a study.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable as the device is a medical machine with integrated functionality, not a standalone algorithm. The "system performance testing" would be considered the standalone performance, but it refers to the entire machine and bibag system in operation.
7. Type of Ground Truth Used
The "ground truth" for the various tests was based on:
- Pre-determined acceptance criteria derived from
- International and national medical device standards: IEC 60601-1-2 (EMC), UL 60601-1 (Electrical Safety), CAN/CSA-C22.2 No. 601.1-M90 (Electrical Safety).
- Pharmacopoeial standards: USP requirements for dissolution testing of materials.
- Biocompatibility standards: USP 32-NF26 biological tests .
- AAMI standards: AAMI RD61:2006 for Bioburden & Endotoxin testing.
- Internal engineering specifications: For software validation, regression testing, and overall system functionality.
8. Sample Size for the Training Set
This is not applicable. This device is a modified hemodialysis machine, not an AI/ML algorithm that requires a training set. The "training" for the device refers to its design and manufacturing processes, which are validated through the testing described.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as 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.”