(266 days)
The Toraysulfone™ Dialyzer, BS-L Series, is indicated for use in hemodialysis treatment of patients with acute or chronic renal failure.
The Toraysulfone Dialyzer, BS-L Series consists of highly permeable polysulfone hollow fibers housed in a polystyrene casing and secured at each end with polystyrene headers. High permeability dialyzers must be used only in conjunction with dialysis machines equipped with an ultrafiltration controller. The Toraysulfone Dialyzer, BS-L Series is provided in a range of three sizes based on the surface area of the hollow fiber membrane. The device is gammaray sterilized and intended for single use only.
The provided text describes the "Toraysulfone Dialyzer, BS-L Series," a medical device used for hemodialysis. The information details the device's technical characteristics, its intended use, and its equivalence to predicate devices, but it does not provide explicit acceptance criteria with specific numerical targets.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study for Toraysulfone™ Dialyzer, BS-L Series
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Implied) |
|---|---|---|
| Bench Testing | All applicable tests conducted in accordance with FDA guidance. | "All samples met the acceptance criteria." "The test results establish that the Toraysulfone Dialyzer, BS-L Series possesses performance characteristics that make it acceptable for its intended use." |
| Performance Characteristics (General) | Characteristics suitable for hemodialysis treatment of patients with acute or chronic renal failure; similar flow and clearance data to predicate devices. | "The features and capabilities of the predicate and proposed devices are identical: they also have similar flow and clearance data." "Some performance characteristics... are described in published materials included in this 510(k) Notification." |
| Material | Membrane material identical to legally marketed Toraysulfone dialyzer. | "The material of the membrane (hollow fiber) of the Toraysulfone Dialyzer, BS-L Series is identical to that of the legally marketed Toraysulfone dialyzer." |
Note: The document explicitly states that "All samples met the acceptance criteria" for bench testing and that the device characteristics are "identical" or "similar" to predicate devices, implying that specific, pre-defined acceptance criteria were met. However, the exact numerical or qualitative targets for these criteria are not detailed in this 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "All samples met the acceptance criteria" for bench testing, but the number of samples is not given.
- Data Provenance: Not explicitly stated as retrospective or prospective. Bench testing data is typically generated in a lab setting. The document also mentions "published materials included in this 510(k) Notification" for some performance characteristics, but their provenance (e.g., country of origin) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This type of information is typically relevant for studies involving subjective assessments, such as image interpretation or clinical diagnosis. The Toraysulfone Dialyzer, BS-L Series is a physical medical device, and its performance is evaluated through objective bench testing and comparison to predicate devices, rather than expert-established ground truth on a test set in the same manner as an AI algorithm.
4. Adjudication Method for the Test Set
Not applicable for a physical device undergoing bench testing. Adjudication methods like "2+1" or "3+1" are used in studies where multiple human readers or algorithms assess discrete outcomes and discrepancies need to be resolved. Performance for this device is based on objective measurements from bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening tools where reader performance is a key outcome. The Toraysulfone Dialyzer, BS-L Series is a treatment device, and its evaluation focuses on its physical and functional performance, not on human reader interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical hemodialyzer, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation largely consists of:
- Objective Measurements: Results from bench testing (e.g., flow and clearance data).
- Predicate Device Performance: Performance data from already legally marketed devices (Toraysulfone Dialyzer K002512 and Fresenius Optiflux 200NR Hemodialyzer K002277), which serve as the standard for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are developed and refined, but not through a "training set" of data in the same way an AI model is.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in this context.
§ 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.”