(301 days)
The DYNAMIC Hollow Fiber Dialyzer DS-Series are indicated for use whenever a patient is in acute or chronic renal failure and hemodialysis is prescribed by a physician. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness.
Blood enters a blood inlet port where it is distributed to hollow fibers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 40 microns. The fibers used in this device which is substantially equivalent to the fibers utilized in the Minntech Primus™ Hollow Fiber Dialyzer (K923727), Fresenius Hemoflow HF Dialyzer (K870724), and Minntech Renaflo™ HDF Hemodiafilter (K910236), which have been previously approved under a 510(k) Notification. The wall thickness of the hollow fibers in Minntech Primus™ Hollow Fiber Dialyzer, Fresenius Hemoflow HF Dialyzer, and the proposed device is 40 microns. The inner diameter of hollow fibers in predicate devices and the proposed device is 200 microns. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
Here's an analysis of the provided text regarding the DYNAMIC Hollow Fiber Dialyzer DS-Series, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" with specific numerical thresholds for each performance metric. Instead, the study aims to demonstrate substantial equivalence to predicate devices. The performance is reported in terms of achievement of this equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Urea Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Creatinine Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Phosphate Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Vitamin B12 Clearance | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Ultrafiltration Coefficient | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Sieving Coefficient | Substantially equivalent to Minntech Primus™ 2000 & Fresenius Hemoflow HF80 Dialyzer | Device is substantially equivalent to predicate devices. |
| Safety and Effectiveness | Safe and effective as predicate devices | Device is safe, effective, and performs as well as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the in vitro performance testing (test set). It only states that "In vitro testing was performed on the proposed device."
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a medical device prior to market, it's highly likely the in vitro testing was prospective.
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 the reported study. The "ground truth" for hollow fiber dialyzers in this context is established by the functional performance characteristics (clearances, ultrafiltration, sieving coefficients) as measured by laboratory equipment and standardized protocols, not by expert interpretation.
4. Adjudication Method for the Test Set
This is not applicable to the in vitro performance testing of a dialyzer. Performance metrics are measured objectively, not adjudicated by human review.
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
No MRMC study was performed. This device is a medical device (dialyzer), not an AI-based diagnostic or imaging device, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical hemodialyzer, not an algorithm. The "standalone" performance refers to the in vitro performance of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for the in vitro performance testing consisted of measured functional performance characteristics such as urea, creatinine, phosphate, and vitamin B12 clearances, ultrafiltration coefficient, and sieving coefficient. These measurements were then compared against the established performance of the predicate devices.
8. The Sample Size for the Training Set
There is no "training set" in the context of this 510(k) submission for a physical medical device. The device's design and manufacturing processes are based on established engineering principles and materials, not on a machine learning training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this type of 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.”