(415 days)
Single Needle Single Lumen Dialysis is indicated for use when a single venipuncture is chosen for use in chronic or acute hemodialysis treatments.
This application is for adding the option of Single Needle Single Lumen dialysis treatment to the current System 1000® Hemodialysis Machine. Single Needle Single Lumen dialysis is performed by controlling blood flow into and out of the patient with a single needle single lumen blood access, as opposed to dialysis blood access with two needle punctures. Because of the single lumen access, the hemodialysis machine operates cyclically, i.e. part of the time blood is aspirated from the patient (arterial phase), and part of the time blood is infused to the patient (venous phase).
Arterial Phase: During the arterial phase, the venous blood line is clamped, and blood is pumped via the peristaltic blood pump from the patient into the machine's extracorporeal circuit, and into (a) holding chamber(s) until a predetermined volume of blood has been accumulated. When the specified volume has been reached, the blood pump is stopped. The arterial phase is now complete.
Venous Phase: During the venous phase, the venous blood line is unclamped, the arterial blood line is clamped, and the blood in the holding chamber(s) and extracorporeal circuit is returned to the patient. When the venous pressure reaches a predetermined Low Pressure Trip Point, the venous blood line is clamped. At this point, the system returns to the arterial phase, and the cycle starts again.
Single Needle Single Lumen dialysis can be performed using either one peristaltic blood pump or two. (The Arterial and Venous phases described above apply to either system configuration). In systems using two pumps, the second pump returns the blood to the patient (Venous Phase). In systems using one pump, the pressure difference between the venous drip chamber and the patient causes the blood to return to the patient.
Single Needle Single Lumen dialysis (with systems using either one peristaltic pump or two) can be performed using either one line clamp or two. (The Arterial and Venous phases described above apply to either system configuration.) The second (arterial) clamp is required only when a blood line with an arterial drip chamber is used.
This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a 510(k) summary for a hemodialysis system, focusing on its description, intended use, and substantial equivalence to predicate devices. It lists technological characteristics and safety systems but does not detail performance metrics, study designs, sample sizes, or ground truth establishment.
§ 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.”