(35 days)
The NxStage System One is indicated for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
The NxStage System One, consisting of hardware, software and a sterile disposable cartridge, is indicated for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis and/or ultrafiltration. All treatments must be administered by a health care provider, under physician prescription.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it describes a Special 510(k) Device Modification for the NxStage System One, a hemodialysis system.
Here's what can be inferred from the text regarding the nature of the submission and the evidence provided:
- Type of Submission: This is a Special 510(k) Device Modification, which relies on demonstrating compliance with Design Control requirements (21 CFR 820.30) for minor changes to an already cleared device. It's not a de novo submission requiring extensive clinical performance studies.
- Basis of Substantial Equivalence: The key argument for substantial equivalence is based on:
- Comparison of descriptive and technological characteristics: The modified device with "one modified warning" was compared to the predicate device (baseline NxStage System One, K030470) and a comparable device (Fresenius 2008K). This implies that the changes were minor enough that new performance data wasn't deemed necessary.
- Design control certification: The sponsor provided certification that the device complies with 21 CFR 820.30 Design Control requirements, indicating that the design changes were controlled and verified internally.
- Focus on Labeling: The conclusion specifically states, "the modified NxStage System One device labeling has been shown to meet the minimum requirements that are considered acceptable for its intended use." This further suggests that the primary modification addressed in this 510(k) was a change to a warning in the device labeling, rather than a significant change to the device's fundamental performance.
Therefore, the requested information about acceptance criteria and a study proving the device meets them (especially in the context of accuracy, sensitivity, specificity, etc.) is not present in the provided text because this type of 510(k) submission typically does not involve such studies. It focuses on demonstrating that a minor modification to an existing, cleared device does not alter its safety or effectiveness or that the modification was made under strict design controls.
§ 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.”