(285 days)
The NxStage System One is indicated for the treatment of acute and chronic renal failure, or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility. The System is also indicated for hemodialysis with or without ultrafiltration in the home.
The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
All treatments must be administered under physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
The NxStage System One is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge, a sterile, singleuse extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cycler. The combined system is designed to deliver hemofiltration. hemodialysis and/or ultrafiltration in an acute or chronic care facility and is also indicated for hemodialysis with or without ultrafiltration in the home. The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
This submission describes a Special 510(k) Device Modification for the NxStage System One, a hemodialysis system. The modification involves increasing the therapy fluid pump rate from 200 ml/min (12 L/hr) to 300 ml/min (18 L/hr).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document states that "All predetermined acceptance criteria were met" for the performance, verification, safety, and software testing. However, the specific acceptance criteria and detailed device performance metrics are not explicitly listed in the provided 510(k) summary. The summary only broadly states that the device is "adequately designed for the labeled indications for use" and "is substantially equivalent to the predicate device."
| Acceptance Criteria (Not explicitly detailed in document) | Reported Device Performance |
|---|---|
| Safety requirements for increased pump rate | Met all predetermined acceptance criteria |
| Performance requirements for increased pump rate | Met all predetermined acceptance criteria |
| Software functionality for increased pump rate | Met all predetermined acceptance criteria |
| Design specifications for increased pump rate | Met design specifications |
| Substantial equivalence to predicate device (K093069) | Achieved |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the non-clinical performance testing. It generally refers to "Performance, verification and validation testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the provided document details non-clinical bench testing for a device modification, not a study involving human expert reading of data to establish ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the provided document details non-clinical bench testing for a device modification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on non-clinical testing to demonstrate the safety and performance of a device modification and its substantial equivalence to a predicate device. It is not an AI-assisted diagnostic device where human reader improvement would be measured.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This information is not explicitly stated in the context of "algorithm only" performance. The device is a hemodialysis system, and the testing described is for the system's operational parameters (pump rate) and overall safety/performance. It's not a standalone diagnostic algorithm. The non-clinical testing likely evaluated the device's performance in an automated/standalone manner, but the term 'algorithm' may not be directly applicable in the same way as an AI diagnostic.
7. The Type of Ground Truth Used:
For the non-clinical test/performance testing, the "ground truth" would be established by engineering specifications, regulatory standards, and the performance characteristics of the predicate device. The testing aimed to verify that the modified device's performance aligned with these established benchmarks.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a hemodialysis system, and the modification involves a physical parameter (pump rate) and associated software/hardware, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention of a training set for a machine learning model.
§ 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.”