(76 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 NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home. 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; the NxStage Cartridge, a sterile, single-use extracorporeal blood and fluid management circuit (with or without a preattached high permeability filter) that mounts integrally within the NxStage Cvcler. The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. The NxStage System One is also indicated for hemodialysis with or without ultrafiltration in the home.
The provided text describes a 510(k) premarket notification for the NxStage System One, a hemodialysis system. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with new acceptance criteria and performance data.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily compares technological characteristics to a predicate device (K122051). While it mentions "predetermined acceptance criteria was met" for performance, it does not explicitly list the acceptance criteria or specific performance values for the new device against those criteria in a table format. Instead, it largely states that the proposed device has "Same" characteristics as the predicate or lists the predicate's specifications as a de facto benchmark.
Therefore, a table that perfectly fits the request cannot be generated from the given information because the specific acceptance criteria values for the current submission's device are not enumerated, nor are detailed "reported device performance" values presented for novel criteria. The comparison is mainly a feature-by-feature match to the predicate.
However, based on the provided "Technological Characteristics Comparison Table," we can infer the "acceptance criteria" were essentially "to match or be equivalent to the predicate device's specifications."
| Parameter | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Intended Use | Hemodialysis, Hemofiltration, Ultrafiltration | Yes |
| Pumps | 4 peristaltic pumps | Same |
| Valves (Clamps) | 2 solenoid actuated pinch clamps, 8 cam driven pinch clamps | Same |
| Air / Fluid Detectors | 3 ultrasonic air/fluid detectors | Same |
| Blood Leak Detector | 1 optical blood leak detector | Same |
| Pressure Transducers | 5 electronic pressure transducers | Same |
| Temperature Sensors | 1 electronic temperature sensor | Same |
| Blood Flow Rate | 10-600 ml/min | Same |
| Prescription Fluid / Dialysate Flow | 0-18000 ml/hr (NX1000-3) | 0-18000 ml/hr (NX1000-4) |
| Ultrafiltration Flow | 0-2400 ml/hr | Same |
| Transmembrane Pressure Monitoring | Yes | Same |
| Venous Pressure Monitor | 0 to 400 mmHg | Same |
| Effluent fluid Pressure Monitor | 0 to 500 mmHg | Same |
| Air Detector Sensitivity | Reduction of detector signal lasting 6 ms minimum (Approximates a 60 micro liter bubble at 400 mmHg venous pressure and 600 ml/min blood flow) | Same |
| Blood Leak Detector Sensitivity | 15% reduction in detector signal lasting 20 seconds minimum. Signal reduction % based on a 0.45 ml/min leak rate of 32 Hct blood. | 15% reduction in detector signal lasting 20 seconds minimum. Signal reduction % based on a 0.35 ml/min leak rate of 32 Hct blood. |
| Effluent Volume Accuracy (sw 4.8+) | Greater of 300 ml/ 12 hr or 3% of exchange volume; Therapy Fluid Flow Rate L/hr) Specification greater of > 3 ±100 ml/hr* + 5% UF* or ≤ 3 ± 25 ml/hr* | Same |
| IV Prescription Fluid | Off-line, sterile- physician prescribed, indicated for infusion | Same |
| Dialysate | Dialysate available as pre-packaged pre-mixed sterile fluids or via the PureFlow SL (K043436 K060296, K090919 & K111174) | Same |
| Compatible Blood Tubing Set | NxStage Standard Cartridge | Same |
| Software Version | Software version 4.8 | Software version 4.9 |
Note: The Blood Leak Detector sensitivity for the proposed device cites 0.35 ml/min leak rate compared to the predicate's 0.45 ml/min. This appears to be a slight improvement in sensitivity, meaning it can detect smaller leaks, which would meet or exceed the predicate's performance.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance, verification and validation testing was conducted" and that "Results of this testing have documented that the proposed NxStage System One is substantially equivalent." However, it does not provide any specific sample sizes for test sets or details about data provenance (e.g., country of origin, retrospective/prospective). The study appears to be entirely bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. Given that the submission is focused on demonstrating substantial equivalence through bench testing, it is unlikely that "experts" were used in the way one might for clinical ground truth establishment (e.g., radiologists interpreting images).
4. Adjudication Method for the Test Set:
This information is not provided. Again, this is a bench testing submission, so adjudication methods typical for clinical studies would not apply.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or conducted. The submission is not about human reader performance with or without AI assistance but rather about the technical specifications and safety of a medical device (hemodialysis system).
6. Standalone (Algorithm Only) Performance Study:
Since this is a physical medical device (hemodialysis system) with software components, not an AI algorithm for interpretation, the concept of a "standalone" or "algorithm-only" performance study in an AI context does not apply in the traditional sense. The device's performance relies on the integrated electromechanical control unit and cartridge. The software functionality itself was presumably validated as part of the overall device's performance testing (e.g., software version 4.9 compared to 4.8).
7. Type of Ground Truth Used:
The "ground truth" for this submission appears to be engineering specifications and performance standards for the hemodialysis system components and overall function, as established and validated during the design and testing phases. This is evidenced by the detailed comparison of parameters like flow rates, pressure monitor ranges, and detector sensitivities.
8. Sample Size for the Training Set:
This information is not provided. This device is not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. Its functionality is based on pre-programmed parameters and electromechanical design, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
As this is not an AI/ML device that undergoes "training," this question is not applicable. The "ground truth" for its design and operation would be based on established medical and engineering principles, regulatory requirements, and the performance of the predicate 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.”