(122 days)
The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration.
All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
The NxStage System One Low Volume Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter that mounts integrally within the NxStage Cycler.
The provided 510(k) summary for the NxStage System One Low Volume Cartridge Express details non-clinical bench testing to demonstrate substantial equivalence to predicate devices. However, it does not explicitly define specific quantitative acceptance criteria or provide the detailed results of each test in a table format as requested. Instead, it offers a general statement that "All predetermined acceptance criteria were met."
Therefore, I cannot populate a table with specific acceptance criteria and reported device performance directly from the provided text. I can only infer the types of testing performed and the general outcome.
Here's a breakdown of the information that can be extracted based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Integrity of strength between connections (pressure leak testing) | "All predetermined acceptance criteria were met." |
| Priming volume assessment | "All predetermined acceptance criteria were met." |
| Tensile testing of joints and materials of tubing segments | "All predetermined acceptance criteria were met." |
| Tubing clamps testing | "All predetermined acceptance criteria were met." |
| Kink resistance testing | "All predetermined acceptance criteria were met." |
| Hemocompatibility testing | "All predetermined acceptance criteria were met." |
| Pressure drop determination | "All predetermined acceptance criteria were met." |
| Ultrafiltration rates determination | "All predetermined acceptance criteria were met." |
| Clearance determination | "All predetermined acceptance criteria were met." |
| Sieving coefficients testing | "All predetermined acceptance criteria were met." |
| Simulated use testing | "All predetermined acceptance criteria were met." and "suitable for the labeled indications for use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "Performance, verification and validation testing was conducted" and refers to "bench" testing. It does not specify the sample size for any of the tests, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective study design). This appears to be non-clinical, in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The study described is a non-clinical bench test of a medical device (dialysis cartridge), not a study involving expert assessment of patient data or images to establish a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically associated with studies requiring human interpretation or subjective assessment. The tests performed are objective, quantitative bench tests.
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
This section is not applicable. An MRMC study is not mentioned as this submission is for a medical device (dialysis cartridge), not an AI-assisted diagnostic tool or an imaging device requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not directly applicable in the context of an "algorithm only" performance because the device is a physical medical component, not a software algorithm. However, the bench testing conducted can be considered "standalone" in that it evaluates the device's performance independently, without human interaction during the test itself (though humans operate the testing equipment).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests would be the established scientific and engineering principles, material specifications, and regulatory standards for a high permeability hemodialysis system. For instance, for "priming volume assessment," the ground truth would be the accurately measured volume according to standardized procedures. For "pressure drop," the ground truth is the physically measured pressure differential. These are objective physical measurements rather than subjective assessments.
8. The sample size for the training set
This section is not applicable. The device is a physical medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
This section is not applicable as there is no training set for this type of device submission.
§ 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.”