(267 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 care facility.
The NxStage Cartridge Express with Speedswap is an optional accessory device to be used exclusively with the NxStage System One for facilitating the removal and replacement of a flow-compromised filter during to acute and chronic renal failure or fluid overload. The device would be used when hemodialysis, and /or ultrafiltration may become disrupted.
All treatments must be administered under a 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 Cartridge Express with Speedswap is a single use extracorporeal blood circuit and fluid management device with a pre-attached detachable high permeability hollow-fiber. The proposed feature, "Speedswap" is a feature in the cartridge design that will allow the user to exchange the filter that is becoming clotted or clogged with a new filter that has been manually primed.
A kit will be required to perform the filter exchange. The proposed optional kit will consist of a filter with tubing connections for manual priming along with a waste bag to collect used saline. The nurse has the option of using the proposed cartridge without using the Speedswap feature. The functionality of the proposed cartridge is the same as the predicate Cartridge. Exchanging a used filter is optional and the facility can choose to dispose of the entire cartridge instead of exchanging the Filter.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: NxStage Cartridge Express with Speedswap
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific, quantitative performance acceptance criteria with numerical targets. However, the testing performed implicitly aims to meet the regulatory and safety standards expected for such a device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence | The NxStage Cartridge Express with Speedswap has the same intended use and utilizes the same fundamental scientific technology as the identified predicate (NxStage System One Cartridge Express, K061837). It is substantially equivalent in design, function, and operation to the predicate. |
| Safety - Manufacturing | Cartridge Integrity: Passed Cartridge Pressure Leak Test and Solvent bond tensile tests. |
| Sterilization: Gamma sterilization at 10-6 SAL, same as predicate. | |
| Safety - Use | Biocompatibility: Passed Cytotoxicity, Guinea Pig Sensitization, Rabbit Intracutaneous Reactivity, USP Rabbit Pyrogen, Bacterial Reverse Mutation, Genotoxicity (Mouse Lymphoma), Hemocompatibility (Coagulation and Hematology), ASTM Hemolysis, ASTM Partial Thromboplastin Time, SC5b-9 Complement Activation, Chemical Characterization, Chronic Toxicity, Carcinogenicity. All tests performed to support safety of valve connectors. |
| Simulated Use: Demonstrated performance in a simulated use environment. | |
| Kink Resistance: Passed Kink Resistance Test. | |
| Waste Bag Integrity: Passed Waste Bag Integrity test. | |
| Performance - General | System and Subsystem Performance: Performed. |
| Blood Line Priming Volume: Assessed. | |
| Chemical Resistance: Passed Disposable Component Chemical Resistance Test. | |
| Usability/ Human Factors | Human Factors Validation (Summative Evaluation): Critical tasks associated with Speedswap features were evaluated. Results, coupled with post-evaluation risk analysis, indicate the device is safe and effective for intended users, uses, and use environments. |
| Shipping/Durability | Ship Testing: Performed. |
| Overall Verification & Validation | All testing passed, confirming the device performs according to product specifications and meets predetermined acceptance criteria. Any new risk control measures or usability requirements were traced to requirements and verified. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for the individual performance, biocompatibility, or human factors tests. It refers to "testing" and "studies" but doesn't quantify the number of units or participants.
The data provenance is industrial testing, likely conducted in a laboratory setting by the manufacturer (NxStage Medical, Inc. in Lawrence, MA), and is therefore considered retrospective to the submission date. There is no information about country of origin for specific test data beyond the manufacturer's location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This type of information is not applicable to the studies described. The "ground truth" here is based on engineering specifications, regulatory standards (e.g., ISO, ASTM), and established biological/chemical safety protocols, rather than expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective measurements against defined criteria (e.g., pass/fail for leak tests, adherence to ISO standards, or clear results for biocompatibility). There is no ambiguity or subjective interpretation that would require an adjudication method.
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:
Not applicable. This device is a medical accessory for a hemodialysis system, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies related to human reader performance with or without AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the various tests relies on established scientific principles, engineering standards, and regulatory guidelines:
- Engineering Specifications: For integrity, kink resistance, priming volume, chemical resistance, and system performance.
- International Standards (e.g., ISO 8638:2010): For performance testing.
- Biocompatibility Standards (e.g., ISO 10993 series implicitly): For cytotoxicity, sensitization, reactivity, pyrogenicity, genotoxicity, hemocompatibility, etc.
- Risk Analysis and Usability Engineering Principles: For human factors validation.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML product that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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.”