Search Results

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.

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.

Ask a specific question about this device