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510(k) Data Aggregation
(184 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 dialysis system consists of an electro-mechanical cycler and a disposable Cartridge Extracorporeal Blood and Fluid Circuit (NxStage Cartridge). The NxStage Cartridge is available with a pre-attached high permeability dialyzer, together referred to as the "NxStage Cartridge Express".
The NxStage Cartridge Express filter is made up of a fiber bundle maintained within a polyethylene terephthalate glycol (PETG) dialyzer housing. The polysulfone fiber bundle is a semipermeable, hollow fiber membrane through which water molecules and smaller molecular weight solutes pass from the blood to the dialysate, but larger molecular weight solutes (such as proteins) do not. Uremic toxins and waste products are removed from the patient's blood by means of diffusion during hemodialysis.
The NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) received a 510(k) clearance (K232803) for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. This device is an updated version of the legally marketed predicate device, NxStage System One with Cartridge Express (K061837). The device is a gamma-sterilized, single-use device, and the dialyzer is provided with the blood pathway sterile and nonpyrogenic.
Here's an analysis of the acceptance criteria and study details:
1. Acceptance Criteria and Reported Device Performance
The submission indicates that performance testing was conducted according to ISO 8637-1 First Edition 2017-11 and the FDA's "Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, August 1998." All testing met predetermined acceptance criteria, demonstrating that the NxStage Cartridge Express is safe and effective for its intended use, similar to the predicate device.
Specifically, key performance indicators for dialyzers are Urea, Creatinine, and Vitamin B12 clearance. The provided table details the in vitro clearance performance data for various blood and dialysate flow rates. Additionally, ultrafiltration rate information is presented for different transmembrane pressures.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Equivalence and Industry Standards) | Reported Device Performance (In Vitro Clearance Data) |
|---|---|---|
| Clearance (mL/min, QUF=0 mL/min) | Must be comparable to or better than the predicate device and meet clinical needs for renal failure treatment. | Specific values are provided for different flow rates: |
| QD=100 mL/min, QB=200 mL/min | ||
| Urea | 100 | |
| Creatinine | 97 | |
| Vitamin B12 | 84 | |
| QD=100 mL/min, QB=300 mL/min | ||
| Urea | 100 | |
| Creatinine | 100 | |
| Vitamin B12 | 92 | |
| QD=100 mL/min, QB=400 mL/min | ||
| Urea | 100 | |
| Creatinine | 99 | |
| Vitamin B12 | 95 | |
| QD=200 mL/min, QB=400 mL/min | ||
| Urea | 195 | |
| Creatinine | 182 | |
| Vitamin B12 | 138 | |
| QD=200 mL/min, QB=500 mL/min | ||
| Urea | 199 | |
| Creatinine | 186 | |
| Vitamin B12 | 143 | |
| Ultrafiltration Rate (Quf in mL/min) | Must be comparable to or better than the predicate device across a range of Transmembrane Pressures (TMP). | Graph provided (Figure 1), showing Quf at various Qb rates (200, 300, 400, 500, 600) across TMP from 0 to 600 mmHg. |
| Structural Integrity | Acceptance of predefined criteria in positive and negative pressure decay testing and blood compartment integrity (membrane integrity). | Testing met predetermined acceptance criteria. |
| Biocompatibility | Meeting ISO 10993-1:2018 standards and no new concerns raised in toxicological risk assessment. | Testing performed to ISO 10993-1:2018 standards, including extractables/leachables, cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility assays. No new biocompatibility concerns were raised. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the "test set" in terms of number of devices or experimental replicates for the performance and structural integrity testing. However, it indicates these were in vitro tests using bovine blood for ultrafiltration rate measurements (Hct. 32%; Total Protein 6 gm/dL; Temperature 37° C). The data provenance is described as in vitro testing. It does not mention any specific country of origin for the data provided from the in-vitro studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The reported performance data appears to be based on objective, quantitative in vitro measurements, not on expert assessment of images or interpretations that would require a "ground truth" established by experts.
4. Adjudication Method for the Test Set
Not applicable, as this was not an expert-based subjective assessment.
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 hardware/disposable (dialysis cartridge), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the objectively measured values from the in vitro performance and structural integrity tests of the dialyzer (e.g., measured clearance rates of specific molecules, ultrafiltration rates, integrity test results). Biocompatibility was assessed against established ISO standards.
8. The Sample Size for the Training Set
Not applicable. This device is hardware and does not utilize a "training set" in the sense of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated above.
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(90 days)
The NxStage System One is indicated for treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. All treatments must be administered by a health care provider, under physician's prescription.
The NxStage System One consists of the NxStage Cycler and the NxStage Cartridge Extracorporeal Blood and Fluid Circuit. The NxStage Cycler is an electro-mechanical device that interfaces with the NxStage Cartridge. The NxStage Cartridge is a single-use extracorporeal blood circuit and fluid management device that mounts integrally within the NxStage Cycler. The NxStage Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollowfiber filter.
The provided text describes the NxStage System One with Cartridge Express, a device intended for the treatment of renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration. However, the document does not contain the detailed information necessary to complete all sections of the request, particularly regarding specific acceptance criteria, a dedicated study proving performance against those criteria, sample sizes for test and training sets, expert qualifications, or details about comparative effectiveness studies.
Here's a summary of the information that can be extracted and a note on what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific numerical acceptance criteria or detail the reported device performance against such criteria. It generally states that "Performance testing was conducted to characterize the performance of the NxStage Cartridge Express during hemodialysis to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the NxStage Cartridge Express is substantially equivalent to the predicate devices and is suitable for the labeled indication for use."
Therefore, a table cannot be constructed with specific criteria or performance metrics from the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Performance testing" but does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with or without AI assistance. The device in question is a medical device (dialyzer system), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an electro-mechanical system for treating renal conditions, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this device described in the document.
7. The Type of Ground Truth Used
The document indicates that performance testing was conducted to demonstrate "substantial equivalence to the predicate devices" and "suitability for the labeled indication for use." This implies that the "ground truth" or reference for evaluating the device's performance was based on the performance characteristics of its predicate devices, rather than an independent gold standard like pathology or long-term outcomes data, as would be typical for a diagnostic device.
8. The Sample Size for the Training Set
The document does not mention a training set, as the device is not an AI/machine learning model that undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this information is not applicable or provided.
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