(121 days)
The NxStage TPE Cartridge is indicated for use only with the NxStage System One for therapeutic plasma exchange in a clinical environment. 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 TPE Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device available without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available Therapeutic Plasma Exchange filter such as such as the Asahi Plasmaflo OP-05W (A) wet filter (PMA P820033 S005 approved on March 16, 2010).
The provided document describes the NxStage Therapeutic Plasma Exchange (TPE) Cartridge and its path to 510(k) clearance. The focus of the study is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through a comparative effectiveness study involving human readers or standalone AI performance.
Therefore, many of the requested categories are not applicable to this submission.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method (Acceptance Criteria) | Reported Device Performance (Result) |
|---|---|
| Pressure leak testing demonstrating the blood tubing can withstand pressures up to 1.5 times the maximum labeled positive and negative pressures | Pass – Results within acceptance criteria |
| Endurance testing of pump segment at maximum labeled blood flow rates and pressures | Pass - Results within acceptance criteria |
| Endurance testing under both positive and negative pressures of any injection ports (if applicable) using the largest recommended gauge needle identified in the labeling | Pass - Results within acceptance criteria |
| Priming volume assessment | Pass - Results within acceptance criteria |
| Tensile testing of joints and materials of all tubing segments | Pass - Results within acceptance criteria |
| The ability of pressure transducers to withstand leakage when subject to pressures up to 2 times the maximum labeled pressure e.g. “strikethrough” | Pass – Results within acceptance criteria |
| Performance testing to evaluate the ability of tubing to resist kinking after repeated clamping, particularly in the post-pump tubing segment | Pass – Results within acceptance criteria |
| Performance testing of the device's clamps to demonstrate that they can successfully occlude blood tubing | Pass – Results within acceptance criteria |
| Hemocompatibility (i.e., mechanical hemolysis) for new or significantly altered hemodialysis tubing design that affects the pattern of blood flow | Pass – Results within acceptance criteria |
| Structural integrity testing on gamma sterilized and thermally stressed samples. ISTA 2A ship testing (Packaging Qualification) | Pass – Results within acceptance criteria |
| Biocompatibility (Cytotoxicity) | Conclusion: Substantially equivalent |
| Biocompatibility (Hemolysis) | Conclusion: Substantially equivalent |
| Biocompatibility (USP Physicochemical) | Conclusion: Substantially equivalent |
| Biocompatibility (FTIR) | Conclusion: Substantially equivalent |
2. Sample size used for the test set and the data provenance
The document specifies "The following tables outline the testing performed on the CAR-510-C to support the determination of substantial equivalence to the predicate device." However, specific sample sizes for each test within the performance and functional tables (Table 2 and Table 3) are not explicitly stated. The testing described appears to be laboratory-based engineering and material testing, not patient data trials. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in the context of this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This point is not applicable. The "ground truth" for the tests described relates to engineering specifications and material properties, not diagnostic interpretations from experts. The testing involved measuring physical properties and verifying performance against predefined technical requirements.
4. Adjudication method for the test set
This point is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving expert interpretation of medical images or patient outcomes. The tests in this document are technical performance evaluations.
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 point is not applicable. This submission is for a medical device (a TPE Cartridge) and is not an AI/CADe/CADx device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. This device is a Therapeutic Plasma Exchange Cartridge, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the various performance and functional tests (e.g., pressure leak, endurance, tensile strength, priming volume, hemocompatibility, packaging integrity) was based on pre-defined engineering specifications, regulatory standards, and manufacturing tolerances. For biocompatibility, it was based on accepted biological evaluation standards (ISO 10993).
8. The sample size for the training set
This point is not applicable. This device does not involve a training set as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
This point is not applicable for the same reason as point 8.
§ 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.”