(437 days)
The single use blood tubing set with pre-attached dialyzer is indicated for use with the B. Braun Dialog Series hemodialysis systems for the treatment of acute and chronic renal failure. There are no known contraindications.
The proposed device provides for the treatment of acute or chronic renal failure when used with the commercially available B. Braun Dialog Series hemodialysis systems. The device is a single use blood tubing set pre-attached to a high flux (permeability) hollow-fiber dialyzer.
The provided document is a 510(k) Premarket Notification Submission for the NxStage Blood Tubing Set with Pre-Attached Dialyzer. It focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.
Here's the breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission broadly states that performance, verification, and validation testing was conducted in accordance with the "Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions" guidance document issued on April 23, 2008.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined acceptance criteria from the "Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions" guidance document (April 23, 2008) | "the predetermined acceptance criteria was met" and "Results of this testing have documented that the proposed device is equivalent to the predicate devices and is suitable for the labeled indication for use." |
Note: The document does not provide specific numerical acceptance criteria (e.g., burst pressure, flow rates) or detailed numerical results for the device's performance. It only offers a general statement that the criteria were met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Performance, verification and validation testing" without detailing the study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the submission. The testing described is non-clinical bench testing, not a clinical study involving expert assessment of patient data.
4. Adjudication Method for the Test Set
This information is not applicable and is not provided in the submission, as the testing described is non-clinical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or conducted. The submission is for a medical device (blood tubing set with dialyzer) and focuses on non-clinical performance and substantial equivalence, not a diagnostic AI algorithm that would involve human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable, as the device is a physical medical device (blood tubing set with dialyzer), not an AI algorithm.
7. Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be established by the specified test methods and accepted industry standards outlined in the referenced FDA guidance document for hemodialysis blood tubing sets. Compliance with these physical and functional specifications serves as the ground truth for evaluating the device's performance.
8. Sample Size for the Training Set
This is not applicable, as the device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as the device is a physical medical device, not an AI algorithm.
§ 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.”