(296 days)
The CLIRANS® T-Series Hollow Fiber Dialyzers are devices used as part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. This device is indicated for single and multiple use.
The CLIRANS® T-Series Hollow Fiber Dialyzers consists of cellulose hollow fibers with 9μ wall thickness. Blood is pumped via a roller pump from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers waste products pass through the membrane of the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.
The CLIRANS® T-Series Hollow Fiber Dialyzers demonstrate substantial equivalence in performance to the predicate device, the CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The performance criteria are focused on the device's ability to clear various substances from the blood and its ultrafiltration rate.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (relative to predicate CL*M151L) | Reported Device Performance (CLIRANS® T-Series) |
|---|---|---|
| Urea Clearance | Substantially Equivalent | "somewhat higher clearance" than M151L |
| Creatinine Clearance | Substantially Equivalent | "somewhat higher clearance" than M151L |
| Phosphates Clearance | Substantially Equivalent | "somewhat higher clearance" than M151L |
| Vitamin B12 Clearance | Substantially Equivalent | "somewhat higher clearance" than M151L |
| UFR (In Vitro & In Vivo) | Substantially Equivalent | "somewhat higher...UFR" than M151L |
| Priming Volume | Substantially Equivalent | Values (101ml, 120ml, 148ml for T-Series models) are similar to M151L (115ml) |
Study that Proves the Device Meets the Acceptance Criteria:
The device's performance was evaluated through a comparative study against the predicate device, the CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L), cleared under 510(k) K854280. The study focused on demonstrating "substantial equivalence" rather than absolute performance thresholds.
Noteworthy findings: The T-Series dialyzers exhibited "somewhat higher clearance and UFR" compared to the M151L, which the submission states is "to be expected with the thinner fiber walls in the T-Series dialyzer." Importantly, the document concludes that "none of the data raises any issues of safety or effectiveness," thus supporting the claim of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the performance tests (e.g., number of dialyzers tested for each metric). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified. These are likely in-house laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The study is a laboratory-based comparative performance test of physical devices, not an assessment requiring expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set:
This information is not applicable, as the tests were performance measurements of the device itself, not clinical outcomes requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of an AI system on human clinical interpretation, which is not relevant for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical device (a dialyzer), not a software algorithm or AI system. Its "performance" refers to its physical characteristics and capabilities in a dialysis system.
7. The Type of Ground Truth Used:
The "ground truth" for this study is the established performance characteristics of the legally marketed predicate device, the CLIRANS® TAF Hollow Fiber Dialyzer (CL*M151L). The performance metrics (clearance for various substances, UFR, priming volume) of the new device were compared directly against those of the predicate device to establish substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not a machine learning device.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.