(544 days)
The ClearFlux™ Dialyzer Reprocessing System is indicated for the reprocessing of polysulfone-based high-flux dialyzers for reuse, for preprocessing the dialyzers prior to their assignment to patients for first use, and for tracking the reprocessed dialyzer for use only by the patient to whom the dialyzer was initially assigned. The steps used in reprocessing hemodialyzers with the ClearFlux™ System include: (1) pre-cleaning, (2) cleaning, (3) rinsing, (4) volume and leak testing, and (5) disinfecting the dialyzers in accordance with the "AAMI Recommended Practice for Reuse of Hemodialyzers." The ClearFlux™ System performs the patented in-situ two-phase cleaning cycle during reprocessing, which recovers the total cell volume and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers. The ClearFlux™ Dialyzer Reprocessing System is also indicated for performing record keeping of the dialyzer processing operation. The ClearFlux™ Dialyzer Reprocessing System is indicated to be used only with the ClearFlux Formula™ cleaning solution.
The ClearFlux™ Dialyzer Reprocessing System includes hardware and software designed to preprocess dialyzers before their first use by patients, to assign preprocessed dialyzers to patients, and to reprocess the dialyzer for reuse by the same patient to whom the dialyzer was originally assigned. The ClearFlux™ System employs the Novaflux patented two-phase flow cleaning process which is to be used only with the ClearFlux Formula™ (Cleaning Solution) in reprocessing reusable polysulfone-based high-flux dialyzers, and recovers the total cell volume (TCV) and the clearance of small and middle molecules of the dialyzers to levels that are approximately equivalent to those of new dialyzers.
The ClearFlux™ Dialyzer Reprocessing System consists of the following hardware and software components: the ClearFlux™ Machine(s), which performs the actual processing of the dialyzer; the ClearFlux™ Records Management System (CRMS), a patient-dialyzer tracking software loaded onto a System Computer to manage dialyzer reprocessing and reuse; a System Computer; a wireless hub for communication between the ClearFlux™ Machine(s) and the CRMS on the System Computer; a bar code reader to maintain identification of the dialyzers, the ClearFlux™ Machine(s), and the users of the System (e.g., technicians, administrators); a label printer to print the labels for the dialyzers, as well as to print the bar codes for the dialyzers. the users, and the ClearFlux™ Machine(s); a report printer; and an oil-less air compressor with a HEPA filter to provide the filtered airflow necessary for the operation of the ClearFlux™ Machine(s). The ClearFlux™ Dialyzer Reprocessing System (with one System Computer loaded with the CRMS software) can operate and track the dialyzer reprocessing operations of up to 12 ClearFlux™ Machines.
The chemicals used by the ClearFlux™ System include: Peracetic Acid Disinfectant used in the preprocessing and reprocessing of the dialyzers and in the daily and weekly disinfection of the fluid pathways of the ClearFlux™ Machine(s); the ClearFlux Formula™, a proprietary cleaning solution used exclusively in the ClearFlux™ Dialyzer Reprocessing System and in the weekly cleaning of the fluid pathways of the ClearFlux™ Machine(s); and optionally, Formula 409 NF for the weekly cleaning of the fluid pathways of the ClearFlux™ Machine(s).
Here's an analysis of the provided text regarding the ClearFlux™ Dialyzer Reprocessing System's acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a structured table. Instead, it describes general performance goals relative to new dialyzers.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Recovery of Total Cell Volume (TCV) | Recovered to levels that are approximately equivalent to those of new dialyzers. |
| Recovery of Small Molecule Clearance | Recovered to levels that are approximately equivalent to those of new dialyzers. |
| Recovery of Middle Molecule Clearance | Recovered to levels that are approximately equivalent to those of new dialyzers. |
| No adverse effects on dialyzers (e.g., Cytotoxicity, Membrane Integrity) | The ClearFlux™ process does not cause adverse effects on the dialyzers. Supported by tests including Cytotoxicity, Scanning Electron Microscopy, X-Ray Photoelectron Spectroscopy, Size Exclusion Chromatography, Albumin Loss, Hydraulic Permeability, and Pressure Leak. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in the context of typical AI/software studies. The performance claims are based on "in vitro and functional tests." There is no information provided on the sample size (number of dialyzers tested) or the provenance (country of origin, retrospective/prospective) of the data used for these non-clinical performance studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The "ground truth" here refers to objective measures of dialyzer physical and functional characteristics (e.g., TCV, clearance values, integrity). These are established through laboratory assays and instrumentation, not expert consensus.
4. Adjudication Method
This is not applicable as the "ground truth" is established through objective measurements, not subjective expert reviews requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed, nor is it relevant to this device. This device is an automated reprocessing system, not an imaging AI diagnostic aid that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
The entire study described is essentially a standalone performance evaluation of the ClearFlux™ Dialyzer Reprocessing System. The system, through its hardware and software, performs the reprocessing automatically. The "non-clinical performance studies" directly assess the algorithm/system's effectiveness in restoring dialyzer function and not causing adverse effects, without human intervention during the reprocessing itself.
7. Type of Ground Truth Used
The ground truth used is based on objective laboratory measurements and tests of dialyzer performance and integrity. This includes:
- Total Cell Volume (TCV) measurements
- Clearance rates of small and middle molecules
- Tests for adverse effects: Cytotoxicity, Scanning Electron Microscopy, X-Ray Photoelectron Spectroscopy, Size Exclusion Chromatography, Complement Activation, Albumin Loss, Hydraulic Permeability, and Pressure Leak.
- Comparison to "new dialyzers" serves as the reference ground truth for desired performance levels.
8. Sample Size for the Training Set
The document does not specify a training set sample size. This is not a typical machine learning AI model that requires a distinct training set in the sense commonly understood in AI development. The "learning" for this system is embedded in its patented two-phase flow cleaning process and algorithms for controlling machine operations, which would have been developed and refined through engineering and iterative testing, rather than supervised machine learning on a large dataset.
9. How the Ground Truth for the Training Set was Established
Since there isn't a "training set" in the conventional AI sense, there's no ground truth established for it. The development of the ClearFlux™ System's cleaning process and algorithms would have been guided by biomedical engineering principles, understanding of dialyzer function, and iterative testing to optimize the recovery of TCV and clearance while ensuring dialyzer integrity. The effectiveness was then demonstrated through the "non-clinical performance studies" described.
§ 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.