(90 days)
Minntech Corporation's RenaClear™ Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers prior to being reprocessed in an approved dialyzer reprocessing program.
The RenaClear™ Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to an institutions approved dialyzer reprocessing program. The stand-alone countertop system is equipped with two header cleaners that attach to the blood ports of a dialyzer. The header cleaners have a retractable, rotating, directional needle jet that will inject a water/air mixture into the dialyzer header and blood pathway. Simultaneously the dialyzer dialysate compartment and the exterior of the dialyzer fibers will be pressurized water to achieve reverse ultrafiltration.
The operator, through the use of a membrane switch front panel, controls the RenaClear™ Dialyzer Cleaning System. Operators have the following cycle choices: Dialyzer clean, system clean, system sanatize and system rinse.
Here's a breakdown of the acceptance criteria and study information for the RENACLEAR™ DIALYZER CLEANING SYSTEM based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety of the RenaClear™ Dialyzer Cleaning System | The device is stated to be safe. |
| Equivalent performance to the predicate device (Renatron® II Dialyzer Reprocessing System pre-clean cycle) | Functionality testing showed equivalent performance to the predicate device. |
| Material compatibility with chemicals used in the system as specified in the labeling | All materials were tested for compatibility with the chemicals used. |
| Effectiveness in facilitating the cleaning of blood and other debris from multiple-use hollow fiber dialyzers | The device is stated to be effective when used in accordance with labeling. |
| Substantial equivalence to legally marketed predicate devices | The FDA determined the device is substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text 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 states that "Minntech Corporation has performed functional testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
The provided information does not mention using experts to establish ground truth or their qualifications. The evaluation appears to be based on functional testing and material compatibility.
4. Adjudication Method for the Test Set
The provided text does not describe any adjudication method for a test set. This type of detail is typically relevant for studies involving human interpretation or subjective assessment, which doesn't seem to be the primary focus here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size for human reader improvement with or without AI assistance. This type of study is not relevant for a device focused on mechanical cleaning.
6. Standalone (Algorithm Only) Performance Study
The provided text does not describe a standalone (algorithm only) performance study. The device is a physical cleaning system, not a software algorithm.
7. Type of Ground Truth Used
The ground truth for this device's evaluation appears to be based on:
- Functional performance criteria: Showing the system performs its intended cleaning function.
- Material compatibility testing: Verifying that the materials used are suitable for the chemicals involved.
- Comparison to a predicate device: Demonstrating that its performance is equivalent to an already approved device.
There is no mention of expert consensus, pathology, or outcomes data as a ground truth for cleaning efficacy in the provided summary.
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. This concept is typically relevant for machine learning or AI models, which is not the nature of this device.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the establishment of its ground truth is not applicable to this device description.
§ 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.