(174 days)
Minntech Corporation's RenaClean™ SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron® Dialyzer Reprocessing System.
The Renaclean SH Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to reprocessing on a Renatron® Dialyzer Reprocessing System. The stand-alone countertop system utilizes ANSI/AAMI quality water and a pre-diluted sodium hypochlorite solution.
The operator, through the use of a membrane switch front panel, controls the Renaclean SH Dialyzer Cleaning System. Operators have the following cycle choices: High Flux dialyzer clean, Low Flux dialyzer clean and System Sanitize.
This device, the RENACLEAN™ SH Dialyzer Cleaning System, is a medical device used to pre-clean dialyzers. The provided text is a 510(k) summary for this device, outlining its description, intended use, and a comparison to a predicate device, as well as the FDA's clearance letter. However, the provided text does not contain detailed acceptance criteria or a comprehensive study plan with specific performance metrics, sample sizes, or ground truth establishment methods typical for AI/ML device evaluations. This submission predates the widespread use of advanced AI/ML in medical devices, and the evaluation relies on functional testing and material compatibility, rather than AI-specific performance metrics.
Based on the information provided, here's a structured response addressing the requested points to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "Minntech Corporation has performed functional testing to show the Renaclean Dialyzer Cleaning System is safe and has equivalent performance with respect to the predicate device." It also mentions "All materials have been tested for material compatibility with the chemicals used in the system as specified in the labeling."
Given the nature of the device (a dialyzer pre-cleaning system) and the submission type (510(k) summary from 2004), the "acceptance criteria" appear to be centered around functional equivalence and material compatibility with the predicate device and specified chemicals. Specific quantitative acceptance criteria are not detailed in the provided documents.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | Demonstrated through functional testing and material compatibility. |
| Equivalent performance to predicate device (Renatron II pre-clean cycle) in cleaning blood/debris from dialyzers prior to reprocessing. | Functional testing performed to show equivalent performance. |
| Material compatibility with chemicals used in the system (ANSI/AAMI quality water and pre-diluted sodium hypochlorite solution). | All materials tested for compatibility as specified in labeling. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the functional testing or material compatibility tests.
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that this is a functional device (a cleaning system) rather than an image analysis or diagnostic AI, the concept of "ground truth established by experts" in the typical AI sense does not directly apply. The evaluation would likely involve engineering and quality control specialists assessing cleaning efficacy and material integrity, but no specific number or qualifications of experts are provided.
4. Adjudication Method for the Test Set
Not applicable to this type of device and evaluation as described. There's no mention of expert review or adjudication in the context of diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided information does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. This type of study is typically associated with diagnostic or image analysis AI/ML devices where human readers interpret data with and without AI assistance. This device is a pre-cleaning system for dialyzers, not a diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the device operates "standalone" in the sense that it performs a pre-cleaning cycle automatically, the concept of "algorithm only without human-in-the-loop performance" as typically discussed for AI/ML devices is not directly applicable. The device's performance is intrinsically linked to its mechanical and chemical processes, not an AI algorithm that makes diagnostic or treatment recommendations. The mentioned "functional testing" would represent the standalone performance of the physical system.
7. Type of Ground Truth Used
For functional testing of a cleaning device, "ground truth" would likely involve objective measurements of cleaning efficacy (e.g., residual blood/debris levels) on dialyzers after the cleaning cycle, compared against established benchmarks or the performance of the predicate device. For material compatibility, it would be material integrity assessments after exposure to chemicals. The specific methodologies are not detailed in the summary.
8. Sample Size for the Training Set
Not applicable. The device is a physical cleaning system, not an AI/ML algorithm that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of 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.