(222 days)
Asahi AM-R Series Dialyzers are intended for use for hemodialysis treatment of patients who have chronic renal failure or acute renal failure.
Asahi AM-R Series Dialyzers have been tested in vitro and in confirmatory clinical studies under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi AM-R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi AM-R Series Dialyzers have not been tested for reuse when reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended.. Accordingly:
- (1) The reprocessed dialyzer may be used only if the residual Total Cell Volume (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of the instructions for use and the instructions of the reprocessing system utilized. Furthermore, the policies, instructions and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
- (2) The reprocessing agent may be either (1) 4% formaldehyde (also known as formalin ) in conjunction with the Seratronics Reprocessing Systems for Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), manufactured by Seratronics, Inc., or (2) Renalin® in conjunction with the Renatron® Dialyzer Reprocessing System, manufactured by Renal Systems, Inc.
- The instructions provided by the manufacturer of the chosen reprocessing (3) agent must be followed in reprocessing the dialyzer.
- The reprocessed dialyzer may be used only on dialysis systems equipped with (4) volumetric ultrafiltration controllers.
The AM-R Series Dialyzers are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The performance of these dialyzers, when new for single or initial (first) use and when reprocessed for reuse, have been documented through laboratory (in vitro) testing and confirmatory clinical testing. Assahi AM-R Series Dialyzers are constructed of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer. Asahi AM-R Series Dialyzers are sterilized before shipment by gamma radiation (y-rays). The dialyzer is no longer sterile after its sterile package is opened for the initial (first) use.
This document describes the Asahi AM-R Series Dialyzers and their approval for reuse after reprocessing. The acceptance criteria and supporting studies are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Residual Total Cell Volume (TCV) | At least 80% of the original TCV after reprocessing for up to 15 cycles. |
| Biocompatibility | Pass: Cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and pyrogenicity after 15 reuse cycles. |
| Ultrafiltration Coefficient (Kuf) | Maintained after reprocessing with formalin/Renalin for up to 15 cycles. |
| Clearances (Urea, Creatinine, Vitamin B12) | Maintained after reprocessing with formalin/Renalin for up to 15 cycles. |
| Removal Rates (Urea, Creatinine, Albumin) | Maintained after reprocessing with formalin/Renalin for up to 15 cycles. |
| Dialyzer leakage or damage | No unacceptable leakage or damage reported, to be followed by institutional policies. |
| Residual blood | Institutional policies regarding residual blood should be followed. |
| Reprocessing Agent | 4% Formaldehyde (Formalin) with Seratronics DRS4™/DPS4™ OR Renalin® with Renatron® Dialyzer Reprocessing System. |
| Reprocessing System Manufacturer Instructions | Manufacturer instructions for the chosen reprocessing agent must be followed. |
| Dialysis System Compatibility | Must be used only on dialysis systems equipped with volumetric ultrafiltration controllers. |
2. Sample Size Used for the Test Set and Data Provenance
- Non-clinical (In Vitro) Testing:
- Biocompatibility: The largest model (AM-R-90U) was subjected to 15 reprocessing cycles.
- Performance (Kuf, Urea, Creatinine, Vitamin B12 clearances): The smallest model (AM-R-50M) and the largest model (AM-R-90U) were tested in vitro for initial use and up to 15 reuse cycles. Outdated human blood from a blood bank was used.
- Clinical Testing:
- The largest model (AM-R-90U) was tested in confirmatory clinical studies for initial use and up to 15 reuse cycles.
- Sample Size: Minimum of 12 patients enrolled at each of two clinical sites. A minimum of 50% of these patients reused the dialyzer 15 times.
- Data Provenance: The study was a prospective clinical study conducted at two clinical sites that utilized both formalin and Renalin® reprocessing agents. The country of origin of the data is not explicitly stated, but it refers to typical US dialysis practices and FDA guidance, suggesting a US context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the clinical studies. However, it mentions that "dialysis sessions were conducted and patients were managed in accordance with established dialysis practices for the respective institutions," implying that qualified medical professionals (e.g., nephrologists, dialysis nurses) were involved in managing patient care and assessing outcomes.
4. Adjudication Method for the Test Set
The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the test set. Clinical outcomes were assessed by comparing reprocessed device performance against initial use performance within each patient, following established clinical protocols at the participating institutions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The study focuses on the device's performance with and without reuse, not on the improvement of human readers with AI assistance, as this is a medical device (dialyzer) and not an AI diagnostic tool.
6. Standalone Performance
A standalone performance evaluation was conducted in both non-clinical (in vitro) and clinical settings. The device's performance metrics (biocompatibility, ultrafiltration coefficient, clearances, and removal rates) were measured directly, independent of human interpretation beyond typical clinical monitoring.
7. Type of Ground Truth Used
- Non-clinical (In Vitro) Testing:
- Biocompatibility: Standardized laboratory tests for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemocompatibility, and pyrogenicity, which have established scientific ground truths.
- Performance (Kuf, Urea, Creatinine, Vitamin B12 clearances): In vitro measurements using outdated human blood, with ground truth established by laboratory analytical methods.
- Clinical Testing:
- Performance (Kuf, Urea, Creatinine, Albumin removal rates): In vivo measurements in patients with chronic renal failure or acute renal failure. The "ground truth" for clinical performance was the patient's own initial dialysis session results, serving as a baseline for comparison with subsequent reused sessions. Outcome data included physiological measurements and patient stability.
8. Sample Size for the Training Set
The document does not explicitly describe a separate "training set" in the context of machine learning, as this is a medical device (dialyzer) evaluation, not an AI model development. The reported studies evaluate the device's performance directly.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the machine learning sense, this question is not applicable to the information provided. The evaluations are direct performance assessments of the dialyzer, not data used to train an algorithm.
§ 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.