(336 days)
This device is intended solely for processing (e.g., in vitro rinsing) of hemodialyzers. Any subsequent clinical use of the dialyzer processed by this machine is the sole responsibility of the patient's physician.
The Seratronics DPS 4 Dialyzer Preparation System is an automatic four-station rinsing machine for removing formaldehyde, glutaraldehyde or peracetic acid from reused dialyzers. Dialyzers are stored filled with the germicide and with the venous and arterial blood ports connected by a filled tubing segment that includes a sample site. This provides a blood side circuit that can be recirculated while the germicide is removed by the process of diffusion across the membrane. The system removes the germicide from the dialyzer by delivering AAMI quality (RD5. 1992) water to the dialysate side of the dialyzer at a controlled temperature and flow rate while the blood side fluid is recirculated by a tubing pump. The germicide is diffused from the blood compartment of the dialyzer to a final concentration prescribed by the physician. The blood side of the dialysis circuit is never opened during the rinsing process on the DPS 4 rinse machine. At a predetermined time in the recirculation cycle (selected on the front panel), an alarm sounds, indicating that the rinse time has been completed. The blood and dialysate side flow continue when this end-of-cycle alarm occurs. A proprietary buffering agent, RINSE-QUICK concentrate, can be added to the rinse solution to reduce rinse out times with formaldehyde only.
The provided text describes the Seratronics DPS 4 Dialyzer Preparation System, an automatic four-station rinsing machine for removing germicides (formaldehyde, glutaraldehyde, or peracetic acid) from reused dialyzers. The core of the submission focuses on demonstrating the effectiveness of a proprietary buffering agent, RINSE-QUICK concentrate, in reducing formaldehyde rinse-out times.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the DPS 4 system itself in terms of numerical thresholds that must be met for device approval. Instead, the study aims to demonstrate the effectiveness of the Rinse-Quick concentrate in reducing rinse times to achieve physician-prescribed final germicide concentrations.
The "acceptance criteria" can be inferred as the ability to reduce germicide (specifically formaldehyde) to a safe level, which is then verified by a manual test by medical professionals prior to patient connection. The reported performance is the reduction in rinse time with the use of Rinse-Quick concentrate compared to rinsing with RO water alone.
| Characteristic | Acceptance Criteria (Inferred) | Reported Device Performance (with Rinse-Quick) |
|---|---|---|
| Germicide Removal Efficacy | Reduce germicide to a "final concentration prescribed by the physician" | Significantly reduces rinse time for formaldehyde to reach 5 PPM and 1 PPM in various dialyzer types. (See detailed data below) |
| Safety | Device operates without introducing harm to user or patient, and does not negatively impact dialysate quality. | Claims the buffering agent "does not introduce new chemicals or higher concentrations of chemicals normally used for dialysis." Multiple warnings and cautions regarding safe operation and post-rinse testing are provided, emphasizing physician responsibility for final verification. |
| Functionality | Automated rinsing of dialyzers. | Performs automatic four-station rinsing with controlled temperature and flow rate; recirculates blood-side fluid. |
Detailed Reported Device Performance for Formaldehyde Rinse-out Rate (with Rinse-Quick concentrate):
| Dialyzer type | Approximate Rinse Time (min) to achieve 5 PPM | Approximate Rinse Time (min) to achieve 1 PPM |
|---|---|---|
| Without R-Q | With R-Q | Without R-Q |
| CDAK 90SCE | 31 | 5 |
| Renak RE-09 | 27 | 8 |
| CDAK 4000 | 52 | 15 |
| Clirans C121 | 42 | 9 |
| CF 12-11 | 40 (est) | 9 |
| Bax. C110G | 7 |
§ 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.