(336 days)
Not Found
No
The description focuses on automated mechanical processes (pumping, flow control, timing) and chemical rinsing, with no mention of AI/ML terms or functions.
No
The device is described as a "four-station rinsing machine for removing formaldehyde, glutaraldehyde or peracetic acid from reused dialyzers," not as a device that directly treats a patient's medical condition. The output of the device (the processed dialyzer) is then used in a therapeutic context, but the device itself is for preparation, not treatment.
No.
The device is described as a "Dialyzer Preparation System" solely for "processing (e.g., in vitro rinsing) of hemodialyzers" to remove germicides. It does not perform any diagnostic function.
No
The device description clearly details a physical machine with hardware components (four-station rinsing machine, tubing pump, front panel, etc.) used for processing hemodialyzers. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely for "processing (e.g., in vitro rinsing) of hemodialyzers." This is a process performed on a medical device (the dialyzer) outside of the human body, but it's not for the purpose of diagnosing a disease or condition.
- Device Description: The description details a machine that rinses germicides from reused dialyzers. This is a preparation step for a medical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status.
- Focus on Device Preparation: The entire description revolves around the process of cleaning and preparing the dialyzer for subsequent use in a medical procedure (hemodialysis).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Seratronics DPS 4 Dialyzer Preparation System is an automatic four-station rinsing machine for removing formaldehyde, glutaraldehyde or peracetic acid from reused dialyzers.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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. This buffering agent. does not introduce new chemicals or higher concentrations of chemicals normally used for dialysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by or on the order of a physician. Care setting is a medical facility that reuses dialyzers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A study was performed to demonstrate the effectiveness of Rinse-Quick concentrate in reducing the rinse times of formaldehyde filled dialyzers.
Following is a table showing the formaldehyde rinse out rate with various dialyzers. The rinse time is different for the various dialyzers, as expected. These data demonstrate that Rinse-Quick concentrate is effective in reducing the rinse time of formaldehyde filled dialyzers as compared to use of RO rinse water alone.
| Dialyzer type | 5 PPM | 1 PPM | ||
|---|---|---|---|---|
| W/O R-Q | W/R-Q | W/O R-Q | W/R-Q | |
| CDAK 90SCE | 31 | 5 | 43 | 13 |
| Renak RE-09 | 27 | 8 | 36 | 13 |
| CDAK 4000 | 52 | 15 | >70 | 35 |
| Clirans C121 | 42 | 9 | 56 | 19 |
| CF 12-11 | 40, est | 9 | 64 | 18 |
| 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.
0
K95 5299
510(k) Summary
This 510(k) summary was prepared on 11/17/95 and submitted by:
Seratronics, Inc. Scott Walker 2637 Shadelands Dr. Walnut Creek, Ca 94598 (510) 295-0200
OCT 21 1996
Contact: Scott Walker
Trade name: DPS 4 Dialyzer Preparation System
Common name: rinse machine
Classification name: none
Changes and amendments made 08/23/1996 by Brooks Rogers at the request of Gema Gonzalez (FDA).
1
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. This buffering agent. does not introduce new chemicals or higher concentrations of chemicals normally used for dialysis.
The rinse times of individual dialyzers can vary significanty, depending on dialyzer type, etc. The germicide concentration may "rebound" if the rinsing process is interrupted due to (de)absorption from the solid components of the dialyzer. The dialyzer must undergo a final prime with sterile saline and flush of the dialysate side in order to bring the dialyzer up to temperature, pH, composition, and complete the final rinse of the dialyzer. It is necessary to test each dialyzer for residual germicide and pH just prior to connection to the patient. This is well known by medical professionals performing reuse and is described in the Operator's Manual.
The original 510(k) for this machine had an integrated analytical system that used a light and photosensor system to automatically determine the level of formaldehyde only in a sample ampule. At this time, we are not distributing the DPS 4 with this capability, and the operating instructions for the analytical capability have been removed (except for a description of the alarm codes, which have been retained for historical purposes). We have no plans at this time to include this feature in the future.
The Operator's manual has been updated from that submitted in the original 510(k).
This machine and accessories described in this submission are substantially equivalent to the device indicated in premarket notification K832230 and to any dialysis machine to the extent that it may be used to rinse germicide or manufacturing residuals from new or reused dialyzers.
There are many articles in the literature relating to germicide removal. The following technical literature is cited:
Man, N. K. Lebkiri, B., Polo, P., Et. Al.: Prevention of Anti-N-Like Antibodies development with Non-formaldehyde Reuse Procedures, Proc Dialy Transpl Forum 10, P 18 - 21, 1980.
Dean, N., Bemis, J. A.: Multiple Use of Hemodialyzers, Final Report to National Institute of Arthritis, Diabetes and Digestive and Kidney Diseases, June 1981.
2
Lewis, K. J.Dewar, P. J., Ward, M. K., Kerr, D. N. S .: Formation of Anti-N-Like Antibodies in Dialysis Patients: Effect of Different Methods of Rinsing to Remove Formaldehyde, Clín Neph 15 (1), P 85 -90, 1981.
Gotch, F. A., Keen, M.L .: Formaldehyde Kinetics in Reused Dialyzers, ASAIO Transactions, 29, p 396 - 401, 1983.
Hakim, R. M., Friedrich, R. A., Lowrie, E. G .: Formaldehyde Kinetics and Bacteriology in Dialyzers, Kidney Int 28, P 936 - 943, 1985.
Held, P. J., Pauly, M. V., Diamond, L.: Survival analysis of patients undergoing dialysis, Journal of the American Medical Association, 257: p 645 - 650, 1987.
Vanholder, R. C., Noens, L., de Smet, R., Ringoir, S.: Development of Anti-N-Like Antibodies during Formaldehyde Reuse in spite of Adequate Predialysis Rinsing, Am J Kidney Dis 11 (6), P 477 - 480, 1988.
CDC: Acute Allergic Reactions Associated with Reprocessed Hemodialyzers -Virginia, MMWR 38 (50):873, 1989.
CDC: Update: Acute Allergic Reactions Associated with Reprocessed Hernodialyzers, MMWR 40 (9):147, 1991.
Alter, M. J., Favero, M. S., Moyer, L. A., Bland, L. A.: National Surveillance of
Dialysis-associated Diseases in the United States, 1989. Transactions of the American Society for Artificial Internal Organs Vol. 37, p 97-109, 1991.
Held, P. J., Wolfe, R. A., Gaylin, D. S., Levin, N. W., Port, K. F., Turenne, M. N., Urban Institute: A Brief Overview of Current Analyses of the Association of Dialyzer Reuse and Patient Outcomes, preliminary report, October 7, 1992.
AAMI: Recommended Practice for Reuse of Hemodialyzers, Arlington VA, Association for Advancement of Medical instrumentation, RD47, 1993.
Tokars, J. L., Alter, M. J., Favero, M. S., et al.: National Surveillance of Dialysis Associated Diseases in the United States, 1991, ASAIO J, 1993 Oct - Dec, 39(4): p 966- 975.
Held, P. J., PhD, Wolfe, R. A., PhD, Gaylin, D. S., BA, Port, F. K., MD, MS, Levin, N. W., MD, Turenne, M. N., BA: Analysis of the Association of Dialyzer Reuse Practices and Patient Outcomes, American Journal of Kidney Diseases, Vol 23, No 5, May, 1994: p 692 - 708.
Straiger, A., Wendenckx, D., Jadoul, M.: Rinsing Time and Disinfectant Release of Reused Dialyzers: Comparison of Formaldehyde, Hypochlorite, Waraxin, and Renalin, American Journal of Kidney Diseases, Vol 26, No 3, September, 1995: 0 549 - 553.
US Code of Federal Regulations, 42 CFR part 405.2150, 1992, amended F.R., Vol 60, Vol 180, Sept. 18, 1995, p 48039 -48044.
3
A study was performed to demonstrate the effectiveness of Rinse-Quick concentrate in reducing the rinse times of formaldehyde filled dialyzers.
Following is a table showing the formaldehyde rinse out rate with various dialyzers. The rinse time is different for the various dialyzers, as expected. These data demonstrate that Rinse-Quick concentrate is effective in reducing the rinse time of formaldehyde filled dialyzers as compared to use of RO rinse water alone.
| Dialyzer type | 5 PPM | 1 PPM | ||
|---|---|---|---|---|
| W/O R-Q | W/R-Q | W/O R-Q | W/R-Q | |
| CDAK 90SCE | 31 | 5 | 43 | 13 |
| Renak RE-09 | 27 | 8 | 36 | 13 |
| CDAK 4000 | 52 | 15 | >70 | 35 |
| Clirans C121 | 42 | 9 | 56 | 19 |
| CF 12-11 | 40, est | 9 | 64 | 18 |
| Bax. C110G | 7 |