Inpersol Cycler 1000
by Abbott Laboratories 510(k)
Active
510(k) K845042
Overview
The Inpersol Cycler 1000 is an automatic peritoneal dialysis delivery system designed for continuous or intermittent peritoneal dialysis. It automates the infusion, dwell, and drainage cycles of dialysate to facilitate fluid exchange and waste removal in patients with renal failure.
This device is intended for use in clinical settings, such as hospitals or dialysis centers, and is regulated under FDA 510(k) clearance (K845042). It operates as a reusable medical system under Class II special controls, adhering to regulatory standards for peritoneal dialysis equipment. No additional sterility or MRI safety information is specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK845042 | Date19 Mar 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Abbott Inpersol Cycler 1000
- 510(k) Number
- FDA Product Code
- FKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5630
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What clinical settings is the Abbott Inpersol Cycler 1000 designed for, and how does it differ from manual peritoneal dialysis methods?
The Abbott Inpersol Cycler 1000 is specifically designed for use in clinical settings like hospitals or dialysis centers, where automated peritoneal dialysis is required. Unlike manual methods, it automates the entire process of fluid exchange—infusing dialysate, maintaining dwell time, and draining waste—reducing the need for constant manual intervention. This automation helps improve consistency, efficiency, and patient comfort during continuous or intermittent peritoneal dialysis for renal failure patients.
Is the Inpersol Cycler 1000 a single-use or reusable device, and what does that mean for maintenance and cost?
The Inpersol Cycler 1000 is a reusable medical system, meaning it is designed for repeated use in clinical environments after proper cleaning, disinfection, and maintenance. This approach reduces per-patient costs compared to single-use devices and aligns with the device’s regulatory classification as a reusable Class II medical system. However, facilities must follow manufacturer guidelines for reprocessing to ensure safety and functionality.
What types of peritoneal dialysis cycles can the Inpersol Cycler 1000 perform, and how does it support patient treatment flexibility?
The Inpersol Cycler 1000 is designed to automate both continuous and intermittent peritoneal dialysis cycles, allowing clinicians to tailor treatment to patient needs. For continuous cycles, it maintains steady fluid exchange over time, while for intermittent cycles, it handles precise infusion, dwell, and drainage phases. This versatility supports flexible treatment regimens for patients with renal failure.
How is the device regulated in the U.S., and what does the FDA clearance (K845042) indicate about its safety and performance?
The Inpersol Cycler 1000 holds FDA 510(k) clearance (K845042), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the FDA has reviewed its design, manufacturing processes, and performance data to confirm it meets regulatory standards for safety and effectiveness as an automatic peritoneal dialysis delivery system. The clearance was granted under the Gastroenterology and Urology (GU) advisory committee and falls under Class II special controls for peritoneal dialysis equipment.
Are there multiple models or configurations of the Inpersol Cycler 1000, and how might a facility determine the right one for their needs?
The provided data lists multiple FEI numbers (e.g., 3030306055, 1721676) associated with the Inpersol Cycler 1000, which may correspond to different product codes (FKX) or configurations. While exact specifications aren’t detailed here, these identifiers suggest variations in software, connectivity, or compatibility with dialysis solutions. Facilities should consult Abbott Laboratories or their distributor to match the device’s features (e.g., cycle automation, connectivity options) with their clinical workflow and patient volume requirements.