WAVES Kidney Perfusion System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111521 FDA 510(k)
- FDA Product Code
- KDN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WAVES Kidney Perfusion System is a perfusion device designed for kidney preservation. It maintains organ viability through controlled perfusion, enabling extended storage and transport of kidneys for transplantation. This system supports both ex vivo kidney perfusion, ensuring optimal graft condition before implantation.
The device consists of a control unit, a disposable WCM cassette, and remote monitoring software. It is intended for single-use and includes backup systems for ice/water and battery power. The WAVES system operates in clinical settings such as transplant centers and is regulated under FDA 510(k) clearance (K111521). Sterility and regulatory compliance are ensured through the disposable cassette design and manufacturer-authorized procedures.
Frequently asked questions
What clinical settings is the WAVES Kidney Perfusion System intended for use in?
The WAVES Kidney Perfusion System is designed specifically for transplant centers, where it supports ex vivo kidney perfusion to maintain organ viability during extended storage and transport before transplantation. Its controlled perfusion technology ensures optimal graft condition, making it ideal for high-volume transplant facilities.
Is the WAVES system reusable, or is it meant for single-use only?
The WAVES system is intended for single-use, with the disposable WCM cassette serving as the sterile component. This design ensures sterility and regulatory compliance while minimizing the risk of cross-contamination between procedures.
What backup systems does the WAVES Kidney Perfusion System include to ensure uninterrupted operation?
The WAVES system includes backup systems for both ice/water and battery power, ensuring continuous perfusion even if primary power or cooling sources fail. This redundancy is critical for maintaining organ viability during transport or storage.
How is the sterility of the WAVES Kidney Perfusion System maintained?
Sterility is maintained through the use of a disposable WCM cassette, which is designed as a single-use component. The manufacturer-authorized procedures further ensure compliance with regulatory standards, reducing the risk of contamination between uses.
What regulatory pathway was followed for the WAVES Kidney Perfusion System, and what does this mean for its use?
The WAVES system was cleared through the FDA’s 510(k) pathway (K111521) under a *Substantially Equivalent* determination, meaning it was deemed comparable to a legally marketed predicate device. This clearance confirms its compliance with FDA requirements for safety and effectiveness in kidney preservation applications, though it does not imply any specific clinical indication beyond what the manufacturer states.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Waters Medical Systems, Waters Medical Systems WAVES Instruction Manual: AI Chat & PDF Access ..., About Us - Waters Medical Systems, Waters Medical Systems, Llc 3900042.000 Waves Control Unit
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111521 | Class II | Active |
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Manufacturer
- Manufacturer
- Waters Medical Systems, LLC
Sources (1)
- FDA 510(k) K111521 24 fields · synced Sep 18, 2026