(175 days)
The RM4 control unit, as part of the RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.
The RM4 Control Unit controls kidney perfusion of hypothermic physiologic solutions and monitors, displays, trends, and saves the perfusion parameters. The RM4 Control Unit is part of the RM4 Kidney Perfusion System (RM4), which is a lightweight and compact renal perfusion system intended to provide controlled perfusion of a hypothermic physiologic solution for the preservation of donor kidney organs before transplantation into the recipient. The RM4 Control Unit is used with a sterile, disposable, singleuse, organ cassette intended to receive one or two kidneys from the same donor. The system is provided with a power cord and a USB flash drive that contains the instructions for use, and is intended to be used with an organ cassette and accessories including an insulation cover, and various cannulas/clamps for arterial cannulation of the kidneys to the perfusate circuit into the cassette.
The provided document is a 510(k) premarket notification for the RM4 control unit, an accessory to an isolated kidney perfusion and transport system. This device is intended for the pulsatile hypothermic machine perfusion of kidneys for preservation prior to transplantation.
The document focuses on demonstrating substantial equivalence to a predicate device (RM3 Renal Preservation System - Control Unit) through non-clinical testing. It does not present a study with specific acceptance criteria and performance data for an AI-powered device or a medical imaging system. Therefore, it is impossible to provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth types, as this information is not contained within the provided text.
The document highlights the following verification and validation activities for the RM4 control unit:
- Software Verification and Validation: Adherence to IEC 62304 and ISO 14971.
- Electrical Safety and Electromagnetic Compatibility: Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62133, and IEC 60601-1-8.
- Performance Testing: Included sensors performance testing, pulsatile pump testing, cooling system testing, operational testing, bubble priming testing, power management testing, and accessories compatibility verification testing.
The conclusion states that these tests demonstrated that the RM4 Control Unit does not raise new issues of safety and effectiveness compared to the predicate device. However, no specific quantitative acceptance criteria or detailed performance results from these tests are provided in a format that would allow filling out the requested table or answering the specific questions about AI/imaging study design.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).