(66 days)
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.
The RM3 Renal Preservation System is a two-part system comprising a control unit for perfusion and monitoring of one or two kidneys, and a sterile, disposable single-use cassette used to contain and circulate perfusate to the kidneys.
This 510(k) summary describes a re-submission for the RM3 Renal Preservation System and claims substantial equivalence to the previously cleared RM3 Renal Preservation System. Therefore, there are no new acceptance criteria or new studies described in this document. The submission references minor material changes to certain components of the organ cassette to improve manufacturability and reduce costs. It states these changes have been evaluated through risk analysis and a biomaterial safety assessment following established Design Control procedures, but it does not provide details of those evaluations or any new studies.
Here's a breakdown of why the requested information cannot be provided from the given document:
- 1. A table of acceptance criteria and the reported device performance: This document is a 510(k) summary for a device claiming substantial equivalence to a predicate device. It does not contain acceptance criteria for performance or reported device performance data from new studies.
- 2. Sample size used for the test set and the data provenance: No new test sets or studies are described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new studies are described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no new studies are described.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as no new studies are described.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device (renal preservation system), not an AI algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no new studies are described.
- 8. The sample size for the training set: Not applicable as this is not an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable as this is not an AI algorithm.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on identical intended use and methodology, with minor material changes. It does not include new performance data, clinical studies, or acceptance criteria beyond what would have been established for the original predicate device.
§ 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).