(87 days)
Perfadex® with THAM is intended for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor, in preparation for eventual transplantation into a recipient
Perfadex® with THAM is a colloid based "extracellular" low potassium electrolyte solution for rapid cooling, perfusion and storage of lungs in connection with transplantation
Perfadex® with THAM contains THAM at strength of 3.3 mmol in a sterile 50 ml glass bottle, while the predicate device (K022730) contains THAM at strength of 1.0 mmol in a 1.0 or 2.8 ml pre-filled syringe with THAM.
Perfadex® with THAM is a clear, sterile, non-pyrogenic, colloid based, lightly buffered so called "extracellular" low potassium dextran solution primarily for rapid cooling, perfusion and storage of lungs in connection with transplantation. The solution is slightly acidic (pH 5.5) to permit long shelf life, and is adjusted shortly before use to pH 7.4 by the addition of THAM solution from the co-packed bottle, 1 mmol of THAM per liter of Perfadex®.
This document is a 510(k) Premarket Notification for a medical device called "Perfadex® with THAM." The device is a solution for lung preservation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not contain explicit acceptance criteria or a study demonstrating device performance in terms of clinical outcomes or specific metrics (e.g., survival rates, organ viability post-transplant). This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical effectiveness through performance criteria.
The "acceptance criteria" here implicitly revolve around demonstrating that the modified device (Perfadex® with THAM containing 3.3 mmol THAM in a 50 ml bottle) is as safe and effective as the predicate device (Perfadex® with THAM containing 1.0 mmol THAM in a 1.0 or 2.8 ml pre-filled syringe), and thus does not raise different questions of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe any "test set" in the context of clinical performance data. The submission is focused on the device's technical characteristics and comparison to a predicate, not a clinical study with a test set of patients or data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as there is no "test set" and corresponding ground truth establishment described for a clinical performance study.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no "test set" or clinical study with adjudication described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This information is not applicable. The device is a solution for lung preservation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect size are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
This information is not applicable. The device is a medical solution, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
This information is not applicable in the context of a clinical performance study or diagnostic accuracy. For a 510(k), the "ground truth" for substantial equivalence is primarily established by comparison to the legally marketed predicate device's established safety and effectiveness. The submission aims to show that the new device's technological characteristics (specifically the different THAM concentration and packaging) do not alter its fundamental nature or intended use from the predicate, and thus its "ground truth" performance is assumed to be equivalent to the predicate.
8. The Sample Size for the Training Set:
This information is not applicable. There is no "training set" as this is not an AI/machine learning device or a clinical trial with a training phase described in this document.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
§ 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).