(456 days)
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® and Perfadex® with THAM is a colloid based "extracellular" low potassium electrolyte solution for rapid cooling, perfusion and storage of lungs in connection with transplantation
This document is a Premarket Notification Summary for Perfadex® and Perfadex® with THAM, a solution for lung preservation. It is a 510(k) submission, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety from scratch.
Therefore, the document does not contain the kind of detailed information typically found in a clinical study report that would establish acceptance criteria and then demonstrate performance against those criteria in a rigorous, quantitative manner. Instead, the focus is on showing that the new device is "substantially equivalent" to existing, cleared devices.
Based on the provided text, here's a breakdown of the requested information, highlighting what is not available in a 510(k) summary of this type:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in this 510(k) summary. For a 510(k) submission, "acceptance criteria" are generally related to demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness profiles, rather than specific performance metrics (like sensitivity, specificity, accuracy) against a predefined benchmark. The "reported device performance" is implicitly that it performs comparably to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/provided as a separate "test set" and corresponding study demonstrating performance against acceptance criteria in the manner expected for a de novo or PMA submission is not included. The 510(k) relies on comparison to predicate devices, whose performance would have been established previously.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable/provided. Ground truth establishment by experts for a specific performance study is not described in this 510(k) summary.
4. Adjudication Method
This information is not applicable/provided. An adjudication method for a test set is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or referenced. This type of study is more common for diagnostic imaging AI devices, whereas this submission concerns a medical solution for organ preservation.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The device is a solution for organ preservation, not an algorithm.
7. Type of Ground Truth Used
Not applicable. Ground truth for a performance study is not described.
8. Sample Size for the Training Set
No training set is mentioned or referenced. This device is not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of What is Available in the Document Regarding "Acceptance Criteria" (Implicit) and "Study" (Substantial Equivalence):
The "acceptance criteria" for a 510(k) submission are implicitly met by demonstrating that the device is "substantially equivalent" to predicate devices. The "study" proving this is presented through a comparison of the new device's characteristics and intended use to those of previously cleared predicate devices.
- Intended Use: The device is intended for "flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient." This matches the intended use of the predicate devices.
- Technological Characteristics:
- Composition: "Perfadex® and 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."
- pH: "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; 1 mmol of THAM per liter of Perfadex®."
- Predicate Device Comparison: The summary explicitly states: "Perfadex® was first 510(k) cleared by the FDA on 8 March 2001 (K000881). Perfadex® with co-packed THAM in a pre-filled syringe was cleared on 27 October 2003 (K022730), and then Perfadex® with co-packed THAM in a 50 ml glass bottle was cleared on 9 October 2008 (K081997)." The current submission (K091989) is for "Perfadex® and Perfadex® with THAM," and the FDA letter confirms substantial equivalence to the predicate devices, implying that the technological characteristics and indications for use are sufficiently similar for clearance.
Essentially, the "study" for this 510(k) is the comparison presented in the "Technological Characteristics" section, which asserts the device is functionally and compositionally similar to already approved versions of Perfadex®. The "acceptance criteria" are met if the FDA agrees that this comparison adequately demonstrates substantial equivalence, meaning the new device is as safe and effective as the predicate devices.
§ 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).