(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.
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Kogiq 89 Page lufz
XII. PREMARKET NOTIFICATION SUMMARY
Submitted by:
Contact Person:
XVIVO Perfusion AB Box 9080 SE-40092 Göteborg SWEDEN
Mr Kjell Kjörk XVIVO Perfusion AB Box 9080 SE-40092 Göteborg SWEDEN +46 31 721 80 77 Phone +46 31 721 80 90 Fax kkjork@vitrolife.com Mail
Date Prepared:
Trade Name:
Common Name:
Classification Name:
Predicate Device:
Description of the Device:
Intended Use:
30 June 2009
Perfadex® and Perfadex® with THAM
Solution for lung preservation
Isolated kidney perfusion and transport system and accessories (21 C.F.R. 8876 5880)
Perfadex® (K000881) and Perfadex® with THAM (K081997)
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
Perfadex® and 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
IOCT " 1 2010
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Technological Characteristics:
Perfadex® is the only solution which has been specifically developed for lung preservation, and is today used in about 90% of the lung transplantations performed world-wide.
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. 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®.
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).
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002
Mr. Kjell Kjörk Pharmacist, Senior Regulatory Affairs Manager XVIVO Perfusion AB Box 9080 SE-40092 Göteborg SWEDEN
OCT 1 2010
Re: K091989
Trade/Device Name: Perfadex® and Perfadex® with THAM Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: August 30, 2010 Received: September 3, 2010
Dear Mr. Kjörk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
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Page 2
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemon MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT XI.
K091989 510(k) Number (if known):
Device Name:
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
Perfadex® and Perfadex® with THAM
Indications for Use:
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-the Counter Use | |
|---|---|---|---|---|
| ( Per 21 C.F.R. § 801.109 ) |
Carolyn Y Newland for Herb Lerner, MD.
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
| 510(k) Number | K091989 |
|---|---|
| --------------- | --------- |
§ 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).