(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.
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XII. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden AB |
|---|---|
| Faktorvägen 13 | |
| SE-434 37 Kungsbacka | |
| SWEDEN | |
| Contact Person: | Mr Kjell Kjörk |
Mr Kjell Kjörk Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN Phone +46 31 721 80 77 Fax +46 31 721 80 90 Mail kkjork@vitrolife.com
| Date Prepared: | 10 July 2008 |
|---|---|
| Trade Name: | Perfadex® with THAM |
| Common Name: | Solution for lung preservation |
| Classification Name: | Isolated kidney perfusion and transport systemand accessories (21 C.F.R. § 876.5880) |
| Predicate Device: | Perfadex® (K022730) |
| Description of the Device: | Perfadex® with THAM is a colloid based"extracellular" low potassium electrolyte solutionfor rapid cooling, perfusion and storage of lungsin connection with transplantation |
| Intended Use: | Perfadex® with THAM is intended for flushing,storage and transportation of isolated lungs afterremoval from the donor in preparation foreventual transplantation into a recipient |
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Technological Characteristics:
The device 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® 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® 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®.
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 then cleared on 27 October 2003 (K022730), and this clearance is used as predicate for the current submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, composed of three stylized figures facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 9 2008
Mr. Kjell Kjörk Pharmacist, Regulatory Affairs Manager Vitrolife Sweden AB Faktorvagen 13 Kungsbacka SWEDEN SE-434 37
Re: K081997
Trade/Device Name: Perfadex® with THAM Regulation Number: 21 CFR §876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: MSB Dated: September 10, 2008 Received: September 12, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jorgu M. Zhang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT XI.
K081997 510(k) Number (if known):
Device Name:
Pcrfadex® 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 (Per 21 C.F.R. § 801.109) Over-the Counter Use
f
Argu M. Khan
OR
(Division S Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
§ 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).