PERFADEX SOLUTION FOR LUNG PRESERVATION

• K Number: K022730
• Device Name: PERFADEX SOLUTION FOR LUNG PRESERVATION
• Manufacturer: VITROLIFE AB
• Date Cleared: 2003-10-27 ( 437 days)
• Product Code: MSB
• Regulation Number: 876.5880
• Type: Traditional
• Panel: Gastroenterology/Urology
• Reference & Predicate Devices: K000881
• Predicate For: K081997

Intended 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.

Device Description

Perfadex® is a clear, sterile, non-pyrogenic, extracellular type solution for hypothermic flushing and storage of isolated lungs. The solution is slightly acidic (pH5.5) to permit long shelf life and is adjusted shortly before use to pH 7.4. The solution is slightly hypertonic (osmolarity 295 mOsm/L) and has a low buffering capacity. The composition of Perfadex® is thus consistent with that of an extracellular solution.

Perfadex® is filled into 1 or 2.8 liter PVC (Viaflex) bags, each of which is sealed in an outer polypropylene bag.

Manufacturing, control and sterilization is performed at an FDA inspected plant owned and operated by Fresenius Kabi Norge AS in Halden, Norway. The product is stored at room temperature.

Perfadex® is supplied with pre-filled, sterile, non-pyrogenic, syringes of THAM (tromethamine USP) for pH adjustment of the solution prior to use.

The pre-filled syringes of THAM are manufactured, packaged, labeled and controlled by Vitrolife UK Ltd., Edinburg, UK.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called Perfadex® Solution for Lung Perfusion. This type of document is for regulatory clearance of a medical device and describes its intended use and its substantial equivalence to a previously marketed device. It does not contain information about studies proving the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes, ground truth establishment, expert adjudication).

The document focuses on:

• Identification of the device: Perfadex® Solution for Lung Perfusion.
• Its intended use: flushing, storage, and transportation of isolated lungs for transplantation.
• Device description: composition, packaging, manufacturing, and sterilization.
• Predicate device: K000881, also Perfadex® Solution for Lung Perfusion.
• Claim of substantial equivalence to the predicate device, specifically noting the addition of pre-filled THAM syringes for pH adjustment as the main difference.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or information about studies related to performance metrics, sample sizes, expert involvement, or comparative effectiveness with or without AI assistance, as this information is not present within the provided text.

This document's purpose is to demonstrate that the new version of Perfadex® is as safe and effective as the previously cleared version, primarily through demonstrating material and compositional equivalence. It is not a clinical study report describing performance against specific, quantifiable acceptance criteria for diagnostic accuracy or clinical outcomes.

Summary

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022730 1042

OCT 27 2003

K022730 - Perfadex® Solution for Lung Perfusion

510 (k) Summary

Date Prepared: October 23, 2003

• 1. Sponsor
• B. Sponsor Name

Vitrolife AB (subsidiary of Xvivo Transplantation Systems AB) Molndalsvagen 30, SE-412 63, Gothenburg, Sweden Tel: [phone] Fax: [phone]

Mr. Hans Lehmann Contact Name: Regulatory Manager

C. Submission Correspondent

Karl Posselt FDA Regulatory Services 155 Cider Mill Road Ringoes, NJ 08551 Tel: [phone] Fax: [phone] E-mail: [e-mail]

• 2. System Identification
• A. Proprietary Name

Perfadex® Solution for Lung Perfusion

• Common or Usual Name B.
  Solution for Organ Preservation

• C. Product Classification
  Panel No. 78 MSB Class II

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Predicate Device 3.

• Name A.
  Classification Name: System & Accessories, Isolated Heart Transport and Preservation Regulation Number: 876.5880 510(k) No. K000881 Perfadex® Solution for Lung Perfusion Vitrolife AB

• 4. Perfadex® Device Information

• Indications for Use A.

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.

• B. Device Description
  Perfadex® is a clear, sterile, non-pyrogenic, extracellular type solution for hypothermic flushing and storage of isolated lungs. The solution is slightly acidic (pH5.5) to permit long shelf life and is adjusted shortly before use to pH 7.4. The solution is slightly hypertonic (osmolarity 295 mOsm/L) and has a low buffering capacity. The composition of Perfadex® is thus consistent with that of an extracellular solution.

Perfadex® is filled into 1 or 2.8 liter PVC (Viaflex) bags, each of which is sealed in an outer polypropylene bag.

Manufacturing, control and sterilization is performed at an FDA inspected plant owned and operated by Fresenius Kabi Norge AS in Halden, Norway. The product is stored at room temperature.

Perfadex® is supplied with pre-filled, sterile, non-pyrogenic, syringes of THAM (tromethamine USP) for pH adjustment of the solution prior to use.

The pre-filled syringes of THAM are manufactured, packaged, labeled and controlled by Vitrolife UK Ltd., Edinburg, UK.

• Substantial Equivalence న.
  Perfadex® supplied with pre-filled syringes of THAM (tromethamine USP) for pH adjustment is substantially equivalent to Perfadex® in a 1 or 2.8 L PVC (Viaflex) bag K000881.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 2003

Vitrolife AB c/o Mr. Karl A. Posselt Submission Correspondent FDA Regulatory Services 155 Cider Mill Road RINGOES NJ 08551

Re: K022730

Trade/Device Name: Perfadex® Solution for Lung Preservation Regulation Number: 21 CFR §876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: 78 MSB Dated: July 25, 2003 Received: July 29, 2003

Dear Mr. Posselt:

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 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); 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.

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Page 2

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 the letter:

8xx. 1xxx	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications For Use

STATEMENT OF 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.

Qeilla. Saggara
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Device 510(k) Number

Prescription Use . (Per 21 CFR 801.109)

Regulation Number and Section

§ 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).