PERFADEX AND PERFADEX WITH THAM

K091989 · Xvivo Perfusion AB · KDN · Oct 1, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K091989
• Device Name: PERFADEX AND PERFADEX WITH THAM
• Applicant: Xvivo Perfusion AB
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Oct 1, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Indications for Use

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

Device Story

Perfadex® and Perfadex® with THAM is a colloid-based, extracellular, low-potassium electrolyte solution used for rapid cooling, perfusion, and storage of donor lungs. The solution is supplied at pH 5.5 for shelf-life stability and adjusted to pH 7.4 using THAM solution immediately prior to clinical use. It is utilized by transplant surgeons and clinical staff during the organ procurement and transport process to preserve lung viability for transplantation. The solution acts as a preservation medium to maintain organ integrity during the interval between donor removal and recipient implantation.

Clinical Evidence

No clinical data provided. The device is a chemical solution for organ preservation; substantial equivalence is based on established formulation and prior regulatory clearance.

Technological Characteristics

Colloid-based, extracellular, low-potassium dextran solution. Sterile, non-pyrogenic. Initial pH 5.5, adjusted to pH 7.4 with THAM (1 mmol/L) prior to use. Chemical preservation medium.

Indications for Use

Indicated for flushing, storage, and transportation of isolated lungs post-donor removal, in preparation for transplantation into a recipient.

Regulatory Classification

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.

Predicate Devices

• Perfadex® (K000881)
• Perfadex® with THAM (K081997)

Reference Devices

• Perfadex® with co-packed THAM in a pre-filled syringe (K022730)

Submission Summary (Full Text)

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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 [phone] Phone [phone] Fax [e-mail] 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 [phone] or [phone] 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 | <b>X</b> | OR | Over-the Counter Use | |
|------------------------------------|----------|----|----------------------|--|
| ( <i>Per 21 C.F.R. § 801.109</i> ) | | | | |

*Carolyn Y Newland for Herb Lerner, MD.*

(Division Sign-Off)

Division of Reproductive, Gastro-Renal, and Urological Devices

| 510(k) Number | K091989 |
|---------------|---------|
|---------------|---------|