PERFADEX SOLUTION FOR LUNG PRESERVATION

K022730 · Vitrolife AB · MSB · Oct 27, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K022730
• Device Name: PERFADEX SOLUTION FOR LUNG PRESERVATION
• Applicant: Vitrolife AB
• Product Code: MSB · Gastroenterology, Urology
• Decision Date: Oct 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

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.

Device Story

Perfadex® is a sterile, non-pyrogenic, extracellular-type solution used for hypothermic flushing, storage, and transport of isolated donor lungs. The solution is supplied in PVC bags and includes pre-filled syringes of THAM (tromethamine) for pH adjustment from 5.5 to 7.4 immediately prior to use. The device is used by transplant clinicians to preserve donor organs during the interval between removal and transplantation. By maintaining the lungs in a hypothermic, extracellular environment, the solution helps preserve organ viability for eventual transplantation into a recipient.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and formulation identity to the predicate device.

Technological Characteristics

Extracellular-type solution; pH 5.5 (adjusted to 7.4 with THAM); osmolarity 295 mOsm/L. Supplied in 1L or 2.8L PVC (Viaflex) bags within polypropylene outer bags. Sterile, non-pyrogenic. No electronic or software components.

Indications for Use

Indicated for flushing, storage, and transportation of isolated donor lungs prior to transplantation.

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® Solution for Lung Perfusion (K000881)

Submission Summary (Full Text)

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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)