COSTORSOL

K091245 · Preservation Solutions, Inc. · KDN · Jun 17, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K091245
• Device Name: COSTORSOL
• Applicant: Preservation Solutions, Inc.
• Product Code: KDN · Gastroenterology, Urology
• Decision Date: Jun 17, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5880
• Device Class: Class 2

Indications for Use

CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

Device Story

CoStorSol® is a sterile, non-pyrogenic organ preservation solution; formulation includes soluble colloids, buffers, sodium/potassium salts, redox stabilizers, and phosphoric compounds to support tissue viability via ATP regeneration. Used by transplant clinicians for hypothermic flushing and cold storage of harvested kidney, liver, and pancreas organs. Supplied in 1-liter flexible bags; must be chilled to 2°–6°C prior to use. Acts as initial vasculature flush medium and subsequent cold storage medium. Facilitates organ transport and eventual transplantation. Removes requirement for point-of-use microfiltration compared to previous versions. Benefits patient by maintaining organ viability during the interval between donor removal and recipient transplantation.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Particulate matter testing conducted per USP <788> for large volume injections. Sterilization validated per ISO 17665 or USP <1211>.

Technological Characteristics

Sterile, non-pyrogenic aqueous solution containing colloids, buffers, salts, and phosphoric compounds. Supplied in 1-liter flexible administration pouches. Hypothermic storage (2°–6°C). Biocompatibility per ISO 10993; particulate limits per USP <788>; sterilization per ISO 17665/USP <1211>.

Indications for Use

Indicated for flushing and cold storage of kidney, liver, and pancreas organs during organ removal from donors, in preparation for storage, transport, and transplantation into recipients.

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

• CoStorSol® (K073693)
• CoStorSol® (K083453)

Submission Summary (Full Text)

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K09/245
182

### 510(k) SUMMARY

#### SUBMITTER INFORMATION

- A. Company Name: Preservation Solutions Inc.
JUN 1 7 2009

- B. Company Address: 980 Proctor Drive Elkhorn, Wisconsin 53121
- C. Company Phone: [phone]
- D. Company Facsimile: 262 723 4013
- E. Contact Person: William Wagner Quality Assurance Director

## DEVICE IDENTIFICATION

- A. Device Trade Name: CoStorSol®
- B. Device Common Name: Organ Storage Solution
- C. Classification Name: Isolated kidney perfusion and transport system and accessories
- D. Class II (21 CRF 876.5880)
- E. Device Code: KDN

### IDENTIFICATION OF PREDICATE DEVICES

CoStorSol®, to be stored at ambient room temperature, is a transplant graft storage solution for harvested organs, which is substantially equivalent to the original CoStorSol® solution cleared to market under premarket notifications K073693 and K083453.

### DEVICE DESCRIPTION

Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, the cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).

CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags, which must be chilled to between 2° and 6° C prior to use. The solution may be used without any point of use filtration.

Traditional 510(k) CoStorSol - No Time of Use Filtration

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# INDICATIONS FOR USE

K091245
2 of 2

CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

# COMPARISON TO PREDICATE DEVICES

CoStorSol® solution was cleared under 510(k) K083453 with a specified shelf life of one (1) year when stored under refrigeration at temperatures no lower than 2°C, or at ambient indoor There has been no change in the formulation, packaging, or temperatures up to 25°C. indication for use for the product. The proposed CoStorSol® solution is identical to the predicate, but label instructions to pass the solution though a microfilter (Pall Blood Transfusion Filter) at the time of use have been removed. Preservation Solutions, Inc. has compiled data showing that unfiltered CoStorSol® is equivalent to filtered CoStorSol®. The directions to chill CoStorSol®, prior to its use for flushing or storing organs for transplant, remain unaltered. Only the instruction to connect a sterile microfilter to the spike port while draining the solution from its flexible container has been deleted from the labeling. The solution was, and is still designed for storage without freezing. CoStorSol® will continue to be supplied in 1-liter flexible bags for connection to standard administration sets for flushing of harvested organs. CoStorSol® is used as an initial vasculature flush medium for an organ, and then as a cold storage medium.

# BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING

Test results have shown CoStorSol® itself to be a biocompatible solution, supplied in flexible solution administration pouches, which have likewise been tested and shown to be biocompatible. The ISO 10993 series of standards were referenced during the planning and execution of all biocompatibility testing. Particulate matter does not exceed the limits set in USP Section <788>, for large volume injections. CoStorSol® is supplied sterile and non-pyrogenic in order to assure safety for transplant recipients. Sterilization processes were validated according to either ISO 17665 or USP Section <1211>, as appropriate.

### CONCLUSION

The above statements establish substantial equivalence between the predicate, CoStorSol® with instructions to pass the solution through a microfilter at the time of use, and the proposed product. CoStorSol® without instructions for final filtration.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle. The seal is in black and white and has a simple, official design.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 7 2009

Preservations Solutions, Inc. % Mr. Neil Burris Principal Neil Burris and Associates 4250 Grove Street DENVER CO 80211

Re: K091245

Trade/Device Name: ÇoStorSo1® Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: April 20, 2009 Received: April 28, 2009

# Dear Mr. Burris:

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 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 (reporting of medical device-related 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) [phone] (Obstetrics/Gynecology) [phone] (Radiology) [phone] [phone]

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K09/245
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### 5. Statement of Indication for Use

Device Name: CoStorSol®

Indications for Use

CoStorSol® is intended for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laura De Norris

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Traditional 510(k) CoStorSol - No Time of Use Filtration