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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called CoStorSol®, an organ storage solution. The submission aims to demonstrate substantial equivalence to a previously cleared version of CoStorSol® (K083453 and K073693) but without the need for a microfilter at the time of use.

The document heavily focuses on demonstrating substantial equivalence by showing that the unfiltered CoStorSol® is equivalent to the filtered CoStorSol®. It does not describe a study to prove a device meets specific acceptance criteria for performance in a traditional sense (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it describes a study proving an attribute of the device (lack of need for filtration) does not negatively impact its performance or safety compared to the predicate device.

Below is an attempt to respond to your request based on the available information, noting where specific details are not provided in the text.

Acceptance Criteria and Device Performance for CoStorSol® (K091245)

The acceptance criteria for K091245 focused on demonstrating that CoStorSol® without instructions for final filtration is substantially equivalent to the predicate CoStorSol® with filtration instructions, particularly regarding safety and biological compatibility. The key performance attributes evaluated were related to particulate matter and sterility/pyrogenicity without the final filtration step.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material Safety (Biocompatibility)	CoStorSol® itself is biocompatible (ISO 10993 series referenced).	"Test results have shown CoStorSol® itself to be a biocompatible solution..."	Demonstrated through testing, although specific results are not detailed.
Packaging Biocompatibility	Flexible solution administration pouches are biocompatible (ISO 10993 series referenced).	"...supplied in flexible solution administration pouches, which have likewise been tested and shown to be biocompatible."	Demonstrated through testing, specific results not detailed.
Particulate Matter	Particulate matter does not exceed limits set in USP Section <788> for large volume injections.	"Particulate matter does not exceed the limits set in USP Section <788>, for large volume injections."	Directly stated that the device met this specific quantitative standard.
Sterility	Solution supplied sterile and non-pyrogenic. Sterilization processes validated according to ISO 17665 or USP Section<1211>.	"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."	Validation conducted against recognized standards, confirming sterility and non-pyrogenicity.
Equivalence to Predicate	Unfiltered CoStorSol® is equivalent to filtered CoStorSol® for its intended use (flushing and cold storage of kidney, liver, and pancreas organs).	"Preservation Solutions, Inc. has compiled data showing that unfiltered CoStorSol® is equivalent to filtered CoStorSol®."	This is the overarching claim for the 510(k) submission, supported by the above tests.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for the tests conducted (biocompatibility, particulate matter, sterility validation).
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's a 510(k) submission to the US FDA, the tests would typically be conducted under GLP (Good Laboratory Practice) guidelines. The phrase "Preservation Solutions, Inc. has compiled data" suggests internal company testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable in the context of this device and submission. This is a medical device for organ preservation, not a diagnostic or AI-driven device requiring expert adjudication of images or clinical outcomes for ground truth. The "ground truth" here is established by adherence to recognized scientific and regulatory standards (USP, ISO, biocompatibility testing).

4. Adjudication Method for the Test Set:

This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for diagnostic accuracy, which is not the focus here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging devices or AI tools, often involving human readers. CoStorSol® is a chemical solution for organ preservation.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable as CoStorSol® is not an algorithm or AI-driven device. The "standalone" performance here refers to the chemical and physical properties of the solution itself, which were evaluated through various bench tests and validations (biocompatibility, particulate matter, sterility).

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance criteria primarily relies on established scientific and regulatory standards, including:
- Pharmacopoeia standards: USP Section <788> for particulate matter, USP Section <1211> for sterilization.
- International standards: ISO 10993 series for biocompatibility, ISO 17665 for sterilization.
The fundamental "ground truth" being demonstrated is that the absence of a final filtration step does not compromise the safety or equivalence of the product compared to its predicate.

8. The Sample Size for the Training Set:

This question is not applicable as CoStorSol® is not an AI/machine learning device that requires a training set. The "training" in manufacturing comes from validating processes against established standards.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the same reason as point 8.

Summary

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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: 262 723 6715
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

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

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INDICATIONS FOR USE

K091245
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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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Page 2

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) (240) 276-0115 (Obstetrics/Gynecology) (240) 276-0115 (Radiology) (240) 276-0120 (240) 276-0100

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 (800) 638-2041 or (240) 276-3150 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
1 of 1

5. Statement of Indication for Use

Device Name: CoStorSol®

Indications for Use

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

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).