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" proneered at the University of Wisconsin by Dr Folkert O Belzer Indeed, the cold storage solution is often referred to as "Belzer UW" solution The formulation includes soluble collords, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to and tissue vrability 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

AI/ML Overview

Here's an analysis of the provided 510(k) summary, structured to address your specific questions. It's important to note that this document is a summary for regulatory clearance, not a detailed scientific paper, so some requested information may not be explicitly present.

Device Name: CoStorSol® (Organ Storage Solution)

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the primary "acceptance criterion" is
substantial equivalence to the predicate device. The performance data presented focuses on demonstrating that the proposed device, stored at ambient temperature, is identical to the predicate device stored under refrigeration, particularly regarding its chemical composition and biocompatibility.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance
Material Identity: No change in formulation	"Chemical analyses on both fresh reference samples naturally aged at 25° ± 2°C, show CoStorSol® to be identical to the predicate solution."
Biocompatibility: Product remains biocompatible	"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..."
Sterility & Non-pyrogenicity: Maintained	"CoStorSol® is supplied sterile and non-pyrogenic... Sterilization processes were validated according to either ISO 17665 or USP Section <1211>, as appropriate."
Packaging Integrity: Maintained	Flexible solution administration pouches tested and shown to be biocompatible. (Implies packaging integrity for safe use.)
Shelf Life (Ambient Temperature): 1 year at up to 25°C	"The proposed CoStorSol® solution is identical to the predicate again, only the long-term storage temperature range has changed." (Supported by "naturally aged" chemical analysis.)

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

The document does not specify a "test set" in the context of clinical performance data involving organs or patients, as this submission focuses on demonstrating equivalence through chemical and biocompatibility testing.

Sample Size:
- For chemical analysis: "both fresh reference samples naturally aged at 25° ± 2°C". The exact number of samples is not stated but implies a comparison between newly manufactured product and product aged under the new storage conditions.
- For biocompatibility: Tests were conducted on CoStorSol® itself and the flexible solution administration pouches. The sample sizes for these specific ISO 10993 tests are not provided but would have been defined by the standards.
Data Provenance: The data appears to be from bench testing and laboratory analysis, rather than human clinical trials. The country of origin of the data is not explicitly stated but is implied to be from the manufacturer or contracted testing labs. It is retrospective in the sense that the studies were performed on existing product formulations to support a change in storage conditions.

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

Not applicable. This submission relies on scientific and engineering testing (chemical analysis, biocompatibility, sterility validation) rather than expert consensus on diagnostic interpretations or clinical outcomes. There is no "ground truth" established by human experts in the context of a test set for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" requiring adjudication by multiple readers/experts in this type of submission. The evaluation is based on objective laboratory measurements and adherence to standards.

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

No. An MRMC study is typically for evaluating the diagnostic performance of a medical imaging device or software. This device is an organ preservation solution, and its evaluation focuses on chemical integrity, safety (biocompatibility, sterility), and stability under new storage conditions.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its chemical properties and physical stability.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Chemical Analysis: Demonstrating the chemical composition of the proposed device (stored ambient) is identical to the predicate device (stored refrigerated). The "truth" is the established chemical formula and stability profile.
Biocompatibility Standards: Adhering to the requirements of ISO 10993 series, where the "truth" is that the materials are deemed safe for biological contact.
Sterility Validation Standards: Adherence to ISO 17665 or USP Section <1211>, establishing "truth" through validated sterilization processes.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this device is not a predictive model or AI system.

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

Not applicable. As explained in point 8, there's no training set for this type of device.

Summary

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K083453
182

510(k) SUMMARY

SUBMITTER INFORMATION

A Company Name Preservation Solutions Inc
B Company Address 980 Proctor Drive Elkhorn, Wisconsın 32121
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 510(k) K073693

DEVICE DESCRIPTION

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

JAN 2 1 2009

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K083453
262

INDICATIONS FOR USE

COMPARISON TO PREDICATE DEVICES

CoStorSol®, cleared under 510(k) K073693 with a specified shelf life of one (1) year at 2℃ to 6°C, serves as an exact predicate for Preservation Solutions, Inc 's CoStorSol® with the same one (1) year shelf life when stored at ambient room temperatures up to 25°C There has been no change in the formulation, packaging, or intended use for the product - The proposed CoStorSol® solution is identical to the predicate Again, only the long-term storage temperature range has changed The solution was, and is still designed for storage without freezing CoStorSol® will continue to be supplied in 1-liter flexible bags to ease connection to standard administration sets for flushing of harvested organs CoStorSol® transplant solution, if stored at room temperature, must be chilied prior to use 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 blocompatible 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 plannıng and execution of all biocompatibility testing CoStorSol® is supplied sterile and non-pyrogenc in order to assure safety for transplant recipients Sterilization processes were validated according to either ISO 17665 or USP Section <1211>, as appropriate

Chemical analyses on both fresh reference samples naturally aged at 25° ± 2°C, show CoStorSol® to be identical to the predicate solution

CONCLUSION

The above statements establish substantial equivalence between CoStorSol® stored for up to one year at room temperature, and predicate solution stored under refrigeration

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Preservation Solutions, Inc c/o Mr Neil Burris Principal, Neil Burris & Associates 4250 Grove Street DENVER CO 80211

JAN 2 1 2009

K083453 Re

Trade/Device Name CoStorSol® Regulation Number 21 CFR §876 5880 Regulation Name Isolated kidney perfusion and transport system and accessones Regulatory Class II Product Code KDN Dated November 18, 2008 Received November 21, 2008

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration

If your device is classified (see above) into etther class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2

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 (OS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000-1050

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding os 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 this letter

21 CFR 876 xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884 xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892 xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device . " Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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 suppot/index. html

Sincerely yours,

Janine M. Norris

anine M N cting 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 Indication for Use ທ

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)

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

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).