Preservation Solutions, Inc. manufacturers MaPerSol® according to a "recipe" pioneered at the University of Wisconsin by Dr. Folkert O. Belzer and Dr. James Southard. The kidney flushing and perfusion storage solution may still be referred to as Belzer-MPS™, UW Machine Perfusion Solution, and is currently sold under that trade name (Trans-Med Corporation, Elk River, MN), as well as under the trade name KPS-1 (Organ Recovery Systems, Des Plaines, IL). The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).

MaPerSol® is a colorless, sterile, non-toxic solution for in-vitro flushing and continuous perfusion of explanted kidnevs. The solution is packaged in 1-liter bags.

AI/ML Overview

This document outlines the acceptance criteria and study information for MaPerSol®, an organ preservation solution.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (MaPerSol®)
Formulation Equivalence	Identical formulation to predicate devices (KPS-1 and Belzer-MPS™)	MaPerSol® is stated to be identical in formulation to both KPS-1 Kidney Perfusion Solution (K022391) and Belzer-MPS™ UW Machine Perfusion Solution (K972066).
Biocompatibility	Verified as biocompatible	Verification that MaPerSol® is biocompatible has been performed.
Particulate Matter Limits	Meets particulate matter limits for large volume parenterals (LVPs)	MaPerSol® meets the particulate matter limits for large volume parenterals (LVPs).
Sterilization	Sterilization processes validated following national and international standards	Sterilization processes have been validated following national and international standards and guidance documents.
Shelf Life	Confirmed 1-year shelf life	A shelf life of 1 year was confirmed using chemical, microbiological, and toxicological tests, as well as Fourier transformed infrared spectrometry. Stored MaPerSol® (12 months) compares favorably with fresh MaPerSol®.
Chemical Consistency (Osmolarity/Osmolality, pH)	Consistent equivalence among MaPerSol® and predicate devices	Routine chemical tests for osmolarity/osmolality and pH show consistent equivalence among MaPerSol® and the two predicates.
Packaging Integrity/Stability	No deleterious effects due to aging in its flexible pouch container	No deleterious effects due to aging occur in its flexible pouch container after 12 months.

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

The provided document describes a premarket notification (510(k)) primarily based on substantial equivalence to predicate devices. It does not contain information about a "test set" in the context of clinical performance evaluations with human patient data. Instead, the "testing" described refers to:

Bench Testing: Chemical, microbiological, toxicological tests, and Fourier transformed infrared spectrometry for shelf life and basic chemical properties.
Biocompatibility Testing: The number of samples or specific method details for biocompatibility verification are not provided in this summary.
Sterilization Validation: Details on the number of samples for sterilization validation are not provided.

Therefore, information on the sample size for a "test set" (as typically understood in AI/imaging studies) and data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this is a device for organ preservation primarily assessed through chemical and physical equivalence to existing approved devices, not through a clinical performance study with patient outcomes data in the format of an AI device.

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

This information is not applicable as the submission does not involve expert-reviewed ground truth for a clinical "test set" in the typical sense of diagnostic or image analysis devices. The "ground truth" for this device revolves around established chemical and physical properties, safety standards (biocompatibility, sterility), and the known performance of its identical predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. This device is an organ preservation solution, not an AI-assisted diagnostic or imaging tool involving human readers.

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

A standalone performance study (in the context of an algorithm) was not done. This device is a chemical solution, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

Established chemical formulations: The exact recipe for the organ preservation solution.
Performance profiles of legally marketed predicate devices: The functionality and safety of the KPS-1 Kidney Perfusion Solution and Belzer-MPS™ UW Machine Perfusion Solution.
Standardized testing: Results from biocompatibility, sterility, particulate matter, and shelf-life tests adhering to recognized national and international standards.
Physical/chemical measurements: Data on osmolarity/osmolality and pH.

There is no "expert consensus," "pathology," or "outcomes data" specifically generated as a ground truth for a novel clinical performance claim in this 510(k) summary. The "ground truth" relies on the established characteristics and regulatory acceptance of the predicate devices and standard laboratory testing.

8. The sample size for the training set

The concept of a "training set" is not applicable to this 510(k) submission. This device is an organ preservation solution whose substantial equivalence is established through its identical formulation to predicate devices and adherence to established chemical and physical standards, not through machine learning or AI models that require training data.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this device.

Summary

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510(k) SUMMARY

SUBMITTER INFORMATION

AUG - 8 2008

A. Company Name: Preservation Solutions Inc.
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: MaPerSol®
B. Device Common Name: Organ Preservation 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

MaPerSol® is a organ preservation solution for explanted kidneys, which is substantially equivalent to a both Belzer-MPS™, UW Machine Perfusion Solution (K972066) and KPS-1 Kidney Perfusion Solution (K022391).

DEVICE DESCRIPTION

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MaPerSol® is a colorless, sterile, non-toxic solution for in-vitro flushing and continuous perfusion of explanted kidnevs. The solution is packaged in 1-liter bags. The Food and Drug Administration requlates such solutions as medical devices as referenced below.

INDICATIONS FOR USE

MaPerSol® organ preservation solution is intended for in-vitro flushing and continuous hypothermic machine perfusion of explanted kidneys.

COMPARISON TO PREDICATE DEVICES

MaPerSol® is identical in formulation to two (2) predicate products, KPS-1 Kidney Perfusion Solution (K022391) and Belzer-MPS™ UW Machine Perfusion Solution (K972066). The solutions maintain organ cleanliness and viability prior to transplantation.

BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING

MaPerSol®, mixed and filled according to written procedures under routine conditions at the manufacturer's (Preservation Solutions, Inc.) site, has been verified as biocompatible and meets the particulate matter limits for large volume parenterals (LVP's).

Compounded and fully dissolved MaPerSol® is filter steritically filled into flexible solutions bags fitted with ports suitable for aseptic connection to standard infusion or administration sets. Sterilization processes have been validated following national and international standards and quidance documents.

A shelf life of 1 year was confirmed using chemical, microbiological,and toxicological tests, as well as via Fourier transformed infrared spectrometry. MaPerSol® solution, fully packaged and labeled as if for sale and stored for approximately 12 months, compares favorably with fresh MaPerSol®. No deleterious effects due to aging occur in either the solution or its flexible pouch container.

Routine chemical tests for osmolarity/osmolality and pH show consistent equivalence among the proposed device MaPerSol® and the two (2) predicates.

CONCLUSION

The above statements establish substantial equivalence between MaPerSol® and the cited predicates.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design resembling three abstract human figures or a symbolic representation of health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2008

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

Re: K080432

Trade/Device Name: MaPerSol® Regulation Number: 21 CFR §876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: July 16, 2008 Received: July 17, 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, 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 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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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.

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 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,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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4. Statement of Indication for Use

Device Name: MaPerSol®

Indication for Use

MaPerSol® organ preservation solution is intended for in-vitro flushing and continuous hypothermic machine perfusion of explanted kidneys.

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)

signature

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

MaPerSol Traditional 510(k)

Preservation Solutions Inc. February 2008,

page 17 of 241 Corrected July 2008

KD80432 PSI MaPerSol Solution

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).