CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, 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® plus G according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, this 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.

CoStorSol® plus G 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, to which 0.922 g of sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "CoStorSol® plus G," a solution for organ preservation. The document primarily focuses on establishing substantial equivalence to a predicate device, CoStorSol®, rather than presenting a detailed study with specific acceptance criteria and performance data in the typical sense of a diagnostic or interventional device.

The "device performance" and "acceptance criteria" here relate to demonstrating that the new device, CoStorSol® plus G, is as safe and effective as the predicate device by showing that the added component (glutathione) does not change its fundamental function or properties.

Here's an attempt to extract and organize the information according to your request, with the caveat that a traditional "study" proving performance against acceptance criteria for a new AI or diagnostic device isn't present in this regulatory document.

Acceptance Criteria and Device Performance for CoStorSol® plus G

The acceptance criteria for CoStorSol® plus G are primarily focused on demonstrating substantial equivalence to its predicate device, CoStorSol®, particularly in chemical composition, intended use, preparation for use, sterility, storage, actions and functions, particulate matter, biocompatibility, and interaction with other medical technology. The key "performance" here is that the modified device remains functionally equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Expected Outcome)	Reported Device Performance (CoStorSol® plus G)	Equivalence Status
Intended Use	Identical intended use as predicate.	"CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient." (Identical to predicate)	Identical
Preparation for Use	Identical preparation steps, including required and optional additives.	"Chill to 2° to 6° C without freezing; Required addition to 1L of CoStorSol®: Penicillin G-200,000 units, Insulin-40 Units, Dexamethasone-16mg; Optional addition to 1L CoStorSol®: glutathione 0.922g" (Identical to predicate)	Identical
Chemical Composition	Identical synthetic medium, pH, and osmolality.	"A synthetic medium of defined organic, and inorganic, soluble chemical compounds with specified purity. pH = 7.4 nominal osmolality ≈ 320 mOsM" (Identical to predicate)	Identical
Packaging - How Supplied	Packaging and sterility. Glutathione is now included with the product.	"Filter sterilized using 0.1μm membrane(s) and aseptically filled into biocompatible, 1 liter flexible solution bags... The bags have integrated delivery set ports, and are packaged with a single 10mL polyethylene terephthalate (PETG) vial holding 0.922 g sterile non-pyrogenic glutathione." (Substantially Equivalent - inclusion of glutathione)	Substantially Equivalent
Sterility	Sterility assured via 0.1 μm membrane filtration.	"Sterility Assured via 0.1 μm membrane filtration" (Identical to predicate)	Identical
Storage Temperature & Shelf Life	Identical storage conditions and shelf life.	"Indoors with temperature controlled at 2°-25°C, without freezing; 1 year (12 month) shelf life" (Identical to predicate) Also, "Preservation Solutions, Inc. has validated shelf life for CoStorSol® plus G using a combination of accelerated aging and natural aging protocols, supporting expiry periods of up to 1 year."	Identical
Actions and Functions	Identical mechanism of action: flushing, cold storage, and maintenance of histological viability.	"Use cold solution to flush organ immediately before and/or after removal to clear blood from the vasculature. Store organs cold in aliquot of the same solution to maintain histological viability by depressing metabolism." (Identical to predicate)	Identical
Particulate Matter & Biocompatibility	Particle counts below USP <788> limits for large volume injections; Biocompatible per ISO 10993-1 battery of tests for prolonged indirect contact.	"Particle Counts less than limits for Large Volume Injections per USP <788>; Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours." (Identical to predicate) Also, "Test results have shown CoStorSol® plus G to be a biocompatible solution..."	Identical
Interaction with Other Medical Technology	Not intended for continuous perfusion; requires standard surgical expertise.	"CoStorSol® plus G is not intended for continuous perfusion. Standard transplantation surgical expertise and techniques are required." (Identical to predicate)	Identical

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

The document does not detail a "test set" in the context of clinical or AI performance evaluation. Instead, testing was conducted on the device itself (CoStorSol® plus G solution and its packaging) to confirm its physical, chemical, and biological properties are equivalent to the predicate.

Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." Testing was performed on batches of the CoStorSol® plus G solution and its components (e.g., bags, glutathione vials).
Data Provenance: The testing appears to be internal validation by Preservation Solutions, Inc. and conducted according to relevant international standards (e.g., ISO, USP). The location of these tests (e.g., country of origin) is not specified, but the company is U.S.-based (Elkhorn, Wisconsin). The nature of the tests (biocompatibility, particulate matter, chemical identity, general appearance, weight loss, package integrity, shelf life) indicates a prospective series of laboratory and bench tests on the manufactured device.

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

N/A. This is not applicable as the "ground truth" here is based on established scientific and regulatory standards (e.g., chemical purity, pH, osmolality, sterility, biocompatibility standards like ISO 10993, and USP <788> for particulate matter) rather than clinical expert consensus on complex medical diagnoses. The company's Quality Assurance Director (William Wagner) is the contact person, implying oversight, but no panel of experts for "ground truth" establishment is mentioned.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used for clinical ground truth establishment in studies involving human interpretation or subjective assessments. Here, the "truth" is determined by objective laboratory measurements against defined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This document is a 510(k) submission for a non-diagnostic, non-AI medical device (organ preservation solution). An MRMC study is not relevant to its type of evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

N/A. This product is a chemical solution, not an algorithm or AI. Standalone performance is not applicable.

7. Type of Ground Truth Used

The "ground truth" for evaluating CoStorSol® plus G is based on defined scientific, chemical, and biological specifications and standards. These include:

Chemical identity and purity of components.
Physical properties (pH, osmolality, particulate matter count).
Sterility (absence of microorganisms).
Biocompatibility (based on ISO 10993 series of tests).
Stability and shelf life (demonstrating consistency over time).
Functional equivalence in vitro/ex vivo (implied by chemical similarity and predicate equivalence, but no specific organ performance studies are detailed in this document for the new device).

8. Sample Size for the Training Set

N/A. A "training set" is relevant for AI/machine learning models. This document describes a chemical solution.

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

N/A. Not applicable for this type of device.

Summary

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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2015

Preservation Solutions, Inc. % Neil Burris Principal Consultant Neil Burris and Associates 4250 Grove Street Denver, CO 80211

Re: K151728

Trade/Device Name: CoStorSol® plus G Regulation Number: 21 CFR§ 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories. Regulatory Class: II Product Code: KDN Dated: June 24, 2015 Received: June 26, 2015

Dear Neil 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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151728

Device Name CoStorSol plus G

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

SUBMITTER INFORMATION

A. Company Name: Preservation Solutions Inc.
B. Company Address: 1099 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® plus G
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® cold storage solution cleared to market under:

Premarket Notifications K091245, K083453, and K073693.

is an exact predicate to the proposed device CoStorSol® plus G.

DEVICE DESCRIPTION

CoStorSol® plus G 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, to which 0.922 g of

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sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.

INDICATIONS FOR USE

INTENDED USE

COMPARISON TO PREDICATE DEVICES

CoStorSol® solution received substantial equivalence determinations after submissions filed under premarket notification (510(k)) numbers K091245, K083453, and K073693. The modified device, CoStorSol® plus G, is exactly the same as the predicate device, except that the new device will include a single vial of sterile glutathione powder (0.922 g). The glutathione is included as a convenience should the attending physicians, and/or transplant team, choose to use it as an optional additive to 1 Liter of CoStorSol® at the time of use. The Instructions for Use of CoStorSol® have always included statements advising the optional addition of 0.922 g of glutathione when deemed necessary due to the exact circumstances of the transplant case. Including a vial of glutathione in a package of CoStorSol® plus G thus represents no change to either the intended use or the specific methods of use for the device.

Substantial Equivalence Comparison Table for CoStorSol® plus G vs. CoStorSol®

DeviceAttribute	CoStorSol® plus G(Proposed Device)	CoStorSol® K091245(Predicate Device)	Equivalent?
Intended Use	•CoStorSol® plus G is intended for theflushing and cold storage of liver, kidney,and pancreas organs at the time of organremoval from the donor in preparation forstorage, transportation and eventualtransplantation into a recipient.	CoStorSol® is intended for the flushingand cold storage of kidney, liver andpancreas organs at the time of organremoval from the donor in preparationfor storage, transportation and eventualtransplantation into a recipient.	Identical
Preparation forUse	Chill to 2° to 6° C without freezing;Required addition to 1L of CoStorSol®:Penicillin G-200,000 units, Insulin-40Units, Dexamethasone-16mg;Optional addition to 1L CoStorSol®:glutathione 0.922g	Chill to 2° to 6° C without freezing;Required addition to 1L of CoStorSol®:Penicillin G-200,000 units, Insulin-40Units, Dexamethasone-16mg;Optional addition to 1L CoStorSol®:glutathione 0.922g	Identical
DeviceAttribute	CoStorSol® plus G(Proposed Device)	CoStorSol® K091245(Predicate Device)	Equivalent?
ChemicalComposition	A synthetic medium of defined organic,and inorganic, soluble chemicalcompounds with specified purity.pH = 7.4 nominalosmolality $\approx$ 320 mOsM	A synthetic medium of defined organic,and inorganic, soluble chemicalcompounds with specified purity.pH = 7.4 nominalosmolality $\approx$ 320 mOsM	Identical
Packaging -How Supplied	Filter sterilized using 0.1μm membrane(s)and aseptically filled into biocompatible, 1liter flexible solution bags made oflaminated plastic with an ethylene-vinyl-acetate (EVA) layer contacting thesolution. The bags have integrateddelivery set ports, and are packaged witha single 10mL polyethylene terephthalate(PETG) vial holding 0.922 g sterile non-pyrogenic glutathione.CoStorSol® is non-pyrogenic. Shelfpacks contain 6, 1-liter bags and 6 vialsof glutathione powder	Filter sterilized using 0.1μm membrane(s)and aseptically filled into biocompatible,1 liter flexible solution bags made oflaminated plastic with an ethylene-vinyl-acetate (EVA) layer contacting thesolution. The bags have integrateddelivery set ports. CoStorSol® is non-pyrogenic. Shelf packs contain 10, 1-liter bags.	SubstantiallyEquivalent -Sterileglutathione, anoptional additiveto both thesubject deviceand predicate,is provided with1L units ofCoStorSol®.
Sterility	Sterility Assured via 0.1 μm membranefiltration	Sterility Assured via 0.1 μm membranefiltration	Identical
StorageTemperatureand Shelf Life	Indoors with temperature controlled at 2°-25°C, without freezing;1year (12 month) shelf life	Indoors with temperature controlled at2°-25°C, without freezing;1 year (12 month) shelf life	Identical
Actions andFunctions	Use cold solution to flush organimmediately before and/or after removalto clear blood from the vasculature. Storeorgans cold in aliquot of the same solutionto maintain histological viability bydepressing metabolism.	Use cold solution to flush organimmediately before and/or after removalto clear blood from the vasculature.Store organs cold in aliquot of the samesolution to maintain histological viabilityby depressing metabolism.	Identical
ParticulateMatter andBiocompatibility	Particle Counts less than limits for LargeVolume Injections per USP <788>;Biocompatible per ISO 10993-1 battery oftests for Externally Communicating BloodPath Indirect Contact for prolongedperiods >24 hours.	Particle Counts less than limits forLarge Volume Injections per USP<788>; Biocompatible per ISO 10993-1battery of tests for ExternallyCommunicating Blood Path IndirectContact for prolonged periods >24hours.	Identical
Interaction withOther MedicalTechnology	CoStorSol® plus G is not intended forcontinuous perfusion. Standardtransplantation surgical expertise andtechniques are required.	CoStorSol® is not intended forcontinuous perfusion. Standardtransplantation surgical expertise andtechniques are required.	Identical

Continued next page

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BIOCOMPATIBILITY, STERILIZATION, PACKAGING, AND BENCH TESTING

Test results have shown CoStorSol® plus G to be a biocompatible solution, supplied in flexible solution bags made of laminated plastic with an ethylene-vinyl-acetate (EVA) layer contacting the solution, 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,

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including: cytotoxicity, acute systemic toxicity, dermal sensitization, hemolysis, and intracutaneous reactivity/irritation. Particulate matter does not exceed the limits set in USP Section <788>, for large volume injections.

The 1 Liter of CoStorSol®, and the single vial of glutathione, are both supplied sterile and nonpyrogenic in order to assure safety for transplant recipients.

Sterilization processes for CoStorSol® plus G were validated according to the ISO 13408 series applicable to aseptic filling, or the ISO 11137 series of standards application to radiation sterilization, as appropriate.

Preservation Solutions, Inc. has validated shelf life for CoStorSol® plus G using a combination of accelerated aging and natural aging protocols, supporting expiry periods of up to 1 year. Shelf life verification tests show that aged CoStorSol® plus G remains functionally equivalent to newly manufactured solution via tests for biocompatibility, particulate matter, chemical identity, general appearance, weight loss, and package integrity.

CONCLUSION

The above statements establish substantial equivalence between the predicate CoStorSol® product, and CoStorSol® plus G.

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).