The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic 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

The BEL-GEN® Cold Storage Solution (BEL-GEN Solution) is clear to light yellow, sterile and pyrogen-free solution. BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L and a pH of 7.4 at 20°C.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BEL-GEN® Cold Storage Solution:

Important Note: The provided text is a 510(k) summary and FDA clearance letter for a medical device (BEL-GEN® Cold Storage Solution). This type of regulatory document primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria as one might find for a novel diagnostic AI algorithm. Therefore, many of the requested fields related to AI model performance, expert ground truth, and comprehensive clinical study design are not applicable or not present in this document.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use Equivalence	Identical intended use as predicate device (SPS-1 Static Preservation Solution)	The BEL-GEN Solution has an identical intended use to the SPS-1 predicate.
Chemical Composition Equivalence	Identical chemical composition as predicate device (SPS-1 Static Preservation Solution)	The BEL-GEN Solution has an identical chemical composition to the SPS-1 predicate.
Principle of Operation Equivalence	Identical principle of operation as predicate device (SPS-1 Static Preservation Solution)	The BEL-GEN Solution has an identical principle of operation to the SPS-1 predicate.
Sterility	Must be sterile	The BEL-GEN Solution is sterile.
Pyrogenicity	Must be pyrogen-free	The BEL-GEN Solution is pyrogen-free.
Clarity	Clear to light yellow solution	The BEL-GEN Solution is clear to light yellow.
Osmolality	Approximate osmolality of 320 mOsm/kg	The BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg.
Sodium Concentration	Sodium concentration of 29 mmol/L	The BEL-GEN Solution has a sodium concentration of 29 mmol/L.
Potassium Concentration	Potassium concentration of 125 mmol/L	The BEL-GEN Solution has a potassium concentration of 125 mmol/L.
pH	pH of 7.4 at 20°C	The BEL-GEN Solution has a pH of 7.4 at 20°C.
Biocompatibility	No new questions of safety or effectiveness compared to predicate	Evaluated through biocompatibility testing; results did not raise new questions of safety or effectiveness.
Stability	No new questions of safety or effectiveness compared to predicate	Evaluated through stability testing; results did not raise new questions of safety or effectiveness.
Chemical Identity	No new questions of safety or effectiveness compared to predicate	Evaluated through chemical identity testing; results did not raise new questions of safety or effectiveness.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- The document does not describe a "test set" in the context of an AI algorithm or a clinical trial with a defined patient sample size. The substantial equivalence determination is based on the chemical and physical properties of the solution and container, as well as its intended use.
- Data provenance for specific tests (biocompatibility, stability, chemical identity) is not specified, but these are typically conducted in-house by the manufacturer or by contract labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI diagnostic device and does not involve expert-established ground truth for a test set in that sense. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the adherence of the new device to its specified chemical and physical properties.
Adjudication method for the test set:
- Not applicable. No "test set" or adjudication method in the context of AI algorithm evaluation is described.
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:
- Not applicable. This is a cold storage solution for organs, not an AI diagnostic device. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical solution, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the substantial equivalence claim relies on:
  - The established safety and effectiveness of the predicate device (SPS-1 Static Preservation Solution).
  - Laboratory test results demonstrating the physico-chemical properties (osmolality, pH, concentrations) of the BEL-GEN Solution.
  - Validation of device characteristics such as sterility, pyrogenicity, and biocompatibility, stability, and chemical identity of the dispensing bag.
The sample size for the training set:
- Not applicable. This is a medical solution, not an AI model, so there is no training set.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

Summary

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2 510(k) Summary

Date Prepared: May 29th, 2012

Submitter's Name / Contact Person

Submitter	Contact Person
Waters Medical Systems, LLC	Robert Warren
2112 - 15th Street NW	Phone: 507-288-7777
Rochester, Minnesota 55901	Email: bobw@wtrs.com

General Information

Trade Name	BEL-GEN® Cold Storage Solution
Common / Usual Name	Cold Storage Solution
Classification	21 CFR 876.5880
Information	Isolated kidney perfusion and transport system and accessories, Class II
Predicate Device	SPS-1™, Organ Recovery Systems, Inc.

Device Description

Intended Use / Indications

Substantial Equivalence and Summary of Studies

The BEL-GEN Cold Storage Solution device is substantially equivalent to the SPS-1 Static Preservation Solution. The BEL-GEN and SPS-1 solutions have an identical intended use, chemical composition and principle of operation. Both the subject and predicate device are sterile, non-pyrogenic, transparent solutions dispensed from a bag. Technological difference in the dispensing bag has been evaluated through biocompatibility, stability and chemical identity testing. Results of these evaluations did not raise any new questions of safety or effectiveness when compared to the predicate device and therefore the BEL-GEN Solution is substantially equivalent to the SPS-1 predicate.

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Public Health Service

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

June 14, 2013

Waters Medical Systems, LLC % Mr. Robert Warren General Manager 2112 - 15th Street NW ROCHESTER MN 55901

Re: K121618

Trade/Device Name: BEL-GEN® Cold Storage Solution Regulation Number: 21 CFR& 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDL, KDN · Dated: May 31, 2013

Received: June 7, 2013

Dear Mr. Warren:

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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Page 2 - Mr. Robert Warren

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Herbert PM Derner -S

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

Enclosure

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Indications for Use

K121618 510(k) Number (if known):

BEL-GEN® Cold Storage Solution Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Herbert開@erner -S

K121618

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).