K Number

Device Name

BEL-GEN Cold Storage Solution

Manufacturer

Institut Georges Lopez

Date Cleared

2022-06-14

(32 days)

Product Code

KDL

Regulation Number

876.5880

Intended Use

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

Institut Georges Lopez manufactures the BEL-GEN Cold Storage Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, 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). The BEL-GEN Cold Storage Solution is a clear to light yellow single use, sterile and non-pyrogenic solution. BEL-GEN Cold Storage Solution has an osmolality of 320 mOsm/kg, a total sodium concentration of 29 mmol/L, a total potassium concentration of 125 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter or 2-liter bags with a shelf life of 2 years. The BEL-GEN Cold Storage solution is used at hospital by health professionals. The BEL-GEN Cold Storage solution must be cooled to +2°C (36° and 43°F) prior to use The cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation to cool the organ and lower its metabolic requirements.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

["K121618", "K091245"]

Reference Devices

KDL, KDN

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a chemical solution for organ preservation and does not involve any computational or analytical components.

Therapeutic

No.
The primary purpose of the solution is for the preservation and storage of organs for transplantation, which is a supportive function to a therapeutic procedure rather than a direct therapeutic effect on a patient. While it aids in the eventual transplantation, the solution itself is not treating a disease or condition in a living patient; it maintains the viability of the organ ex vivo.

Diagnostic

The device is a cold storage solution used for preserving organs for transplantation. It does not diagnose any condition or disease.

SaMD (Software as a Medical Device)

The device description clearly states it is a "solution" with a specific chemical formulation, packaged in bags, and used for flushing and storing organs. This is a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the BEL-GEN Cold Storage Solution is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the flushing and hypothermic storage of organs (kidney, liver, pancreas) for transplantation. This is a procedure performed on the organ itself, outside of the body, to preserve its viability.
Device Description: The description details the chemical composition and physical properties of the solution used for organ preservation.
Lack of Diagnostic Purpose: There is no mention of the device being used to analyze a sample from the human body to provide information for diagnosis, monitoring, or screening. IVDs are typically used to test blood, urine, tissue, or other bodily fluids.
Anatomical Site: The anatomical site is the organ itself, not a sample taken from a patient.
Performance Studies: The performance studies focus on the safety and stability of the solution for organ preservation, not on diagnostic accuracy or performance metrics like sensitivity or specificity.

The BEL-GEN Cold Storage Solution is a medical device used in the process of organ transplantation, specifically for organ preservation. It does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

KDL, KDN

Device Description

The BEL-GEN Cold Storage Solution is a clear to light yellow single use, sterile and non-pyrogenic solution. BEL-GEN Cold Storage Solution has an osmolality of 320 mOsm/kg, a total sodium concentration of 29 mmol/L, a total potassium concentration of 125 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter or 2-liter bags with a shelf life of 2 years.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

kidney, liver and pancreas organs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

used at hospital by health professionals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No performance standards have been established by FDA for the BEL-GEN Cold Storage Solution.

The following tests were performed to demonstrate safety based on current industry standards:

The BEL-GEN Cold Storage Solution is supplied sterile and non-pyrogenic in order to assure safety for transplant recipients. The validation of the sterilizing filtration and aseptic filling process were carried out according to ISO 13408-1 and ISO 13408-2.
-The biomaterial safety of the BEL-GEN Cold Storage Solution has been evaluated through ISO 10993 compliant testing, which included cytotoxicity test, skin sensitization test in guinea pigs, primary skin irritation, hemolysis test and acute systemic toxicity test in mice. Results of this testing, showed the BEL-GEN Cold Storage Solution is safe for the intended biocontact.
The stability testing has showed that aging of test articles at the recommended storage conditions of 2-25°C (35.6° - 77°F) does not affect the product specifications for the BEL-GEN Cold Storage Solution labeled with 2-year shelf life.

The results of these tests indicate that BEL-GEN Cold Storage Solution is substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K121618, K091245

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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June 14, 2022

Institut Georges Lopez Matthieu Prouteau Director of Quality Affairs and Regulatory Affairs Parc Tertiaire du Bois Dieu RN 6 - 1 Allee des Chevreuils Lissieu. 69380 France

Re: K221387

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: Class II Product Code: KDL Dated: May 6, 2022 Received: May 13, 2022

Dear Matthieu Prouteau:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K221387

Device Name BEL-GEN Cold Storage Solution

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Repackaging Use (Part 21 CFR 201.2 Subject to Phase I) Over-The-Counter Use (21 CFR 201.2 Subject to Phase I)	Repackaging Use (Part 21 CFR 201.2 Subject to Phase I)	Over-The-Counter Use (21 CFR 201.2 Subject to Phase I)
Repackaging Use (Part 21 CFR 201.2 Subject to Phase I)	Over-The-Counter Use (21 CFR 201.2 Subject to Phase I)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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K221387 Page 1 of 5

Traditional 510(k) Premarket Notification BEL-GEN Cold Storage Solution

510(k) Summary

[As Required by 21 CFR 807.92]

Written on June, 14 2022

I. Submitter:

Institut Georges Lopez (IGL) Parc Tertiaire du Bois Dieu RN6 - 1 allée des Chevreuils 69380 Lissieu France Telephone: +33 437 646 332 Official Contact: Matthieu Prouteau - Director of Quality and Regulatory Affairs

II. Device Information

Trade Name:	BEL-GEN Cold Storage Solution
Common Name:	Cold Storage Solution
Regulation Description:	Isolated kidney perfusion and transport system and accessories
Regulation Number:	21 CFR 876.5880
Class:	Class II
Product Code:	KDL, KDN

III. Predicate Device Identification

Primary predicate: BEL-GEN Cold Storage Solution - Waters Instruments, Inc. - K121618 Secondary predicate: CoStorSol® - Preservation Solution Inc. - K091245

IV. Device Description

The BEL-GEN Cold Storage solution is used at hospital by health professionals. The BEL-GEN Cold Storage solution must be cooled to +2°C (36° and 43°F) prior to use The cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation to cool the organ and lower its metabolic requirements.

Confidential

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K221387 Page 2 of 5

Traditional 510(k) Premarket Notification BEL-GEN Cold Storage Solution

V. Indications for Use

VI. Comparison of Technological Characteristics

The BEL-GEN Cold Storage Solution received substantial equivalence determination after submission premarket notification (510(k) number K121618). Modified BEL-GEN Cold Storage Solution is an addition of packaging size, an extension of shelf life and storage conditions from the primary predicate.

The subject device BEL-GEN Cold Storage Solution and secondary predicate are labeled as sterile with a 2-year shelf life at 2-25°C whereas the primary predicate solution with a 1 year shelf life at 2-8°C. However, all three Solutions must be cooled to 2-6°C and do not need to be filtered before use.

BEL-GEN Cold Storage Solution is substantially equivalent to primary and secondary predicate devices. The subject device has the same intended use, indication for use and the principle of operation as predicate devices. All three solutions have the same pH, osmolality, and chemical composition based on Belzer UW solution (except for Hydrochloric acid indicated in primary predicate and not necessary to adjust the pH at 7.4).

The subject and the both predicate devices are sterile, single use, non-pyrogenic and transparent solutions. All three solutions are sterilized by filtration and aseptically filled in similar design dispensing bags (3 ports) and made of EVA as fluid contact layer.

The following table provides a comparison of attributes between the subject device and the predicate devices:

	Subject Device	Primary Predicate	Secondary Predicate	Comparison
Device	BEL-GEN Cold
Storage Solution	BEL-GEN Cold
Storage Solution	CoStorSol®
510(k) Number	K221387	K121618	K091245
Manufacturer	Institut Georges
Lopez,
France	Institut Georges
Lopez,
France	Preservation Solutions,
Inc.
WI, USA	NA
Classification
& Product
Code	876.5880, KDL, KDN	876.5880, KDL, KDN	876.5880, KDN	Same, except for
secondary
predicate
Device
Classification
Name	Isolated kidney
perfusion and transport
system and accessories	Isolated kidney
perfusion and transport
system and accessories	Isolated kidney
perfusion and transport
system and accessories	Same
Device
Description	The BEL-GEN Cold
Storage Solution is a
clear to light yellow,
sterile and non-
pyrogenic solution.	The BEL-GEN Cold
Storage Solution is a
clear to light yellow,
sterile and non-
pyrogenic solution.	CoStorSol® is a clear
to light yellow, sterile
and non-pyrogenic
solution.	Same
	Subject Device	Primary Predicate	Secondary Predicate	Comparison
Format	The solution is
packaged in 1-liter
and 2-liter bags	The solution is
packaged in 1-liter
bags	The solution is
packaged in 1-liter
bags	Similar
The 2-liter format
is added for the
subject device
Intended use	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.	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.	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	Same
Solution Type	Intracellular
Na+ 29 mmol/L
K+ 125 mmol/L	Intracellular
Na+ 29 mmol/L
K+ 125 mmol/L	Intracellular
Na+ 29 mmol/L
K+ 125 mmol/L	Same
Composition	Pentafraction (HES)
(50 g/L) ; Lactobionic
acid (35.83 g/L) ;
Potassium Phosphate
monobasic (3.4 g/L) ;
Magnesium Sulfate
heptahydrate (1.23
g/L) ; Raffinose
pentahydrate
(17.83 g/L) ;
Adenosine (1.34 g/L)
Allopurinol (0.136
g/L) ; Glutathione
(0.922 g/L) ;
Potassium Hydroxide
(5.61 g/L) ; Sodium
Hydroxide (qs pH 7.4)
Water for injection (qs
1 Litre)	Pentafraction (HES)
(50 g/L) ; Lactobionic
acid (35.83 g/L) ;
Potassium Phosphate
monobasic (3.4 g/L) ;
Magnesium Sulfate
heptahydrate (1.23
g/L) ; Raffinose
pentahydrate
(17.83 g/L) ;
Adenosine (1.34 g/L)
Allopurinol (0.136
g/L) ; Glutathione
(0.922 g/L) ;
Potassium Hydroxide
(5.61 g/L) ; Sodium
Hydroxide /
Hydrochloric acid (qs
pH 7.4)
Water for injection (qs
1 Litre)	Pentafraction (HES)
(50 g/L) ; Lactobionic
acid (35.83 g/L) ;
Potassium Phosphate
monobasic (3.4 g/L) ;
Magnesium Sulfate
heptahydrate (1.23
g/L) ; Raffinose
pentahydrate
(17.83 g/L) ;
Adenosine (1.34 g/L)
Allopurinol (0.136
g/L) ; Glutathione
(0.922 g/L) ;
Potassium Hydroxide
(5.61 g/L) ; Sodium
Hydroxide(qs pH 7.4)
Water for injection (qs
1 Litre)	Same as
secondary
predicate.
Similar to
primary predicate
pH at room
temperature	7.4	7.4	7.4	Same
Osmolality	320 mOsm/Kg	320 mOsm/Kg	320 mOsm/Kg	Same
Sterility	Sterile solution	Sterile solution	Sterile solution	Same
Sterilization
Method	Aseptic filtration
(sterile A)	Aseptic filtration
(sterile A)	Aseptic filtration
(sterile A)	Same
Single use	Yes	Yes	Yes	Same
	Subject Device	Primary Predicate	Secondary Predicate	Comparison

Filtration
required before
use?	No	No	No	Same
Dispensing bag	Dispensing bags are
made of ethylene-vinyl
acetate (EVA) as fluid
contact layer, with 3
tubing connections
(ports)	Dispensing bags are
made of ethylene-vinyl
acetate (EVA) as fluid
contact layer, with 3
tubing connections
(ports)	Dispensing bags are
made of ethylene-vinyl
acetate (EVA) as fluid
contact layer, with 3
tubing connections
(ports)	Same
Shelf life	24 months (2 years)	12 months (1 year)	24 months (2 years)	Same as
secondary
predicate.
Shelf life
Extension from
primary predicate.
Storage
Condition	Room temperature (2-
25°C)
(35.6° - 77°F)	Room temperature (2-
8°C)
(35.6° - 46.4°F)	Room temperature (2-
25°C)
(35.6° - 77°F)	Same as
secondary
predicate.
Storage
conditions
extension from
primary predicate.
Pre-use
conditions	Cool at 2-6°C	Cool at 2-6°C	Cool at 2-6°C	Same

Image /page/5/Picture/0 description: The image is a blue square with the letters "IGL" in white. There is a white jagged line running vertically through the square, slightly off-center to the left. The letters are stacked vertically, with "I" on top, "G" in the middle, and "L" on the bottom.

Traditional 510(k) Premarket Notification

Confidential

Image /page/6/Picture/0 description: The image is a square logo with a blue background. The letters "IGL" are written in white, sans-serif font. A white, jagged line runs vertically through the logo, slightly off-center to the left, resembling a crack or lightning bolt. The overall design is simple and clean, with a focus on the contrast between the blue background and the white elements.

Traditional 510(k) Premarket Notification BEL-GEN Cold Storage Solution

VII. Summary of Non-Clinical Testing

No performance standards have been established by FDA for the BEL-GEN Cold Storage Solution.

The following tests were performed to demonstrate safety based on current industry standards:

The BEL-GEN Cold Storage Solution is supplied sterile and non-pyrogenic in order to assure safety for transplant recipients. The validation of the sterilizing filtration and aseptic filling process were carried out according to ISO 13408-1 and ISO 13408-2.
-The biomaterial safety of the BEL-GEN Cold Storage Solution has been evaluated through ISO 10993 compliant testing, which included cytotoxicity test, skin sensitization test in guinea pigs, primary skin irritation, hemolysis test and acute systemic toxicity test in mice. Results of this testing, showed the BEL-GEN Cold Storage Solution is safe for the intended biocontact.
The stability testing has showed that aging of test articles at the recommended storage conditions of 2-25°C (35.6° - 77°F) does not affect the product specifications for the BEL-GEN Cold Storage Solution labeled with 2-year shelf life.

The results of these tests indicate that BEL-GEN Cold Storage Solution is substantially equivalent to the predicate devices.

Image /page/7/Picture/0 description: The image is a square with rounded corners. The square is blue and has the letters "IGL" in white on it. There is a white line that looks like a crack running vertically through the middle of the square.

Traditional 510(k) Premarket Notification BEL-GEN Cold Storage Solution

VIII. Conclusion

The technological differences between the subject and predicate devices were evaluated through nonclinical testing. The results of these tests demonstrated that the subject device does not raise of safety and effectiveness compared to the predicate devices. The indications for use, technological characteristics, and performance characteristics of BEL-GEN Cold Storage Solution stored for up to 2 years at 2-25°C (35.6° - 77°F) assessed to be substantially equivalent to the predicate devices.