BEL-GEN Cold Storage Solution
Device Facts
| Record ID | K221387 |
|---|---|
| Device Name | BEL-GEN Cold Storage Solution |
| Applicant | Institut Georges Lopez |
| Product Code | KDL · Gastroenterology, Urology |
| Decision Date | Jun 14, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5880 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for 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 Story
BEL-GEN Cold Storage Solution is a sterile, non-pyrogenic, clear-to-light-yellow solution based on the Belzer UW solution formulation. It contains soluble colloids, buffers, sodium/potassium salts, redox stabilizers, and phosphoric compounds to support tissue viability by facilitating ATP regeneration. Used by healthcare professionals in hospitals, the solution is cooled to 2-6°C and used to flush isolated organs immediately before or after removal from the donor. It remains in the organ vasculature during hypothermic storage and transport to lower metabolic requirements. The device is supplied in 1-liter or 2-liter EVA bags. It benefits patients by preserving organ viability for transplantation.
Clinical Evidence
Bench testing only. Biocompatibility testing performed per ISO 10993 (cytotoxicity, skin sensitization, primary skin irritation, hemolysis, acute systemic toxicity). Sterilization validation performed per ISO 13408-1 and ISO 13408-2. Stability testing confirmed product specifications are maintained over a 2-year shelf life at 2-25°C.
Technological Characteristics
Intracellular-type preservation solution; pH 7.4; osmolality 320 mOsm/kg. Composition: Pentafraction (HES), Lactobionic acid, Potassium Phosphate, Magnesium Sulfate, Raffinose, Adenosine, Allopurinol, Glutathione, Potassium Hydroxide, Sodium Hydroxide, Water for injection. Packaging: 1L/2L EVA bags with 3 ports. Sterilization: Aseptic filtration. Storage: 2-25°C.
Indications for Use
Indicated for flushing and hypothermic storage of kidney, liver, and pancreas organs during organ removal from donors, in preparation for storage, transport, and transplantation into recipients.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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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.
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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); 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
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## Indications for Use
510(k) Number (if known) K221387
Device Name BEL-GEN Cold Storage Solution
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | <table><tr><td><svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M3,3 L13,13 M13,3 L3,13" stroke="black" stroke-width="2"></path> </svg> Repackaging Use (Part 21 CFR 201.2 Subject to Phase I) </td><td><svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 201.2 Subject to Phase I) </td></tr></table> | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M3,3 L13,13 M13,3 L3,13" stroke="black" stroke-width="2"></path> </svg> Repackaging Use (Part 21 CFR 201.2 Subject to Phase I) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 201.2 Subject to Phase I) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M3,3 L13,13 M13,3 L3,13" stroke="black" stroke-width="2"></path> </svg> Repackaging Use (Part 21 CFR 201.2 Subject to Phase I) | <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> 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
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.
Confidential
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K221387 Page 2 of 5
Traditional 510(k) Premarket Notification BEL-GEN Cold Storage Solution
#### V. Indications for 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.
#### 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<br>Storage Solution | BEL-GEN Cold<br>Storage Solution | CoStorSol® | |
| 510(k) Number | K221387 | K121618 | K091245 | |
| Manufacturer | Institut Georges<br>Lopez,<br>France | Institut Georges<br>Lopez,<br>France | Preservation Solutions,<br>Inc.<br>WI, USA | NA |
| Classification<br>& Product<br>Code | 876.5880, KDL, KDN | 876.5880, KDL, KDN | 876.5880, KDN | Same, except for<br>secondary<br>predicate |
| Device<br>Classification<br>Name | Isolated kidney<br>perfusion and transport<br>system and accessories | Isolated kidney<br>perfusion and transport<br>system and accessories | Isolated kidney<br>perfusion and transport<br>system and accessories | Same |
| Device<br>Description | The BEL-GEN Cold<br>Storage Solution is a<br>clear to light yellow,<br>sterile and non-<br>pyrogenic solution. | The BEL-GEN Cold<br>Storage Solution is a<br>clear to light yellow,<br>sterile and non-<br>pyrogenic solution. | CoStorSol® is a clear<br>to light yellow, sterile<br>and non-pyrogenic<br>solution. | Same |
| | Subject Device | Primary Predicate | Secondary Predicate | Comparison |
| Format | The solution is<br>packaged in 1-liter<br>and 2-liter bags | The solution is<br>packaged in 1-liter<br>bags | The solution is<br>packaged in 1-liter<br>bags | Similar<br>The 2-liter format<br>is added for the<br>subject device |
| Intended use | The BEL-GEN Cold<br>Storage Solution is<br>intended for the<br>flushing and the<br>hypothermic storage of<br>kidney, liver and<br>pancreas organs at the<br>time of organ removal<br>from the donor in<br>preparation for storage,<br>transportation and<br>eventual<br>transplantation into a<br>recipient. | The BEL-GEN Cold<br>Storage Solution is<br>intended for the<br>flushing and the<br>hypothermic storage of<br>kidney, liver and<br>pancreas organs at the<br>time of organ removal<br>from the donor in<br>preparation for storage,<br>transportation and<br>eventual<br>transplantation into a<br>recipient. | CoStorSol ® is<br>intended for the<br>flushing and cold<br>storage of kidney, liver<br>and pancreas organs at<br>the time of organ<br>removal from the<br>donor in preparation<br>for storage,<br>transportation and<br>eventual<br>transplantation into a<br>recipient | Same |
| Solution Type | Intracellular<br>Na+ 29 mmol/L<br>K+ 125 mmol/L | Intracellular<br>Na+ 29 mmol/L<br>K+ 125 mmol/L | Intracellular<br>Na+ 29 mmol/L<br>K+ 125 mmol/L | Same |
| Composition | Pentafraction (HES)<br>(50 g/L) ; Lactobionic<br>acid (35.83 g/L) ;<br>Potassium Phosphate<br>monobasic (3.4 g/L) ;<br>Magnesium Sulfate<br>heptahydrate (1.23<br>g/L) ; Raffinose<br>pentahydrate<br>(17.83 g/L) ;<br>Adenosine (1.34 g/L)<br>Allopurinol (0.136<br>g/L) ; Glutathione<br>(0.922 g/L) ;<br>Potassium Hydroxide<br>(5.61 g/L) ; Sodium<br>Hydroxide (qs pH 7.4)<br>Water for injection (qs<br>1 Litre) | Pentafraction (HES)<br>(50 g/L) ; Lactobionic<br>acid (35.83 g/L) ;<br>Potassium Phosphate<br>monobasic (3.4 g/L) ;<br>Magnesium Sulfate<br>heptahydrate (1.23<br>g/L) ; Raffinose<br>pentahydrate<br>(17.83 g/L) ;<br>Adenosine (1.34 g/L)<br>Allopurinol (0.136<br>g/L) ; Glutathione<br>(0.922 g/L) ;<br>Potassium Hydroxide<br>(5.61 g/L) ; Sodium<br>Hydroxide /<br>Hydrochloric acid (qs<br>pH 7.4)<br>Water for injection (qs<br>1 Litre) | Pentafraction (HES)<br>(50 g/L) ; Lactobionic<br>acid (35.83 g/L) ;<br>Potassium Phosphate<br>monobasic (3.4 g/L) ;<br>Magnesium Sulfate<br>heptahydrate (1.23<br>g/L) ; Raffinose<br>pentahydrate<br>(17.83 g/L) ;<br>Adenosine (1.34 g/L)<br>Allopurinol (0.136<br>g/L) ; Glutathione<br>(0.922 g/L) ;<br>Potassium Hydroxide<br>(5.61 g/L) ; Sodium<br>Hydroxide(qs pH 7.4)<br>Water for injection (qs<br>1 Litre) | Same as<br>secondary<br>predicate.<br>Similar to<br>primary predicate |
| pH at room<br>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<br>Method | Aseptic filtration<br>(sterile A) | Aseptic filtration<br>(sterile A) | Aseptic filtration<br>(sterile A) | Same |
| Single use | Yes | Yes | Yes | Same |
| | Subject Device | Primary Predicate | Secondary Predicate | Comparison |
| | | | | |
| Filtration<br>required before<br>use? | No | No | No | Same |
| Dispensing bag | Dispensing bags are<br>made of ethylene-vinyl<br>acetate (EVA) as fluid<br>contact layer, with 3<br>tubing connections<br>(ports) | Dispensing bags are<br>made of ethylene-vinyl<br>acetate (EVA) as fluid<br>contact layer, with 3<br>tubing connections<br>(ports) | Dispensing bags are<br>made of ethylene-vinyl<br>acetate (EVA) as fluid<br>contact layer, with 3<br>tubing connections<br>(ports) | Same |
| Shelf life | 24 months (2 years) | 12 months (1 year) | 24 months (2 years) | Same as<br>secondary<br>predicate.<br>Shelf life<br>Extension from<br>primary predicate. |
| Storage<br>Condition | Room temperature (2-<br>25°C)<br>(35.6° - 77°F) | Room temperature (2-<br>8°C)<br>(35.6° - 46.4°F) | Room temperature (2-<br>25°C)<br>(35.6° - 77°F) | Same as<br>secondary<br>predicate.<br>Storage<br>conditions<br>extension from<br>primary predicate. |
| Pre-use<br>conditions | Cool at 2-6°C | Cool at 2-6°C | Cool at 2-6°C | Same |
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# Traditional 510(k) Premarket Notification
Confidential
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### 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.
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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.
