K Number

Device Name

PERF-GEN Pulsatile Perfusion Solution

Manufacturer

Institut Georges Lopez

Date Cleared

2022-06-14

(32 days)

Product Code

KDL

Regulation Number

876.5880

Intended Use

The PERF-GEN Pulsatile Perfusion is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Device Description

Institut Georges Lopez manufactures the PERF-GEN Pulsatile Perfusion Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, often referred to as "Belzer-MPS solution" used as kidney flushing and perfusion storage solution. 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). The PERF-GEN Pulsatile Perfusion Solution is a clear to light yellow, sterile, non-pyrogenic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. PERF-GEN Pulsatile Perfusion Solution has an osmolality of 300 mOsm/kg, a total sodium concentration of 100 mmol/L, a total potassium concentration of 25 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter bags with a shelf life of 18 months. The PERF-GEN Pulsatile Perfusion Solution is used at hospital by health professionals. The PERF-GEN Pulsatile Perfusion Solution must be cooled to +2°C and +8°C (35.6-46.5°F) prior to use. The colution is used for the in-vitro flushing and temporary continuous perfusion of explanted kidneys.

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

K121736

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a chemical solution for organ preservation and does not mention any computational or analytical components that would utilize AI/ML.

Therapeutic

No.
A therapeutic device is typically used to treat or manage a disease or condition in a living organism. This device is described as a solution for "in-vitro flushing and temporary continuous perfusion of explanted kidneys," meaning it's used on organs outside the body for preservation, rather than directly treating a patient.

Diagnostic

The device description indicates it is a "solution" used for flushing and continuous hypothermic machine perfusion of kidneys. Its purpose is to preserve the organs for transplantation, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

The device description clearly states it is a "solution" and describes its chemical composition, packaging, and physical properties. It is a liquid product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the PERF-GEN Pulsatile Perfusion Solution is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation. This is a process performed on the organ itself to preserve its viability, not to diagnose a condition or provide information about a patient's health status.
Device Description: The description details the chemical composition and physical properties of the solution used for organ preservation. It does not describe a test or assay performed on a biological sample from a patient to obtain diagnostic information.
Lack of Diagnostic Claims: There are no claims or indications that the solution is used to detect, measure, or analyze any substance or characteristic in a biological sample for diagnostic purposes.
Performance Studies: The performance studies focus on the safety and stability of the solution for its intended use in organ preservation, not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc.

In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PERF-GEN Pulsatile Perfusion Solution does not fit this definition. It is a solution used in the process of organ transplantation, which is a medical procedure, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

KDL

Device Description

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).

The PERF-GEN Pulsatile Perfusion Solution is a clear to light yellow, sterile, non-pyrogenic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. PERF-GEN Pulsatile Perfusion Solution has an osmolality of 300 mOsm/kg, a total sodium concentration of 100 mmol/L, a total potassium concentration of 25 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter bags with a shelf life of 18 months.

The PERF-GEN Pulsatile Perfusion Solution is used at hospital by health professionals. The PERF-GEN Pulsatile Perfusion Solution must be cooled to +2°C and +8°C (35.6-46.5°F) prior to use. The colution is used for the in-vitro flushing and temporary continuous perfusion of explanted kidneys.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

kidneys

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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)

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

The PERF-GEN Pulsatile Perfusion 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 PERF-GEN Pulsatile Perfusion 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 PERF-GEN Pulsatile Perfusion 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℃ (35.6° - 77°F) does not affect the product specifications for the PERF-GEN Pulsatile Perfusion Solution labeled with 18 months shelf life.

The results of these tests indicate that PERF-GEN Pulsatile Perfusion is substantially equivalent to the predicate device.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121736

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 14, 2022

Institut Georges Lopez Matthieu Prouteau Director of Quality Affairs and Regulatory Affairs Parc Tertiaire du Bois Dieu RN6 - 1 Allee des Chevreuils Lissieu. 69380 France

Re: K221386

Trade/Device Name: PERF-GEN Pulsatile Perfusion 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-reportingcombination-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 mediation-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)

Device Name

PERF-GEN Pulsatile Perfusion Solution

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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Image /page/3/Picture/0 description: The image is a square logo with a blue background. The letters "IGL" are written in white, with the "I" and "L" being larger than the "G". A white, jagged line runs vertically through the middle of the logo, appearing like a crack or a stylized design element. The overall impression is clean and professional, possibly representing a company or organization with the initials IGL.

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:	PERF-GEN Pulsatile Perfusion Solution
Common Name:	Pulsatile Perfusion Solution
Regulation Description:	Isolated kidney perfusion and transport system and accessories
Regulation Number:	21 CFR 876.5880
Class:	Class II
Product Code:	KDL

III. Predicate Devices Identification

PERF-GEN Pulsatile Perfusion Solution - Waters Instruments, Inc. - K121736

IV. Device Description

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).

Confidential

Image /page/4/Picture/0 description: The image is a square logo with a blue background. The letters "IGL" are displayed in white, with the "I" and "GL" on either side of a white, vertical, jagged line that appears to be a crack. The letters are in a serif font and are large and bold.

V. Indications for Use

VI. Comparison of Technological Characteristics

The PERF-GEN Pulsatile Perfusion Solution received substantial equivalence determination after submission premarket notification (510(k) number K121736). Modified PERF-GEN Pulsatile Perfusion Solution is an extension of shelf life and storage conditions from the predicate.

The subject device PERF-GEN Pulsatile Perfusion Solution is labeled as sterile with a 18 months shelf life at 2-25°C whereas the predicate solution with a 12 months shelf life at 2-8°C. However, both solutions must be cooled to 2-8°C and do not need to be filtered before use.

The PERF-GEN Pulsatile Perfusion Solution is substantially equivalent to the predicate device. The subject device has the same intended use, indication for use and the principle of operation as the predicate device. The subject and predicate have the same pH, osmolality, and chemical composition based on Belzer MPS solution.

The subject and predicate device are sterile, single use, non-pyrogenic and transparent solutions. Both solutions are sterilized by filtration and aseptically filled in similar design dispensing bags (3 ports) and made in 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	Comparison
Device	PERF-GEN Pulsatile
Perfusion Solution	PERF-GEN Pulsatile
Perfusion Solution
510(k) Number	K221386	K121736
Manufacturer	Institut Georges Lopez,
France	Institut Georges Lopez,
France	-
Classification
& Product
Code	876.5880, KDL	876.5880, KDL	Same
Device
Classification
Name	Isolated kidney perfusion and
transport system and
accessories	Isolated kidney perfusion and
transport system and
accessories	Same
Device
Description	The PERF-GEN Pulsatile
Perfusion Solution is a clear
to light yellow, sterile and
non-pyrogenic solution.	The PERF-GEN Pulsatile
Perfusion Solution is a clear
to light yellow, sterile and
non-pyrogenic solution.	Same
Format	The solution is packaged in
1-liter bags	The solution is packaged in
1-liter bags	Same
	Subject Device	Primary Predicate	Comparison
Intended use	The PERF-GEN Pulsatile
Perfusion Solution is
intended to be used for
flushing and continuous
hypothermic machine
perfusion of kidneys at the
time of their removal from
the donor in preparation for
storage, transportation, and
eventual transplantation into
a recipient.	The PERF-GEN Pulsatile
Perfusion Solution is
intended to be used for
flushing and continuous
hypothermic machine
perfusion of kidneys at the
time of their removal from
the donor in preparation for
storage, transportation, and
eventual transplantation into
a recipient.	Same
Solution Type	Extracellular
Na+ 100 mmol/L
K+ 25 mmol/L	Extracellular
Na+ 100 mmol/L
K+ 25 mmol/L	Same
Composition	Calcium Chloride Dihydrate
(0.068 g/L) ; Sodium
gluconate (17.45 g/L) ;
Adenine (0.68 g/L) ;
Potassium Phosphate
monobasic (3.4 g/L) ;
Pentafraction (HES) (50 g/L)
; Magnesium gluconate (1.13
g/L) - HEPES (2.38 g/L) -
Glucose (1.80 g/L) ;
Glutathione (0.92 g/L) -
Ribose (0.75 g/L) ; Mannitol
(5.4 g/L) ; Sodium
Hydroxide (qs pH 7.4) -
Water for injection (qs 1
litre)	Calcium Chloride Dihydrate
(0.068 g/L) ; Sodium
gluconate (17.45 g/L) ;
Adenine (0.68 g/L) ;
Potassium Phosphate
monobasic (3.4 g/L) ;
Pentafraction (HES) (50 g/L)
; Magnesium gluconate (1.13
g/L) - HEPES (2.38 g/L) -
Glucose (1.80 g/L) ;
Glutathione (0.92 g/L) -
Ribose (0.75 g/L) ; Mannitol
(5.4 g/L) ; Sodium
Hydroxide (0.70 g/L) - Water
for injection (qs 1 litre)	Same
pH at room
temperature	7.4	7.4	Same
Osmolality	300 mOsm/Kg	300 mOsm/Kg	Same
Sterility	Sterile solution	Sterile solution	Same
Sterilization
Method	Aseptic filtration (sterile A)	Aseptic filtration (sterile A)	Same
Single use	Yes	Yes	Same
Filtration
required before
use?	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)	Same
Shelf life	18 months (1.5 years)	12 months (1 year)	Shelf life Extension from
predicate.
Storage
Condition	Room temperature (2-25°C)
(35.6° - 77°F)	Room temperature (2-8°C)
(35.6° - 46.4°F)	Storage conditions
extension from predicate.
Pre-use
conditions	Cool at 2-8°C
(35.6° - 46.5°F)	Cool at 2-8°C
(35.6° - 46.5°F)	Same

Confidential

Image /page/5/Picture/0 description: The image shows a blue square with the letters "IGL" in white. A white vertical line runs through the middle of the square, creating a visual separation. The letters are stacked vertically, with "I" on top and "GL" on the bottom.

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 between the "I" and "G", resembling a lightning bolt or a crack. The logo has rounded corners.

VII. Summary of Non-Clinical Testing

No performance standards have been established by FDA for the PERF-GEN Pulsatile Perfusion Solution.

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

-The PERF-GEN Pulsatile Perfusion 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 PERF-GEN Pulsatile Perfusion 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 PERF-GEN Pulsatile Perfusion 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℃ (35.6° - 77°F) does not affect the product specifications for the PERF-GEN Pulsatile Perfusion Solution labeled with 18 months shelf life.

The results of these tests indicate that PERF-GEN Pulsatile Perfusion is substantially equivalent to the predicate device.

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 device. The indications for use, technological characteristics, and performance characteristics of the PERF-GEN Pulsatile Perfusion Solution stored for up to 18 months at 2-25°C (35.6° - 77°F) assessed to be substantially equivalent to the predicate device.