(175 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on controlling and monitoring perfusion parameters, and the performance studies are based on standard engineering and safety tests.
Yes
The device is used for the preservation of donor kidney organs before transplantation, which is a therapeutic intervention.
No
The device is intended for the preservation and eventual transplantation of kidneys through pulsatile hypothermic machine perfusion, and it monitors and controls perfusion parameters. It does not perform any diagnostic function.
No
The device description explicitly states that the RM4 Control Unit is part of a larger system that includes hardware components like a control unit, organ cassette, power cord, and accessories. The performance studies also include hardware-related testing such as electrical safety, electromagnetic compatibility, and testing of sensors, pumps, and the cooling system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the pulsatile hypothermic machine perfusion of kidneys for preservation and eventual transplantation. This is a process performed on the organ itself, outside of the body, to maintain its viability for transplantation. It does not involve testing or analyzing samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for a health issue.
- Device Description: The device controls and monitors the perfusion process. It handles the organ and the perfusate solution. It does not interact with patient samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
- Measuring analytes in a sample.
The device is a medical device used for organ preservation, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The RM4 control unit, as part of the RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.
Product codes (comma separated list FDA assigned to the subject device)
KDN
Device Description
The RM4 Control Unit controls kidney perfusion of hypothermic physiologic solutions and monitors, displays, trends, and saves the perfusion parameters. The RM4 Control Unit is part of the RM4 Kidney Perfusion System (RM4), which is a lightweight and compact renal perfusion system intended to provide controlled perfusion of a hypothermic physiologic solution for the preservation of donor kidney organs before transplantation into the recipient. The RM4 Control Unit is used with a sterile, disposable, singleuse, organ cassette intended to receive one or two kidneys from the same donor. The system is provided with a power cord and a USB flash drive that contains the instructions for use, and is intended to be used with an organ cassette and accessories including an insulation cover, and various cannulas/clamps for arterial cannulation of the kidneys to the perfusate circuit into the cassette.
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
healthcare professional environment.
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)
Verification and validation testing was conducted on the subject device to ensure that these differences do not impact the safety and effectiveness of the subject device compared to the predicate device. Testing included sensors performance testing, pulsatile pump testing, cooling system testing, operational testing, bubble priming testing, power management testing, and accessories compatibility verification testing.
Software Validation: Software validation was conducted to ensure that the software of the RM4 does not raise new issues of safety and effectiveness compared to the RM3.
Non-Clinical Testing: Software Verification and Validation (IEC 62304:2006/Amd 1:2015, ISO 14971:2019), Electrical Safety and Electromagnetic Compatibility (ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2 Edition 4.0 2014-02, IEC 62133 Edition 2.0 2012-12, IEC 60601-1-8 Edition 2.1 2012-11), Performance Testing (sensors performance testing, pulsatile pump testing, cooling system testing, operational testing, bubble priming testing, power management testing, and accessories compatibility verification testing).
Results: The results of these tests indicate that the RM4 Control Unit 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.
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
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
October 15, 2021
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
K211224 Trade/Device Name: RM4 control unit Regulation Number: 21 CFR 876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Code: KDN Dated: September 14, 2021 Received: September 17, 2021
Dear Matthieu Prouteau:
Re:
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.
1
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.
for Glenn B. Bell, Ph.D. 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211224
Device Name RM4 control unit
Indications for Use (Describe)
The RM4 control unit, as part of the RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.
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 on the left side of the logo. A white line runs vertically down the middle of the logo, separating the letters from the right side of the logo. The logo has rounded corners.
K211224 Page 1 of 3
Traditional 510(k) Premarket Notification RM4 Control Unit
510(k) Summary
[As Required by 21 CFR 807.92(c)]
Written on April, 20 2021
Manufacturer:
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 Affairs and Regulatory Affairs
Device Information
| Trade Name: | RM4 control unit |
|---|---|
| Common Name: | System, Perfusion, Kidney |
| Regulation Description: | Isolated kidney perfusion and transport system and accessories |
| Regulation Number: | 21 CFR 876.5880 |
| Class: | Class II |
| Product Code: | KDN |
| Premarket Review: | Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A) |
| Review Panel: | Gastroenterology/Urology |
Predicate Device Identification
RM3 Renal Preservation System - Control Unit (Waters Instruments, Inc.) - K971571 (The predicate device has not been subject to a design-related recall)
Device Description
The RM4 Control Unit controls kidney perfusion of hypothermic physiologic solutions and monitors, displays, trends, and saves the perfusion parameters. The RM4 Control Unit is part of the RM4 Kidney Perfusion System (RM4), which is a lightweight and compact renal perfusion system intended to provide controlled perfusion of a hypothermic physiologic solution for the preservation of donor kidney organs before transplantation into the recipient. The RM4 Control Unit is used with a sterile, disposable, singleuse, organ cassette intended to receive one or two kidneys from the same donor. The system is provided with a power cord and a USB flash drive that contains the instructions for use, and is intended to be used with an organ cassette and accessories including an insulation cover, and various cannulas/clamps for arterial cannulation of the kidneys to the perfusate circuit into the cassette.
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Image /page/4/Picture/0 description: The image is a logo for IGL, which is displayed on a blue square with rounded corners. The letters "IGL" are in white and are stacked on top of each other on the left side of the square. A white, vertical, jagged line runs down the middle of the square, separating the letters from the right side of the square. The blue color of the square is a medium shade of blue.
Traditional 510(k) Premarket Notification RM4 Control Unit
Indications for Use
The RM4 control unit, as part of the RM4 Kidney Perfusion System is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.
Comparison of Technological Characteristics
The subject device has the same intended use as the predicate device. The indications for use of the subject device were updated compared to the predicate device to better reflect the conditions of use of the device. While the indications for use statements are not identical, the conditions and environments of use of the subject device are identical to the ones of the predicate device and do not affect the determination of substantial equivalence. As a modernized version of the predicate device, the subject device has identical features and principle of operation as the predicate device. Both devices use the same disposable organ cassette and present similar technical specifications. The main differences between the subject device and the predicate device are the design and the software.
The design and internal components of the RM4 Control Unit were changed compared to the predicate RM3 Control Unit in order to optimize the dimensions and weight of the device to facilitate its manipulation, as well as to improve the performance of the device. Verification and validation testing was conducted on the subject device to ensure that these differences do not impact the safety and effectiveness of the subject device compared to the predicate device. Testing included sensors performance testing, pulsatile pump testing, cooling system testing, operational testing, bubble priming testing, power management testing, and accessories compatibility verification testing.
The software of the subject device was redesigned compared to the predicate device in order to provide a more user-friendly interface without changing the main features. Software validation was conducted to ensure that the software of the RM4 does not raise new issues of safety and effectiveness compared to the RM3.
Summary of Non-Clinical Testing
No performance standards have been established by FDA for the RM4 Control Unit. The following tests were performed to demonstrate safety based on current industry standards:
Software Verification and Validation: The software development and testing were executed according to the following standards:
- -IEC 62304:2006/Amd 1:2015 Medical device software - Software life cycle processes
- ISO 14971:2019 Medical devices Application of risk management to medical devices -
Electrical Safety and Electromagnetic Compatibility: The subject device was tested for compliance to the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment -- Part 1: -General requirements for basic safety and essential performance
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Image /page/5/Picture/0 description: The image is a logo for IGL, which is displayed on a blue square with rounded corners. The letters "IGL" are in white and are stacked on top of each other on the left side of the square. A white, jagged line runs vertically down the center of the square, separating the letters from the rest of the blue background.
Traditional 510(k) Premarket Notification RM4 Control Unit
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance — Collateral Standard: Electromagnetic disturbances — Requirements and tests
- -IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
- -IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment. General requirements for safety. Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical system
Performance Testing: The performance testing of the subject device included sensors performance testing, pulsatile pump testing, cooling system testing, operational testing, bubble priming testing, power management testing, and accessories compatibility verification testing.
The results of these tests indicate that the RM4 Control Unit is substantially equivalent to the predicate device.
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 new issues of safety and effectiveness compared to the predicate device. The indications for use, technological characteristics, and performance characteristics of the RM4 Control Unit are assessed to be substantially equivalent to the predicate device.