(64 days)
RM3 Renal Preservation System
Not Found
No
The description focuses on controlled perfusion, monitoring of physical parameters (flow, temperature, pressure, resistance), and basic alarm/data logging functions. There is no mention of AI/ML terms or functionalities like image analysis, predictive modeling, or adaptive control based on complex data patterns.
No
The device is described as a preservation system for organs prior to transplant, not a device used to treat a medical condition in a patient.
No
The device is for maintaining organs before transplant, not for diagnosing a medical condition.
No
The device description explicitly states it is a "two-part system comprising a control unit for perfusion and monitoring" and a "sterile, disposable single-use cassette," indicating significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- RM3 Renal Preservation System Function: The RM3 system is designed to maintain and preserve organs (kidneys) for transplant. It works directly with the organ itself, not with specimens taken from a patient. It monitors and controls the environment and flow of solutions around the organ.
The description clearly indicates its purpose is organ preservation and transportation, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
Product codes
KDK, KDN
Device Description
The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.
The RM3 Renal Preservation System is a two-part system comprising a control unit for perfusion and monitoring of one or two kidneys, and a sterile, disposable single-use cassette used to contain and circulate perfusate to the 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
Not Found
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)
Not Found
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.
RM3 Renal Preservation System
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
§ 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).
0
510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Submitter's Name / Contact Person
| Manufacturer | Contact Person |
|---|---|
| Waters Medical Systems | Dave Schollman |
| 2112 Fifteenth Street NW, Suite A | General Manager |
| Rochester MN 55903-6117 | Tel: (800)426-9877; Fax: (507)252-3700 |
| 2. General Information | |
| Trade Name | RM3 Renal Preservation System |
| Trade Name | RM3 Renal Preservation System |
|---|---|
| Common / Usual Name | Renal preservation system |
| Classification Name | Isolated kidney perfusion and transport system and accessories |
| Identification of Equivalent Devices | Waters Medical Systems - RM3 Renal Preservation System |
3. Intended Use
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
4. Device Description
The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.
The RM3 Renal Preservation System is a two-part system comprising a control unit for perfusion and monitoring of one or two kidneys, and a sterile, disposable single-use cassette used to contain and circulate perfusate to the kidneys.
5. Substantial Equivalence Comparison
The proposed RM3 Renal Preservation System and the predicate RM3 Renal Preservation System are identical in intended use and methodology. The two systems are substantially similar in system components; they share an identical control unit and both utilize a sterile, single-use, disposable cassette. The cassette module for both the subject and predicate devices are substantially similar in design, configuration and materials. A minor material change in the cassette will improve manufacturability. The material change has been evaluated through risk analysis and a biomaterial safety assessment following established Design Control procedures. The disposable cassette module material changes raise no new questions of safety or effectiveness.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2006
Mr. Dave Schollman General Manager Waters Medical Systems™ 13705 26th Avenue North, Suite 102 MINNEAPOLIS MN 55441-3644
Re: K053169
Trade/Device Name: RM3 Renal Preservation System Regulation Number: 21 CFR §876.5880 Regulation Name: Isolated kidney perfusion and transport system and accessories Regulatory Class: II Product Codes: KDK and KDN Dated: December 21, 2005 Received: December 27, 2005
Dear Mr. Schollman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms leae. with anow yours obgen mating of substantial equivalence of your device to a legally prematics notheation: "The PDF maning was ification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acreer of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, process note the regulation charaly cornation on your responsibilities under the Act from the 807.77). I va may ootan other general meeting and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _
: K053/69
Device Name: RM3 Renal Preservation System
Indications for Use:
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ____ (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)
Nancy C. Brogdon
(Division Sign-Off)
Division of Repr and Radiological I 510(k) Number
Page __ of ___
(Posted November 13, 2003)