(64 days)
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
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.
Here's an analysis of the provided text regarding the RM3 Renal Preservation System, broken down by your requested categories.
Important Note: The provided text is a 510(k) Summary and FDA Clearance Letter. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific acceptance criteria and performance metrics for a new device. Therefore, much of the information you requested regarding study design, acceptance criteria, and quantitative performance will likely be absent or only indirectly inferable, as the primary justification for clearance is the similarity to an already approved device.
Acceptance Criteria and Study Details for RM3 Renal Preservation System
1. Table of acceptance criteria and the reported device performance
The provided 510(k) summary and FDA letter do not specify quantitative acceptance criteria or detailed reported device performance metrics for the RM3 Renal Preservation System in the way one might see for a diagnostic AI or imaging device. The core of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device (also the "RM3 Renal Preservation System").
Therefore, the "acceptance criteria" here are implicitly tied to maintaining the same safety and effectiveness as the predicate. The "reported device performance" is essentially that it functions equivalently to the predicate.
| Criteria Category | Specific Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance (Inferred from 510(k)) |
|---|---|---|
| Intended Use | Maintain kidneys for transplant. | Identical to predicate device. |
| Methodology | Perfusion and monitoring of kidneys. | Identical to predicate device. |
| Safety | No new safety concerns. | Material change evaluated through risk analysis and biomaterial safety assessment; no new questions of safety raised. |
| Effectiveness | Function as a renal preservation system. | Substantially similar to predicate in design, configuration, and materials; control unit identical. |
| Material Change | Improve manufacturability without impacting safety or effectiveness. | Successfully improved manufacturability without raising new safety/effectiveness questions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The 510(k) summary describes a comparison to a predicate device (also named "RM3 Renal Preservation System") and mentions a "risk analysis and a biomaterial safety assessment" for a material change. This is typically a technical/engineering assessment, not a clinical study involving a "test set" of patient data or clinical outcomes. No details on sample size, data provenance, or study type (retrospective/prospective) are present because a clinical study of this nature was likely not required for this type of 510(k) clearance based on substantial equivalence to an identical predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable/Not provided. There is no mention of a "test set" or "ground truth" establishment by experts in the context of clinical performance, as this was not a clinical effectiveness study. The evaluation focused on engineering and material equivalence to the predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. No clinical test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not provided. This device is a renal preservation system, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant to its function and was not performed or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a physical system that performs renal perfusion and monitoring, not an algorithm. Its operation is inherently "standalone" in mechanical function, but "human-in-the-loop" is always present for medical device use (e.g., technicians operating it, surgeons using the preserved organ). This question is framed for AI/software, which isn't the primary nature of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. For the material change, the "ground truth" was likely established through engineering specifications, material testing standards, risk assessments (e.g., ISO standards), and biomaterial safety assessments, rather than clinical outcome data or expert consensus on clinical cases. For the device as a whole, the "ground truth" for its function and safety is its predicate device.
8. The sample size for the training set
Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there is no training set mentioned, this question is not applicable.
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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.
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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.
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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
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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)
§ 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).