(66 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.
This 510(k) summary describes a re-submission for the RM3 Renal Preservation System and claims substantial equivalence to the previously cleared RM3 Renal Preservation System. Therefore, there are no new acceptance criteria or new studies described in this document. The submission references minor material changes to certain components of the organ cassette to improve manufacturability and reduce costs. It states these changes have been evaluated through risk analysis and a biomaterial safety assessment following established Design Control procedures, but it does not provide details of those evaluations or any new studies.
Here's a breakdown of why the requested information cannot be provided from the given document:
- 1. A table of acceptance criteria and the reported device performance: This document is a 510(k) summary for a device claiming substantial equivalence to a predicate device. It does not contain acceptance criteria for performance or reported device performance data from new studies.
- 2. Sample size used for the test set and the data provenance: No new test sets or studies are described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new studies are described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no new studies are described.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as no new studies are described.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device (renal preservation system), not an AI algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no new studies are described.
- 8. The sample size for the training set: Not applicable as this is not an AI algorithm.
- 9. How the ground truth for the training set was established: Not applicable as this is not an AI algorithm.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on identical intended use and methodology, with minor material changes. It does not include new performance data, clinical studies, or acceptance criteria beyond what would have been established for the original predicate device.
{0}------------------------------------------------
10→//
510(k) Summary
Kouzzzy
510(k) Summary and Certification
OCT 2 2 2004
[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 |
- General Information
| 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.
Device Description 4.
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 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. Minor material changes to certain components of the organ cassette will improve manufacturability and reduce costs. The material changes have been evaluated through risk analysis and a biomaterial safety assessment following established Design Control procedures. The RM3 Organ Cassette material changes raise no new questions of safety or effectiveness.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2004
Mr. Dave Schollman General Manager Waters Medical Systems 13705 26th Avenue N, Suite 102 MINNEAPOLIS MN 55441-3644
Re: K042224
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 Code: 78 KDN Dated: September 23, 2004 Received: September 24, 2004
Dear Mr. Schollman:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced in we nave reviewed your becalled by equivalent (for the indications for use stated in above and have decemined the devices marketed in interstate commerce prior to the enclosure) to regally manector predical Device Amendments, or to devices that have been May 26, 1978, the Claculient dato of the Federal Food, Drug, and Cosmetic Act (Act (Act (Act the reclassified in accordance with and proval application (PMA). You may, therefore, market the do not require approval of a premation of the Act. The general controls provisions of the Act. device, subject to the general connois provisions 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 If your device is classified (300 additional controls. Existing major regulations affecting your Approval), it thay be subject to sail aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device can be found in the Sourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advisou mar 1271 s tosantes of eevice complies with other requirements of the Act or any FDA nas made a decemination and your as roo receives. You must comply with all the Federal statues and regulations administer of economics of CFR Part 807); labeling Act s requirements, including, but hot minted to regular
(21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); 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 Scetion 510(k) I his letter will anow you to begin hanceing your antial equivalence of your device to a legally premarket nothication. THE PDA midnig of backannal vice 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 spective advice for your device of our moreing of
contact the Office of Compliance at one 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, please note the regulation charies, commition on your responsibilities under the Act from the 807.97). I Tuu May Ootain other general managan and Consumer Assistance at its toll-free number (800) Division of Small Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number (if known):
Device Name: RM3 Renal Preservation System
Indications for Use:
The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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).