RM3 RENAL PRESERVATION SYSTEM

K053169 · Waters Instruments, Inc. · KDK · Jan 17, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053169
• Device Name: RM3 RENAL PRESERVATION SYSTEM
• Applicant: Waters Instruments, Inc.
• Product Code: KDK · Gastroenterology, Urology
• Decision Date: Jan 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5880
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.

Device Story

RM3 Renal Preservation System is a transportable, self-contained device for hypothermic perfusion and monitoring of kidneys prior to transplant. System comprises a control unit and a sterile, single-use disposable cassette. Device circulates hypothermic physiologic solutions through the kidney; monitors, displays, and trends perfusion parameters including flow, temperature, pressure, and renal resistance. Control unit features user-configurable audio/visual alarms for parameter limits and data printing capabilities. Operated by clinical staff in a transplant setting. Provides continuous monitoring during transport to ensure organ viability; assists clinicians in assessing kidney status via real-time parameter tracking.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, intended use, and risk analysis of material changes.

Technological Characteristics

Two-part system: control unit and sterile, single-use disposable cassette. Provides hypothermic perfusion of physiologic solutions. Monitors perfusate flow, temperature, pressure, and renal resistance. Features audio/visual alarms and data printing. Material changes in the cassette were validated via risk analysis and biomaterial safety assessment.

Indications for Use

Indicated for the maintenance of kidneys intended for transplant.

Regulatory Classification

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.

Predicate Devices

• RM3 Renal Preservation System (K053169)

Submission Summary (Full Text)

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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: [phone]; Fax: [phone] |
| 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 [phone] or [phone] 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

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(Posted November 13, 2003)