RENACLEAN SH DIALYZER CLEANING SYSTEM

K033505 · Minntech Corp. · LIF · Apr 27, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033505
• Device Name: RENACLEAN SH DIALYZER CLEANING SYSTEM
• Applicant: Minntech Corp.
• Product Code: LIF · Gastroenterology, Urology
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

Minntech Corporation's Renaclean SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron Dialyzer Reprocessing System.

Device Story

Renaclean SH Dialyzer Cleaning System is a stand-alone countertop device used to pre-clean multiple-use hollow fiber dialyzers. It removes blood and debris before the dialyzer undergoes full reprocessing on a Renatron system. The device uses ANSI/AAMI quality water and a pre-diluted sodium hypochlorite solution. An operator controls the system via a membrane switch front panel, selecting from three cycles: High Flux dialyzer clean, Low Flux dialyzer clean, or System Sanitize. By automating the pre-cleaning phase, the device prepares dialyzers for subsequent testing and sterilization, supporting the maintenance of multiple-use dialyzers in clinical settings.

Clinical Evidence

Bench testing only. Functional testing was performed to demonstrate safety and performance equivalence to the predicate device. Material compatibility testing was conducted for all system components exposed to the cleaning chemicals.

Technological Characteristics

Stand-alone countertop system. Utilizes ANSI/AAMI quality water and pre-diluted sodium hypochlorite solution. Features a membrane switch front panel for operator control. Cycles include High Flux clean, Low Flux clean, and System Sanitize. Materials tested for chemical compatibility.

Indications for Use

Indicated for cleaning blood and debris from multiple-use hollow fiber dialyzers prior to reprocessing in a Renatron Dialyzer Reprocessing System.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Renatron II Dialyzer Reprocessing System (K904210)

Submission Summary (Full Text)

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K033505

# RENACLEAN™ SH DIALYZER CLEANING SYSTEM

510(k) Summary of Safety and Effectiveness

| Manufacturer: | Minntech Corporation |
|-------------------|-------------------------------------------------------------------------|
| Address: | 14605 28th Avenue North<br>Mpls, MN 55447<br>USA |
| Official Contact: | Craig Smith<br>Vice President, Regulatory Affairs and Quality Assurance |

Minntech Corporation has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalency of the Renaclean™ SH Dialyzer Cleaning System to other dialyzer pre-cleaning cycles in automated dialyzer reprocessing systems currently in distribution in the United States.

#### 1. Device Description

The Renaclean SH Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to reprocessing on a Renatron® Dialyzer Reprocessing System. The stand-alone countertop system utilizes ANSI/AAMI quality water and a pre-diluted sodium hypochlorite solution.

The operator, through the use of a membrane switch front panel, controls the Renaclean SH Dialyzer Cleaning System. Operators have the following cycle choices: High Flux dialyzer clean, Low Flux dialyzer clean and System Sanitize.

- 2. Intended Use
Minntech Corporation's Renaclean SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron Dialyzer Reprocessing System.

- 3. Comparison to Another Device in Commercial Distribution Within the United States
The Renaclean SH Dialyzer Cleaning System is equivalent to other dialyzer precleaning cycles in automated dialyzer reprocessing systems currently in distribution in the United States. The Renatron II Dialyzer Reprocessing System (K904210) pre-clean cycle is intended to pre-clean multiple-use dialyzers prior to testing and sterilization.

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K033505

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#### Summary 4.

- 4.1 Minntech Corporation has performed functional testing to show the Renaclean Dialyzer Cleaning System is safe and has equivalent performance with respect to the predicate device.
- All materials have been tested for material compatibility with the chemicals 4.2 used in the system as specified in the labeling.
- ડ. Summary of Substantial Equivalence

Minntech Corporation has provided the above information within the 510(k) to support the claim that the Renaclean Dialyzer Cleaning System is safe and effective when used in accordance with the device labeling.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Mr. Richard M. Ormsbee Senior Regulatory Affairs Specialist MINNTECH® 14605 28th Avenue, N. MINNEAPOLIS MN 55447

Re: K033505

Trade/Device Name: Renaclean™ SH Dialyzer Cleaning System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LIF Dated: February 4, 2004 Received: April 5, 2004

Dear Mr. Ormsbee:

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 cither 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.

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 (OS) 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 mis letter will anow you to cognituding of substantial equivalence of your device to a legally premairce noticated on: "The a classification 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 It you desire spoolite activery at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of [phone]. Also, please note the regulation entitled, "Misbranding Other or other warket notification" (21CFR Part 807.97) you may obtain. Other general of release to promation of your responsibilities under the Act may be obtained from the Division of Small mioritation on your velpenal and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrf/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

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### Indications for Use

510(k) Number (if Known):

K033505

Device Name:

RenaClean™ SH Dialyzer Cleaning System

Indications for Use:

Minntech Corporation's RenaClean™ SH Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers, prior to being reprocessed on a Renatron® Dialyzer Reprocessing System.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per21 CFR 801.109) OR

Over-the Counter-use (Optional Format 1-1-96)

Nancy C. Braydon

(Division Sign-Off) Division of Reproductive, Abdo minal and Radiological De 510(k) Number