MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K041884 · Mueller Water Conditioning, Inc. · FIP · Feb 28, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K041884
• Device Name: MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Applicant: Mueller Water Conditioning, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Feb 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. The System is used to dilute dialysate concentrate to form dialysate and to produce purified water for dialyzer reprocessing, equipment rinse and disinfection. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Device Story

System treats facility water for hemodialysis; removes organic/inorganic substances and microbial contaminants. Core components: multimedia filtration, water softeners, carbon filtration, reverse osmosis (RO) unit, deionization tanks, UV lamps, and final filtration. Pretreatment (multi-media, softening, carbon, sediment) matches influent water to AAMI standards. Post-treatment (deionization, pumps, flow meters) polishes water. System uses worker-polisher configurations for carbon and deionization tanks. RO unit includes remote alarms for nurses' station. Resistivity monitor on polisher tank provides local/remote alarm at 5 megohms. Final 0.2-micron filters and UV lamps control endotoxins/bacteria. Operated by facility staff under physician direction. Output is purified water meeting AAMI standards for dialysate preparation and equipment reprocessing. Benefits include reliable, cost-effective water treatment for hemodialysis patients.

Clinical Evidence

Bench testing only. Performance data from a test system in Houston, TX, demonstrated that the system produces water meeting or exceeding AAMI standards for various chemical and physical parameters, including sodium, potassium, aluminum, calcium, copper, magnesium, selenium, zinc, chromium, chlorine, chloramine, lead, arsenic, mercury, cadmium, beryllium, antimony, thallium, silver, barium, fluoride, nitrate, sulfate, pH, and resistivity.

Technological Characteristics

System components: multimedia filters, water softeners, carbon filters, RO units, deionization tanks, UV lamps, and final filters. Materials are FDA or NSF approved. Piping: PVC Schedule 80. Sensing: resistivity monitor (temperature compensated), flow meters, pressure gauges. Connectivity: local/remote alarms. Sterilization: UV lamps and chemical sanitization. Software: rule-based monitoring/alarms.

Indications for Use

Indicated for use in hemodialysis treatment to produce purified water by removing organic, inorganic, and microbial contaminants. Used to dilute dialysate concentrate and for dialyzer reprocessing, equipment rinse, and disinfection. Prescription use only.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• U.S. Filter Corporation Water Purification System for Hemodialysis (K980182)

Submission Summary (Full Text)

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FEB 2 8 2005

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TER CONDITIONING, IN

Houston, Texas 77043 1500 Sherwood Forest Dr. . · Fax [phone] [phone]

510(k) Summary

# Mueller Water Conditioning, Inc. 1500 Sherwood Forest Dr. Houston TX 77043

## Phone: [phone] Fax: [phone]

| Contact: | |
|------------------------------|--|
| Date of summary preparation: | |

David W. Mueller June 1, 2004

Device Name:

Proprietary Name: Common Name:

Mueller RO/DI System for Hemodialysis Water Purification System for Hemodialysis

Classification:

Class II CFR #876.5665 F1P Product Code:

Device claiming equivalence to:

U.S. Filter Corporation Water Purification System for Hemodialysis 510(k) #K980182

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KCL 994
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## DEVICE DESCRIPTION

The Mueller RO/Di system for hemodialysis treats incoming facility water to provide water The Mueller RO/Di system for hemodialysis use in respect to respect to reganic and inorganic and intraganic conforming to AAMI standards for hemodiatists for water intended for use as dilute lialysate, as dilute lialysate, as dilute lialysate, Substances as well as well as microbia.
bicarbonate, acetate and sterilant for dialyzer reprocessing.

The core components of the system include carbon filters along with reverse osmosis (RO) unit The core components of the system include carbeth alarms to remove oxidants from
and portable exchange deionization tanks along with approve oxidants from organized and portable exchange delonization tanks along will rappigination of the equip nont will
the water that are harmful to patient The specific onfiguration A Mi the water that are narmul to pallent health. "The Spoolle obling the minimum AAM
depend upon the customer's water quality desires (specifications) beyond the minimum AAM standards.

Pretreatment is used before the RO unit to match the specific influent water quality to those Pretreatment is used before the RO unit to mater the oppositions. Prefections will include multi-media filtration, water softening, carbon filtration, and sediment filtration.

Post treatment is used after the RO unit to polish and monitor the water of any maters. Delinitiation Post treatment is used and to polici and many and many pumps, flow meters, Deionization machines.

The Mueller Water Conditioning, Inc. (MWCl) water purification system utilizes no new water The Mueller Water Conditioning, The RWVOr, nultimedia filtration, carticige filtration, care the occa reverse osmosis (R.O.), deionization, ultraviolet light and particulate filitration are the core reverse of treatment for this system. The storage, ping, repressures arrization, emergency memous of treathent for this System. - The cornentation round out the efforts to ensure Dybasses, Samization, Tabeling, Training and Costered device we are claiming substantial equivalent proper delivery of the treateds ic principles to perform their function.

Below is a summary for each component of the system.

### Multimedia Filters

MWCI uses multimedia filters constructed of materials that are F.D.A. or "NSF" aproved. MWCT USes Intuitinedia illiers constractor or thysician direction, either time clock or meter-Dependant upon System Toquilting and e, twin or twin alternating configuration. Where time intitutions may be used, ones, in a creating the relay precludes R.O operation during filter backwash operations.

### Water Softeners

MWCI uses water softeners constructed of materials that are F.D.A. or "NSF" approved. MWCI USes Water Sonchere Sonotrants and physician direction, either time clock or meter-initiated Dependant upon system roquirements and pri jor twin alternating configuration. Where time clock softeners thay be used, citier in a onglo, thir or while while would be not of the softener regeneration.

### Carbon Filtration

Chloramines and chlorine are both filtered utilizing carbon filtration in a "worker-polisher" Grilliannes and chionne are bon microler after each filter. Minimum empty bed contact time Connguration with Test personing and Classes as recommended by the FDA. (EDOT) of of of minuted is informe and chloramine breakthrough prior to each patient shift. MWOr recommonde touting for only in either system. Both utilize carbon with a Dypass piping of the Garbon illuralism is is where single-patient systems are in use, MWCI allows milling in soo fourile handon. In theatless where minimum standards EBCT can be met, but in no instances is a multi-patient system installed without worker-polisher carbon tank configuration unless so directed by the attending physician.

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## Cartridge Filtration

MWCI uses R.O. particulate cartridge filtration of non-cotton construction. Where an its includion ta MWCT uses H.O. panticulate carmoge intration of non octastalled with isolation valves to
be shut down for cartridge replacement, dual filter housings are installed with is of be snut down for carthuge replacement while the R.O. is in operation. MWCl uses 1 or 5 micron cartridge filtration of melt-blown construction.

## Reverse Osmosis

MWCI uses only R.O. units that are registered Medical devices. Modification to the R.O. systems MWCT uses only 11.0. unlis that are regiored modificed by the manufacturer and as delivered by the manufacturer is forbladem aniest processions for external, remote alarms documented. H.O. systems area (typically in the nurses' station). Use of the remote for installation mo the dialysis treatment arou (typioany in the his in direct view of the system.

## Water Storage

MWCI uses R.O. water storage tanks constructed of F.D.A. or "NSF" approved materials MWCI uses T.C. Watch Storago tanks ovents. Vent filters are replaced annually.

## Repressurization/Recirculation

MWCI uses R.O. product water repressurization/recirculation pumps sized for adequate flow and MWCT uses H.O. product water repressunzation in originalism personalism of 3 pressure for the intended asc. While poculate, the flow point. Where Direct Feed systems rinay teet per second (ips) volonity at the lows for of the point where the loop return feeds to the F.O. intet. Where dual recirculation pumps are installed, the pumps shall be installed in a parallel intel. "While dual roomation ply to minimize water stagnation. This pump alternation shall be Comigation and allernatou wookly or automatically depending on the direction of the attending physician.

## Piping

MWCI uses PVC schedule 80 piping and valves for water distribution post-R.O., unless otherwise MWOT ass I VO tonound ou piping and -R.O. piping may include a combination of galvanized, copper, brass and PVC piping and valving.

### Deionization

Unless otherwise directed by the attending physician, MWCI uses mixed-bed deionization tanks in a series, "worker-polisher" configuration. MWCI uses a local 1-megohm quality control light on the "worker" tank, and a temperature compensated resistivity monitor on the "polisher" tank. The the worker tamily and a temporal calibration utilizing NIST traceable calibration equipment as directed by the monitor manufacturer unless otherwise directed by the attending physician. The monitor has a remote alarm capability or is itself installed in the common area (such as the nurses' station) of the unit, with the probe installed immediately after the polishing deionizer. The alarm set point of the resistivity monitor is set to indicate an alarm condition at 5 megohms, unless otherwise directed by the attending physician.

### Final Filtration and U.V. Lamps

MWCI uses 0.2-micron absolute final filters and/or ultrafiltration in all system designs to remove bacterial contamination and control endotoxin levels. MWCI also uses UV lamps in all system designs unless otherwise directed by the attending physician, with the final filters installed downstream of the UV lamps.

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#### Emergency bypass

MWCI provides emergency bypass lines and valving that are clearly tagged and labeled. Usage MWCI provides emergency bypass intes and varing that are areany any and or their agents as identified by the customer.

## SANITIZATION

To avoid additional valving and/or dead legs, introduction of sanitizing agents shall be via either To avoid additional valving andror dead logo, infroductions of eatherwise directed by the artending physician.

In summary, the MWCI system is quite similar in design and function to other systems already in your In surfifialy, the basic water purification components and methods are idential. Most of the mankelplace. The basic water pamilation components in of MWCI to provide reliable, costeffective treatment and design.

## INTENDED USE STATEMENT

Mueller Water Conditioning's Water Treatment System for Hemodialysis is intended to be used Mueller Water Used in hemodialysis treatment by removing organic, increanic, and Tor punlying the water used in nomballary.com will be restricts this device to sale by or on the order of a physician.

| COMPARISON | MUELLER WATER<br>CONDITIONING | U.S. FILTER |
|--------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Hemodialysis Water<br>Treatment | Hemodialysis Water<br>Treatment |
| Equipment: | Incorporates FDA-certified<br>R.O. unit | Incorporates FDA-cert.fied<br>R.O. unit |
| Pre-Treatment Equipment: | Designed based upon water<br>analysis, R.O. manufacturer's<br>requirement, and AAMI specs. | Designed based upon water<br>analysis, R.O. manufacturer's<br>requirement, and AAMI specs. |
| Water Contact Materials: | FDA NSF Compliant | FDA NSF Compliant |
| Safety Features: | Utilizes R.O. safety features.<br>Water conductivity/resistivity<br>and tank water self-monitored<br>and alarmed. | Utilizes R.O. safety features.<br>Water conductivity/resistivity<br>and tank water self-monitored<br>and alarmed. |
| Performance: | Meets or exceeds AAMI<br>Standards | Meets or exceed AAMI<br>Standards |
| Capacity: | Determined by R.O. Capacity | Determined by R.O. Capacity |

# TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

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KC418821
PAGE 5 of 5

# CONCLUSION OF PERFORMANCE DATA

The following data was obtained from a test system installed at our facility in Houston, TX. The water used for dielysis The following data was oblanced willity for determing the quality of the water used for dialysis,
customer has the ultimate responsibility for determing the mater used for di customer has the ultimate responsibility for doternming .
but the following results show the water tested to AAMI standards.

| COMPONENT | RESULT | UNITS | REFERENCE | MEETS OR EXCEEDS AAMI STANDARDS |
|------------------|---------|-------|-----------|---------------------------------|
| Sodium Water | 0.054 | mg/L | 70 | Yes |
| Potassium, Water | <1.000 | mg/L | 0.8 | Yes |
| Aluminum, Water | <0.008 | mg/L | 0.0.01 | Yes |
| Calcium, Water | <0.050 | mg/L | 0-2 | Yes |
| Copper, Water | <0.005 | mg/L | 0-0.1 | Yes |
| Magnesium, Water | <0.050 | mg/L | 0-4 | Yes |
| Selenium, Water | <0.005 | mg/L | 0-0.09 | Yes |
| Zinc, Water | <0.005 | mg/L | 0-0.1 | Yes |
| Chromium, Water | <0.005 | mg/L | 0-0.014 | Yes |
| Chlorine | 0.0 | mg/L | 0.5 | Yes |
| Chloramine | 0.0 | mg/L | 0.1 | Yes |
| Lead, Water | <0.002 | mg/L | 0-0.005 | Yes |
| Arsenic, Water | <0.002 | mg/L | 0-0.005 | Yes |
| Mercury, Water | <0.0002 | mg/L | 0-0.0002 | Yes |
| Cadmium, Water | <0.0010 | mg/L | 0-0.001 | Yes |
| Beryllium, Water | <0.0004 | mg/L | 0-0.0004 | Yes |
| Antimony, Water | <0.006 | mg/L | 0-0.006 | Yes |
| Thallium, Water | <0.002 | mg/L | 0-0.002 | Yes |
| Silver, Water | <0.003 | mg/L | 0-0.005 | Yes |
| Barium, Water | <0.001 | mg/L | 0-0.1 | Yes |
| Fluoride, Water | <0.10 | mg/L | 0-0.20 | Yes |
| Nitrate, Water | <0.2 | mg/L | 0-2.0 | Yes |
| Sulfate, Water | <1.0 | mg/L | 0.100 | Yes |
| pH | 5.7 | UNITS | | |
| Resistivity | 0.769 | | | |

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Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services (DHHS). The seal features a stylized bird with outstretched wings, symbolizing health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.

FEB 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David W. Mueller Vice President Mueller Water Conditioning, Inc. 1500 Sherwood Forest Drive HOUSTON TX 77043

Re: K041884

K04186+
Trade/Device Name: Mueller RO/DI System for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: January 31, 2005 Received: February 1, 2005

Dear Mr. Mueller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have levewed your Secure 510(ts) probantially equivalent (for the indications for use stated in aoove and nave decemined the as treaticate devices marketed in interstate commerce prior to the enclosure) to legally mankelou products deal Device Amendments, or to devices that have been May 26, 1970, the Chacinent date of the Frederal Food, Drug, and Cosmetic Act (Act) that recrassified in accordatics with the proval application (PMA). You may, therefore, market the do not require approvat of a premiation of the Act. The general controls provisions of the Act device, subject to the general controls provices, 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 sour adentions, Title 21, Parts 800 to 898. In addition, FDA device can be nound in the 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 advised mar PDA s issues is use ice complies with other requirements of the Act or any FDA has made a uccemination and your as read by other Federal agencies. You must comply with all the Federal statues and regulations administer of registration and listing (21 CFR Part 807); labeling Act s requirements, metuding, but hot mines is reguleements as set forth in the quality systems (QS) (21 CFR Part 801); good manafacturing product radiation control 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 his letter will anow you'to begin manieing of substantial equivalence of your device to a legally premarket notheation: "The PDF missification 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 active act 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 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 7 / . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. F Srogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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WATER CONDITIONIN

1500 Sherwood Forest Drive Houston, TX 77043 Tel: [phone] Fax: [phone]

# Indications for Use

510(k) Number (if known): __ K041884 _________________________________________________________________________________________________________________________________________

Mueller RO/DI System for Hemodialysis Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in Mueller Water Conditioning Water Panisation Cystoic and inorganic substances and t hemodialysis treatment. The System is used to dilute dialysate concentrate to form dialysate and to
microbial contaminants from water used to dilute dialysation. When used microbial contaminants from water about to allars and disinfection. When used as
produce purified water for dialyzer reprocessing, equipment rinse and discussion of a physic produce purnled water for dialyzer reproboooing, oquipment on the order of a physician.
a medical device, Federal law restricts this device to sale by or on the order of a ph

> 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)

David h. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __