NELSON WATER SYSTEMS FOR HEMODIALYSIS

K993877 · Nelson Environmental Technologies, Inc. · FIP · May 25, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993877
• Device Name: NELSON WATER SYSTEMS FOR HEMODIALYSIS
• Applicant: Nelson Environmental Technologies, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: May 25, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

Nelson Water Treatment Systems' Water Treatment System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment by removing organic, inorganic, and microbial substances. When used as a medical device, Federal Law restricts this device to sale by or on the order of a physician.

Device Story

Water purification system for hemodialysis; accepts facility water as input; removes organic, inorganic, and microbial contaminants to meet AAMI standards. System components include carbon filters, reverse osmosis (RO) unit, and/or portable exchange mixed-bed deionization (DI) tanks. Pretreatment stages (sediment filtration, softening, pH balancing) configured based on influent water quality. Includes conical-bottomed storage tank with air-filtered vent, level switches, and repressurizing pumps. Optional post-treatment includes resin traps, sub-micron filters, and UV disinfection. System is self-monitored with pressure gauges and sample ports; conductivity monitor/controller placed at nurses' station. Alarms trigger for RO unit status, tank water levels, conductivity limits, and resistivity thresholds. Provides purified water for hemodialysis treatment; helps ensure water quality meets clinical safety standards for patient dialysis.

Clinical Evidence

Bench testing only. Performance data provided from a system installation in Houston. Water samples analyzed for 20 chemical/mineral components (e.g., Calcium, Magnesium, Chlorine, Heavy Metals) compared against AAMI standards. Results demonstrate all measured parameters met or exceeded AAMI requirements after 48 hours of residence time.

Technological Characteristics

System utilizes reverse osmosis and/or mixed-bed deionization. Materials are FDA/NSF compliant. Features include pressure boosting, sediment/colloidal filtration, water softening, pH balancing, and UV disinfection. Monitoring includes conductivity/resistivity sensors and level switches. Connectivity includes local and remote alarm integration at nurses' stations. Designed to meet AAMI hemodialysis water standards.

Indications for Use

Indicated for purifying water used in hemodialysis treatment by removing organic, inorganic, and microbial contaminants. Intended for use in clinical settings under physician order.

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

• Zyzatech Water Treatment System for Hemodialysis (K964539)

Submission Summary (Full Text)

{0}------------------------------------------------

## NELSON ENVIRONMENTAL TECHNOLOGIES

Image /page/0/Picture/3 description: The image shows the logo for the Water Quality Association. The logo consists of three curved lines on the left, which are stacked on top of each other. To the right of the curved lines is the text "Water Quality ASSOCIATION" stacked on top of each other. Below the logo is the word "MEMBER".

## SUMMARY OF SAFETY & EFFECTIVENESS

1999 November 10

1. Submitter: Nelson Environmental Technologies, Inc. 301-E N. Mocoll Rd. MªAllen, TX 78501 Contact: Burke A. West, P.E., CWS-VI 956-618-0375 telephone [phone] fax

| 2. Device Classification Name: | Water Purification System for Hemodialysis |
|--------------------------------|--------------------------------------------|
|--------------------------------|--------------------------------------------|

- Zyzatech Water Systems, Inc. 3. Substantial Equivalence: Water Treatment System for Hemodialysis 510(k)#K964539
4. Device Description:

The water purification system is a complete system accepting the influent facility water and providing purified water meeting AAMI standards for hemodialysis use. It removes organic, inorganic, and microbial contaminants from the water.

The heart of the system includes carbon filters along with a reverse osmosis (RO) unit and/or portable exchange (PE) mixed-bed (MB) deionization (DI) tanks along with appropriate alarms. This equipment removes the oxidants such as chlorine and chloramines and mineral salts (dissolved solids) from the water. The specific configuration of the equipment will depend upon the customer's water quality desires (specifications) beyond the minimum AAMI standards.

Pretreatment is used before the RO unit to match the specific influent water quality to those needs of the RO unit and/or final water specifications. Pretreatment can include pressure boosting, sediment and colloidal material filtration, water softening, pH balancing and specific element or compound reduction such as iron.

The system usually includes a storage tank that is conical-bottomed and sealed. It has an air-filtered vent, checked over-flow, level switches and sprayer. Repressurizing pump(s) are used to deliver the water to the hemodialysis system.

Deionization is used either to polish the RO water or to remove total dissolved solids (TDS) from the influent water. The latter will occur either in emergency conditions when an RO is being used in the system and it is being by-passed or as an alternative

P.O. Box 5026, McAllen, TX 78502-5026

{1}------------------------------------------------

Nelson Water Systems For Hemodialysis' Water Purification System for Hemodialysis, 510(k) Notification

to an RO unit. When PE MB DI tanks are used, two tanks are always used with resistivity indicators/alarms following each one. Then following the tanks are a resin trap, sub-micron filter(s), and optionally a shut-down valve and ultraviolet (UV) disinfection.

The system is self-monitored and alarms are activated when operator attention is needed. Pressure gauges and sample ports are strategically placed throughout the system for system performance monitoring. A conductivity monitor/controller is placed in sight of the nurses' station. Its probe is located at the end of the watertreatment system. Alarms at site and/or remotely located near the nurses' station sound when an alarm condition exists with the RO unit, the water level in the tank drops to a pre-set level, the conductivity at the exit of the watertreatment system exceeds the pre-set level, and if PE MB DI tanks are used, the outlet resistivity falls below the pre-set limit.

- 3. Intended Use Statement:
Nelson Water Treatment Systems' Water Treatment System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment by removing organic, inorganic, and microbial substances. When used as a medical device, Federal Law restricts this device to sale by or on the order of a physician.

## 4. Technological Characteristics Compared to the predicate Device

Predicate Device is Zyzatech Water Treatment System for Hemodialysis 510(k)#K964539

| Item | Nelson Environmental<br>Technologies, Inc. | Zyzatech Water Systems, Inc. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Hemodialysis Treatment | Hemodialysis Treatment |
| Equipment | Incorporates FDA-certified RO<br>unit | Incorporates FDA-certified RO<br>unit |
| Pre-treatment<br>Stage | Designed based upon water<br>analysis, RO manufacturer's<br>requirements, and AAMI<br>specifications | Designed based upon water<br>analysis, RO manufacturer's<br>requirements, and AAMI<br>specifications |
| Water Contact<br>Materials | FDA NSF Compliant | FDA NSF Compliant |
| Safety Features | Utilizes RO safety features<br>Water conductivity/resistivity<br>self-monitored and alarmed<br>Tank water self-monitored and<br>alarmed<br>Remote alarms at Nurses'<br>Station | Utilizes RO safety features<br>Water conductivity/resistivity<br>self-monitored and alarmed<br>Tank water self-monitored and<br>alarmed<br>Remote alarms at Nurses'<br>Station |
| Performance | Meets or exceeds AAMI | Meets or exceeds AAMI |

{2}------------------------------------------------

| | 1<br>----------- | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Acres of Cattle. | A A P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P<br>andarde<br> | ---------<br>andarde |
| | | |

K993877

P3/3

## ર . Conclusions of Performance Data

The following data was obtained from an installation in Houston meeting the design specifications of the proposed system.

| Component | Feed Water<br>mg/L | Permeate<br>mg/L | AAMI<br>Standard<br>mg/L | Meets or<br>Exceeds AAMI<br>Standard |
|-------------|--------------------|------------------|--------------------------|--------------------------------------|
| Calcium | 341.3 | 0.144 | 2 | Yes |
| Magnesium | 3.5 | 0.002 | 4 | Yes |
| Sodium | 37.2 | 2.6 | 70 | Yes |
| Potassium | 4.2 | 0.025 | 8 | Yes |
| Fluoride | 0.0 | 0.0 | 0.2 | Yes |
| Chlorine | 0.15 | 0.0 | 0.5 | Yes |
| Chloramines | 0.35 | 0.0 | 0.1 | Yes |
| Nitrate | 0.4 | 0.0 | 2 | Yes |
| Sulfate | 37.7 | 0.0 | 100 | Yes |
| Copper | 0.043 | 0.000 | 0.1 | Yes |
| Barium | 0.061 | 0.0005 | 0.1 | Yes |
| Zinc | 0.026 | 0.024 | 0.1 | Yes |
| Aluminum | 0.107 | 0.0005 | 0.01 | Yes |
| Arsenic | 0.001 | 0.000 | 0.005 | Yes |
| Lead | 0.002 | 0.0001 | 0.005 | Yes |
| Silver | 0.000 | 0.00009 | 0.005 | Yes |
| Cadmium | 0.00001 | 0.000 | 0.001 | Yes |
| Chromium | 0.005 | 0.000 | 0.014 | Yes |
| Selenium | 0.001 | 0.000 | 0.05 | Yes |
| Mercury | 0.0001 | 0.0002 | 0.0002 | Yes |

Thus, based upon the above results taken from a system after 48 hours of residence time in system, the water produced and stored meets or exceeds AAMI stand of roomonoo mint m treatment.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head facing left, with three curved lines extending from the back of the head, resembling wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2000

Burke A. West, P.E., CWS-VI President Nelson Environmental Technologies, Inc. 301-E N. McColl Road McAllen, TX 78501

Re: K993877 Water Purification System for Hemodialysis Dated: March 21, 2000 Received: March 23, 2000 Requiatory Class: II 21 CFR §876.5665/Procode: 78 FIP

Dear Mr. West:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices roo to oubotainary of the 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). You may, therefore, nave boon rockeened in 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 III (Premarket Aproval), 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, Sublional obnitrols: Extrang major regalatent antine your es compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and requirements of on on in the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might the reading together 1 roces not of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 and additionally 809.10 for iggjitg n you don't devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{4}------------------------------------------------

510 (k) NUMBER (IF KNOWN) : K993877

DEVICE NAME : Water Purification System for Hemodialysis

INDICATIONS FOR USE:

Nelson Water Systems' Water Purification for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment. It removes organic, inorganic, and microbial contaminants from the water.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

ייני

OR

Over-The-Counter-Use (Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number