WATER TREATMENT SYSTEM FOR HEMODIALYSIS

K983512 · Water Vault, Inc. · FIP · Apr 28, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K983512
• Device Name: WATER TREATMENT SYSTEM FOR HEMODIALYSIS
• Applicant: Water Vault, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Apr 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The WaterVault Cube Water Treatment System for HemoDialysis is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.

Device Story

Water Vault Cube is a water treatment system for hemodialysis clinics. It processes municipal water to remove organic, inorganic, and microbial contaminants for dialysate preparation. The system utilizes a multi-stage process: water softening for hardness removal; granular activated carbon for chloramine removal; filament cartridge filters for particulate control; reverse osmosis (RO) using a pressure gradient across a semipermeable membrane to reject concentrated contaminants; hollow fiber ultrafiltration to remove microorganisms, pyrogens, and endotoxins; and UV sterilization (minimum 30,000 microwatts/cm2 sec) to inhibit bacterial growth. The device is operated by clinic staff. Output is treated water meeting AAMI standards, which is then used by hemodialysis machines to prepare dialysate for patient treatment. The system benefits patients by ensuring the water used in dialysis meets safety and purity requirements.

Clinical Evidence

Bench testing only. A demonstration unit (Osmonics Solorss RO unit) was tested against 20 chemical and microbial parameters. Results confirmed that the permeate water met or exceeded AAMI standards for all tested contaminants, including calcium, magnesium, sodium, fluoride, chlorine, chloramines, and various heavy metals (e.g., lead, copper, arsenic).

Technological Characteristics

System includes water softener, granular activated carbon, filament cartridge filters, reverse osmosis membrane, hollow fiber ultrafilter, and UV light source (30,000 microwatts/cm2 sec). Materials are FDA/NSF compliant. System is non-networked, standalone equipment. No software-based control algorithms described.

Indications for Use

Indicated for use in hemodialysis clinics to treat water for the dilution and preparation of dialysate solutions used in hemodialysis machines.

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

• MARCOR Water Treatment System For Hemodialysis (K945559)

Submission Summary (Full Text)

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4/28/99

K983512

#### 5 | OK SUMMARY

Water Vault Corporation 2003 Blair Blvd Nashville, TN 37212 615-292-7336 Contact: Michael Peterson

Water Vault Cube, Watertreatment System for Hemodialysis Class II Device

Legally Marketed Predicate Device - MARCOR Water Treatment System For Hemodialysis K#945559

Jinnia Darriad

| | Water Vault Inc. | Predicate Device |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | MARCOR #K945559 |
| INTENDED USE | Hemodialysis | Hemodialysis |
| EQUIPMENT: | Makes Use Of Existing FDA<br>Cleared Reverse Osmosis Unit<br><br>Pretreatment Equipment Sized<br>Based upon water analysis<br>And RO Mfg. Requirements | Makes Use Of Existing FDA<br>Cleared Reverse Osmosis Unit<br><br>Pretreatment Equipment Sized<br>Based upon water analysis<br>And RO Mfg. Requirements |
| SAFETY FEATURES: | Makes Use Of Existing Features<br>Incorporated in Design of RO Unit | Makes Use Of Existing Features<br>Incorporated in Design of RO Unit |
| WATER CONTACT<br>MATERIALS: | FDA NSF Compliant | FDA NSF Compliant |
| PERFORMANCE<br>SPECIFICATIONS: | Delivery Of Specified Quantity<br>Of AAMI Standard Quality | Delivery Of Specified Quantity<br>Of AAMI Standard Quality |
| CAPACITY: | Determined By RO Capacity | Determined By RO Capacity |

How The Device Works:

Organic, inorganic and microbial contaminants are removed from water supplied to hemodialysis clinics for use in the dilution and preparation of dialysate solutions used in hemodialysis machines. The water treatment system includes a means of tempering the water and pretreatment, followed by reverse osmosis, ultrafiltration and UV sterilization. Pretreatment includes water softening to remove hardness and Granular Activated Carbon treatment to remove Chloramines in addition to filament cartridge filters to control particulate solids. Reverse Osmosis utilizes a pressure gradient to reverse the process water diffusion across a semipermeable membrane, concentrating the contaminants which are subsequently rejected as concentrate. Water forced through the membrane known as "Permeate" is then passed through a hollow fiber ultra filter to remove microorganisms, pyrogens and endotoxins. A UV light source that provides a minimum of 30,000 microwatts/cm2 sec limits further bacterial growth in the treated water.

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## 5 | OK Summary

#### Nonclinical Test Results:

The following sample results were taken from tests of a demonstration unit using an Osmonics Solorss reverse osmosis unit Serial Number 96-61650-11

| Component | Feed Water<br>mg/l | Permeate<br>mg/l | AAMI Standard<br>mg/l | Meets or Exceeds<br>AAMI Standard |
|-------------|--------------------|------------------|-----------------------|-----------------------------------|
| Calcium | 34.3 | 1 | 2 | Yes |
| Magnesium | 5.63 | 1 | 4 | Yes |
| Sodium | 5.68 | 1 | 70 | Yes |
| Potassium | 1.55 | 1 | 8 | Yes |
| Fluoride | 0.82 | 0.1 | 0.2 | Yes |
| Chlorine | 1.68 | 0.02 | 0.5 | Yes |
| Chloramines | 0.02 | 0.02 | 0.1 | Yes |
| Nitrate | 0.37 | 0.1 | 2 | Yes |
| Sulfate | 28.8 | 5 | 100 | Yes |
| Copper | 0.105 | 0.01 | 0.1 | Yes |
| Barium | 0.022 | 0.01 | 0.1 | Yes |
| Zinc | 0.115 | 0.02 | 0.1 | Yes |
| Aluminum | 0.221 | 0.01 | 0.01 | Yes |
| Arsenic | 0.005 | 0.005 | 0.005 | Yes |
| Lead | 0.101 | 0.003 | 0.005 | Yes |
| Silver | 0.005 | 0.005 | 0.005 | Yes |
| Cadmium | 0.001 | 0.001 | 0.001 | Yes |
| Chromium | 0.005 | 0.005 | 0.014 | Yes |
| Selenium | 0.005 | 0.005 | 0.05 | Yes |
| Mercury | 0.0002 | 0.0002 | 0.0002 | Yes |

Based upon the above water assay, the water produced meets or exceeds AAMI standards for water to be used in the preparation of dialysate.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three intertwined lines forming a shape similar to a bird or a wave.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1999

Michael J. Peterson, P.E. President Water Vault, Inc. 2003 Blair Boulevard Nashville, Tennessee 37212 Re:

K983512 Water Vault Cube Dated: February 9, 1999 Received: February 10, 1999 Regulatory class: II 21 CFR §876.5665/Product code: 78 FIP

Dear Mr. Peterson:

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 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, 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 895. A substantially equivalent determination assumes 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 that, through periodic QS inspections, 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 have under sections 531 through 542 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 predicate device results in 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 and additionally 809.10 for in vitro diagnostic 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, "Misbranding by reference to premarket notification" (21 CFR 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983512 510(k) Number (if known):_

Device Name: Water Vault Cube, Water Treatment System for HemoDialysis

### Indications For Use:

The WaterVault Cube Water Treatment System for HemoDialysis is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate.

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| Computers of experiences from the proportion of the controlled with the count | | | | | |
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| | | | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Severson

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devic 510(k) Number.