PURE WATER, INC.'S WATER PURIFICATION SYSTEMS

K992786 · Pure Water, Inc. · FIP · Jan 24, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K992786
• Device Name: PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
• Applicant: Pure Water, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Jan 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Pure Water, Inc. Water Purification System is intended to be used in the purification of water to be used to dilute dialysate concentrate and in the reprocessing of dialyzers for reuse.

Device Story

The Pure Water, Inc. Water Purification System is a water treatment device designed for hemodialysis applications. It utilizes reverse osmosis (RO) technology, employing a semi-permeable membrane and high hydrostatic pressure to purify source water. The system includes pretreatment components to protect RO membranes from damage and storage/distribution components to deliver purified water to the point of use. The system is customizable to meet specific user water requirements. It is intended for use in clinical settings where hemodialysis is performed. By providing purified water that meets or exceeds AAMI standards, the device ensures the quality of dialysate concentrate and supports safe dialyzer reprocessing, ultimately benefiting patients undergoing hemodialysis by reducing exposure to waterborne contaminants.

Clinical Evidence

No clinical data. The device's substantial equivalence is based on technological characteristics and compliance with AAMI National Standards for Hemodialysis.

Technological Characteristics

Reverse osmosis water purification system. Components include semi-permeable membranes, pretreatment modules, and storage/distribution hardware. Operates via high hydrostatic pressure. Meets AAMI National Standards for Hemodialysis. No software or electronic algorithm components described.

Indications for Use

Indicated for the purification of water used to dilute dialysate concentrate and for the reprocessing of dialyzers for reuse in hemodialysis patients.

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

• Better Water's Water Purification System for Hemodialysis (K920186)
• ZyzaTech Water System, Inc.'s Water Purification Systems and Components and Portable Reverse Osmosis Systems (K964539)

Submission Summary (Full Text)

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JAN 2 4 200

Image /page/0/Picture/1 description: The image shows a logo for "Pure Water 2000". The logo is circular and contains an image of ocean waves. The text "Pure Water" is written in a semi-circle above the waves, and the number "2000" is written on the left side of the logo.

305 W. Market Street Anderson, SC 29624 Phone: [phone] Fax: [phone]

K992786 p.1/1

## 510(k) Summary

## Submitter Information:

| Company Name: | Pure Water, Inc. |
|------------------|--------------------------|
| Company Address: | 305 West Market Street |
| | Anderson, South Carolina |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Rhonda S. McCoy |
| Prepared: | August 17, 1999 |

Pure Water, Inc. Water Purification System Trade Name:

Classification Name:Water Purification System for Hemodialysis

- The Pure Water, Inc. Water Purification System is substantially Equivalency: equivalent to Better Water's Water Purification System for Hemodialysis (510(k) #: K920186) and ZyzaTech Water System, Inc.'s Water Purification Systems and Components and Portable Reverse Osmosis Systems (510(k) #: K964539), which are currently in commercial distribution.
- The Pure Water, Inc. Water Purification System uses Reverse Device Description: Osmosis technology to produce pure water. Reverse Osmosis utilizes a semi-permeable membrane and high hydrostatic pressure.

Pretreatment is used for the purpose of removing elements present in the source water that can damage the RO membranes.

The storage and distribution components of the system serves to deliver pure water produced by the RO to the point of use.

The Pure Water, Inc. Water Purification System can be customized to best meet the water needs of the user.

The Pure Water, Inc. Water Purification System meets or exceeds all Association for the Advancement of Medical Instrumentation (AAMI) National Standards for Hemodialysis.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2000

Ms. Rhonda S. McCoy Office Manager Pure Water, Inc. 305 West Market Street Anderson, South Carolina 29624 Re: K992786

Pure Water, Inc. Water Purification System Dated: November 23, 1999 Received: November 26, 1999 Regulatory Class: Il 21 CFR §876.5665/Procode: 78 FIP

Dear Ms. McCov:

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 (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 requiation (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 regult 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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Page 1 of 1

510(k) Number (if known):_K992786

Device Name: Pure Water, Inc. Water Purification System for Hemodialysis

Indications For Use:

The Pure Water, Inc. Water Purification System is intended to be used in the The Puter Water Tunneation of water to be used to dilute dialysate concentrate and in the reprocessing of dialyzers for reuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donald A. D'Amato

of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number

Prescription Use
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)