PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM

K993272 · Pure Water, Inc. · FIN · Apr 10, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993272
• Device Name: PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
• Applicant: Pure Water, Inc.
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Apr 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pure Water, Inc.'s Bicarb Mix, Storage and Distribution system is intended to be used for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

Device Story

System performs batch mixing of bicarbonate liquid concentrate, storage, and distribution to point-of-use in hemodialysis settings. Utilizes reverse osmosis technology. System components include a mix tank, storage tank, and distribution plumbing. Designed for customization to meet specific facility needs. Operates to deliver concentrate for hemodialysis treatment; ensures compliance with AAMI standards for hemodialysis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System utilizes reverse osmosis for water processing. Includes mix tank, storage tank, and distribution components. Meets or exceeds AAMI National Standards for Hemodialysis.

Indications for Use

Indicated for hemodialysis patients requiring bicarbonate liquid concentrate for treatment.

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

• 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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Image /page/0/Picture/1 description: The image shows a logo for "Pure Water". The logo is circular and contains an image of waves. The text "Pure Water" is written around the top of the circle.

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

K993272

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## 510(k) Summary

## Submitter Information:

| Company Name: | Pure Water, Inc. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 305 W. Market St.<br>Anderson, SC 29624 |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Rhonda S. McCoy |
| Prepared: | September 27, 1999 |
| Trade Name: | Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System |
| Classification Name: | Bicarb Mix, Storage and Distribution System for Hemodialysis |
| Equivalency: | Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System is substantially 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. |
| Device Description: | Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System uses Reverse Osmosis, provides for batch mixing of Bicarb liquid concentrate, transfer to storage and delivery to point of use.<br>The Bicarb Mix Tank allows Bicarb liquid concentrate to be mixed in batches then transferred to a Storage Tank.<br>The Storage and Distribution components of the system serve to deliver Bicarb liquid concentrate to the point of use.<br>Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System can be customized to best meet the needs of the user.<br>Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System meets or exceeds all Association for the Advancement of Medial Instrumentation (AAMI) National Standards for Hemodialysis. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2000

Ms. Rhonda S. McCoy Office Manager Pure Water, Inc. 305 W. Market Street Anderson, SC 29624

Re: K993272 Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System Dated: January 19, 2000 Received: January 24, 2000 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FIN and KPO

Dear Ms. McCoy:

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 pror 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 Cosmelic 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 equivalion 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 Radiation Control provisions, or other Federal laws or requlations.

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 nolification" (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/dsma/dsmamain.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)

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## INDICATIONS FOR USE STATEMENT

The Pure Water, Inc.'s Bicarb Mix, Storage and Distribution system is intended to be The Furt Walk, Inc. 6 Dicare Inzi, Secrage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

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(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

**510(k) Number** K993272

Bicarb Mix, Storage and Distribution 510(k) Submission September 27, 1999

Exhibit "QQ"