PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL

K993058 · Pure Water, Inc. · FIN · Jan 24, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K993058
• Device Name: PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
• Applicant: Pure Water, Inc.
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Jan 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Indications for Use

The Pure Water, Inc. Acidified Storage and Distribution system with Remote Fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of hemodialysis patients.

Device Story

System provides bulk storage and distribution of acidified concentrate for hemodialysis treatment. Utilizes one-piece molded seamless linear polyethylene tanks. Includes optional remote fill feature allowing vendor access from outside the building for tank replenishment. Used in clinical hemodialysis settings; operated by facility staff. Ensures concentrate availability for dialysis machines. Meets AAMI National Standards for Hemodialysis.

Clinical Evidence

Bench testing only; no clinical data provided. Device compliance with AAMI National Standards for Hemodialysis is the primary basis for safety and effectiveness.

Technological Characteristics

Materials: Linear polyethylene (one-piece molded seamless tanks). Function: Bulk storage and distribution of acidified concentrate. Connectivity: None. Energy: Not specified. Form factor: Storage tank system with remote fill capability. Standards: Meets AAMI National Standards for Hemodialysis.

Indications for Use

Indicated for use in hemodialysis facilities for the storage and distribution of acid concentrate for the treatment of hemodialysis patients.

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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510(k) Summary

## Submitter Information:

| Company Name: | Pure Water, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 305 West Market Street<br>Anderson, South Carolina |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Rhonda S. McCoy |
| Prepared: | September 10, 1999 |
| Trade Name: | Pure Water, Inc. Acidified Storage and Distribution System with<br>Optional Remote Fill |
| Classification Name: | Acidified Storage and Distribution System with optional Remote<br>Fill for Hemodialysis |
| Equivalancy: | Pure Water, Inc.'s Acidified Storage and Distribution System with<br>Optional Remote Fill is substantially equivalent to Better Water's<br>Water Purification System for Hemodialysis (510(k) #: K920186)<br>and ZyzaTech Water System, Inc.'s Water Purification Systems<br>and Components and Portable Reverse Osmosis Systems (510(k)<br>#: K964539) which are currently in commercial distribution. |
| Device Description: | Pure Water, Inc.'s Acidified Storage and Distribution System with<br>Optional Remote Fill uses "one-piece molded seamless tanks<br>constructed of linear polyethylene" for bulk storage of acidified<br>concentrate.<br><br>The Optional Remote Fill allows the storage tanks to be filled by<br>the vendor from outside the building.<br><br>Pure Water, Inc.'s Acidified Storage and Distribution System with<br>optional Remote Fill meets or exceeds all Association for the<br>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: K993058 Pure Water, Inc. Acidified Storage and Distribution System Dated: December 29, 1999 Received: December 30, 1999 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FIN 21 CFR §876.5820/Procode: 78 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 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verily 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 Compilance 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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510(k) Number (if known): K993058

Device Name: Pure Water, Inc. Acidified Storage and Distribution System

Indications For Use:

The Pure Water, Inc. Acidified Storage and Distribution system with Remote Fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of hemodialysis patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Dinda H.P.
Siti Aisah Dom

(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K993058 510(k) Number

Prescription Use J (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)