SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM

K992793 · Better Water, Inc. · FIN · Nov 16, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992793
• Device Name: SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
• Applicant: Better Water, Inc.
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Nov 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are intended to be used in a hemodialysis facility to allow safe and effective central delivery of concentrates, and central mixing and delivery of sodium bicarbonate solution necessary for a dialysis treatment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Device Story

System comprises central mixing/delivery tanks for sodium bicarbonate and bulk storage/delivery tanks for pre-mixed concentrates; used in hemodialysis facilities. Bicarbonate system: AAMI-standard water mixed with sodium bicarbonate powder in tank; solution checked for quality; delivered manually or automatically to patient stations. Concentrate system: pre-mixed solution transferred to bulk storage; delivered to dialysis machines. Dialysis machines perform final mixing/dilution at patient station. Facilitates centralized fluid management for dialysis treatment; reduces manual handling of concentrates; ensures consistent delivery of dialysis solutions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System utilizes mixing tanks and delivery piping for dialysis concentrates. Bicarbonate system requires AAMI-standard water. Manual or automatic delivery modes. No software or electronic control algorithms described; mechanical/fluidic operation.

Indications for Use

Indicated for use in hemodialysis facilities to facilitate the central mixing of sodium bicarbonate powder with AAMI-standard water and the central delivery of resulting bicarbonate solution or pre-mixed concentrate solutions to dialysis machines for patient 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

• G.E.M Water Systems, International Sodium Bicarbonate Mixers/Delivery Systems (K970674)

Submission Summary (Full Text)

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

NOV 1 6 1999

K992793
Page 1 of 1

## Better Water, Inc.

## 510(k) SUMMARY

Better Water, Inc. 698 Swan Dr. Smyrna, TN. 37167 Mike Sterling Director of Regulatory Affairs

Device Names: Central Concentrate Delivery System for Dialysis, Central Bicarbonate Mixing/Delivery System.

Substantial Equivalence: G.E.M Water Systems, International Sodium Bicarbonate Mixers/Delivery Systems #K970674

Classification Name: "Hemodialysis System and Accessories" (21 CFR 876.5820)

Intended Use: These devices are intended to be used in a hemodialysis facility to allow safe and effective central delivery of concentrates, and central mixing and delivery of sodium bicarbonate solution necessary for a dialysis treatment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Device Description: The central mixing and delivery sodium bicarbonate system (tank) is filled with AAMI standard water, into which a specific amount of sodium bicarbonate powder is poured. It is then mixed in the tank, checked for proper solution, then delivered either manually, or automatically to each patient station on the treatment floor, where it is then mixed/diluted by the dialysis machine for the intended treatment.

The central delivery concentrate system works much the same way, with the exception that the solution is not mixed in the system provided by Better Water, Inc. The solution is either pre-mixed and bulk transferred, or it is mixed in a separate piece of equipment, and then transferred to the bulk storage and delivery system, provided by Better Water, Inc.

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 6 1999

Mr. Mike Sterling Director of Regulatory Affairs Better Water, Inc. 698 Swan Drive Smyrna, TN 37167

Re: K992793

Sodium Bicarbonate Mixing/Delivery System and Concentrate Delivery System Dated: September 14, 1999 Received: September 14, 1999 Regulatory Class: II 21 CFR § 876.5820/Procode: 78 FIN

Dear Mr. Sterling:

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 III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requiration 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

1. 9

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

## INDICATION FOR USE STATEMENT

THE INTENDED USE OF THESE DEVICES IS TO ALLOW THE HEMODIAL YSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PURIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIAL YSIS TREATING TO BUIL ALLOW MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE ALLYSIS MACHINES. IT IS ALSO INTENDED TO AUTOMATICALLY DELIVER A PRE-MIXED CONCENTRATE SOLUTION TO THE DIALYSIS MACHINE.

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, 510(k) Number_K992793

Prescription Use
(Per 21 CFR 801.109)

Over -the-Counter Use ________________________________________________________________________________________________________________________________________________________