G.E.M. WATER SYSTEMS, INTERNATIONAL

K970674 · G.E.M. Water Systems · FIN · Nov 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970674
• Device Name: G.E.M. WATER SYSTEMS, INTERNATIONAL
• Applicant: G.E.M. Water Systems
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THE INTENDED USE OF THESE DEVICES IS ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PRUIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW THE MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES.

Device Story

Device mixes sodium bicarbonate powder with purified water (AAMI standard compliant) for hemodialysis; automatically delivers resulting solution to dialysis machines. Used in clinical hemodialysis facilities; operated by trained facility staff. Automates preparation and distribution process; ensures consistent solution delivery to dialysis equipment; supports hemodialysis treatment workflow.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System for mixing and automated delivery of sodium bicarbonate solution. Uses purified water meeting AAMI standards. Mechanical mixing and fluid delivery components.

Indications for Use

Indicated for use in hemodialysis facilities to prepare and deliver sodium bicarbonate solution for hemodialysis 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

NOV 19 1997

Mr. Jack Enkowitz
G.E.M. Wafer Systems, Int'l.
5940 Lakeshore Drive
Cypress, California 90630

Re: K970674
AKS-BM, AKS-BM1, AKS-BM2, and AKS-BM2-2
Sodium Bicarbonate Mixers/Delivery Systems
Dated: September 23, 1997
Received: September 26, 1997
Regulatory class: II
21 CFR §876.5820/Product code: 78 FIN and KPO

Dear Mr. Enkowitz:

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 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 requirement, 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/dsmamain.html".

Sincerely yours,


Enclosure

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# INDICATION FOR USE STATEMENT

THE INTENDED USE OF THESE DEVICES IS ALLOW THE HEMODIALYSIS FACILITY TO MIX SODIUM BICARBONATE POWDER WITH PRUIFIED WATER THAT MEETS AAMI STANDARDS FOR HEMODIALYSIS TREATMENT, AND ALLOW THE MIXED SOLUTION TO BE AUTOMATICALLY DELIVERED TO THE DIALYSIS MACHINES.

*Robert P. Sathing*
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number *15970674*

Prescription Use ☑
(Per 21 CFR 801.109)

Over-the-Counter Use _________________________

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