GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM

K981085 · Gambro Healthcare · FIP · May 18, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K981085
• Device Name: GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
• Applicant: Gambro Healthcare
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.

Device Story

Gambro Water Treatment System purifies water for hemodialysis applications. Used in clinical settings by trained personnel to prepare water for dialysate concentrate dilution and dialyzer reprocessing. System ensures water quality meets standards for hemodialysis procedures. Healthcare providers utilize purified water output to facilitate safe dialysis treatment and equipment maintenance. Benefits include consistent water quality for patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Water purification system designed for hemodialysis clinic infrastructure. Operates via filtration/purification processes to meet water quality standards for dialysate preparation and dialyzer reprocessing. Standalone clinical equipment.

Indications for Use

Indicated for use in hemodialysis clinics for water purification required for dialysate concentrate dilution and dialyzer reprocessing.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 1998

Mr. William M. Townsend Senior Regulatory Specialist GAMBRO Healthcare 1185 Oak Street Lakewood, CO 80215-4498 Re: K981085

Gambro® Water Purification System Dated: March 23, 1998 Received: March 25, 1998 Regulatory Class: II 21 CFR 876.5665/Procode: 78 FIP

Dear Mr. Townsend:

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 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 substantialion assumes compliance with the Current Good Manufacturing Practice requirements. as set forth in the Quality System Regulation (OS) 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 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/cdrb/dsmaldsmam.html".

Sincerely yours.

Lillian Yin, Ph.D.

Director. Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement 10.0

MBRO Healthcare Renal Care Products 1185 Oak Street Lakewood, CO 80215.498

> The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.

Robert R. Satting/

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

510(k) Number 108

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use_