OZONE GENERATOR

K043207 · Ge Infrastructure Water & Process Technologies · NII · Nov 4, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043207
• Device Name: OZONE GENERATOR
• Applicant: Ge Infrastructure Water & Process Technologies
• Product Code: NII · Gastroenterology, Urology
• Decision Date: Nov 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2

Intended Use

The OzZ Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS sustem until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is thenrecirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.

Device Story

O3Z Ozone System functions as an accessory to GE Solution Delivery Systems (SDS) for hemodialysis bicarb mixing/distribution loops. Device is wall-mounted near SDS; connects via valve bypass and injector. Operation: user fills mix tank with RO/deionized water; configures bypass valves; starts mix pump to draw O3/air mixture into solution. System achieves 0.70 mg/L ozone in mix tank; distributes to loop until 0.30 mg/L reached at end of loop; recirculates for 15 minutes; performs final rinse until ozone-free. Disinfection process reduces microbial counts in fluid path. Benefits patient by maintaining sanitary conditions in dialysis fluid delivery equipment.

Clinical Evidence

Bench testing only. Effectiveness of disinfection process demonstrated through microbial reduction testing, confirming consistent reduction of high total organism counts to acceptable levels when operated per manual.

Technological Characteristics

Ozone generator; wall-mounted; connects to SDS via valve bypass and injector. Uses ozone gas/air mixture for chemical disinfection of fluid paths. Operates with RO or deionized water. No software or complex electronics described.

Indications for Use

Indicated for disinfection of bicarb mixing and distribution systems within hemodialysis clinics using GE Solution Delivery Systems (SDS).

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• Karlson Ozone Sterilizer (K873200)
• Minncare (not 510(k) number provided)
• Renalin (K830575)

Submission Summary (Full Text)

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K043207

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are three decorative swirls or flourishes evenly spaced around the outer edge of the circle. The logo is black and white.

GE Infrastructure Water & Process Technologies

# 510(k) SUMMARY

DATE PREPARED:

November 2, 2005

#### SUBMITTER 1.

GE Infrastructure, Water & Process Technologies 5951 Clearwater Drive Minnetonka, MN 55343-8995

#### CONTACT PERSON 2.

Name: Charlene Nash Phone: [phone] Fax: [phone] Email: [e-mail]

#### DEVICE IDENTIFICATION 3.

Ozone Generator/Ozone Generating System Common Name:

Trade Name/Proprietary Name:

O3Z Ozone System used on the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies

#### CLASSIFICATION NAME AND REFERENCE 4.

Classification Names: Tank, Holding, Dialysis and Accessories

Classification: Class II, 21 CFR 876.5820 Panel: Gastroenterology Product Code: FIN

#### PREMARKET NOTIFICATION NUMBER: K043207 ട.

General Electric Company 5951 Clearwater Drive Minnetonko, MN 55343-8995 USA

T 952-933-2277 952-988-6056 F

Image /page/0/Picture/21 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance.

Poge 1 of 2

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are white and set against a black circular background. The circle has three white decorative elements around its perimeter.

- The O3Z Ozone System is an optional accessory for the INDICATION FOR USE: ട. Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies, and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.
- The Ozone Generating System attaches to the Solution 7. DEVICE DESCRIPTION: Delivery System (SDS) through a valve bypass system and an injector. It is wall mounted in the vicinity of the SDS and is connected to the injector, which is installed in the output piping of the mix pump. The SDS mix tank is filled with RO or DI water; the bypass valves are manually configured for ozone production and then the mix pump is started, causing the injector to draw O3/air mixture into solution. When the proper concentrations of ozone are achieved, the ozonated water is re-circulated throughout the mixing and delivery system to disinfect the fluid path.
- STATEMENT OF SUBSTANTIAL EQUIVALENCE: The ozone generator for system 8. disinfection is substantially equivalent in technological characteristics of the Karlson Ozone Sterilizer (K873200). It is substantially equivalent in intended use to Minncare®, which is commonly used in hemodialysis clinics to disinfect the reverse osmosis water purification equipment and the water distribution loop and Renalin® (K830575), another common disinfectant used in dialysis clinics primarily to reprocess dialyzers and disinfect dialysis machines.

#### PERFORMANCE: SAFETY AND EFFECTIVENESS INFORMATION 9.

Testing of the ozone generator demonstrated that the disinfection process was effective, reliable and consistent in reducing microorganisms with high total organism counts to acceptable levels after disinfection when used in accordance with the Operation and Maintenance Manual for the Ozone Generating System.

Image /page/1/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has small, teardrop-shaped embellishments around its perimeter. The logo is presented in black and white.

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General Electric Company 5951 Clearwater Drive Minnetonka, MN 55343-8995

952-933-2277 952-988-6056

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 4 2005

Ms. Charlene Nash Quality Assurance & Regulatory Affairs Manager GE Infrastructure Water & Process Technologies GE Osmonics, Minnetonka Medical Operations 5951 Clearwater Drive Minnetonka, Minnesota 55343

Re: K043207

Trade/Device Name: 03Z 0Zone System Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: NII Dated: October 14, 2005 Received: October 19, 2005

Dear Ms. Nash:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Nash

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## GE Infrastructure, Water & Process Technologies 5951 Clearwater Drive Minnetonka, MN 55343-8995

#### 510(k) Number (if known): K043207

Device Name:

OzZ Ozone System used on the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies

### Indications for Use Statement

The OzZ Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS sustem until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is thenrecirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.

Concurrence of CDRH, Office of Device Evoluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

Shiela A. Murphy, MD 10/3/00
Division Sign Off

sion of Anesthesiology. General Hospital Infection Control. Dantal Devices

510(k) Number: K043207