HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM

K022747 · Hydropure Systems, Inc. · FIP · Feb 11, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K022747
• Device Name: HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM
• Applicant: Hydropure Systems, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Indications for Use

HydroPure Deionization Systems with pre & post-treatment and product water distribution components are intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrates to form dialysate, reprocessing of hemodialyzers and equipment rinse and disinfection.

Device Story

HydroPure PEDI systems purify potable feed water for hemodialysis via deionization. System components include pretreatment (pressure regulators, check valves, cartridge filters, carbon tanks) and post-treatment (submicron/ultrafilters, resistivity alarms). Input: potable feed water; Output: purified water meeting ANSI/AAMI RD62:2001 standards. Operation: pretreatment conditions water; deionization tanks remove ions; post-treatment removes bacteria/endotoxins. Monitoring: temperature-compensated audible/visual resistivity alarms (set at 1 megohm or greater) and mid-tank quality indicators. Used in clinical settings (acute/central/back-up); operated by clinical staff. If water quality drops below 1 megohm, alarm triggers, treatments discontinue, and tanks require replacement. Benefits: provides purified water for dialysate, dialyzer reprocessing, and equipment disinfection.

Clinical Evidence

Bench testing only. The device demonstrates compliance with ANSI/AAMI RD62:2001 standards for water treatment equipment for hemodialysis applications. No clinical data provided.

Technological Characteristics

System utilizes deionization tanks, carbon filtration, and submicron/ultrafilters. Features include pressure reducing valves, check valves, and resistivity monitoring (1 megohm threshold). Connectivity includes audible/visual alarms and remote alarm capability. Complies with ANSI/AAMI RD62:2001. Materials include carbon and mixed bed DI media.

Indications for Use

Indicated for use with hemodialysis systems to remove organic/inorganic substances and microbial contaminants from water used for dialysate preparation, dialyzer reprocessing, and equipment disinfection. Applicable to single-patient (Acute), multi-patient (Central), and back-up/polishing (Back-up) configurations.

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.

Predicate Devices

• US Filter Corporation's water treatment system for dialysis

Submission Summary (Full Text)

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

KO22747 PAGE 1 OF 2

FEB 1 1 2003

# 510(k) Summary of Safety and Effectiveness

This 510(k) Summary of Safety and Effectiveness is provided as part of this Premarket Notification to comply with the provisions of the safe Medical Devices Act of 1990 requiring that either a summary be included in a submission or a statement that a summary is available upon request.

#### Submitter

Robert V. Price HydroPure Systems, Inc. 3319 Bartlett Blvd. Orlando, FL. 32811 TEL: [phone] FAX: [phone] July 23, 2002

#### Device Names

Trade Names

HydroPure "Acute" Portable Exchange Deionization (PEDI) System HydroPure "Central" PEDI System HydroPure "Back-up" PEDI System

#### Common or usual name

Deionization systems with pre & post treatment and product water distribution components.

#### Classification name

Water purification systems for hemodialysis (21CFR 876.5665)

#### Intended Use

HydroPure Deionization Systems with pre & post-treatment and product water distribution components are intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrates to form dialysate, reprocessing of hemodialyzers and equipment rinse and disinfection.

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

# K022747 PAGE 2 OF 2

## Device Description

The HydroPure systems purify potable feed water through deionization. Deionization is used to remove 99.99+% of ions from water. Deionization alone does not remove particulates, organics, bacteria, viruses or endotoxins. The systems require adequate pretreatment and post-treatment. Deionizers are designed for the hemodialysis application to treat RO or carbon filtered potable water. Inappropriate use can result in the formation of Nitrosamines in the effluent of the deionizer.

The purpose of the pretreatment section of the system is to condition the feed water supplying the deionizers. Conditioning the feed water will include: pressure reducing valves to regulate system pressure, check valves to prevent back-flow of the treated water into the potable water source, cartridge filters to reduce particulates and sediment, carbon filtration tanks to remove chloramines and sample ports after each carbon tank to check feed water conductivity and for any chlorine/chloramine residual.

The purpose of the post-treatment section of the system is to remove bacteria and endotoxins or lower them to acceptable levels as required by the AAMI standards. The post-treatment section of the system will include: submicron/ultrafilters after the deionizers. sample ports to check for microbial contamination and to test for comprehensive AAMI analysis, a 200K ohm quality control light at mid tank and a temperature compensated audible visual resistivity alarm set at one megohm or greater for final water quality. A remote alarm will be installed if the deionization system is not located in the patient treatment area. A distribution section of a system is necessary to deliver product water that meets ANSI/AAMI standards to the points of use. During use, continual monitoring of the effluent through the use of the temperature compensated audible and visual resistivity alarm is required. Routine monitoring of the mid tank quality indicator is also required on intervals during the day, at least before and after each patient treatment.

Should final water quality fall at or below 1 megohm, the alarm will sound and light up red and all patient treatments must be discontinued. The deionization tanks must be replaced as per Appendix C of the operating manual prior to resuming any patient treatment.

Depending upon the PEDI system size and feed water quality of 10grains TDS, HydroPure systems produce typically 250 gallons per deionization tank exchange at a flow-rate of up to 0.75gpm, to 3,600 gallons per deionization tank exchange at a flowrate of up to 15gpm.

HydroPure's water purification systems will produce product water that meets the requirements of the standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD62:2001, Water Treatment Equipment For Hemodialysis Applications.

### Predicate Device

The Hydropure PEDI Systems and pretreatment and product water distribution components are substantially equivalent to US Filter Corporation's water treatment system for dialysis which utilizes carbon and deionization cylinders to purify water for hemodialysis.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 11 2003

Mr. Robert V. Price President HydroPure Systems, Inc. 3319 Bartlett Blvd. ORLANDO FL 32811

Re: K022747

Trade/Device Name: HydroPure Systems, Inc. PEDI Water Purification Systems for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: December 11, 2002 Received: December 17, 2002

Dear Mr. Price:

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 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.

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.

{3}------------------------------------------------

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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

{4}------------------------------------------------

Page 1 of 1

510(k) Number K022747

HydroPure "Acute" Portable Exchange Deionization (PEDI) System Device Name: HydroPure "Central" PEDI System. HydroPure "Back-up" PEDI System

Indications For Use:

The HydroPure "Acute" Portable Exchange Deionization (PEDI) System consists of two each small carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be placed on the back of a dialysis machine or on a handcart for single patient dialysis.

The HydroPure "Central" PEDI System consists of two or more carbon and mixed bed DI tanks with pre & post-filtration. It is intended to be installed in a central location for multiple patient dialysis.

The HydroPure "Back-up" PEDI System consists of two or more mixed bed DI tanks as a component in a "back-up" condition when a RO system or major component on a water purification system for hemodialysis is in need of repair. It may also be used in DI polishing mode to remove ions that an RO could not lower to safe levels.

All three PEDI systems with appropriate pre & post-filtration and components is intended for use with a hemodialysis system to remove organic and inorganic substances from water that is used to dilute dialysis concentrates to form dialysate and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use . (Per 21 CFR 801.109) (Optional Format 3-10-98)

David A. Segner

and Rad 510(k) Nun