AQUA PURE DEIONIZER EXCHANGE SERVICE

K072158 · Staubach Barror Water Systems, Inc. · FIP · Feb 21, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072158
• Device Name: AQUA PURE DEIONIZER EXCHANGE SERVICE
• Applicant: Staubach Barror Water Systems, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Feb 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pretreatment and post-treatment.

Device Story

Device consists of FRP tanks filled with mixed bed ion exchange resin; designed to purify water for dialysis applications. Components include machined PVC schedule 80 head, stand pipe, fill port, and distributor basket; utilizes glass-filled Noryl widget connectors. System integrates with Resi-Lite 1 megohm audio/visual alarm for monitoring. Used in clinical dialysis settings as part of a larger water treatment system requiring pre- and post-treatment. Provides dialysis-grade water by removing ionic contaminants via ion exchange. Healthcare providers use the system to ensure water meets AAMI RD 62 standards for patient safety during dialysis procedures.

Clinical Evidence

No clinical data; bench testing only. Device performance is based on adherence to AAMI standards (RD 62) for water purification and equivalence to the predicate device.

Technological Characteristics

FRP tanks; MBD-10 mixed bed resin; PVC schedule 80 heads, fill plugs, stand pipes, and distributor baskets; glass-filled Noryl widget connectors; high purity PVC interconnecting tubing. Includes Resi-Lite 1 megohm audio/visual alarm. Passive ion exchange purification technology. No software or electronic processing.

Indications for Use

Indicated for use in dialysis facilities to supply dialysis-grade water for hemodialysis, concentrate preparation, dialyzer reuse, and rinsing of sterilants. Used as primary or emergency backup water purification within a larger treatment system.

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

• Ameriwater Dialysis Deionizer Exchange Tanks (K991519)

Submission Summary (Full Text)

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#### K072158 - 510(k) Pre-market Notification D.I. Exchange Tanks for Dialysis

### 1. Submitter: Aqua Pure Staubach Barror Water systems Inc. FEB 21 2008 495 Rotterdam Ind. Park Schenectady, NY 12306 Contact Person: Jarrod Staubach V.P. / Quality Manager Tel:[phone] November 26, 2007 Date prepared: 2. Device name: D.I. Exchange Tanks for Dialysis. 3. Device Classification: Class II Medical Device under 21 CFR \$876.5665 4. Predicate Device: Ameriwater Dialysis Deionizer Exchange Tanks

## 510(k) Summary

- 5. Device Description: Aqua Pure's D.I. Exchange Tanks for Dialysis are FRP tanks filled with mixed bed resin. Widget connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. Our tanks are designed to supply AAMI standard water for dialysis through ion exchange. The D.I. exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks K991519.
- 6. Indications for use: The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pretreatment and post-treatment.

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K472158
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- 7. Comparison with predicate device: Aqua Pure's D.I. Exchange Tanks for Dialysis are substantially equivalent to the currently marketed Ameriwater Dialysis Deionizer Tanks, and have not altered the fundamental scientific technologies or materials used in the predicate device. The intended use of the D.I. Exchange Tanks for Dialysis is the same as the intended use of the predicate device K991519.

| Tank parts and<br>manufacturers. | Ameriwater Dialysis<br>Deionizer Exchange<br>Service | Aqua Pure D.I. Exchange<br>Tanks for Dialysis |
|---------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Tank type and manufacturer | FRP tanks manufactured from<br>Park International | FRP tanks manufactured from Park<br>International |
| Resin type and manufacturer | MBD-10 Resin manufactured by<br>ResinTech | MBD-10 Resin manufactured by<br>ResinTech |
| Audio alarm type | Resi-Lite 1 megohm audio/visual<br>alarm positioned between worker<br>and polisher | Resi-Lite 1 megohm audio/visual<br>alarm positioned between worker<br>and polisher |
| Interconnecting tubing | High purity PVC interconnecting<br>tubing | High purity PVC interconnecting<br>tubing |
| Connectors | Widget connectors made of<br>glass filled Noryl | Widget connectors made of<br>glass filled Noryl |
| Heads and fill plugs | PVC schedule 80 machined head<br>with PVC schedule 80 fill plug. | PVC schedule 80 machined head<br>with PVC schedule 80 fill plug. |
| Stand pipe and distributor<br>baskets | PVC schedule stand pipe and<br>distributor basket. | PVC schedule stand pipe and<br>distributor basket. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

FEB 2 1 2008

Food and Drug Administration 9200 Corporate Boylevard Rockville MD 20850

Mr. Jarrod J. Staubach Vice President/Quality Manager Staubach Barror Water Systems, Inc. (DBA: Aqua Pure) 495 Rotterdam Industrial Park SCHENECTADY NY 12306

K072158 Re:

> Trade/Device Name: D.I. Exchange Tanks for Dialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: January 2, 2008 Received: February 5, 2008

Dear Mr. Staubach:

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 Rederal Register.

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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 fisting (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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |
|-----------------|----------------------------------|--------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | |
| Other | | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.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

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# Indications for Use

510(k) Number: K072158

Device Name: D.I. Exchange Tanks for Dialysis

Indications for Use: The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pre-treatment and post-treatment.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(vers 6/25/05)

Halut Reiner

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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