NX STAGE WATER PURIFICATION SYSTEM

K042089 · Nxstage Medical, Inc. · FIP · Nov 24, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K042089
• Device Name: NX STAGE WATER PURIFICATION SYSTEM
• Applicant: Nxstage Medical, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The NxStage Water Purification System is a stand-alone water treatment system designed to pretreat and purify water for use in hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. It is intended to be used in a variety of environments, including acute or chronic care facility or home.

Device Story

Stand-alone water purification system for hemodialysis applications; used in acute/chronic care facilities or home. Comprised of three main components: pretreatment system (check valve, sediment filter, air vent) for sediment/air removal; Pump Controller unit for flow/pressure/quality monitoring; replaceable resin system for chemical/microbiological contaminant removal. System produces water meeting ANSI/AAMI RD62:2001 standards. Operated by end-user; controller manages system operation and safety. Output is purified water for dialysate preparation, equipment maintenance, and dialyzer reprocessing. Benefits patient by ensuring water quality for hemodialysis therapy.

Clinical Evidence

Bench testing only. Performance testing was conducted to characterize the system and demonstrate compliance with ANSI/AAMI RD62:2001 standards for water treatment equipment in hemodialysis applications. Results confirmed the system is suitable for its labeled indications and equivalent to predicate devices.

Technological Characteristics

Stand-alone water purification system. Components: check valve, sediment filter, air vent, Pump Controller, and replaceable resin system. Energy source: electrical (Pump Controller). Connectivity: not specified. Sterilization: not specified. Software: embedded control and safety software for flow, pressure, and water quality monitoring. Complies with ANSI/AAMI RD62:2001.

Indications for Use

Indicated for patients requiring hemodialysis in acute care, chronic care, or home settings. Used for water pretreatment and purification for dialysate preparation, equipment rinsing/disinfection, and dialyzer reprocessing. No known contraindications.

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 Portable RO+ Model MROS09 (K030059)
• HydroPure Deionization Systems (K022747)
• Water & Power Technologies of Texas, Inc. (K994292)
• Total Water Treatment System (K002045)

Submission Summary (Full Text)

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K042089
Page 1 of 3

# Section VII: 510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

#### A. Submitter's Information:

| Name: | NxStage Medical, Inc. | |
|----------------------|--------------------------------------------------------|--|
| Address: | 439 South Union Street, Suite 50<br>Lawrence, MA 01843 | |
| Phone: | [phone] | |
| Fax: | [phone] | |
| Contact Person: | Norma LeMay<br>Manager, Regulatory Affairs | |
| Date of Preparation: | July 13, 2004 | |

#### B. Device Name:

| Trade Name: | NxStage Water Purification System |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Water Purification System |
| Classification Name: | Water Purification System for Hemodialysis (Class<br>II medical device under 21 CFR 875.5665<br>(Product Code 78 FIP)) |

#### C. Substantial Equivalence/Predicate Devices:

The proposed NxStage Water Purification System is substantially equivalent to the following legally marketed predicate devices previously cleared by FDA:

- AmeriWater Portable RO+ Model MROS09, (K030059, cleared 04/07/03) .
- . HydroPure Deionization Systems, (K022747, cleared 02/11/03)
- Water & Power Technologies of Texas, Inc. (K994292, cleared 01/02/01) .
- . Total Water Treatment System, (K002045, cleared 02/16/01)

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## NxStage Medical, Inc. Water Purification System 510(k) Premarket Notification

K042089
Page 2 of 3

# Section VII: 510(k) Summary of Safety & Effectiveness

#### D. Device Description/Indications for Use:

The NxStage Water Purification System is a stand-alone water System designed to pre-treat and purify water for use with hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. The System is intended to be used in a variety of environments, including an acute or chronic care facility or the home. There are no known contraindications with the use of the NxStage Water Purification System.

The System is single patient use and is comprised of three major components: 1) a pretreatment system which consists of a check valve, sediment filter and air vent to remove trapped air, sediment, and any impurities, 2) a Pump Controller unit which contains the control and safety software that controls the flow rate, monitors pressure, water quality and system operation and 3) a replaceable resin system that removes organic and inorganic chemical contaminants as well as microbiological contaminants such as bacteria and endotoxins. The System flow rate is specified by the end user.

With proper use, the System will produce water that meets or exceeds 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.

#### Indications for use:

The NxStage Water Purification System is a stand-alone water treatment system designed to pretreat and purify water for use in hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. It is intended to be used in a variety of environments, including acute or chronic care facility or home.

#### E. Technological Characteristics:

The proposed device has the same technological characteristics and is similar in design and configuration as compared to the predicate devices. The proposed device is designed and assembled with components commonly found in the predicate devices.

## F. Summary of Non-Clinical Test/Performance Testing

NxStage Medical believes that the information and data provided in this submission clearly describes the proposed device and demonstrates that the device is adequately designed for the labeled indications for use. Performance testing was conducted to characterize performance of the proposed NxStage Water Purification System to provide a basis of comparison to the predicate devices. Results of the

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## NxStage Medical, Inc. Water Purification System 510(k) Premarket Notification

KC42089
Page 3 of 3

# Section VII: 510(k) Summary of Safety & Effectiveness

performance testing have demonstrated that the NxStage Water Purification System is substantially equivalent to the predicate devices and is suitable for the labeled indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2004

NxStage Medical, Inc. c/o Mr. Casey Conry Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719

Re: K042089

Trade/Device Name: NxStage Water Purification System Regulation Number: 21 CFR §876.5665 Regulation Name: Water Purification System for Dialysis Regulatory Class: II Product Code: 78 FIP Dated: November 1, 2004 Received: November 2, 2004

Dear Mr. Conry:

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 (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 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.

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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 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" (21 CFR 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/dsmaldsmamain.html

Sincerely yours,

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

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#### INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Indications for Use:

K042089

NxStage Water Purification System

The NxStage Water Purification System is a stand-alone water treatment system designed to pretreat and purify water for use in hemodialysis applications. The purified water can be used in preparation of dialysate, equipment rinsing and disinfection, and dialyzer reprocessing. It is intended to be used in a variety of environments, including acute or chronic care facility or home.

Prescription Use _ X Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-Off)

Division of Renrodu and Radiological Dev 510(k) Number

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