NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER

K110285 · Nephros, Inc. · FIP · Jul 14, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110285
• Device Name: NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
• Applicant: Nephros, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Jul 14, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The DSU, MSU, SSU Filters are intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU, MSU, SSU Filters assist in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).

Device Story

Nephros DSU, MSU, and SSU filters are point-of-use or inline filtration devices designed for hemodialysis applications. They process water or bicarbonate concentrate to remove biological contaminants, ensuring hemodialysis-quality fluids. The filters function as an adjunct to primary water treatment systems like Reverse Osmosis (RO) or Deionization (DI) units. They are intended for clinical use within hemodialysis facilities. By reducing biological load, the filters help maintain fluid purity, supporting safe hemodialysis procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Filtration device for water or bicarbonate concentrate in hemodialysis. Designed for removal of biological contaminants. Operates as an adjunct to existing water treatment systems (RO, DI).

Indications for Use

Indicated for use in hemodialysis settings to filter water or bicarbonate concentrate to remove biological contaminants. Must be used as an adjunct to other water treatment systems (e.g., RO, DI).

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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. James Summerton Manager Product Development Nephros. Inc. 41 Grand Ave. RIVER EDGE NJ 07661

JUL 1 4 2011

Re: K110285

> Trade Name: Nephros Inc. DSU. MSU. SSU Filter Regulation Number: 21 CFR \$876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: July 5, 2011 Received: July 6, 2011

Dear Mr. Summerton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K110285 Device Name: Nephros Inc. DSU, MSU, SSU Filter

Indications For Use:

The DSU, MSU, SSU Filters are intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU, MSU, SSU Filters assist in providing hemodialysis quality water or bicarbonate concentrate. The device is not a complete water treatment system, but serves to remove biological contaminants. Therefore, it must be used in conjunction with other water treatment equipment (i.e., RO, DI, etc.).

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

Over-The-Counter Use (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)

Aorgu In Wh

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110285

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