NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER

K090885 · Nephros, Inc. · FIP · Jun 29, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K090885
• Device Name: NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
• Applicant: Nephros, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Jun 29, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The DSU Dual Stage Ultrafilter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU assists 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

DSU Dual Stage Ultrafilter is a hollow fiber filter designed for hemodialysis applications. It functions as a point-of-use or inline filtration component to remove biological contaminants—specifically bacteria, viruses, and endotoxins—from water or bicarbonate concentrate. The device is not a standalone water treatment system; it must be integrated into a broader water treatment infrastructure (e.g., Reverse Osmosis or Deionization systems). By providing hemodialysis-quality fluids, the filter helps ensure the safety of the dialysis process. It is intended for use by healthcare professionals in clinical settings where hemodialysis is performed. The device operates via physical filtration through its hollow fiber membrane structure.

Clinical Evidence

Bench testing only. Performance data included flow rate versus pressure drop, bicarbonate composition effect, pyrogen removal, virus challenge test, bacteria challenge test, and chemical compatibility.

Technological Characteristics

Hollow fiber filter cartridge; designed for removal of bacteria, viruses, and endotoxins from hemodialysis water/bicarbonate concentrate. Operates as a physical filtration barrier. Intended for integration with 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, including bacteria, viruses, and endotoxins, as an adjunct to existing 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.

Predicate Devices

• FiberFlo™ Hollow Fiber Cartridge Water Filters (K983126)

Submission Summary (Full Text)

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K090885 pgs lot 2

Traditional 510(k) Premarket Notification

JUN 29 2009

| Submitter: | Nephros Inc.<br>41 Grand Ave<br>River Edge, NJ 07661<br>Establishment Registration # 3003337893 |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vikki M. O'Connor, Director QA/RA<br>41 Grand Ave<br>River Edge, NJ 07661<br>201-207-2490 (p)<br>201-343-5207 (f)<br>[e-mail] |
| Date Prepared | March 30, 2009 |
| Trade Name | DSU Dual Stage Ultrafilter |
| Proposed Class | Class II |
| Classification Name<br>and Number | 21 CFR Part 876.5665 Water Purification System for<br>Hemodialysis |
| Product Code | FIP |
| Predicate Devices | FiberFlo™ Hollow Fiber Cartridge Water Filters - K983126 |
| Device Description | The DSU Dual Stage Ultrafilter is a hollow fiber filter that<br>removes bacteria, viruses, endotoxin and particulate from<br>water and bicarbonate concentrate used in hemodialysis. |
| Intended Use | The DSU Dual Stage Ultrafilter is intended to be used to<br>filter water or bicarbonate concentrate used in<br>hemodialysis devices. The DSU assists in providing<br>hemodialysis quality water or bicarbonate concentrate. The<br>device is not a complete water treatment system, but<br>serves to remove biological contaminants. Therefore it<br>must be used in conjunction with other water treatment<br>equipment (i.e., RO, DI, etc.). |
| Summary of the<br>Technological<br>Characteristics | The proposed device has the same technological<br>characteristics and is similar in design as compared to the<br>predicate device. |
| Assessment of<br>Non-clinical<br>Performance Data /<br>Substantial<br>Equivalence | The DSU Dual Stage Ultra Filter has been tested for<br>performance. The tests conducted include Flow Rate<br>versus Pressure Drop, Bicarbonate Composition Effect,<br>Pyrogen Removal, Virus Challenge Test, Bacteria<br>Challenge Test and Chemical Compatibility. This filter was<br>found to be substantially equivalent to the predicate<br>Minntech Fiberflo Filter (K983126). |

510(k) Summary: DSU Dual Stage Ultrafilter

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K090885 page 2 of 2

Nephros Inc. DSU Dual Stage Ultrafilter

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Traditional 510(k) Premarket Notification

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vikki M. O'Connor Director, OA/RA Nephros, Inc. 41 Grand Avenue RIVER EDGE NJ 07661

Re: K090885

Trade/Device Name: Nephros Inc. DSU Filter Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 30, 2009 Received: April 3, 2009

Dear Ms. O'Connor:

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); medical device reporting of medical

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device-related 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/CDRH/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 hitp://www.fda.gov/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation -Center for Devices and Radiological Health

Enclosure

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K09085 page lot 1

Traditional 510(k) Premarket Notification

## Indications for Use

510(k) Number (if known): K 090885 Device Name: Nephros Inc. DSU Filter

Indications For Use:

The DSU Dual Stage Ultrafiter is intended to be used to filter water or bicarbonate concentrate used in hemodialysis devices. The DSU Ultrafilter assists 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 _____________________________________________________________________________________________________________________________________________________________ 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)

Hulu Rem
Division Sign-Off

Division of Reproductive, Abdominal,
and Radiological Devices
K990875

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