NEPHROS DSU-H, NEPHROS SSU-H

K141731 · Nephros, Inc. · NHV · Oct 24, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141731
• Device Name: NEPHROS DSU-H, NEPHROS SSU-H
• Applicant: Nephros, Inc.
• Product Code: NHV · Gastroenterology, Urology
• Decision Date: Oct 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.

Device Story

DSU-H and SSU-H Ultrafilters are hollow fiber ultrafiltration devices designed for in-line plumbing installation. The device utilizes a polysulfone hollow fiber membrane encased in an ABS housing to remove bacteria, viruses, and endotoxins from EPA-quality drinking water via size exclusion. The filters are used in clinical settings to provide ultrapure water for patient washing, drinking, wound cleansing, and cleaning of medical equipment. The device is operated by healthcare personnel. By reducing biological contaminants, the filters aid in infection control. The device does not require complex software or electronic processing; it functions as a passive mechanical filtration system.

Clinical Evidence

Bench testing only. Performance testing demonstrated retention capabilities: bacteria reduction > 10^11, virus reduction > 10^8, and endotoxin reduction > 10^5. These results were compared against the predicate device, showing equivalent or superior performance in contaminant removal.

Technological Characteristics

Hollow fiber ultrafilter; polysulfone membrane; ABS housing; size exclusion filtration principle; in-line plumbing installation; passive mechanical operation; no energy source; no software.

Indications for Use

Indicated for filtering EPA quality drinking water to provide ultrapure water for patient washing, drinking, wound cleansing, cleaning of medical equipment, and washing of surgeon's hands to aid in infection control. Not for use as a substitute for USP sterile water.

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

• MainStream™ Water Purification Device (K012716)

Reference Devices

• DSU and SSU Filters (K110285)

Submission Summary (Full Text)

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

October 24, 2014

Nephros Incorporated Mr. Jim Summerton Manager Product Development 41 Grand Avenue River Edge, NJ 07661

Re: K141731

Trade/Device Name: DSU-H and SSU-H Ultrafilters Regulation Number: 21 CFR 876.5665 Regulation Name: Water Purification Device, General Medical Use Regulatory Class: II Product Code: NHV Dated: September 24, 2014 Received: September 26, 2014

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.

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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 listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K141731

Device Name: DSU-H and SSU-H Ultrafilters

Indications For Use:

The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon's hands. The filters are not intended to provide water that can be used as a substitute for USP sterile water.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _____________

(Part 21 CFR 801 Subpart D)

(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) | |
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Attachment 3

005: 510(k) Summary

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| Submitter: | Nephros Inc.<br>41 Grand Ave<br>River Edge, NJ 07661<br>Establishment Registration # 3003337893 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jim Summerton, Manager Product Development<br>41 Grand Ave<br>River Edge, NJ 07661<br>201-343-5202 (p)<br>201-343-5207 (f)<br>[e-mail] |
| Date Prepared | September 22, 2014 |
| Trade Name | DSU-H and SSU-H Ultrafilters |
| Proposed Class | Class II |
| Classification Name<br>and Number | 21 CFR Part 876.5665 Water Purification Device, General<br>Medical Use |
| Product Code | NHV |
| Predicate Device | MainStream™ Water Purification Device – K012716 |
| Reference Devices | DSU and SSU Filters – K110285 |
| Device Description | The DSU-H and SSU-H Ultrafilters are hollow fiber ultrafilters<br>that retain bacteria, viruses, endotoxin and particulate from water<br>used for washing and drinking. |
| Intended Use | The DSU-H and SSU-H Ultrafilters are intended to be used to<br>filter EPA quality drinking water. The filters retain bacteria,<br>viruses and endotoxin. By providing ultrapure water for washing<br>and drinking, the filters aid in infection control. The filters<br>produce water that is suitable for wound cleansing, cleaning of<br>equipment used in medical procedures and washing of surgeon's<br>hands. The filters are not intended to provide water that can be<br>used as a substitute for USP sterile water. |

## 510(k) Summary: DSU-H and SSU-H Ultrafilters

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| Summary of the | The proposed device contains a polysulfone hollow fiber |
|----------------------|------------------------------------------------------------------|
| Technological | membrane encased in an ABS housing that retains bacteria, |
| Characteristics | viruses and endotoxin. Retention of contaminants is through size |
| | exclusion. Further details of the technology can be found in |
| | Section 11 'Device Description'. |
| Assessment of Non- | Based on non-clinical performance testing, the DSU-H and SSU- |
| clinical Performance | H Ultrafilters have been found to be substantially equivalent to |
| Data / Substantial | the predicate PrisMedical MainStream Filter (K012716). |
| Equivalence | |

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## SUBJECT - PREDICATE COMPARISON TABLES

| | Subject Device | Predicate Device | Reference Device |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Number | K141731 | K012716 | K110285 |
| Manufacturer<br>Name | Nephros Inc. | PrisMedical | Nephros Inc. |
| Indications<br>for Use | The DSU-H and SSU-H<br>Ultrafilters are intended<br>to be used to filter EPA<br>quality drinking water.<br>The filters retain<br>bacteria, viruses and<br>endotoxin. By<br>providing ultrapure<br>water for washing and<br>drinking, the filters aid<br>in infection control. The<br>filters produce water<br>that is suitable for<br>wound cleansing,<br>cleaning of equipment<br>used in medical<br>procedures and washing<br>of surgeon's hands. The<br>filters are not intended<br>to provide water that<br>can be used as a<br>substitute for USP<br>sterile water. | To produce from EPA<br>grade drinking water,<br>sterile purified water to<br>be used within 24 hours<br>of collection that is<br>suitable for:<br>- Cleaning and rinsing<br>open wounds<br>- Infection control<br>(cleaning equipment<br>used in medical<br>procedures, medical<br>personnel's hands)<br>- Use as a diluent for<br>enteral, nutritional,<br>oral vaccine, or oral<br>drug preparations<br>- All other uses of<br>sterile purified water<br>the practitioner or<br>clinician deems<br>necessary<br>- Not for parenteral<br>administration | The DSU and SSU<br>Filters are intended to<br>be used to filter water<br>or bicarbonate<br>concentrate used in<br>hemodialysis devices.<br>They assist in<br>providing<br>hemodialysis quality<br>water or bicarbonate<br>concentrate. The<br>device is not a<br>complete water<br>treatment system, but<br>serves to remove<br>biological<br>contaminants.<br>Therefore it must be<br>used in conjunction<br>with other water<br>treatment equipment<br>(RO, DI, etc.). |
| | Subject Device | Predicate Device | Reference Device |
| Operation | | | |
| Feed Water<br>Source | In-line plumbing | Gravity feed | In-line plumbing |
| Use Life | up to 3 Mo. (SSU-H)<br>up to 6 Mo. (DSU-H) | 3 Liters | 1 Year |
| Maximum<br>Inlet Pressure | 75 psi (SSU-H)<br>100 psi (DSU-H) | < 10 psi | 75 psi |
| Flow Rate<br>and Pressure<br>Drop | See Section 18 for<br>subject device flow<br>curves | 30 ml/min at 5 psi | Same as subject<br>device |
| Materials | | | |
| Casing | ABS | Polycarbonate | ABS |
| Filter | Polysulfone | Ultrafiltration Sheet | Polysulfone |
| Element(s) | Ultrafiltration Hollow<br>Fiber | Ultrafiltration<br>Membrane<br>Polypropylene mesh<br>Activated Carbon<br>Deionization Resin<br>Beads | Ultrafiltration Hollow<br>Fiber |
| Retention | | | |
| Bacteria<br>Reduction | > 1011 | > 107 | > 1011 |
| Virus<br>Reduction | > 108 | > 104 | > 108 |
| Endotoxin<br>Reduction | > 105 | > 104 | > 105 |
| Organic<br>Reduction | N/A | TOC reduced to < 1 ppm | N/A |
| Ion Reduction | N/A | > 103 dissociable ions | N/A |

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