HydraGuard 10 UltraFilter

K161467 · Nephros, Inc. · NHV · Dec 22, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161467
• Device Name: HydraGuard 10 UltraFilter
• Applicant: Nephros, Inc.
• Product Code: NHV · Gastroenterology, Urology
• Decision Date: Dec 22, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands. Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

Device Story

HydraGuard 10" UltraFilter is a water purification device designed for clinical environments. It processes EPA-quality drinking water to remove bacteria, viruses, and endotoxins. The device functions as a physical barrier filter to produce ultrapure water, aiding in infection control. It is used by healthcare personnel for patient-related hygiene, wound cleaning, and instrument preparation. The output is high-purity water, which supports clinical infection control protocols and patient safety during medical procedures. It is not intended to replace USP sterile water.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrafiltration membrane technology designed to retain bacteria, viruses, and endotoxins. Form factor is a 10-inch filter cartridge. Mechanical filtration principle. No energy source or software components.

Indications for Use

Indicated for use in clinical settings to provide filtered water for patient washing, drinking, wound cleaning, equipment cleaning, and surgeon hand washing. 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.

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

December 22, 2016

Nephros Inc. Hollie Johnson Director Quality Assurance and Regulatory Affairs 41 Grand Ave River Edge, New Jersey 07661

Re: K161467

Trade/Device Name: HydraGuard 10" UltraFilter Regulation Number: 21 CFR 876.5665 Regulation Name: Water Purification System For Hemodialysis Regulatory Class: Class II Product Code: NHV Dated: November 15, 2016 Received: December 6, 2016

Dear Hollie Johnson:

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 (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K161467

Device Name HydraGuard 10" UltraFilter

## Indications for Use (Describe)

The HydraGuard 10" UltraFilter is intended to be used to filter EPA quality drinking water. The filter retains bacteria, viruses and endotoxin. By providing ultrapure water for patient washing and drinking, the filter aids in infection control. The filter produces water that is suitable for patient wound cleaning of equipment used in medical procedures and washing of surgeon's hands.

Medical: The filter is not intended to provide water that can be used as a substitute for USP sterile water.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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