EndoPur Filter

K161304 · Nephros, Inc. · FIP · Mar 2, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161304
• Device Name: EndoPur Filter
• Applicant: Nephros, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Mar 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The EndoPur Endotoxin 10" Filter Flat is intended to be used to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. 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 (Reverse Osmosis, Deionization, etc.).

Device Story

EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter designed to remove biological contaminants—bacteria, viruses, endotoxin, and particulates—from water used in hemodialysis. The device functions as a component within a larger water treatment system (e.g., Reverse Osmosis or Deionization units). It is intended for use in clinical settings where hemodialysis is performed. The filter operates by passing water through hollow fibers to retain contaminants, thereby assisting in the production of hemodialysis-quality water. It is a passive, non-active device requiring no software or electrical power. Healthcare providers or technicians integrate the filter into the existing water treatment infrastructure to ensure water quality meets safety standards for patient treatment, reducing the risk of exposure to biological contaminants during hemodialysis.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via flow rate vs. pressure drop, pyrogen removal, virus challenge, bacteria challenge, and disinfection compatibility testing. Biocompatibility assessed via extractable and leachable testing evaluated by a toxicologist. AAMI panel testing performed per ANSI/AAMI 13959.

Technological Characteristics

Hollow fiber ultrafilter. Materials of construction are identical to the predicate device. Passive device; no electrical energy source. Dimensions: 10-inch filter flat. Disinfection compatibility: compatible with standard disinfection processes (excluding heat sterilization above 80°C for specific housings).

Indications for Use

Indicated for filtering water used in hemodialysis devices to assist in providing hemodialysis quality water. Must be used in conjunction with other water treatment equipment (e.g., Reverse Osmosis, Deionization). Contraindicated for heat sterilization with polypropylene housings not rated for temperatures above 80°C.

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 (K954349)

Reference Devices

• DSU/SSU

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

March 2, 2017

Nephros, Inc. Hollie Johnson Director Quality and Requlatory 41 Grand Ave River Edge, NJ 07661

Re: K161304

> Trade/Device Name: EndoPur Endotoxin 10" Filter Flat Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System For Hemodialysis Regulatory Class: II Product Code: FIP Dated: December 23, 2016 Received: December 27, 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.

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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 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,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director 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) K161304

Device Name EndoPur Endotoxin 10" Filter Flat

#### Indications for Use (Describe)

#### INDICATIONS FOR USE

Indications for Use: The EndoPur Endotoxin 10" Filter Flat is intended to filter water used in hemodialysis devices. It assists in providing hemodialysis quality water. 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 (Reverse Osmosis, Deionization, etc.).

#### CONTRAINDICATIONS

Heat sterilization is contraindicated for use with polypropylene housings that are not rated for disinfection temperatures above 80°C

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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| Submitter: | Nephros Inc.<br>41 Grand Ave<br>River Edge, NJ 07661<br>Establishment Registration # 3003337893 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Hollie Johnson ; Director of Quality and Regulatory<br>41 Grand Ave<br>River Edge, NJ 07661<br>201-343-5202 x101(p)<br>201-343-5207 (f)<br>[e-mail] |
| Date Prepared | December 28, 2016 |
| Trade Name | EndoPur Endotoxin 10" Filter Flat |
| 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 – K95439 |
| Device Description | The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter<br>that retains bacteria, viruses, endotoxin and particulate from<br>water used in hemodialysis. |
| Intended Use | The EndoPur Endotoxin 10" Filter Flat is a hollow fiber ultrafilter<br>that retains bacteria and endotoxin from fluid. |
| Indications For Use | The EndoPur Endotoxin 10" Filter Flat is intended to be used to<br>filter water used in hemodialysis devices. It assists in providing<br>hemodialysis quality water. The device is not a complete water<br>treatment system, but serves to remove biological<br>contaminants. Therefore it must be used in conjunction with |
| | other water treatment equipment (Reverse Osmosis,<br>Deionization, etc.). |
| | CONTRAINDICATIONS |
| | Heat sterilization is contraindicated for use with polypropylene<br>housings that are not rated for disinfection temperatures above<br>80°C |
| Summary of the<br>Technological<br>Characteristics | The subject device has the same technological characteristics<br>and is similar in design as compared to the primary and<br>reference devices; see executive summary located in section<br>10. |
| Assessment of Non-<br>clinical Performance<br>Data / Substantial<br>Equivalence | The EndoPur Endotoxin 10" Filter Flat has been tested for<br>performance. The tests conducted include Flow Rate versus<br>Pressure Drop, Pyrogen Removal, Virus Challenge Test,<br>Bacteria Challenge Test and Disinfection Compatibility. This<br>filter was found to be substantially equivalent to the primary<br>predicate Minntech Fiberflo Filter (K954349) and reference<br>device, DSU/SSU. |
| Biocompatibility<br>Testing | Exhaustive Extractable and Leach testing was performed,<br>evaluated by a toxicologist and found to be safe. AAMI panel<br>was executed using ANSI/AAMI 13959 Water for Hemodialysis<br>and Related Therapies to determine residual levels after each<br>disinfection process on accelerated aged product. All results<br>were found to be acceptable. |
| Electrical Safety and<br>Electromagnetic<br>Compatibility (EMC) | Not Applicable; not and Active Medical Device |
| Software Verification<br>and Validation Testing | Not Applicable; No Software contained |
| Mechanical and<br>Acoustic Study | Not Applicable |
| Animal Study | Not Applicable |
| Clinical Studies | Not Applicable |
| Conclusions | Since the predicate device is comprised of the same materials<br>of construction that have no adverse events while on the<br>market and the safety testing completed by Nephros<br>demonstrates no toxicity concerns, Nephros EndoPur<br>Endotoxin 10” filter Flat is ready for marketing for its intended<br>use, which is the same as its predicate and reference devices. |

## 510(k) Summary: EndoPur Endotoxin 10" Filter Flat

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