Pall-Aquasafe Water Filter

K153434 · Pall International Sarl · NHV · Jun 10, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153434
• Device Name: Pall-Aquasafe Water Filter
• Applicant: Pall International Sarl
• Product Code: NHV · Gastroenterology, Urology
• Decision Date: Jun 10, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Indications for Use

The Pall-Aquasafe Water Filter is intended to be used to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), 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 grade sterile water.

Device Story

Pall-Aquasafe Water Filter is an in-line, sterile, 0.2-micron Supor (polyethersulfone) membrane filter cartridge; designed for healthcare environments to reduce waterborne microorganisms (bacteria, protozoa, fungi) via size exclusion. Device connects to in-line plumbing; operates for up to 31 days. Healthcare providers use filtered water for washing, drinking, superficial wound cleansing, and cleaning medical equipment. Bacteriostatic additive in PBT housing reduces external microbial contamination. Benefits include infection control for immune-compromised patients exposed to waterborne pathogens. Device is not a substitute for USP sterile water.

Clinical Evidence

Bench testing only. Microbial retention validated per ASTM F838-05 and HIMA guidance using Brevundimonas diminuta (≥ 1x10^7 CFU/cm2). Fungi retention tested with Aspergillus fumigatus. Biocompatibility testing performed per ISO 10993 (L929 MEM Elution, Kligman Guinea Pig Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen). Mechanical integrity confirmed via burst pressure, shelf-life, and flow rate testing.

Technological Characteristics

0.2 µm Supor (polyethersulfone) membrane with integral pre-filter; PBT (polybutylene terephthalate) housing with bacteriostatic additive. In-line plumbing connection. Max pressure 75 psi at 140°F. Sterilized. Size exclusion principle. No software/electronics.

Indications for Use

Indicated for use in healthcare environments (hospitals, nursing homes, clinical settings) to filter EPA-quality drinking water for immune-compromised patients, washing, drinking, superficial wound cleansing, and cleaning medical equipment/surgeon's hands.

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

• DSU-H and SSU-H Ultrafilters (K141731)
• Mainstream™ Water Purification Device (K012716)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare. The logo is presented in black and white.

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

June 10, 2016

Pall International, Sarl Karen D. Peterson-Doyle Director, Regulatory Affairs 25 Harbor Park Drive Port Washington, NY 11050

Re: K153434

> Trade/Device Name: Pall-Aquasafe™ Water Filter Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: NHV Dated: Mav 2, 2016 Received: May 2, 2016

Dear Karen D. Peterson-Doyle:

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.

{1}------------------------------------------------

## Page 2 - Karen D. Peterson-Doyle

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,

# Joyce M. Whang -S

for

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K153434

Device Name

Pall-Aquasafe Water Filter

#### Indications for Use (Describe)

The Pall-Aquasafe Water Filter is intended to be used to filter EPA (Environmental Protection Agency in USA) quality drinking water. By retaining bacteria, the filters may aid in infection control. The filters produce water that is suitable for washing and drinking, superficial wound cleansing (minor cuts, scrapes, or abrasions), 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 grade 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

As required by 21 CFR 807.92

# Pall-Aquasafe™ Water Filter

# Administrative Information

| Date: | April 28, 2016 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K153434 |
| Submitter: | Pall International, Sarl<br>Ave De Tivoli 3<br>Fribourg, Switzerland 1700 |
| Establishment<br>Registration Number: | 3008412416 |
| Contact Person: | Karen D. Peterson-Doyle<br>Pall Corporation<br>25 Harbor Park Drive,<br>Port Washington, NY, USA 11050<br>516.801.9267 |

# Device Identification

| Device Name: | Pall-Aquasafe™ Water Filter |
|------------------------------|-----------------------------------------------------------------------------------------|
| Common Name: | water purification system for general purposes |
| Device Classification Name: | water purification system for general purposes |
| Classification Product Code: | NHV |
| Device Classification: | Class II |
| Panel: | Gastroenterology/Urology |
| Predicate Devices: | DSU-H and SSU-H Ultrafilters, K141731<br>Mainstream™ Water Purification Device, K012716 |

{4}------------------------------------------------

The Pall-Aquasafe™ Water Filter is supplied sterile and integrity tested. The Supor® membrane within the filter cartridge is rated and validated at 0.2 micron to remove bacteria, protozoa, fungi and particles in the water supply. It is designed to be used for a maximum of one calendar month (31 days) following initial connection. Suspending use does not extend filter life. The Pall-Aquasafe Water Filter is intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immune-compromised patients may be exposed to waterborne microorganisms originating from the water supply.

### Substantial Equivalence Discussion

This Premarket Notification submission requests clearance for the Pall-Aquasafe Water Filter. A comparison of the Pall-Aquasafe Water Filter to the predicate devices is provided in the following table.

| | Subject Device | Primary Predicate | Reference Device |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K153434 | K141731 | K012716 |
| Trade Name | Pall-Aquasafe™ Water<br>Filter Models: AQINA,<br>AQ31F1SA, AQ31F1RA,<br>AQF4A | DSU-H and SSU-H<br>Ultrafilters | Mainstream™ Water<br>Purification Device |
| Manufacturer | Pall Medical | Nephros Inc. | PrisMedical |
| Indications<br>for Use | The Pall-Aquasafe™<br>Water Filter is intended<br>to be used to filter EPA<br>(Environmental<br>Protection Agency in<br>USA) quality drinking<br>water. By retaining<br>bacteria, the filters may<br>aid in infection control.<br>The filters produce water<br>that is suitable for<br>washing and drinking,<br>superficial wound<br>cleansing (minor cuts,<br>scrapes, or abrasions),<br>cleaning of equipment<br>used in medical<br>procedures and washing<br>of surgeon's hands. The<br>filters are not intended to<br>provide water that can<br>be used as a substitute<br>for USP grade sterile<br>water. | 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 providing<br>ultrapure water for<br>washing and drinking,<br>the filters aid in infection<br>control. The filters<br>produce water that is<br>suitable for wound<br>cleansing, cleaning of<br>equipment used in<br>medical procedures and<br>washing of surgeon's<br>hands. The filters are<br>not intended to provide<br>water that can be used<br>as a 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, oral<br>vaccine, or oral drug<br>preparations<br>- All other uses of sterile<br>purified water the<br>practitioner or clinician<br>deems necessary<br>- Not for parenteral<br>administration |

{5}------------------------------------------------

| Device<br>Description | Sterilizing grade 0.2 µm<br>Supor® membrane<br>filtration with integral<br>pre-filter that retains<br>bacteria from water<br>through size exclusion. | Polysulfone 5 nm hollow<br>fiber membrane<br>ultrafilters encased in an<br>ABS housing that<br>retains bacteria, viruses,<br>endotoxin and<br>particulate from water<br>through size exclusion. | Single-use sheet<br>membrane device<br>providing USP Sterile<br>Purified Water through<br>the processes of<br>prefiltration, depth<br>filtration, deionization<br>and sterilizing<br>membrane filtration. |
|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | | | |
| Casing | polybutylene<br>terephthalate (PBT) | ABS | Polycarbonate |
| Filter<br>Element(s) | 0.2 µm Supor®<br>(polyethersulfone)<br>membrane filtration with<br>integral pre-filter | 5 nm Polysulfone<br>Ultrafiltration Hollow<br>Fiber | Ultrafiltration Sheet<br>Membrane,<br>Polypropylene mesh,<br>Activated Carbon,<br>Deionization Resin<br>Beads |
| Operation | | | |
| Feed Water<br>Source | In-line plumbing | In-line plumbing | Gravity feed |
| Use Life | 31 days | up to 3 Mo. (SSU-H)<br>up to 6 Mo. (DSU-H) | Single-use, 3 Liters |
| Maximum Inlet<br>Pressure | 75 psi @ 140 °F | 75 psi (SSU-H)<br>100 psi (DSU-H) | < 10 psi |
| Flow Rate and<br>Pressure Drop | Per individual model<br>specification | Unknown | 30 ml/min at 5 psi |
| Filter Retention | | | |
| Bacteria<br>Reduction* | > 107 CFU/cm2<br>> 1010 CFU/device | > 1011 | > 107 |
| Virus<br>Reduction* | N/A | > 108 | > 104 |
| Endotoxin<br>Reduction* | N/A | > 105 | > 104 |
| Organic<br>Reduction | N/A | N/A | TOC reduced to < 1 ppm |
| Ion Reduction* | N/A | N/A | > 103 dissociable ions |
| *Bacterial, virus, endotoxin and ion reduction units are not specified for the predicate and<br>reference devices. | | | |

## Non-clinical Tests Include

Microbial Retention Verification – Testing designed using ASTM F838-05 and Health Industry Manufacturers Association (HIMA) Guidance for validating 0.2 micron sterilizing grade filters using Brevundimonas diminuta at a challenge level of ≥ 1 x 10' colony forming units (CFU) per cm of effective filtration area. All analysis membranes were found to be free of the test organism.

Microbial Retention in Intermittent Use – Testing designed to confirm that the Pall-Aquasafe Water Filters retain the microbial challenge organism Brevundimonas diminuta during typical intermittent use for a period of 35 days using ASTM F838-05 and Health Industry Manufacturers

{6}------------------------------------------------

Association (HIMA) Guidance for validating 0.2 micron sterilizing grade membranes. All analysis membranes were found to be free of the test organism.

Retention of Fungi – Testing performed to demonstrate that the Pall-Aquasafe Water Filters are capable of retaining fungi during a period of one calendar month (maximum 31 days) using Aspergillus fumigatus delivered (Day 1: 1 x10° CFU; Day 15: 2 x 10+ CFU and Day 36: 2.4 x 10° CFU). Plates were incubated for 10 days and then integrity tested. Less than 1 (CFU/500mL) were recovered downstream of the filter.

Maximum Operating Temperature and Pressure Rating - Pall-Aquasafe Water filters were tested for operating at a continuous maximum temperature of 60 ℃ combined with a maximum inlet pressure of 5 bar. The filters were also tested to withstand 70 ℃ for a cumulative period of 30 minutes over the life of the filter. Filters were integrity tested and testing demonstrated that the filters maintain their integrity over their simulated service life.

## Flow Rate Testing at water pressures of 15, 25, 45, 60 and 75 psi

Shelf Life Testing The following testing was performed: Integrity Testing of the Packaging Bacterial Challenge Burst Pressure Testing Three-year real-time Shelf Life Testing Five-year accelerated aging Shelf Life Testing All filter capsules tested retained integrity and maintained a safety margin above maximum operating pressure after three and five year real-time storage and five years accelerated aging.

### Evaluation of Bacteriostatic Additive

Testing demonstrated that the bacteriostatic additive incorporated within the housing polymer to reduce external microbial contamination by greater than 99.5% after 24 hours contact.

### Biocompatibility Testing

Biocompatibility evaluation for the Briostor Transfer/Freezing Bag Set was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing: May 1, 1995, and the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA.

The Pall-Aquasafe Water Filters are categorized as an "External Communicating Device, Breached/compromised surfaces, Contact Duration: Limited Exposure.

The battery of testing include:

L929 MEM Elution - ISO

Kligman Guinea Pig Maximization Test - 2 extracts - ISO

Intracutaneous Injection - 2 extracts - ISO

{7}------------------------------------------------

Systemic Injection Test – 2 extracts - ISO Rabbit Pyrogen Test - Material Mediated - ISO

Statement of Equivalence

The Pall-Aquasafe™ Water Filter is substantially equivalent to the Nephros Inc. DSU-H and SSU-H Ultrafilters (K141731). When used according to the intended use, the Pall-Aquasafe Water Filter does not raise new questions of safety and effectiveness and is at least as safe and effective as the legally marketed devices.