(196 days)
Not Found
No
The device description and performance studies focus on physical filtration mechanisms and material properties, with no mention of AI or ML.
Yes
The device is intended to aid in infection control by filtering out bacteria, protozoa, fungi, and particles from water, making the water suitable for uses that directly relate to patient health and medical procedures (e.g., superficial wound cleansing, cleaning of equipment used in medical procedures, washing of surgeon's hands), especially in healthcare environments with immunocompromised patients. These applications contribute to patient therapy and care.
No
The device is a water filter intended for infection control and purifying water for various uses, not for diagnosing diseases or conditions. Its function is to remove microorganisms and particles from water.
No
The device description and performance studies clearly indicate this is a physical water filter with a membrane and housing, not a software-only device.
Based on the provided information, the Pall-Aquasafe™ Water Filter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to filter drinking water to remove bacteria and aid in infection control. It produces water for washing, drinking, superficial wound cleansing, cleaning equipment, and washing hands. This is a physical filtration process applied to water, not a diagnostic test performed on biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The description focuses on the physical mechanism of filtration using a membrane to remove microorganisms from water.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the filter's ability to remove microorganisms from water, not on its ability to diagnose or detect disease markers in biological samples.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Pall-Aquasafe™ Water Filter does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHV
Device Description
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.
Sterilizing grade 0.2 micrometer Supor® membrane filtration with integral pre-filter that retains bacteria from water through size exclusion. Casing material: polybutylene terephthalate (PBT). Filter Element(s): 0.2 micrometer Supor® (polyethersulfone) membrane filtration with integral pre-filter. Operation: In-line plumbing. Use Life: 31 days. Maximum Inlet Pressure: 75 psi @ 140 °F.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 at least 1 x 10^7 colony forming units (CFU) per cm^2 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 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 x 10^4 CFU; Day 15: 2 x 10^4 CFU and Day 36: 2.4 x 10^4 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 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". 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, Systemic Injection Test – 2 extracts - ISO, Rabbit Pyrogen Test - Material Mediated - ISO.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacteria Reduction: > 10^7 CFU/cm^2, > 10^10 CFU/device.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5665 Water purification system for hemodialysis.
(a)
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.(b)
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.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 |
| Ave De Tivoli 3 | |
| Fribourg, Switzerland 1700 | |
| Establishment | |
| Registration Number: | 3008412416 |
| Contact Person: | Karen D. Peterson-Doyle |
| Pall Corporation | |
| 25 Harbor Park Drive, | |
| Port Washington, NY, USA 11050 | |
| 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 |
| 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 | ||
| Filter Models: AQINA, | |||
| AQ31F1SA, AQ31F1RA, | |||
| AQF4A | DSU-H and SSU-H | ||
| Ultrafilters | Mainstream™ Water | ||
| Purification Device | |||
| Manufacturer | Pall Medical | Nephros Inc. | PrisMedical |
| 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. | 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 | |||
| 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. | To produce from EPA | ||
| grade drinking water, | |||
| sterile purified water to | |||
| be used within 24 hours | |||
| of collection that is | |||
| suitable for: |
- Cleaning and rinsing
open wounds - Infection control
(cleaning equipment
used in medical
procedures, medical
personnel's hands) - Use as a diluent for
enteral, nutritional, oral
vaccine, or oral drug
preparations - All other uses of sterile
purified water the
practitioner or clinician
deems necessary - Not for parenteral
administration |
5
| Device
Description | Sterilizing grade 0.2 µm
Supor® membrane
filtration with integral
pre-filter that retains
bacteria from water
through size exclusion. | Polysulfone 5 nm hollow
fiber membrane
ultrafilters encased in an
ABS housing that
retains bacteria, viruses,
endotoxin and
particulate from water
through size exclusion. | Single-use sheet
membrane device
providing USP Sterile
Purified Water through
the processes of
prefiltration, depth
filtration, deionization
and sterilizing
membrane filtration. |
|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | | | |
| Casing | polybutylene
terephthalate (PBT) | ABS | Polycarbonate |
| Filter
Element(s) | 0.2 µm Supor®
(polyethersulfone)
membrane filtration with
integral pre-filter | 5 nm Polysulfone
Ultrafiltration Hollow
Fiber | Ultrafiltration Sheet
Membrane,
Polypropylene mesh,
Activated Carbon,
Deionization Resin
Beads |
| Operation | | | |
| Feed Water
Source | In-line plumbing | In-line plumbing | Gravity feed |
| Use Life | 31 days | up to 3 Mo. (SSU-H)
up to 6 Mo. (DSU-H) | Single-use, 3 Liters |
| Maximum Inlet
Pressure | 75 psi @ 140 °F | 75 psi (SSU-H)
100 psi (DSU-H) | 107 CFU/cm2
1010 CFU/device | > 1011 | > 107 |
| Virus
Reduction* | N/A | > 108 | > 104 |
| Endotoxin
Reduction* | N/A | > 105 | > 104 |
| Organic
Reduction | N/A | N/A | TOC reduced to 103 dissociable ions |
| *Bacterial, virus, endotoxin and ion reduction units are not specified for the predicate and
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.