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 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.

AI/ML Overview

The document provided describes the Pall-Aquasafe™ Water Filter and its performance testing. Below is an attempt to structure the information according to your request. However, please note that the document is a 510(k) summary for a medical device (water filter), not an AI/ML medical device. Therefore, many of the requested categories (e.g., test set, training set, number of experts, adjudication, MRMC study, standalone performance) are not applicable or cannot be fully answered as they relate to AI/ML model validation, which is not covered in this type of document for a physical filter.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Microbial Retention	Bacterial Retention: ≥ 1 x 10^7 CFU/cm^2 of effective filtration area of Brevundimonas diminuta.	> 10^7 CFU/cm^2 and > 10^10 CFU/device. All analysis membranes were found to be free of the test organism (Brevundimonas diminuta).
	Bacterial Retention (Intermittent Use): Retention of Brevundimonas diminuta during typical intermittent use for a period of 35 days (using methods from ASTM F838-05 and HIMA Guidance).	All analysis membranes were found to be free of the test organism.
	Fungi Retention: Capable of retaining fungi during a period of one calendar month (maximum 31 days) when challenged with Aspergillus fumigatus.	Less than 1 CFU/500mL were recovered downstream of the filter after challenges on Day 1 (1 x 10^6 CFU), Day 15 (2 x 10^6 CFU), and Day 36 (2.4 x 10^6 CFU).
Physical Performance	Maximum Operating Temperature and Pressure: Maintain integrity when operating at a continuous maximum temperature of 60 ℃ combined with a maximum inlet pressure of 5 bar (approx. 72.5 psi). Withstand 70 ℃ for a cumulative period of 30 minutes.	Tested at 60 ℃ and 5 bar. Also tested to withstand 70 ℃ for a cumulative period of 30 minutes over the life of the filter. Filters were integrity tested and demonstrated to maintain their integrity over their simulated service life.
	Flow Rate: Documented performance at various water pressures.	Flow rate tested at water pressures of 15, 25, 45, 60, and 75 psi. (Specific flow rates were not reported in detail but stated as "Per individual model specification" which implies meeting pre-defined specifications).
	Shelf Life: Maintain integrity of packaging and filter function over specified real-time and accelerated aging periods, including bacterial challenge and burst pressure.	Three-year real-time and five-year accelerated aging Shelf Life Testing performed. All filter capsules tested retained integrity and maintained a safety margin above maximum operating pressure after both three and five-year real-time storage and five years accelerated aging.
Material Safety	Bacteriostatic Additive: Reduce external microbial contamination.	Reduction of external microbial contamination by greater than 99.5% after 24 hours contact.
	Biocompatibility: Meet ISO 10993 standards for an "External Communicating Device, Breached/compromised surfaces, Contact Duration: Limited Exposure."	Performed L929 MEM Elution - ISO, Kligman Guinea Pig Maximization Test (2 extracts) - ISO, Intracutaneous Injection (2 extracts) - ISO, and Systemic Injection Test (2 extracts) - ISO, Rabbit Pyrogen Test - Material Mediated - ISO. (The document states testing was conducted in accordance with the standards, implying the device met the criteria, though specific passing results for each test are not detailed beyond their performance).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated with a single number for a "test set" as is common for AI/ML studies. The testing described (microbial retention, shelf life, temperature/pressure, biocompatibility) involves different quantities of filter units and biological samples specific to each test. For instance, microbial retention validation using Brevundimonas diminuta refers to "All analysis membranes" being free of the organism, but the total number of membranes/filters tested is not given. Shelf life testing mentions "All filter capsules tested" but doesn't quantify them.
Data Provenance: The studies are non-clinical (laboratory-based) performance tests conducted by the manufacturer (Pall Medical) to demonstrate the physical performance and safety of the filter. The data is prospective, generated specifically for this 510(k) submission. Country of origin of the testing is not specified, but the applicant's contact information is in Port Washington, NY, USA, while the submitter is in Fribourg, Switzerland, and Pall Medical is the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is a physical medical device (water filter) and not an AI/ML diagnostic or predictive algorithm requiring expert interpretation of results for ground truth. Verification is based on objective laboratory measurements and standardized protocols (e.g., ASTM, HIMA, ISO).

4. Adjudication method for the test set

Not applicable for a physical device. Test results are objective measurements (e.g., colony forming units, pressure readings, chemical analysis) rather than subjective assessments requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a water filter, not an AI/ML system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a water filter, not an AI/ML system. The performance evaluated is the standalone performance of the filter itself in retaining microorganisms and maintaining integrity under specified conditions.

7. The type of ground truth used

The "ground truth" for this device's performance is established through:
- Microbiological assays: Direct measurement of microbial (bacteria, fungi) presence/absence downstream of the filter.
- Physical measurements: Pressure, temperature, flow rate, burst pressure, and integrity testing.
- Chemical analysis: For bacteriostatic additive effectiveness and biocompatibility.
- Standardized protocols: Adherence to established industry standards like ASTM F838-05, HIMA Guidance, and ISO 10993 for biocompatibility ensures that the 'ground truth' is based on scientifically accepted methods for evaluating filter performance and material safety.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of AI/ML model development.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML training set for this physical device.

Summary

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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.

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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

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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)

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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, SarlAve De Tivoli 3Fribourg, Switzerland 1700
EstablishmentRegistration Number:	3008412416
Contact Person:	Karen D. Peterson-DoylePall Corporation25 Harbor Park Drive,Port Washington, NY, USA 11050516.801.9267

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, K141731Mainstream™ Water Purification Device, K012716

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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™ WaterFilter Models: AQINA,AQ31F1SA, AQ31F1RA,AQF4A	DSU-H and SSU-HUltrafilters	Mainstream™ WaterPurification Device
Manufacturer	Pall Medical	Nephros Inc.	PrisMedical
Indicationsfor Use	The Pall-Aquasafe™Water Filter is intendedto be used to filter EPA(EnvironmentalProtection Agency inUSA) quality drinkingwater. By retainingbacteria, the filters mayaid in infection control.The filters produce waterthat is suitable forwashing and drinking,superficial woundcleansing (minor cuts,scrapes, or abrasions),cleaning of equipmentused in medicalprocedures and washingof surgeon's hands. Thefilters are not intended toprovide water that canbe used as a substitutefor USP grade sterilewater.	The DSU-H and SSU-HUltrafilters are intendedto be used to filter EPAquality drinking water.The filters retainbacteria, viruses andendotoxin. By providingultrapure water forwashing and drinking,the filters aid in infectioncontrol. The filtersproduce water that issuitable for woundcleansing, cleaning ofequipment used inmedical procedures andwashing of surgeon'shands. The filters arenot intended to providewater that can be usedas a substitute for USPsterile water.	To produce from EPAgrade drinking water,sterile purified water tobe used within 24 hoursof collection that issuitable for:- Cleaning and rinsingopen wounds- Infection control(cleaning equipmentused in medicalprocedures, medicalpersonnel's hands)- Use as a diluent forenteral, nutritional, oralvaccine, or oral drugpreparations- All other uses of sterilepurified water thepractitioner or cliniciandeems necessary- Not for parenteraladministration

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DeviceDescription	Sterilizing grade 0.2 µmSupor® membranefiltration with integralpre-filter that retainsbacteria from waterthrough size exclusion.	Polysulfone 5 nm hollowfiber membraneultrafilters encased in anABS housing thatretains bacteria, viruses,endotoxin andparticulate from waterthrough size exclusion.	Single-use sheetmembrane deviceproviding USP SterilePurified Water throughthe processes ofprefiltration, depthfiltration, deionizationand sterilizingmembrane filtration.
Materials
Casing	polybutyleneterephthalate (PBT)	ABS	Polycarbonate
FilterElement(s)	0.2 µm Supor®(polyethersulfone)membrane filtration withintegral pre-filter	5 nm PolysulfoneUltrafiltration HollowFiber	Ultrafiltration SheetMembrane,Polypropylene mesh,Activated Carbon,Deionization ResinBeads
Operation
Feed WaterSource	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 InletPressure	75 psi @ 140 °F	75 psi (SSU-H)100 psi (DSU-H)	< 10 psi
Flow Rate andPressure Drop	Per individual modelspecification	Unknown	30 ml/min at 5 psi
Filter Retention
BacteriaReduction*	> 107 CFU/cm2> 1010 CFU/device	> 1011	> 107
VirusReduction*	N/A	> 108	> 104
EndotoxinReduction*	N/A	> 105	> 104
OrganicReduction	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 andreference 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

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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

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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.

Regulation Number and Section

§ 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.