The intended use of the i3 Membrane Water Filters i3 ONE, i3 TWO connect, i3 TWO direct is to filter EPA quality drinking water. The i3 Membrane Water Filters retain bacteria, which may aid in infection control. The filters produce water that is appropriate for washing and drinking, superficial wound cleansing (minor cuts, scrapes and abrasions), cleaning of equipment used in medical procedures and washing of surgeon's hands. The i3 Membrane Water Filters are not intended to provide water that can be used as a substitute for USP grade sterile water.

Device Description

The i3 Point-of-Use Water Filters are supplied sterile and 100% integrity tested. The membrane within the filter cartridge is rated and validated at 0.2 µm to remove bacteria and particles in the water supply. This membrane reduces bacteria with more than 7 log levels per square centimeter filtration area. This represents the bacterial retention, the core element of infection prevention. Furthermore, a bacteriostatic additive is present in the outer housings parts of the filter, which prevents retrograde contamination of the filter. In addition, the inlet of the tap water filter is inclined to prevent the water from hitting the siphon. This also prevents retrograde contamination from the siphon, which would be caused by rising aerosols from the direct impact of the water jet. The Water Filters are designed to be used for a maximum of 50 days following initial connection. Suspending use does not extend filter life. The i3 ONE / i3 TWO connect / i3 TWO direct Water Filters are intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply. The i3 Membrane Water Filters are disposable and designed for the use on tap or the shower.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the absence of information related to AI/ML devices as the text concerns water filters:

This document describes a medical device submission for water filters (i3 ONE, i3 TWO connect, i3 TWO direct), not an AI/ML device. Therefore, many of the requested categories related to AI/ML performance, such as test sets, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance, and training set information, are not applicable and are absent from the provided text.

1. A table of acceptance criteria and the reported device performance

Since this is not an AI/ML device, the "acceptance criteria" are generally related to the physical, chemical, and microbiological performance of the water filters. The document describes several performance tests against established standards and criteria, rather than specific numerical "acceptance criteria" in a table format. However, the reported performance is presented in relation to the requirements for such devices.

Acceptance Criterion (Inferred from testing)	Reported Device Performance and Related Information
Microbial Retention:
Bacterial retention of membrane filters	- Examined following ASTM F 838 - 15a. - Showed very good retention performances with reductions of bacterial count of more than 10^7 colony-forming units (CFU)/cm² filter area. - All filters passed integrity test prior to and after bacterial retention test. - (Filter Retention in comparison table): > 10^7 CFU/cm²; > 10^10 CFU/device (matching predicate).
Bacteriostatic Additive Efficacy:
Prevention of retrograde contamination	- Reduces retrograde contamination by *more than 99.5% for Pseudomonas aeruginosa* even after 8 weeks of use. - Achieved 99.5% protection against retrograde contamination** for Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Acinetobacter baumannii, and Staphylococcus aureus.
Silver Migration:
Acceptable levels of silver ion migration	- Silver-based ions found to be more than 10 times less according to the suggestion of the Environmental Protection Agency.
Maximum Operating Temperature & Pressure:
Withstand thermal disinfection	- Tested at up to 5 bar and up to 70°C (for 30 minutes continuous period). - Filters passed integrity tests after these conditions.
Flow Rate:
Guaranteed function at various pressures	- Tested at 1, 2, 3, 4, and 5 bar (approx. 15, 30, 45, 60, and 75 PSI) static water pressure. - Intended use guaranteed at each of these pressures.
Sterilization:
Sterility and shelf life	- Available sterile with a shelf life of 50 days. - Bioburden and sterilization validation assessed and conducted successfully. - Sterilization dose of 25 kGy for SAL 10^-6 substantiated.
Shelf Life:
Maintenance of integrity and sterility over time	- Tested by a 5-year accelerated test. - 5-year real-time aging test started in 2019. - Packaging passed peel, dye, and bubble tests. - Filter confirmed sterile after a 5-year life. - Further integrity tests of the filter carried out.
Biocompatibility:
Compatibility with biological systems	- Biocompatibility review performed for all three filter types using ISO 10993-1 and subsequent ISO 10993 series standards. - Concluded that the products are biocompatible.
Additional Tests (Passed product specifications):
Mechanical integrity and chemical resistance	- Burst Pressure Testing - Durability Testing - Transport Testing - Drop Testing - Chlorine Testing for chemical disinfection - Wipe Disinfection Testing
Risk Management:
Acceptable risk profile	- Hazards assessed under ISO 14971. - No risk deemed unacceptable; overall risk profile low (risks mitigated under design control and ASTM testing).

The following questions are not applicable to the submitted device (water filter) as it is not an AI/ML product. The document does not contain information on these aspects.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This is not an AI/ML device. The "test set" refers to the tested filter samples, but specific sample sizes for each test are not detailed in the summary. The tests are non-clinical performance and lab-based.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not an AI/ML device. Ground truth for the performance of a physical device like a water filter is established through standardized laboratory testing (e.g., CFU counts, integrity tests, material analysis) rather than expert consensus on medical images or patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not an AI/ML device. Adjudication methods are relevant for ambiguous cases in human interpretation, which is not applicable here.
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 an AI/ML device. MRMC studies are for evaluating diagnostic performance with human readers, typically in imaging.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not an AI/ML device. This refers to algorithm-only performance, which isn't applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, "ground truth" is based on the results of standardized physico-chemical and microbiological laboratory tests (e.g., bacterial count reduction as per ASTM F 838 - 15a, material analysis for silver migration, physical stress tests).
The sample size for the training set
- Not an AI/ML device. There is no training set mentioned or applicable.
How the ground truth for the training set was established
- Not an AI/ML device. Not applicable.

Summary

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June 2, 2023

i3 Membrane GmbH Thor Hinnerk Meyer Product & Project Manager Theodorstrasse 41P Hamburg, 22761 GERMANY

Re: K222727

Trade/Device Name: i3 ONE (203100-S); i3 TWO connect (203200-S); i3 TWO direct (203300-S) Regulation Number: 21 CFR 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: NHV Dated: September 5, 2022 Received: May 5, 2023

Dear Thor Hinnerk Meyer:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Gema Gonzalez -S

Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K222727

Device Name

i3 ONE (203100-S);

i3 TWO connect (203200-S);

i3 TWO direct (203300-S)

Indications for Use (Describe)

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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Image /page/3/Picture/1 description: The image shows the logo for i3, which is a white lowercase "i" followed by the number "3" inside of an orange circle. The "i" has a dot above it, and the "3" is stylized with a curved top and a flat bottom. The orange circle provides a contrasting background that makes the white text stand out.

Section 5: 510(k) Summary

As required by 21 CFR 807.92

Submitter Information

2022/09/05 Date Prepared:
Submitter: i3 Membrane GmbH Christoph-Seydel-Straße 1 01454 Radeberg Germany

Germany

Telephone Number: +49 40 2576748 61
Fax Number: +49 40 2576748 48

Contact Person: Thor Hinnerk Meyer t.meyer@i3membrane.de Theodorstraße 41P 22761 Hamburg

Device Identification

Trade Name:	i3 ONE / i3 TWO connect / i3 TWO direct
Common Name:	Point-of-Use Water Filter
Classification Name:	Water purification system for hemodialysis
Classification Product Code:	NHV
Panel:	Gastroenterology/Urology
Predicate Device:Reference Device:	Pall-Aquasafe Water Filter, K153434Ecolab POU Water Filter, K182164

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Image /page/4/Picture/1 description: The image shows the logo for i3. The logo consists of the letters 'i' and '3' in white, set against a solid orange circle. The 'i' is lowercase, and the '3' is stylized to fit within the circular shape. The overall design is simple and modern.

Device Description / Intended Use

Furthermore, a bacteriostatic additive is present in the outer housings parts of the filter, which prevents retrograde contamination of the filter.

In addition, the inlet of the tap water filter is inclined to prevent the water from hitting the siphon. This also prevents retrograde contamination from the siphon, which would be caused by rising aerosols from the direct impact of the water jet.

The Water Filters are designed to be used for a maximum of 50 days following initial connection. Suspending use does not extend filter life. The i3 ONE / i3 TWO connect / i3 TWO direct Water Filters are intended to be used within the healthcare environment such as hospitals, nursing homes, health care facilities or clinical settings where immunecompromised patients may be exposed to waterborne microorganisms originating from the water supply.

The i3 Membrane Water Filters are disposable and designed for the use on tap or the shower.

Indications for Use

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Image /page/5/Picture/1 description: The image is a logo consisting of the letters 'i' and '3' inside of an orange circle. The 'i' is lowercase and the '3' is standard. The letters are white and appear to be a sans-serif font. The orange circle is a solid color.

Performance Data

Non-clinical performance testing was conducted to characterize the subject i3 Water Filters and is summarized as follows:

-Microbial Retention
The examinations for bacterial retention of the i3 Membrane Water Filters following ASTM F 838 - 15a: Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration showed very good retention performances of the tested filter with reductions of the bacterial count of more than 107 colony-forming units (CFU)/cm² filter area. All filters passed the filter integrity test prior to and after the performance of the bacterial retention test.

-Evaluation of Bacteriostatic Additive

The effect of antibacterial activity on plastic surface has been proven. The bacteriostatic additive reduces a retrograde contamination of the filters by more than 99.5% for Pseudomonas aeruginosa even after 8 weeks of use. Further tests were carried out with Escherichia coli, Klebsellia pneumoniae, Proteus mirabilis, Acinetobacter baumannii and Staphylococcus aureus. Here the protection aqainst retrograde contamination was also 99.5% in each case.

Silver Migration Testing -

The Material of the filter was analyzed on its silver content and the migration of silver ions in water was simulated. The measurements of any silver-based ions were done using optical emission spectrometry (ICP-OES). The silver-based ions were found to be more than 10 times less according to the suggestion of the Environmental Protection Agency.

-Maximum Operating Temperature and Pressure Testing

All i3 Membrane Water Filters were tested at up to 5 bar and up to 70°C (for a continuous period of 30 minutes) to ensure that filters withstand a thermal disinfection. Filters were integrity tested after these tests to verify that these conditions are withstood.

-Flow Rate Testing

All filters were tested at 1, 2, 3, 4 and 5 bar (approx. 15, 30, 45, 60 and 75 PSI) static water pressure for the respective flow. The intended use of the filters can be guaranteed at each of these pressures.

-Sterilization Testing

The i3 Membrane Water Filters are available sterile with a shelf life of 50 days. Bioburden and sterilization validation were assessed and conducted. The microbiological validation has been successful and the sterilization dose of 25 kGy for SAL 10 ° has been substantiated.

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Image /page/6/Picture/1 description: The image shows the logo for i3. The logo consists of the letters 'i' and the number '3' in white, set against a solid orange circle. The 'i' is lowercase, and the '3' is stylized to complement the 'i'. The overall design is simple and modern.

Shelf Life Testing -

The shelf life of i3 Membrane Water Filters has been tested by a 5-year accelerated test and a 5-year real time ageing test is started in 2019. The packaging was then subject to a peel test, a dye test and a bubble test. All tests were passed. The filter is therefore sterile even after a 5-year life and can be used safely during this period. Further integrity tests of the filter have been carried out.

-Biocompatibility Testing

A biocompatibility review for all three i3 Membrane Water Filters for which a 510(k) clearance is requested was performed. The biocompatibility was performed using the ISO 10993-1 standard and subsequent ISO 10993 series standards and concluded that the products are biocompatible.

-Additional Tests

During verification the following tests were performed and successfully passed according to the product specifications:

Burst Pressure Testing ।
-Durability Testing
-Transport Testing
-Drop Testing
Chlorine Testing for chemical disinfection -
-Wipe Disinfection Testing

Risk Management

Hazards associated with design and development, verification and validation, and all manufacturing and sterilization processes, and use of the i3 Membrane POU Water Filters have been assessed under ISO 14971 and documented in the risk management file and related documents. The full product life cycle is also considered in the risk management plan. The results of the residual risk assessment conclude that no additional actions are necessary with risk reduction and control actives having been completed.

No risk was deemed unacceptable, and the overall risk profile of the device was deemed to be low as all risks are mitigated under design control and ASTM testing.

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Image /page/7/Picture/1 description: The image shows a circular logo with an orange background. The logo contains the letters "i" and the number "3" in white. The "i" is lowercase, and the "3" is standard. The logo is simple and modern.

Substantial Equivalence Discussion

This Premarket Notification Submission requests clearance for the i3 ONE / i3 TWO connect / i3 TWO direct Water Filters. A comparison of the i3 ONE / i3 TWO connect / i3 TWO direct Water Filters to the predicate devices is provided in the following table.

	Subject Device	Primary Predicate	ReferenceDevice	FilterElements	0,2 μmPolyethersulfone(PES) pleatedmembrane	0.2 μmSupor®(Polyethersulfone)membrane filtration withintegral pre-filter	Polyethersulfone(PES)pleatedmembrane
510(k)Number	N/A	K153434	K182164	Operation
Trade Name	i3 Point-of-UseWater FilterFilter Models:i3 ONE,i3 TWO connect,i3 TWO direct	Pall-Aquasafe™WaterFilter Models: AQINA,AQ31F1SA, AQ31F1RA,AQF4A	Ecolab POUWater Filter	Feed WaterSource	Drinking waterplumbing at Point ofUse	In-line plumbing	Drinking waterplumbing at pointof use.
Manufacturer	i3 Membrane GmbH	Pall Medical	Ecolab Inc.	Use Life	50 days	31 days	Up to 62 days
Indicationsfor Use	The intended use ofthe i3 MembraneWater Filters i3ONE, i3 TWOconnect, i3 TWOdirect is to filter EPAquality drinkingwater. The i3Membrane WaterFilters retainbacteria, which mayaid in infectioncontrol. The filtersproduce water that isappropriate forwashing anddrinking, superficialwound cleansing(minor cuts, scrapesand abrasions),cleaning ofequipment used inmedical proceduresand washing ofsurgeon's hands.The i3 MembraneWater Filters are notintended to providewater that can be	The Pall-Aquasafe™Water Filter isintended to be used tofilter 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 can beused as a substitute forUSP grade sterile water.	The Ecolab POUWater Filters areintended tooperate on EPAquality drinkingwater sources asa microbialretention filter.Ecolab POUWater Filters aresuitable for thecontrol ofbacteria equal toor greater in sizethanBrevundimonsdiminuta. ThePOU Filters aresuitable forgeneral point ofuse infectioncontrol forprocedures suchas superficialwound cleansing,cleaning ofequipment,washing ofsurgeon's hands	MaximumInletPressure	75 psi @ 140 °F	75 psi @ 140 °F	89.9 psi (6.2bargauge):tapfilters 79.8 psi(5.5 bargauge):showerwands
	used as a substitutefor USP grade sterilewater.		and bathingwhere thereduction of suchmicroorganismsin the water isdesired. TheEcolab POUFilters are notintended for usein the productionof USP sterilewater for use ininfusion, injectionor production offluids for use indialysistreatments.	Flow Rateand PressureDrop	Per individual modelspecification	Per individual modelspecification	7L/min and11L/min at 3 bar
DeviceDescription	A disposablePolyethersulfone(PES) membranefilter sealed in apolypropylenehousing designed tobe installed at pointof use locationswhere the control ofbacteria in EPAquality drinkingwater is desired forhand-washing,bathing, showeringand instrumentcleaningapplications. Thesefilters are designedto be installed asattachments tofaucets or as ahandheld showerhead attached to awater outlet.	Sterilizing grade 0.2 µmSupor® membranefiltration with integral pre-filter that retains bacteriafrom water through sizeexclusion.	A disposablePolyethersulfone(PES) membranefilter sealed in awhitepolypropylenehousing designedto be installed byfacility personnelat point of uselocations wherethe control ofbacteria in EPAquality drinkingwater is desiredfor hand-washing, bathing,showering andinstrumentcleaningapplications.These filters aredesigned to beinstalled asattachments tofaucets or as ahandheld showerhead attached toa water outlet.	Filter Retention
MaterialsCasing	Polpropylene (PP)	Polybutyleneterephthalate (PBT)	Polypropylene(PP)	BacteriaReduction	> 107 CFU/cm²> 1010 CFU/device	> 107 CFU/cm²> 1010 CFU/device	Greater than 107

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Image /page/8/Picture/1 description: The image shows the logo for i3. The logo consists of a lowercase "i" and the number "3" inside of an orange circle. The letters are white and the circle is a solid color.

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Image /page/9/Picture/1 description: The image is a circular logo with an orange background. Inside the circle, there is the text "i3" in white. The "i" is lowercase, and the "3" is larger than the "i". The logo is simple and modern.

Table 1: Comparison with Predicate and Reference Device

Substantial Equivalence

Comparison of the indications for use, technical characteristics and performance of the i3 Membrane Water Filters and the Pall-Aquasafe Water Filter provided in the 510(k) submission, is sufficient to demonstrate substantial equivalence. All test performance of nonclinical tests is at least as the predicate device test results. If they are used after the intended use, no new questions about safety or effectiveness arise. It is at least as safe and effective as previous 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.