i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)

K222727 · I3 Membrane GmbH · NHV · Jun 2, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K222727
• Device Name: i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
• Applicant: I3 Membrane GmbH
• Product Code: NHV · Gastroenterology, Urology
• Decision Date: Jun 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

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 Story

Disposable point-of-use water filters; installed on faucets or as handheld shower heads. Input: tap water. Mechanism: 0.2 µm polyethersulfone (PES) pleated membrane removes bacteria via size exclusion; bacteriostatic additive in polypropylene housing prevents retrograde contamination; inclined inlet prevents siphon contamination. Output: filtered water for clinical hygiene. Used in hospitals/clinics by staff or patients. Benefits: infection control by reducing waterborne bacteria exposure. Healthcare providers use output for hand-washing, wound cleansing, and equipment cleaning to reduce infection risk.

Clinical Evidence

No clinical data. Bench testing only. Microbial retention validated per ASTM F 838-15a (>10^7 CFU/cm² reduction). Bacteriostatic additive efficacy tested against P. aeruginosa, E. coli, K. pneumoniae, P. mirabilis, A. baumannii, and S. aureus (>99.5% reduction). Biocompatibility per ISO 10993. Additional testing: silver migration (ICP-OES), thermal disinfection (70°C), pressure (up to 5 bar), flow rate, sterilization (25 kGy), shelf life (5-year accelerated/real-time), burst pressure, and drop testing.

Technological Characteristics

Disposable point-of-use filter; 0.2 µm pleated polyethersulfone (PES) membrane; polypropylene (PP) housing with bacteriostatic additive. Dimensions/form factor: faucet attachment or handheld shower head. Energy source: none (passive filtration). Sterilization: 25 kGy gamma irradiation. Connectivity: none. Standards: ASTM F 838-15a (bacterial retention), ISO 10993 (biocompatibility), ISO 14971 (risk management).

Indications for Use

Indicated for use in healthcare environments (hospitals, nursing homes, clinical settings) to filter EPA quality drinking water for washing, drinking, superficial wound cleansing, equipment cleaning, and surgeon hand-washing; intended for use where immunocompromised patients may be exposed to waterborne microorganisms.

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

• Pall-Aquasafe Water Filter (K153434)

Reference Devices

• Ecolab POU Water Filter (K182164)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 ([e-mail]) or phone [phone] 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)

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.

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: [phone]
- Fax Number: [phone]

Contact Person: Thor Hinnerk Meyer [e-mail] 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:<br>Reference Device: | Pall-Aquasafe Water Filter, K153434<br>Ecolab 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

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.

### Indications for Use

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.

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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 | Reference<br>Device | Filter<br>Elements | 0,2 μm<br>Polyethersulfone<br>(PES) pleated<br>membrane | 0.2 μm<br>Supor®(Polyethersulfone)<br>membrane filtration with<br>integral pre-filter | Polyethersulfone<br>(PES)pleated<br>membrane |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| 510(k)<br>Number | N/A | K153434 | K182164 | Operation | | | |
| Trade Name | i3 Point-of-Use<br>Water Filter<br>Filter Models:<br>i3 ONE,<br>i3 TWO connect,<br>i3 TWO direct | Pall-Aquasafe™Water<br>Filter Models: AQINA,<br>AQ31F1SA, AQ31F1RA,<br>AQF4A | Ecolab POU<br>Water Filter | Feed Water<br>Source | Drinking water<br>plumbing at Point of<br>Use | In-line plumbing | Drinking water<br>plumbing at point<br>of use. |
| Manufacturer | i3 Membrane GmbH | Pall Medical | Ecolab Inc. | Use Life | 50 days | 31 days | Up to 62 days |
| Indications<br>for Use | The intended use of<br>the i3 Membrane<br>Water Filters i3<br>ONE, i3 TWO<br>connect, i3 TWO<br>direct is to filter EPA<br>quality drinking<br>water. The i3<br>Membrane Water<br>Filters retain<br>bacteria, which may<br>aid in infection<br>control. The filters<br>produce water that is<br>appropriate for<br>washing and<br>drinking, superficial<br>wound cleansing<br>(minor cuts, scrapes<br>and abrasions),<br>cleaning of<br>equipment used in<br>medical procedures<br>and washing of<br>surgeon's hands.<br>The i3 Membrane<br>Water Filters are not<br>intended to provide<br>water that can be | The Pall-<br>Aquasafe™Water Filter is<br>intended to be used to<br>filter EPA (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 be<br>used as a substitute for<br>USP grade sterile water. | The Ecolab POU<br>Water Filters are<br>intended to<br>operate on EPA<br>quality drinking<br>water sources as<br>a microbial<br>retention filter.<br>Ecolab POU<br>Water Filters are<br>suitable for the<br>control of<br>bacteria equal to<br>or greater in size<br>than<br>Brevundimons<br>diminuta. The<br>POU Filters are<br>suitable for<br>general point of<br>use infection<br>control for<br>procedures such<br>as superficial<br>wound cleansing,<br>cleaning of<br>equipment,<br>washing of<br>surgeon's hands | Maximum<br>Inlet<br>Pressure | 75 psi @ 140 °F | 75 psi @ 140 °F | 89.9 psi (6.2<br>bargauge):<br>tapfilters 79.8 psi<br>(5.5 bargauge):<br>showerwands |
| | used as a substitute<br>for USP grade sterile<br>water. | | and bathing<br>where the<br>reduction of such<br>microorganisms<br>in the water is<br>desired. The<br>Ecolab POU<br>Filters are not<br>intended for use<br>in the production<br>of USP sterile<br>water for use in<br>infusion, injection<br>or production of<br>fluids for use in<br>dialysis<br>treatments. | Flow Rate<br>and Pressure<br>Drop | Per individual model<br>specification | Per individual model<br>specification | 7L/min and<br>11L/min at 3 bar |
| Device<br>Description | A disposable<br>Polyethersulfone<br>(PES) membrane<br>filter sealed in a<br>polypropylene<br>housing designed to<br>be installed at point<br>of use locations<br>where the control of<br>bacteria in EPA<br>quality drinking<br>water is desired for<br>hand-washing,<br>bathing, showering<br>and instrument<br>cleaning<br>applications. These<br>filters are designed<br>to be installed as<br>attachments to<br>faucets or as a<br>handheld shower<br>head attached to a<br>water outlet. | Sterilizing grade 0.2 µm<br>Supor® membrane<br>filtration with integral pre-<br>filter that retains bacteria<br>from water through size<br>exclusion. | A disposable<br>Polyethersulfone<br>(PES) membrane<br>filter sealed in a<br>white<br>polypropylene<br>housing designed<br>to be installed by<br>facility personnel<br>at point of use<br>locations where<br>the control of<br>bacteria in EPA<br>quality drinking<br>water is desired<br>for hand-<br>washing, bathing,<br>showering and<br>instrument<br>cleaning<br>applications.<br>These filters are<br>designed to be<br>installed as<br>attachments to<br>faucets or as a<br>handheld shower<br>head attached to<br>a water outlet. | Filter Retention | | | |
| Materials<br>Casing | Polpropylene (PP) | Polybutylene<br>terephthalate (PBT) | Polypropylene<br>(PP) | Bacteria<br>Reduction | > 107 CFU/cm²<br>> 1010 CFU/device | > 107 CFU/cm²<br>> 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.