(267 days)
Pall-Aquasafe Water Filter, K153434
Ecolab POU Water Filter, K182164
No
The device description and performance studies focus on physical filtration and material properties, with no mention of AI or ML.
No
The device is a water filter used for infection control and not for treating a disease or condition.
No
The device is a water filter used for infection control by retaining bacteria in potable water. It does not diagnose any condition or disease.
No
The device description clearly details a physical water filter with a membrane, housing, and bacteriostatic additive. It undergoes physical performance testing like flow rate, temperature, and pressure, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Intended Use: The intended use of the i3 Membrane Water Filters is to filter EPA quality drinking water to retain bacteria. While this may aid in infection control and the water is used for purposes related to healthcare (washing, cleaning equipment, handwashing), it does not involve the examination of specimens from the human body.
- Device Description: The device description focuses on the physical filtration mechanism and its ability to remove bacteria from water. There is no mention of analyzing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Specimen types (blood, urine, etc.)
- Analytes being measured
- Diagnostic claims
- Performance metrics like sensitivity, specificity, PPV, NPV in the context of diagnosing a condition.
The device is a water filter intended for use in healthcare settings to provide clean water for various purposes, primarily for infection control by removing bacteria from the water supply. This falls under the category of a general medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NHV
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.
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)
- 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.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial retention: > 10^7 colony-forming units (CFU)/cm² filter area
- Bacteriostatic additive: reduces retrograde contamination by more than 99.5% for Pseudomonas aeruginosa, Escherichia coli, Klebsellia pneumoniae, Proteus mirabilis, Acinetobacter baumannii and Staphylococcus aureus.
- Silver Migration: more than 10 times less than EPA suggestion.
- Maximum Operating Temperature: 70°C for 30 minutes
- Maximum Operating Pressure: 5 bar
- Sterilization dose: 25 kGy for SAL 10-6
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.
Pall-Aquasafe Water Filter, K153434
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.
Ecolab POU Water Filter, K182164
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/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.
1
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
2
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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3
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, K153434 |
| Ecolab POU Water Filter, K182164 |
4
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.
5
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.
6
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
Device | Filter
Elements | 0,2 μm
Polyethersulfone
(PES) pleated
membrane | 0.2 μm
Supor®(Polyethersulfone)
membrane filtration with
integral pre-filter | Polyethersulfone
(PES)pleated
membrane |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| 510(k)
Number | N/A | K153434 | K182164 | Operation | | | |
| Trade Name | i3 Point-of-Use
Water Filter
Filter Models:
i3 ONE,
i3 TWO connect,
i3 TWO direct | Pall-Aquasafe™Water
Filter Models: AQINA,
AQ31F1SA, AQ31F1RA,
AQF4A | Ecolab POU
Water Filter | Feed Water
Source | Drinking water
plumbing at Point of
Use | In-line plumbing | Drinking water
plumbing at point
of use. |
| Manufacturer | i3 Membrane GmbH | Pall Medical | Ecolab Inc. | Use Life | 50 days | 31 days | Up to 62 days |
| 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 | 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 Ecolab POU
Water Filters are
intended to
operate on EPA
quality drinking
water sources as
a microbial
retention filter.
Ecolab POU
Water Filters are
suitable for the
control of
bacteria equal to
or greater in size
than
Brevundimons
diminuta. The
POU Filters are
suitable for
general point of
use infection
control for
procedures such
as superficial
wound cleansing,
cleaning of
equipment,
washing of
surgeon's hands | Maximum
Inlet
Pressure | 75 psi @ 140 °F | 75 psi @ 140 °F | 89.9 psi (6.2
bargauge):
tapfilters 79.8 psi
(5.5 bargauge):
showerwands |
| | used as a substitute
for USP grade sterile
water. | | and bathing
where the
reduction of such
microorganisms
in the water is
desired. The
Ecolab POU
Filters are not
intended for use
in the production
of USP sterile
water for use in
infusion, injection
or production of
fluids for use in
dialysis
treatments. | Flow Rate
and Pressure
Drop | Per individual model
specification | Per individual model
specification | 7L/min and
11L/min at 3 bar |
| Device
Description | A disposable
Polyethersulfone
(PES) membrane
filter sealed in a
polypropylene
housing designed to
be installed at point
of use locations
where the control of
bacteria in EPA
quality drinking
water is desired for
hand-washing,
bathing, showering
and instrument
cleaning
applications. These
filters are designed
to be installed as
attachments to
faucets or as a
handheld shower
head attached to a
water outlet. | Sterilizing grade 0.2 µm
Supor® membrane
filtration with integral pre-
filter that retains bacteria
from water through size
exclusion. | A disposable
Polyethersulfone
(PES) membrane
filter sealed in a
white
polypropylene
housing designed
to be installed by
facility personnel
at point of use
locations where
the control of
bacteria in EPA
quality drinking
water is desired
for hand-
washing, bathing,
showering and
instrument
cleaning
applications.
These filters are
designed to be
installed as
attachments to
faucets or as a
handheld shower
head attached to
a water outlet. | Filter Retention | | | |
| Materials
Casing | Polpropylene (PP) | Polybutylene
terephthalate (PBT) | Polypropylene
(PP) | Bacteria
Reduction | > 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.
9
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.