(295 days)
The NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of equipment, hand washing and bathing where the reduction of such microorganisms in the water is desired.
The Nosogard is not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.
Nosogard Filters are disposable Polyethersulfone (PES) membrane filters sealed in a polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in the drinking water supply is desired for device cleaning, handwashing and bathing applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head.
The Evoqua Water Technologies Nosogard Filters are intended as microbial retention filters for EPA quality drinking water sources, for general point-of-use infection control in procedures like cleaning, rinsing equipment, hand washing, and bathing. They are not intended for producing USP sterile water for infusion, injection, or dialysis treatments.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally focused on bacterial retention (no grow-through), flow rate, structural integrity (housing burst pressure, pulse testing, drop testing), and shelf-life, along with biocompatibility and sterilization efficacy.
| Acceptance Criteria / Performance Claim | Reported Device Performance (Nosogard Filters) |
|---|---|
| Bacterial Retention (Brevundimonas diminuta) | |
| No grow through ≤7 days when challenged with >10^7 cfu/cm² Brevundimonas diminuta | Passed (Nosogard 7/31 Filter) |
| No grow through ≤31 days when challenged with >10^7 cfu/cm² Brevundimonas diminuta | Passed (Nosogard 31 Day Filter, Nosogard 31 Day Shower Wand) |
| No grow through ≤62 days when challenged with >10^7 cfu/cm² Brevundimonas diminuta | Passed (Nosogard 62 Day Filter, Nosogard 62 Day Shower Wand) |
| Bacterial Retention (Legionella pneumophila) | |
| No grow through ≤31 days when challenged with >10^7 cfu/cm² Legionella pneumophila | Passed (Nosogard 7/31 Filter, Nosogard 31 Day Shower Wand) |
| No grow through ≤62 days when challenged with >10^7 cfu/cm² Legionella pneumophila | Passed (Nosogard 62 Day Filter, Nosogard 62 Day Shower Wand) |
| Flow Rate | |
| 1.25" Nosogard 7/31 Filter: 0.22 ft³/min at 44psi inlet pressure | Passed |
| 2.5" Nosogard 7/31 Filter: 0.40 ft³/min at 29psi inlet pressure | Passed |
| Nosogard 31 Day Filter: 0.19 ft³/min at 44psi inlet pressure | Passed |
| Nosogard 62 Day Filter: 0.25 ft³/min at 44psi inlet pressure | Passed |
| Nosogard 31 Day Shower Wand: 0.79 ft³/min at 44psi inlet pressure | Passed |
| Nosogard 62 Day Shower Wand: 0.39 ft³/min at 44psi inlet pressure | Passed |
| Housing Burst Pressure | |
| 10 Barg at 40°C | Passed (All models explicitly mentioned) |
| Pulse Testing / Integrity after Cycles | |
| Nosogard 7/31 Filter: Integral post 2000 cycles x 5 mins x 0-6.2 Barg pulses at 66°C | Passed |
| Nosogard 31 Day Filter: Integral post 2000 cycles x 5 mins x 0-6.2 Barg pulses at 66°C | Passed |
| Nosogard 31 Day Shower Wand: Integral post 124 cycles x 7 mins x 0-5 Barg pulses at 40°C | Passed |
| Nosogard 62 Day Shower Wand: Integral post 248 cycles x 7 mins x 0-5 Barg pulses at 40°C | Passed |
| Shelf Life | |
| Packaging forms a sterile barrier for at least 3 years | Passed (All models implicitly covered, explicitly stated for all listed models not described above) |
| Biocompatibility | |
| Meets requirements in FDA memorandum #G95-1 | Passed (All models implicitly covered, explicitly stated for all listed models not described above), including USP Class VI, USP Biological Reactivity Tests, In Vitro, ISO 10993 Part 5 (cytotoxicity), Part 10 (irritation and skin sensitization). |
| Sterilization | Adequate dosage and exposure utilized to assure a sterile product prior to release (tested post gamma irradiation in accordance with ANSI/AAMI/ISO 11137-2:2012). |
| Integrity after Drop Test | Retains integrity at stated maximum operating pressure and temperatures after being subjected to a 6-foot unprotected drop. Integrity verified with membrane diffusional flow testing. |
| Integrity after Simulated Use/Cycle Testing | Successfully retains integrity after exposure to repeated pressurization, flow, and depressurization cycles at maximum stated temperatures and pressure. Integrity verified with diffusional flow testing. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample size for each test. However, it indicates that "All filter designs were placed in test assemblies and operated continuously for a period at least equal to the useful life of the model with repetitive inoculations of the subject microbe." This implies that a sufficient number of units representing each filter design were tested.
- Sample Size: Not explicitly quantified with a specific number for each test across all models. It implies a representative sample of "all filter designs."
- Data Provenance: The studies are described as "Non-Clinical Performance Testing" and "Bench Testing," which are laboratory-based studies conducted by the manufacturer (Evoqua Water Technologies, LLC.) to evaluate device performance against established standards. The data is retrospective in the sense that the results are being reported after the tests were conducted for the 510(k) submission. There is no mention of country of origin for the data, but it is submitted to the FDA in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device. The ground truth for device performance, such as bacterial retention or physical integrity, is established through standardized laboratory testing methods (e.g., ASTM F838 for bacterial retention, pressure tests). These tests rely on objective measurements and established scientific protocols rather than expert consensus on interpretation of, for example, medical images.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of data by multiple human experts (e.g., radiologists interpreting images) to establish a consensus ground truth. For the laboratory-based performance testing of a water filter, the results are derived from objective measurements per defined testing protocols.
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
This information is not applicable. MRMC studies are used to evaluate AI systems that assist human readers in tasks like medical image interpretation. The Nosogard Filter is a physical water filtration device, not an AI-powered diagnostic tool. Therefore, human reader performance or AI assistance effects are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The Nosogard Filter is a physical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation of the Nosogard Filters is based on objective, quantifiable measurements derived from standardized laboratory bench testing.
- Bacterial Reduction: Measured according to ASTM F838 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, using specific bacterial challenges (Brevundimonas diminuta, Legionella pneumophila) at defined concentrations. The "ground truth" is the quantitative reduction in colony-forming units (cfu) to demonstrate "no grow through" or a >10^7 reduction.
- Physical Integrity (Flow Rate, Burst Pressure, Pulse Testing, Drop Testing): The ground truth is adherence to specified physical parameters (e.g., specific flow rates, resisting a certain pressure, maintaining integrity after cycles/drops) as verified by direct measurement and observation under controlled conditions.
- Biocompatibility: Adherence to established standards (e.g., USP Class VI, ISO 10993) which define acceptable biological responses.
- Sterilization: Demonstrated efficacy according to ANSI/AAMI/ISO 11137-2:2012.
- Shelf Life: Demonstrated sterile barrier integrity for a specified period (3 years) based on ISO 11607:2009.
8. The Sample Size for the Training Set
This information is not applicable. The Nosogard Filter is not an AI or machine learning device that requires a "training set" for model development. Its performance is based on its physical design and material properties.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
Evoqua Water Technologies, LLC Robert Dudek Regulatory Manager 10 Technology Drive Lowell, Massachusetts 01851
Re: K153784
Trade/Device Name: Nosogard Filters Regulation Number: 21 CFR 876.5665 Regulation Name: Water Purification System For Hemodialysis Regulatory Class: Class II Product Code: NHV Dated: September 11, 2016 Received: September 20, 2016
Dear Robert Dudek:
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. 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 devicerelated 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.
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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, Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153784
Device Name NOSOGARD FILTERS
Indications for Use (Describe)
The NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of equipment, hand washing and bathing where the reduction of such microorganisms in the water is desired.
The Nosogard is not intended for use in the production of USP sterile water for use in infusion, injection of fluids for use in dialysis treatments.
Type of Use (Select one or both, as applicable)X 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/0 description: The image shows the logo for Evoqua Water Technologies. The logo consists of a stylized water droplet above the company name. The water droplet is light blue and appears to be made of overlapping shapes. The company name, "evoqua," is in a sans-serif font, and the words "WATER TECHNOLOGIES" are in a smaller font below the company name.
510k Summary (K153784) of the Nosogard™ Filters
| Submitter: | Evoqua Water Technologies, LLC.10 Technology DriveLowell, MA 01851Establishment Registration - Pending |
|---|---|
| Contact: | Robert DudekEvoqua Water Technologies, LLC.10 Technology DriveLowell, MA 01851E-Mail: Robert.Dudek@Evoqua.comPhone: 978-614-7359Fax: 978-441-6037 |
| Date Prepared | September 11, 2016 (amended 10-20-2016) |
| Trade Name | Nosogard Filters |
| Proposed Class | Class II |
| Classification Nameand Number | 21 CFR Part 876.5665 Water Purification Device,General Medical Use |
| Product Code | NHV |
| Predicate Device 1 | Nephros Inc. – DSU-HTM and SSU-HTM Filters – K141731 |
| Predicate Device 2 | PrisMedical - MainStreamTM Water Purification Device - K012716 |
| Device Description | Nosogard Filters are disposable Polyethersulfone (PES) membranefilters sealed in a polypropylene housing designed to be installed byfacility personnel at point of use locations where the control ofbacteria in the drinking water supply is desired for device cleaning,handwashing and bathing applications. These filters are designed tobe installed as attachments to faucets or as a handheld showerhead. |
| Intended Use | The NOSOGARD line of filters are intended to operate on EPA qualitydrinking water sources as a microbial retention filter. NOSOGARDfilters are available in models suitable for the control of bacteria equalto or greater in size than Brevundimons diminuta and models formicrobial removal equal to or greater than Legionella peumophila. TheNOSOGARD is suitable for general point of use infection control forprocedures such as cleaning, rinsing of equipment, hand washing andbathing where the reduction of bacterial microorganisms in the water isdesired.The Nosogard is not intended for use in the production of USP sterilewater for use in infusion, injection or production of fluids for use indialysis treatments. |
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Image /page/4/Picture/0 description: The image shows the logo for Evoqua Water Technologies. The logo features a stylized water droplet above the company name. The words "WATER TECHNOLOGIES" are written in a smaller font below the company name.
| Evoqua Nosogard Filters | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| 510(k) Number | K153784 | K141731 | K012716 |
| ManufacturerName | Evoqua WaterTechnologies, LLC. | Nephros Inc. | PrisMedical |
| Indicationsfor Use | The Nosogard Filters areintended to operate on EPAquality drinking watersources as a microbialretention filter and aresuitable for general point ofuse infection control forprocedures such ascleaning, rinsing ofequipment, hand washingand bathing where thereduction of bacterialmicroorganisms in the wateris desiredThe Nosogard is notintended for use in theproduction of USP sterilewater for use in infusion,injection or production offluids for use in dialysistreatments. | The DSU-H andSSU-H Ultrafilters areintended to be usedto filter EPA qualitydrinking water. Thefilters retain bacteria,viruses andendotoxin. Byproviding ultrapurewater for washingand drinking, thefilters aid in infectioncontrol. The filtersproduce water that issuitable for woundcleansing, cleaning ofequipment used inmedical proceduresand washing ofsurgeon's hands. Thefilters are notintended to providewater that can beused as a substitutefor USP sterile water. | To produce fromEPA grade drinkingwater, sterilepurified water to beused 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,oral vaccine, or oraldrug preparations -All other uses ofsterile purified waterthe practitioner orclinician deemsnecessary -Not forparenteraladministration |
| Feed WaterSource | Drinking water plumbing atpoint of use. | In-Line plumbing | Feed Container(tank) |
| Evoqua Nosogard FiltersK153784 | Predicate Device 1 | Predicate Device 2 | |
| Feed WaterQuality | Potable Water as definedby the EPA NationalPrimary Drinking WaterRegulations (EPA QualityWater) | EPA Quality Water | EPA Grade Water |
| Useful Life | Up to 7 days, 31 days or 62days depending on model | up to 3 Mo. (SSU-H)up to 6 Mo. (DSU-H) | 3 Liters |
| Maximum InletPressure | 89.9 psi (pounds / squareinch) | 75 psi (SSU-H)100 psi (DSU-H) | Gravity feed (< 10 psi) |
| Sterile Device | Shipped in sterile conditionand package | No | No |
| Casing | Polypropylene | ABS Plastic | PolycarbonatePlastic |
| Bacteria FilterElement(s) | Polyethersulfone (PES)pleated membrane | PolysulfoneUltrafiltration HollowFiber | Polyethersulfone flatmembrane |
| PerformanceClaims | Evoqua Nosogard Filters | Predicate Device 1 | Predicate Device 2 |
| BacteriaReduction | Greater than 107 | Greater than 1011 | Greater than 107 |
| Virus Reduction | No performance claims | Greater than 108 | Greater than 104 |
| EndotoxinReduction | No performance claims | Greater than 105 | Greater than 104 |
| OrganicReduction | No performance claims | N/A | TOC reduced to lessthan 1 ppm |
| Ion Reduction | None | N/A | Greater than 103dissociable ions |
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Image /page/5/Picture/0 description: The image shows the logo for Evoqua Water Technologies. The logo features a stylized water droplet in a light blue color above the company name. The company name, "evoqua," is written in a dark blue sans-serif font, with the words "WATER TECHNOLOGIES" in a smaller, lighter blue font below it.
Table 1 - Comparison to predicate devices
Device Description & Summary of Technological Characteristics:
The Nosogard Filter are disposable Polyethersulfone (PES) membrane filters sealed in a polypropylene housing designed to be installed by facility personnel at point of use locations where the control of bacteria in the EPA quality drinking water supply is desired for device cleaning, handwashing and bathing applications. These filters are designed to be installed as attachments to faucets or as a handheld shower head attached to a water outlet. Further details of the technology may be located in the 510k submission Section 12, Materials and Design. The filter is not intended or marketed as a device to reduce endotoxin or virus in general washing applications and the difference to predicate devices is not applicable. Biocompatibility testing (located in the 510k submission Section 16, Biocompatibility) demonstrates that all materials are safe for use in this
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Image /page/6/Picture/0 description: The image shows the logo for Evoqua Water Technologies. The logo consists of a stylized water droplet above the company name. The water droplet is light blue and appears to be formed by two curved shapes. The company name, "evoqua," is written in a dark teal sans-serif font, and below it, in smaller light teal letters, are the words "WATER TECHNOLOGIES."
application and are free of harmful extractable or leachable chemicals. These materials of construction are commonly used in other medical devices that have been previously approved for use in products regulated under 21CFR876.5665
The product models are based on the anticipated useful life of the product in specific roles. These are identified as filters suitable for maximum use periods of 7 days (type Nosoqard 7/31 Filter), 31 days (Nosoqard 31 Day Filter) or 62 days (Nosoqard 62 Day Filter) depending on the size of the bacterial component targeted for removal and other particulate matter in the source water. Internal differences in membrane arrangement, density of pleating and pre-filtration elements within the cartridge determine the maximum anticipated useful life of the filter. The Nosogard line of filters are offered with a choice of style of connection to water source, outlet flow type and both a large and normal size 7/31 model. In addition handheld shower wands are available in 31 and 62 day models. Each model is identified by a unique part number and information regarding application is also identified on the product labeling.
| PartNumber | Description | Inlet Connection | Outlet Flow | Microbial Performance | |
|---|---|---|---|---|---|
| Brevundimons diminuta(or larger) | Legionella pneumophila(or larger) | ||||
| W2T42138 | Nosogard 7/31 Filter (1.25" size) | Quick Connect | Stream | Not to exceed 7 days | Not to exceed 31 days |
| W2T42134 | Nosogard 7/31 Filter (1.25" size) | Quick Connect | Shower | Not to exceed 7 days | Not to exceed 31 days |
| W2T42138 | Nosogard 7/31 Filter (2.5" size) | Quick Connect | Stream | Not to exceed 7 days | Not to exceed 31 days |
| W2T42138 | Nosogard 7/31 Filter (2.5" size) | Quick Connect | Shower | Not to exceed 7 days | Not to exceed 31 days |
| W2T42138 | Nosogard 7/31 Filter (2.5" size) | Quick Connect | 1/2" NPT | Not to exceed 7 days | Not to exceed 31 days |
| W2T82022 | Nosogard 31 Day Filter (1.25" size) | Quick Connect | Shower | Not to exceed 31 days | Not to exceed 31 days |
| W2T82022 | Nosogard 31 Day Filter (1.25" size) | Quick Connect | Stream | Not to exceed 31 days | Not to exceed 31 days |
| W2T82022 | Nosogard 62 Day Filter (1.25" size) | Quick Connect | Shower | Not to exceed 62 days | Not to exceed 62 days |
| W2T82022 | Nosogard 62 Day Filter (1.25" size) | Quick Connect | Stream | Not to exceed 62 days | Not to exceed 62 days |
| W2T82022 | Nosogard 31 Day Shower Wand | 1/2" NPT | Shower | Not applicable | Not to exceed 31 days |
| W2T82023 | Nosogard 31 Day Shower Wand | 1/2" NPT | Shower | Not to exceed 31 days | Not to exceed 31 days |
| W2T82023 | Nosogard 62 Day Shower Wand | 1/2" NPT | Shower | Not to exceed 62 days | Not to exceed 62 days |
NOSOGARD® FILTER MODELS
Table 2 – Nosoqard Models & Part Numbers
Non-Clinical Performance Testing
Results reflected in summary Table 3, Nosogard Performance Testing are contained in the submission sections titled Biocompatibility and Bench Testing in full detail.
All filter designs were placed in test assemblies and operated continuously for a period at least equal to the useful life of the model with repetitive inoculations of the subject microbe. Testing for bacterial reduction rates of 10 to the 7th were demonstrated successful at the time of installation and remained effective throughout the use period stated for each model using the ASTM F838 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liguid Filtration. This reduction rate testing and ASTM F838 standard was also utilized to demonstrate bacterial grow through of the membrane did not occur during the stated use period for each model.
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Image /page/7/Picture/0 description: The image shows the logo for Evoqua Water Technologies. The logo features a stylized water droplet above the company name. The droplet is light blue and appears to be formed by two curved lines. Below the company name, in smaller font, are the words "WATER TECHNOLOGIES".
All filter designs and housings were tested to pressures equal to or greater than stated operating limits to demonstrate the Nosogard filter retains integrity at the stated operating limits. Integrity testing and pressure testing was conducted using the protocols in ASTM F838 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration.
Drop testing was conducted to demonstrate that the filter was not compromised at the stated maximum operating pressure and maximum operating temperatures after being subjected to a 6 foot unprotected drop. Integrity was verified with membrane diffusional flow testing.
Simulated use testing (cycle testing) demonstrates the Nosogard filter successfully retains integrity after exposure to repeated pressurization, flow and depressurization cycles at maximum stated temperatures and pressure. Integrity was verified with diffusional flow testing.
Sterilization testing conducted in accordance with ANSI/AAMI/ISO 11137-2:2012 Sterilization of health care products was conducted post gamma irradiation and demonstrates that the dosage and exposure utilized is adequate to assure a sterile product prior to release.
Testing of the packaging utilizing ISO 11607:2009 Packaging for terminally sterilized medical devices demonstrated the packaging is capable of maintaining a sterile barrier for a period of three years.
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Image /page/8/Picture/0 description: The image shows the logo for Evoqua Water Technologies. The logo features a stylized water droplet in a light blue color above the company name. The company name, "evoQUA," is written in a sans-serif font, with the "Q" stylized to resemble a water wave. Below the company name, the words "WATER TECHNOLOGIES" are written in a smaller, sans-serif font.
| Nosogard Performance Testing | |||||||
|---|---|---|---|---|---|---|---|
| NosogardModel | Parameter | Minimum Objective of Non-Clinical Testing & Materials forNosogard Brand Filters | PassingResult? | NosogardModel | Parameter | Minimum Objective of Non-Clinical Testing & Materials forNosogard Brand Filters | PassingResult? |
| Nosogard 7/31Filter | 7day, B.dim growthrough. | No grow through ≤7days whenchallenge with >107 cfu/cm²Brewundimonas diminuta | Passed | NOSOGARD 31Day shower wand(handheldshower) | 31day, legionellagrow through. | No grow through ≤31days whenchallenge with >107 cfu/cm²Legionella pneumophila | Passed |
| 31day, legionellagrow through. | No grow through ≤31days whenchallenge with >107 cfu/cm²Legionella pneumophila | Passed | Flow Rate | 0.79ft³/min at 44psi inlet pressure | Passed | ||
| Flow rate | 1.25" = 0.22ft³/min at 44psi inletpressure2.5" = 0.40ft³/min at 29psi inletpressure | Passed | Housing burstpressure | 10Barg at 40°C | Passed | ||
| Housing burstpressure | 10Barg at 40°C | Passed | Pulse testing | Integral post 124 cycles x 7mins x 0-5Barg pulses at 40°C | Passed | ||
| Pulse testing | 7day:Integral post 2000 cycles x 5mins x0-6.2Barg pulses at 66°C31day:Integral post 2000 cycles x 5mins x0-6.2Barg pulses at 66°C | Passed | Shelf life | Packaging forms a sterile barrier forat least 3 years. | Passed | ||
| Shelf life | Packaging forms a sterile barrier forat least 3 years. | Passed | Biocompatibility | Meets requirements in FDAmemorandum #G95-1 | Passed | ||
| Biocompatibility | Meets requirements in FDAmemorandum #G95-1 | Passed | NOSOGARD 31Day shower wand(handheldshower) | 31day, B.dimgrow through. | No grow through ≤31days whenchallenge with >107 cfu/cm²Brewundimonas diminuta | Passed | |
| Flow Rate | 0.32ft³/min at 44psi inlet pressure | Passed | |||||
| NOSOGARD 31Day Filter | 31day, B.dimgrow through. | No grow through ≤31days whenchallenge with >107 cfu/cm²Brewundimonas diminuta | Passed | Housing burstpressure | 10Barg at 40°C | Passed | |
| Flow Rate | 0.19ft³/min at 44psi inlet pressure | Passed | Pulse testing | Integral post 124 cycles x 7mins x 0-5Barg pulses at 40°C | Passed | ||
| Housing burstpressure | 10Barg at 40°C | Passed | Shelf life | Packaging forms a sterile barrier forat least 3 years. | Passed | ||
| Pulse testing | Integral post 2000 cycles x 5mins x0-6.2Barg pulses at 66°C | Passed | Biocompatibility | Meets requirements in FDAmemorandum #G95-1 | Passed | ||
| Shelf life | Packaging forms a sterile barrier forat least 3 years. | Passed | NOSOGARD 62Day shower wand(handheldshower) | 62day, B.dimgrow through. | No grow through ≤62days whenchallenge with >107 cfu/cm2Brewundimonas diminuta | ||
| Biocompatibility | Meets requirements in FDAmemorandum #G95-1 | Passed | Flow Rate | 0.39ft³/min at 44psi inlet pressure | |||
| NOSOGARD 62Day Filter | 62day, B.dimgrow through. | No grow through ≤62days whenchallenge with >107 cfu/cm²Brewundimonas diminuta | Passed | Housing burstpressure | 10Barg at 40°C | Passed | |
| Flow Rate | 0.25ft³/min at 44psi inlet pressure | Passed | Pulse testing | Integral post 248 cycles x 7mins x 0-5Barg pulses at 40°C | Passed | ||
| Housing burstpressure | 10Barg at 40°C | Passed | Shelf life | Packaging forms a sterile barrier forat least 3 years. | Passed | ||
| Pulse testing | Integral post 4000 cycles x 5mins x0-6.2Barg pulses at 66°C | Passed | Biocompatibility | Meets requirements in FDAmemorandum #G95-1 | Passed | ||
| Shelf life | Packaging forms a sterile barrier forat least 3 years. | Passed | |||||
| Biocompatibility | Meets requirements in FDAmemorandum #G95-1 | Passed |
Biocompatibility Testing Results
Biocompatibility of Nosogard Filters was tested in the form of fully assembled products and passed the following tests for biocompatibility:
-
- General Chapter <88> of the United States Pharmacopeia and National Formulary, Section USP Class VI Plastics
- a. Intracutaneous Reactivity Testing
- b. Acute Systemic Injection Testing
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- c. Intramuscular Implant Testing
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- General Chapter <87> of the United States Pharmacopeia, Biological Reactivity Tests, In Vitro
- a. Minimal Essential Media Elution Test for Cytotoxicity
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- ISO 10993:2010 Biological evaluation of medical devices Part 5:
- a. Part 5: Tests for in vitro cytotoxicity
- b. Part 10: Tests for irritation and Skin Sensitization
Summary of Standards Utilized in the Design and Performance Evaluation of the Nosogard
- General Chapter <88> of the United States Pharmacopeia and National ● Formulary, Section USP Class VI Plastics
- General Chapter <87> of the United States Pharmacopeia, Biological . Reactivity Tests, In Vitro
- . ISO 10993:2010 Biological evaluation of medical devices
- ASTM F838 Standard Test Method for Determining Bacterial Retention of ● Membrane Filters Utilized for Liquid Filtration
- ANSI/AAMI/ISO 11137-2:2012 Sterilization of health care products ●
- ISO 11607:2009 Packaging for terminally sterilized medical devices ●
- Blue Book Memorandum #G95-1, Use of International Standard ISO-. 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
Summary of Substantial Equivalence:
Based on non-clinical performance testing, the Nosogard filters have been found to be substantially equivalent to the predicate PrisMedical MainStream Filter (K012716) and Nephros DSU & SSU filters (K141731) for the intended use.
§ 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.