Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical filtration capabilities of the membrane and housing, with no mention of AI or ML technologies.

Therapeutic

No
The device is a water filter intended for microbial retention in drinking water for general infection control, not for treating a disease or condition.

Diagnostic

No

The device is a water filter designed to remove microorganisms from water for infection control purposes. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical filter (disposable Polyethersulfone (PES) membrane filters sealed in a polypropylene housing) designed to be installed as attachments to faucets or as a handheld shower head. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The device is intended to operate on drinking water sources as a "microbial retention filter" for "general point of use infection control." While it's filtering water, the purpose is to reduce microorganisms for procedures like cleaning, rinsing of equipment, hand washing, and bathing where the reduction of such microorganisms is desired. This directly relates to preventing the spread of infection, which falls under the umbrella of diagnostic or preventative measures in a healthcare setting.
Device Description: The description mentions it's designed for "point of use locations where the control of bacteria in the drinking water supply is desired for device cleaning, handwashing and bathing applications." Again, the focus is on controlling microbial contamination for health-related purposes.
Performance Studies: The performance studies focus on "bacterial reduction rates" and demonstrating the filter's effectiveness in removing specific microorganisms (Brevundimons diminuta and Legionella pneumophila). This type of testing is characteristic of devices intended to impact the microbial content of a substance for health-related reasons.
Predicate Devices: The predicate devices listed (K141731 and K012716) are also water filters used in healthcare settings for microbial control. This further supports the classification of this device as an IVD.

While the device itself is a filter and not directly analyzing a biological sample from a patient, its intended use and function are directly related to controlling microbial contamination in a healthcare environment to prevent infection. This aligns with the definition of an IVD, which includes devices used to examine specimens derived from the human body or to provide information for diagnostic, preventative, or treatment purposes. In this case, the "specimen" is the water, and the information provided by the filter's function is the reduction of microorganisms for preventative purposes in a healthcare setting.

The exclusion for "USP sterile water for use in infusion, injection of fluids for use in dialysis treatments" doesn't negate its IVD status for the stated intended uses.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NHV

Device Description

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.

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

Facility personnel at point of use locations

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)

Non-Clinical Performance Testing:
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.

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.

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 of the United States Pharmacopeia and National Formulary, Section USP Class VI Plastics
a. Intracutaneous Reactivity Testing
b. Acute Systemic Injection Testing
c. Intramuscular Implant Testing
General Chapter of the United States Pharmacopeia, Biological Reactivity Tests, In Vitro
a. Minimal Essential Media Elution Test for Cytotoxicity
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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K141731, K012716

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.5665 Water purification system for hemodialysis.

(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Summary

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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.

1

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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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 Drive
Lowell, MA 01851
Establishment Registration - Pending |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Robert Dudek
Evoqua Water Technologies, LLC.
10 Technology Drive
Lowell, MA 01851
E-Mail: Robert.Dudek@Evoqua.com
Phone: 978-614-7359
Fax: 978-441-6037 |
| Date Prepared | September 11, 2016 (amended 10-20-2016) |
| Trade Name | Nosogard Filters |
| Proposed Class | Class II |
| Classification Name
and 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) 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. |
| Intended Use | 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 peumophila. 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 bacterial 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 or production of fluids for use in
dialysis 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
Manufacturer
Name	Evoqua Water
Technologies, LLC.	Nephros Inc.	PrisMedical
Indications
for Use	The Nosogard Filters are
intended to operate on EPA
quality drinking water
sources as a microbial
retention filter and are
suitable for general point of
use infection control for
procedures such as
cleaning, rinsing of
equipment, hand washing
and bathing where the
reduction of bacterial
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 or production of
fluids for use in dialysis
treatments.	The DSU-H and
SSU-H Ultrafilters are
intended to be used
to filter EPA quality
drinking water. The
filters retain bacteria,
viruses and
endotoxin. By
providing ultrapure
water for washing
and drinking, the
filters aid in infection
control. The filters
produce water that is
suitable for wound
cleansing, 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 sterile water.	To produce from
EPA grade drinking
water, sterile
purified water to be
used within 24 hours
of collection that is
suitable for: -
Cleaning and rinsing
open wounds -
Infection control
(cleaning equipment
used in medical
procedures, medical
personnel's hands) -
Use as a diluent for
enteral, nutritional,
oral vaccine, or oral
drug preparations -
All other uses of
sterile purified water
the practitioner or
clinician deems
necessary -Not for
parenteral
administration
Feed Water
Source	Drinking water plumbing at
point of use.	In-Line plumbing	Feed Container
(tank)
	Evoqua Nosogard Filters
K153784	Predicate Device 1	Predicate Device 2
Feed Water
Quality	Potable Water as defined
by the EPA National
Primary Drinking Water
Regulations (EPA Quality
Water)	EPA Quality Water	EPA Grade Water
Useful Life	Up to 7 days, 31 days or 62
days depending on model	up to 3 Mo. (SSU-H)
up to 6 Mo. (DSU-H)	3 Liters
Maximum Inlet
Pressure	89.9 psi (pounds / square
inch)	75 psi (SSU-H)
100 psi (DSU-H)	Gravity feed (107 cfu/cm²
Brewundimonas diminuta	Passed	NOSOGARD 31
Day shower wand
(handheld
shower)	31day, legionella
grow through.	No grow through ≤31days when
challenge with >107 cfu/cm²
Legionella pneumophila	Passed
	31day, legionella
grow through.	No grow through ≤31days when
challenge with >107 cfu/cm²
Legionella pneumophila	Passed		Flow Rate
	Flow rate	1.25" = 0.22ft³/min at 44psi inlet
pressure
2.5" = 0.40ft³/min at 29psi inlet
pressure	Passed		Housing burst
pressure	10Barg at 40°C	Passed
	Housing burst
pressure	10Barg at 40°C	Passed
5Barg pulses at 40°C	Passed
	Pulse testing	7day:
Integral post 2000 cycles x 5mins x
0-6.2Barg pulses at 66°C
31day:
Integral post 2000 cycles x 5mins x
0-6.2Barg pulses at 66°C	Passed		Shelf life
at least 3 years.	Passed
	Shelf life	Packaging forms a sterile barrier for
at least 3 years.	Passed		Biocompatibility
memorandum #G95-1	Passed
	Biocompatibility	Meets requirements in FDA
memorandum #G95-1	Passed	NOSOGARD 31
Day shower wand
(handheld
shower)	31day, B.dim
grow through.	No grow through ≤31days when
challenge with >107 cfu/cm²
Brewundimonas diminuta	Passed

NOSOGARD 31
Day Filter	31day, B.dim
grow through.	No grow through ≤31days when
challenge with >107 cfu/cm²
Brewundimonas diminuta	Passed		Housing burst
pressure	10Barg at 40°C	Passed
	Flow Rate	0.19ft³/min at 44psi inlet pressure	Passed
5Barg pulses at 40°C	Passed
	Housing burst
pressure	10Barg at 40°C	Passed
at least 3 years.	Passed
	Pulse testing	Integral post 2000 cycles x 5mins x
0-6.2Barg pulses at 66°C	Passed		Biocompatibility
memorandum #G95-1	Passed
	Shelf life	Packaging forms a sterile barrier for
at least 3 years.	Passed		NOSOGARD 62
Day shower wand
(handheld
shower)	62day, B.dim
grow through.	No grow through ≤62days when
challenge with >107 cfu/cm2
Brewundimonas diminuta
	Biocompatibility	Meets requirements in FDA
memorandum #G95-1	Passed
NOSOGARD 62
Day Filter	62day, B.dim
grow through.	No grow through ≤62days when
challenge with >107 cfu/cm²
Brewundimonas diminuta	Passed	Housing burst
pressure		10Barg at 40°C	Passed
	Flow Rate	0.25ft³/min at 44psi inlet pressure	Passed
5Barg pulses at 40°C	Passed
	Housing burst
pressure	10Barg at 40°C	Passed	Shelf life
at least 3 years.	Passed
	Pulse testing	Integral post 4000 cycles x 5mins x
0-6.2Barg pulses at 66°C	Passed	Biocompatibility	Meets requirements in FDA
memorandum #G95-1	Passed
	Shelf life	Packaging forms a sterile barrier for
at least 3 years.	Passed
	Biocompatibility	Meets requirements in FDA
memorandum #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:

1. General Chapter 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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Image /page/9/Picture/0 description: The image shows the logo for Evoqua Water Technologies. The logo features a stylized water droplet in shades of blue above the company name. The company name is written in a modern, sans-serif font, with "evoqua" in a darker blue and "WATER TECHNOLOGIES" in a lighter blue below it.

c. Intramuscular Implant Testing
1. General Chapter of the United States Pharmacopeia, Biological Reactivity Tests, In Vitro
- a. Minimal Essential Media Elution Test for Cytotoxicity
1. 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 of the United States Pharmacopeia and National ● Formulary, Section USP Class VI Plastics
General Chapter 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.