The Amerilyater MROZ Reverse Osmosis System is a water treatment device intended for use in hemodialysis applications. It is intended to be used as a component in the AmeriWater Water Purification System (K991519), and is intended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater MROZ is intended for use in water rooms in a hospital, clinic, or dialysis center. The device is intended to be a component in a complete water purfication system, and is not a complete water treatment system. It must be preceeded by pro-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards.

Model MRO3Z is a 3 membrane system designed to supply 6,600 gallons per day (gpd) of product water. Model MRO4Z is a 4 membrane system designed to supply 8,800 gpd of product water. Model MRO5Z Is a 5 membrane system designed to supply 11,000 gpd of product water. Model MRO6Z is a 6 membrane systems designed to supply 13,200 gpd of product water. Model MRO7Z is a 7 membrane system designed to supply 15,400 gpd of product water. Model MRO8Z is an 8 membrane system designed to supply 17,600 gpd of product water. Each model is available in a 208V, 230V, or 460V variant and includes a divert- to-drain feature to prevent patient exposure to unsafe product water. Each model includes temperature compensated online monitors that display conductivity and percent rejection. The conductivity monitor activates an audible and visual alarm when the product water conductivity exceeds a preset alarm limit.

Device Description

The AmeriWater MROZ Reverse Osmosis System is a water treatment system intended for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater MROZ Reverse Osmosis System is intended to be used in water rooms located in hospitals, clinics, and dialysis centers. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: ABS, Acrylic, Nylon, PVC, Polyethylene, Polypropylene, Stainless Steel, Tygon, and Thin Film Composite Membrane (polyimide). The MROZ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the feed water is supplied to the membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater MROZ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.

AI/ML Overview

This document describes the AmeriWater MROZ Reverse Osmosis System, a water treatment device intended for use in hemodialysis applications.

1. Table of Acceptance Criteria and Reported Device Performance

The device is intended to produce water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis. While specific numerical acceptance criteria for each contaminant level are not explicitly listed in this summary, the general performance criteria are:

Acceptance Criteria Category	Specific Criteria (Implicitly AAMI & Federal U.S. Standards)	Reported Device Performance
Water Quality	Produces water suitable for hemodialysis applications by removing organic and inorganic substances and contaminants.	"Results of performance testing indicate that the device produces water that meets current AAMI and Federal (U.S.) standards."
Alarm Functionality	Audible and visual alarm when product water conductivity exceeds a preset alarm limit.	"The conductivity monitor activates an audible and visual alarm when the product water conductivity exceeds a preset alarm limit."
Safety	Biocompatibility, electrical safety.	"Test results from biocompatibility testing, performance testing, and electrical safety testing indicate that the device is safe and effective for its intended purpose."
Output Capacity	Specific gallons per day (gpd) output for each model (e.g., MRO3Z: 6,600 gpd, MRO8Z: 17,600 gpd).	The device is designed to supply the specified gpd for each model (e.g., "Model MRO3Z is a 3 membrane system designed to supply 6,600 gallons per day (gpd) of product water.").

2. Sample size used for the test set and the data provenance

The document states, "Non-clinical testing was conducted to verify and validate the performance of the reverse osmosis function." However, specific sample sizes for the test set and data provenance (e.g., country of origin, retrospective or prospective) are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes a medical device for water purification, not an AI or diagnostic system that requires expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for this device's performance would be the objective measurements of water quality parameters against established AAMI and Federal U.S. standards.

4. Adjudication method for the test set

This information is not applicable as the document describes objective performance testing of a physical device against established standards, not a diagnostic task requiring expert adjudication.

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 as the device is a water purification system, not a diagnostic imaging or AI-assisted system that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a water purification system and does not involve an algorithm with standalone performance in the context of AI.

7. The type of ground truth used

The ground truth for this device's performance is based on established objective physical and chemical measurements of water quality parameters as defined by current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.

8. The sample size for the training set

This information is not applicable as the device is a physical water purification system and does not involve a "training set" in the context of machine learning or AI models. The design and performance are based on engineering principles and established water purification technologies.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

Summary

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1303 STANLEY AVENUE DAYTON, OH 45404 USA 937-461-8833, 800-535-5585 937-461-1988 www.AMERIWATER.com

510(K) SUMMARY
510(K) Number:	K131622 June 18, 2013
Submitter:	AmeriWater
Contact:	Brian R. Bowman, Quality & Regulatory Administrator1303 Stanley Avenue, Dayton, OH 45404Phone: (937)461-8833 Fax: (937)461-1988brianbowman@ameriwater.com
Proprietary Name:	AmeriWater MROZ Reverse Osmosis System
Common Name:	Reverse Osmosis System SEP 2 0 2013
Classification Name:	Water purification system for hemodialysis
Classification:	Class II Medical Device under §876.5665Panel: GastroenterologyProduct Code: FIP
Predicate Devices:	AmeriWater Aseptech Portable RO+ cleared for market under K924695,AmeriWater MRO systems included in K991519,AmeriWater MRO Portable RO System cleared for market under K111740

The AmeriWater MROZ Reverse Osmosis System is a water treatment system intended Device Description: for use in hemodialysis applications. The system is designed to remove organic and inorganic substances and contaminants from potable water. The purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate. The AmeriWater MROZ Reverse Osmosis System is intended to be used in water rooms located in hospitals, clinics, and dialysis centers. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: ABS, Acrylic, Nylon, PVC, Polyethylene, Polypropylene, Stainless Steel, Tygon, and Thin Film Composite Membrane (polyimide). The MROZ Reverse Osmosis System purifies water by applying pressure (greater than the osmotic pressure difference) to the feed water to reverse the water flow through a semi-permeable membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the feed water is supplied to the membrane where it is split into permeate which has passed through the membrane and the concentrate which passes over the membrane and carries the contaminants to drain. The AmeriWater MROZ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.

Indications for Use: The AmeriWater MROZ Reverse Osmosis System is a water treatment device intended for use in hemodialysis applications. It is intended to be used as a component in the AmeriWater Water Purification System (K991519), and is intended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater MROZ is intended for use in water rooms in a hospital, clinic, or dialysis center. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceeded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards. Model MRO3Z is a 3 membrane system designed to supply 6,600 gallons per day (gpd) of product water. Model MRO4Z is a 4 membrane system designed to supply 8,800 gpd of product water. Model MRO5Z is a 5 membrane system designed to supply 11,000 gpd of product water. Model MRO62 is a 6 membrane systems designed to supply 13,200 god of product water. Model MRO7Z is a 7

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membrane system designed to supply 15,400 gpd of product water. Model MRO8Z is an 8 membrane system memorate system designed to supply 15, 100 gpd of product hatel. Thousin in a 200V, 230V, or 460V varian and includes a divert- to-drain feature to prevent patient exposure to unsafe product water. Each model includes temperature compensated online monitors that display conductivity and percent rejection. The conductivity terriportales an audible and visual alarm when the product water conductivity exceeds a preset alarm limit.

Statement of Substantial Equivalence: The AmeriWater MROZ is substantially equivalent to the Aseptech Portable RO+ cleared for market under K924695, the AmeriWater MRO systems included in K991519, and the AmeriWater MRO Portable RO System cleared for market under K111740. The MROZ is the same in design, operation, technology, and intended purpose as the predicate device with the exception that the predicate devices are completely enclosed in a cabinet and a portion of the MROZ is an open frame design. The following table compares and contrasts the predicate devices and the new device. The MROZ is designed to meet the needs of dialysis facilities that require higher product water output than those provided by the predicate devices.

	AmeriWater MROZ	K991519	K924695	K111740
Intended Use	The MROZ is intended foruse in hemodialysisapplications. It is designedto pre-treat and purifypotable water for use inmaking dialysate forhemodlalysis and to meetcurrent AAMI and Federal(U.S.) standards. TheMROZ is intended for usein a hospital, clinic, ordialysis center.	The AmeriWaterPurification System forHemodialysis is intended tobe used in hemodialysis toremove organic andinorganic substances andmicrobial contaminantsfrom water. Purified (ortreated) water will then beused to prepare and dilutedialysate concentrate toform dialysate and/or rinsedialyzers for multiple use.	The Aseptech PortableRO+ is a standalone watertreatment system for use inhemodialysis applications.lt is designed to pre-treatand purify potable water foruse in making dialysate forhemodialysis. TheAseptech Protable RO+ isintended to be used inhospitals, clinics, homecare, and dialysis centers.	The AmeriWater MROPortable Reverse OsmosisSystems are watertreatment systems intendedfor use in hemodialysisapplications. They aredesigned to pre-treat andpurify potable water for usein making dialysate forhemodialysis and to meetcurrent AAMI and Federal(U.S.) standards. TheMROS model is intendedfor use in a hospital, clinic,dialysis center, or for homecare for single patient use.The AmeriWater PortableMRO1 model is fortreatment of up to twopatients in a hospital, clinic,or dialysis centers.
Technology	Reverse Osmosis	Reverse Osmosis	Reverse Osmosis	Reverse Osmosis
Enclosure	Open frame with partialcabinet, stationary (nocasters)	Cabinet with casters	Cabinet with casters	Cabinet with casters
WaterContactingMaterials	ABS, Acrylic, Nylon, PVC,Polyester, Polyethylene,Polypropylene, StainlessSteel, Tygon, and Thin FilmComposite Membrane(polyimide)	ABS, Acrylic, Nylon, PVC,Polyester, Polyethylene,Polypropylene, StainlessSteel, Tygon, and Thin FilmComposite Membrane(polyimide), Carbon	ABS, Acrylic, Nylon, PVC,Polyester, Polypropylene,Stainless Steel, Tygon, andThin Film CompositeMembrane (polyimide).Carbon, Resin - petreated	ABS, Acrylic, Nylon, PVC,Polyester, Polyethylene,Polypropylene, StainlessSteel, Tygon, and Thin FilmComposite Membrane(polyimide), Carbon
PowerRequirements	208V/230V/460V,60Hz, 20A	115V/ 208V/230V/460V,60Hz, 20A	115V, 60Hz, 20A	115V, 60Hz, 20A
Minimum FeedPressure	20 psi	20 psi	20 psi	20 psi
Maximum FeedPressure	50 psi	90 psi	90 psi	50 psi
MaximumOutput ProductWater	17,600 gpd	6,000 gpd	2,400 gpd	1,296 gpd

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Summary of Performance Testing: Non-clinical testing was conducted to verify and validate the performance of the reverse osmosis function. Results of performance testing indicate that the device produces water that meets current AAMI and Federal (U.S.) standards. Test results from biocompatibility testing, performance testing, and electrical safety testing indicate that the device is safe and effective for its intended purpose.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 20, 2013

AmeriWater, Inc. % Brian R. Bowman Quality and Regulatory Administrator 1303 Stanley Avenue Dayton, OH 45404

Re: K131622

Trade/Device Name: AmeriWater MROZ Reverse Osmosis System Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: August 19, 2013 Received: August 22, 2013

Dear Brian R. Bowman,

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.

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Page 2 - Brian R. Bowman

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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AmeriWater

4888888888888888888

1303 STANLEY AVENUE DAYTON, OH 45404 USA 937-461-8833, 800-535-5585 1 EL FAX 937-461-1988 www.AMERIWATER.com

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INDICATIONS FOR USE

510(K) Number (if known): K131622

Device Name: AmeriWater MROZ Reverse Osmosis System

Indications For Use: The Amerilyater MROZ Reverse Osmosis System is a water treatment device intended for use in hemodialysis applications. It is intended to be used as a component in the AmeriWater Water Purification System (K991519), and is intended to purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater MROZ is intended for use in water rooms in a hospital, clinic, or dialysis center. The device is intended to be a component in a complete water purfication system, and is not a complete water treatment system. It must be preceeded by pro-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAM and Federal (U.S.) standards.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2013.09.20 13:57:29 -04'00'

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.