The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAM and Federal (U.S.) standards. 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 preceded 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. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.

Device Description

The AmeriWater Centurion 1500+ 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 Centurion 1500+ Reverse Osmosis System is intended to be used in hospitals, clinics, dialysis centers, and for home care use. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: Nylon, Polypropylene, Stainless Steel, EPDM, and Thin Film Composite Membrane (Polyamide). The Centurion 1500+ 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. The feed water enters the Centurion through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RO 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 Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications. The AmeriWater Centurion 1500+ Reverse Osmosis System also includes a built in heat sanitization feature. Heat sanitization can be activated manually using the HEAT SANITIZATION function from the controller's main menu. The frequency of thermal sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for thermal sanitization.

AI/ML Overview

The provided text describes a medical device, the "AmeriWater Centurion 1500+ Reverse Osmosis System," and its performance relative to existing standards and predicate devices. However, it does not describe an AI/ML powered medical device, nor does it contain a study with acceptance criteria related to typical AI/ML performance metrics (like sensitivity, specificity, AUC).

The document is a 510(k) summary for a Class II medical device, which is a water purification system for hemodialysis. The "acceptance criteria" and "study" mentioned in the document relate to the device's ability to purify water to specific physical, chemical, and microbiological standards, and its safety.

Therefore, many of your requested points are not applicable to the provided document. I will extract the information that is present and indicate where the requested information is not available due to the nature of the document.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "The AmeriWater Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications." and "Results of performance testing indicate that the device produces water that meets current AAM and Federal (U.S.) standards. Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria. Clinical studies show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis."

The table provided in the document compares the new device with predicate devices across several specifications, which could be interpreted as performance metrics. The implicit acceptance criteria are that the device meets AAMI and Federal (U.S.) standards for water used in hemodialysis applications. The table below presents the comparative performance aspects mentioned.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (AmeriWater Centurion 1500+)
Water Quality	Meets current AAMI and Federal (U.S.) standards for hemodialysis.	Produces water that meets current AAMI and Federal (U.S.) standards.
Microbiological Impact	Effective reduction of bacteria by heat sanitization.	Heat sanitization function is effective in the reduction of bacteria.
Total Dissolved Salts	Superior to predicate devices (e.g., >96% or >94% rejection).	> 98% rejection rate.
Permeate Flow Rates	Appropriate for hemodialysis applications.	1.5 l/min at 10°C.
Drain Requirements	Manageable for intended use.	Max 3.0 l/min.
Biocompatibility	Safe for body contact indirectly through purified water.	Test results indicate device is safe and effective.
Software Validation	Software functions as intended.	Test results indicate device is safe and effective.
Electrical Safety	Complies with IEC 60601-1.	Test results indicate device is safe and effective (in accordance with IEC 60601-1).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for specific tests (e.g., how many water samples, how many bacteria cultures). The text refers to "Non-clinical testing" and "Microbiological testing" and "Clinical studies" generally.
Data Provenance: Not specified.
Retrospective/Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable: This document concerns a physical device that purifies water, not an AI/ML algorithm that interprets medical images or data requiring expert human-established ground truth. Water quality standards (AAMI, Federal U.S. standards) are objective chemical and microbiological measurements, not expert consensus opinions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used for reconciling disagreements among human experts in cases where subjective interpretation is involved, common in image review. This is not relevant for objective water quality testing.

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

Not Applicable: This is not an AI/ML device, so no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not Applicable: This is not an AI/ML algorithm. The device operates as a standalone water purification system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth Type: Physical and chemical measurements against established AAMI and Federal (U.S.) standards for water used in hemodialysis. This includes specific limits for various contaminants (e.g., total dissolved salts, bacteria count) and functional parameters (e.g., permeate flow rates).

8. The sample size for the training set

Not Applicable: This is not an AI/ML device that requires a "training set." The device is engineered and then tested against established physical standards.

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

Not Applicable: No training set or associated ground truth as this is not an AI/ML device.

Summary

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000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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

February 27, 2014

510(K) SUMMARY

510(K) Number:	K133783
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 Centurion 1500+ Reverse Osmosis System
Common Name:	Reverse Osmosis System
Classification Name:	Water purification system for hemodialysis
Classification:	Class II Medical Device under §876.5665Panel: GastroenterologyProduct Code: FIP
Equivalent Devices:	K131904, AmeriWater MediQA Reverse Osmosis System

K111740, AmeriWater MRO Portable Reverse Osmosis System MROS Device Description: The AmeriWater Centurion 1500+ 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 Centurion 1500+ Reverse Osmosis System is intended to be used in hospitals, clinics, dialysis centers, and for home care use. There is no direct contact between the patient and any part of the device invasive. Materials that contact that contact the product water include: Nylon, Polypropylene, Stainless Steel, EPDM, and Thin Film Composite Membrane (Polyamide). The Centurion 1500+ 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. The feed water enters the Centurion through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RO 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 Centurion 1500+ Reverse Osmosis System produces water that meets current AAMI and Federal (U.S.) standards for water used in hemodialysis applications.

The AmeriWater Centurion 1500+ Reverse Osmosis System also includes a built in heat sanitization feature. Heat sanitization can be activated manually using the HEAT SANITIZATION function from the controller's main menu. The frequency of thermal sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for thermal sanitization.

Indications for Use: The AmeriWater Centurion 1500+ Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. 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 preceded by pre-treatment devices, and may need to be followed by post-

K133783

Page 1 of 3

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treatment devices as well to meet current AAM and Federal (U.S.) standards. The Centurion 1500+ Reverse Osmosis System is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The device includes an integrated heat sanitization process.

Statement of Substantial Equivalence: The AmeriWater Centurion is substantially equivalent to the AmeriWater MRO Portable Reverse Osmosis System (MROS) cleared for market under K111740, and the AmeriWater MediQA Reverse Osmosis System cleared for market under K131904. The following table compares and contrasts the predicate devices and the new device. This table along with the documentation included in this submission demonstrates that there are no new issues of safety or effectiveness associated with this design change, and that the new device is substantially equivalent to the predicate device.

	Predicate DeviceAmeriWater MEDIQA (K131904)	Predicate DeviceAmeriWater MROS(K111740)	AmeriWaterCenturion 1500+
Indications for use	The AmeriWater MediQA ReverseOsmosis System is onecomponent of a water treatmentsystem designed to pre-treat andpurify potable water using reverseosmosis for making dialysate forhemodialysis applications. Thedevice is intended to be acomponent in a complete waterpurification system, and is not acomplete water treatment system.It must be preceded by pre-treatment devices, and may needto be followed by post-treatmentdevices as well to meet currentAAMI and Federal (U.S.)standards. The AmeriWaterMediQA is intended for use inwater rooms in a hospital, clinic, ordialysis center. The deviceincludes an integrated heatsanitization process.	The AmeriWater MRO PortableReverse Osmosis Systems arewater treatment systems intendedfor use in hemodialysisapplications. They are designed topre-treat and purify potable waterfor use in making dialysate forhemodialysis and to meet currentAAMI and Federal (U.S.)standards. The AmeriWaterPortable MROS model is intendedfor use in a hospital, clinic, dialysiscenter, or for home care for singlepatient use. The AmeriWaterPortable MRO1 model is fortreatment of up to two patients in ahospital, clinic, or dialysis centers.	The AmeriWater Centurion 1500+Reverse Osmosis Systems arewater treatment systems intendedfor use in hemodialysisapplications. They are designed topre-treat and purify potable waterfor use in making dialysate forhemodialysis and to meet currentAAMI and Federal (U.S.)standards. The device is intendedto be a component in a completewater purification system, and isnot a complete water treatmentsystem. It must be preceded bypre-treatment devices, and mayneed to be followed by post-treatment devices as well to meetcurrent AAMI and Federal (U.S.)standards. The Centurion 1500+Reverse Osmosis System isintended for use in a hospital,clinic, dialysis center, or for homecare for single patient use. Thedevice includes an integrated heatsanitization process.
For Use In:	Hospitals, clinics, or dialysiscenters	Hospitals, clinics, dialysis centers,home care	Hospitals, clinics, dialysis centers,home care
Power Requirements	208/230V; 60 Hz; 3-phase	115V 60 Hz 20 Amp	115V 60 Hz 20 Amp
Purification process	Reverse Osmosis	Reverse Osmosis	Reverse Osmosis
RO Membrane	Polyamide, thin film composite,spiral wound	Polyamide, thin film composite,spiral wound	Polyamide, thin film composite,spiral wound
Rejection rates	Total dissolved salts > 96%	Total dissolved salts > 94%	Total dissolved salts > 98%
Permeate Flow Rates	19 to 48 l/min at 10°C	1.8 l/min at 10°C	1.5 l/min at 10°C
Drain Requirements	Max 96 l/min	Max 3.6 l/min	Max 3.0 l/min
RO Disinfection	Chemical or Heat	Chemical	Chemical or Heat
Water ContactingMaterials	Polyamide, Polypropylene, CPVC,Nitrile, EPDM, Stainless steel,Polyacetal, PTFE, Viton(FKM),Fiberglass, PA66 (Nylon), PETNoryl	ABS, Acrylic, Carbon, Nylon, PVC,Polyester, Polyethylene,Polypropylene, Stainless Steel,Tygon, Buna N	Nylon, Polypropylene, StainlessSteel, EPDM, and TFC Membrane(Polyamide)

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Summary of Performance Testing: Non-clinical testing was conducted to verify and validate the performance of the reverse osmosis function and the efficacy of the heat sanitization of bacteria. Results of performance testing indicate that the device produces water that meets current AAM and Federal (U.S.) standards. Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria. Clinical studies show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis. Test results from biocompatibility testing, software validation, and electrical safety testing (in accordance with IEC 60601-1) indicate that the device is safe and effective for its intended purpose.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

April 16, 2014

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

Re: K133783

Trade/Device Name: AmeriWater Centurion 1500 + Reverse Osmosis System Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: March 12, 2014 Received: March 20, 2014

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 (OS) 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/CDRHQffices/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" (21CFR 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,

Herbert P. Lerner -S

for 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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Ameriliorer

ច្បាទចេចចេចចេនចេននេះជាជាវេរ

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

Image /page/5/Picture/3 description: The image contains two overlapping circles with text inside. The larger circle on the left has the text "Suez environnement". The smaller circle on the right has the text "Degremont" and a logo above it. The image appears to be a logo or emblem for a company or organization.

Indications for Use

510(k) Number (if known): K133783

Device Name: AmeriWater Centurion 1500+ Reverse Osmosis System

Indications For Use:

X 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)

Herbert P. Leerne 2014.04.16 14:29:32

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.