The AmeriWater Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeriWater Water Purification System (WPS) for hemodialysis applications. The AmeriWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operator's attention. The AmeriWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water. The Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The Alarm Panels are designed to meet current AAMI and Federal (U.S.) standards.

Device Description

The AmeriWater Alarm Panel is designed to let technicians and nurses know when something is not functioning properly with the water equipment. The Alarm Panels warn the user by illuminating an alarm light and sounding an audible alarm, indicating that some limit has been exceeded. This submission is for a design change to the existing AmeriWater Alarm Panel cleared for market use in the AmeriWater Water Purification System (WPS) for hemodialysis applications (K991519). The AmeriWater Alarm Panel design has been upgraded from a panel with switches operating relays, to a digital panel operated by a microprocessor. All of the Alarm Panels are provided with an LCD display that will indicate the status of the water system. The nurse's station remote will correspond to what is indicated on the alarm panel. The selection of possible water properties to be monitored has been chosen during the original purchase of this equipment. The properties that this system can monitor include Low Resistivity, High Conductivity, R/O Alarm, Low Storage Tank, and Low Bicarb. There are also 5 additional dry contact inputs provided.

AI/ML Overview

The AmeriWater Alarm Panel (K121022) is a Class II medical device intended to notify operators of conditions within the AmeriWater Water Purification System (WPS) for hemodialysis applications. It is an upgrade from a relay-based system to a microprocessor-controlled digital panel with an LCD display.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's functions and how it meets AAMI and Federal (U.S.) standards. However, it does not provide specific quantitative acceptance criteria or detailed numerical performance metrics in a tabular format. Instead, it offers a general statement of successful performance based on functional verification.

The table below summarizes the listed functionalities of the K121022 AmeriWater Alarm Panel compared to the predicate device (K991519) and the reported performance.

Feature / Acceptance Criteria (Implied)	K991519 Alarm Panel (Predicate) Performance (Baseline)	K121022 Alarm Panel Performance (Reported)
Core Function: Central monitoring of water treatment system	Central monitor of the water treatment system.	Central monitor of the water treatment system. Reported as successful.
Operation Method: Switches vs. Digital	Switches operating relays	Digital operation controlled by microprocessor. Test verified all alarm functions operate as intended and meet design specifications.
Electrical Circuit: Operating voltage	Operated on 115V electrical circuit	Operated on 115V electrical circuit. Test verified all alarm functions operate as intended and meet design specifications.
Remote Alarm Power: Voltage transformation	Transforms down to a 24V for the remote alarm	Transforms down to a 24V for the remote alarm. 24 VAC lights were used to verify operation of 24 VAC outputs, successful.
Conductivity/Resistivity Monitoring	Off the shelf conductivity and resistivity monitors installed in panel	Conductivity and resistivity monitoring integrated into control. Test data indicates monitors are accurate when compared to a known standard over expected operational ranges.
Alarm Types: Audible and visible alarms	Audible and visible alarms	Audible and visible alarms. Test verified all alarm functions operate as intended and meet design specifications.
Remote Interface: Audio and visual alarms on remote	Interfaces with the remote alarm; also with audio and visual alarms	Interfaces with the remote alarm; also with audio and visual alarms. Test verified all alarm functions operate as intended and meet design specifications.
Alarm Silence Location: Only main panel	Silence button only located on the main panel in the water room	Silence button only located on the main panel in the water room. Test verified all alarm functions operate as intended and meet design specifications.
Alarm Silence Reset Time: 180 seconds	Silence button has a 180 second reset.	Silence button has a 180 second reset. Test verified all alarm functions operate as intended and meet design specifications.
Visible Alarm Status during Silence: Active	Visible alarms remain active when audible alarm is silenced.	Visible alarms remain active when audible alarm is silenced. Test verified all alarm functions operate as intended and meet design specifications.
Water Quality Display:	Good Water Light	Water quality digital display. Test verified all alarm functions operate as intended and meet design specifications.
Specific Alarms (RO, Storage Tank, Conductivity, Resistivity, Bicarb Low)	Alarm light w/ audible alarm for each.	Alarm light w/ audible alarm and digital display for each (except Remote Bicarb Low which is only light w/ audible). Test verified all alarm functions operate as intended and meet design specifications.
Additional Contact Inputs:	No additional contact inputs	5 additional dry contact inputs. Test verified all alarm functions operate as intended and meet design specifications.
Compliance with Standards:	Not explicitly stated in this section for K991519, but implied as predicate.	Designed to meet current AAMI and Federal (U.S.) standards. Performance testing was successful and all acceptance criteria were met, including AAMI requirements.
Software Validation:	Not applicable (relay-based)	Conducted in accordance with requirements for a software device with a moderate level of concern. Successful.

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

Test Set Sample Size: "Each of the test units was bench tested." "100% of distributed product will be subjected to performance testing prior to shipment." While the exact number of units bench tested for this submission is not explicitly stated as a single number, it indicates that
- performance testing was conducted on "initial production units representing the approved final design."
- all possible features were tested on these units.
- 100% of distributed product will undergo similar performance testing.
Data Provenance: The testing was conducted in-house by AmeriWater as part of their design verification and validation process for a design change to an existing device. It is therefore prospective for the new design. The document does not specify a country of origin for the data other than the company being based in the USA.

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

The document does not mention the use of external experts or a formal "ground truth" establishment by experts for the performance testing.
The testing was focused on verifying the device's functional operation against its design specifications and AAMI requirements. This suggests that internally defined technical specifications and AAMI standards served as the "ground truth" or reference for performance.

4. Adjudication method for the test set:

No adjudication method (e.g., 2+1, 3+1) is mentioned as the testing performed was functional verification against design specifications and AAMI standards, not subjective assessment requiring multiple adjudicators.

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:

No MRMC comparative effectiveness study was done for this device. This device is an alarm panel for a water purification system, not an imaging or diagnostic AI-assisted device that would involve human "readers" or AI assistance in interpretation.

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

This device is not an AI algorithm. It is a microprocessor-controlled alarm panel. The "standalone" performance in this context refers to the device's ability to accurately detect and signal conditions according to its programming and sensor inputs, which was verified through bench testing. The software validation was conducted for a moderate level of concern, indicating the algorithm (control logic) was tested without human intervention in its core alarm triggering functionalities.

7. The type of ground truth used:

The ground truth used was based on:
- Design Specifications: The intended operational parameters and alarm thresholds defined during the design phase of the AmeriWater Alarm Panel.
- AAMI Standards: Compliance with current AAMI (Association for the Advancement of Medical Instrumentation) standards for water purification systems for hemodialysis.
- Known Standards for Sensor Accuracy: For conductivity and resistivity monitors, comparison to "a known standard over the operation ranges expected" served as the ground truth for their accuracy.

8. The sample size for the training set:

This device is a hardware device with embedded software (microprocessor-controlled). It does not employ machine learning or AI algorithms that require a "training set" in the conventional sense of data-driven model learning. The software was developed and validated, not "trained."

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

As there is no conventionally defined "training set" for this device, the concept of establishing ground truth for it does not apply in the context of machine learning. The software's logic and parameters are based on engineering design, AAMI standards, and the requirements for monitoring water quality in hemodialysis systems.

Summary

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AmeriWater

ងច្បាប់ចងចន់ចនេះបារបរ រ

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

510(K) SUMMARY

510(K) Number:	K121022
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 Alarm Panel
Common Name:	Alarm Panel
Classification Name:	Water purification system for hemodialysis
Classification:	Class II Medical Device under §876.5665Panel: GastroenterologyProduct Code: FIP

SEP 17 2012K991519, AmeriWater Water Purification System Equivalent Device:

Device Description: The AmeriWater Alarm Panel is designed to let technicians and nurses know when something is not functioning properly with the water equipment. The Alarm Panels warn the user by illuminating an alarm light and sounding an audible alarm, indicating that some limit has been exceeded. This submission is for a design change to the existing AmeriWater Alarm Panel cleared for market use in the AmeriWater Water Purification System (WPS) for hemodialysis applications (K991519). The AmeriWater Alarm Panel design has been upgraded from a panel with switches operating relays, to a digital panel operated by a microprocessor. All of the Alarm Panels are provided with an LCD display that will indicate the status of the water system. The nurse's station remote will correspond to what is indicated on the alarm panel. The selection of possible water properties to be monitored has been chosen during the original purchase of this equipment. The properties that this system can monitor include Low Resistivity, High Conductivity, R/O Alarm, Low Storage Tank, and Low Bicarb. There are also 5 additional dry contact inputs provided

The Low Resistivity alarm warns the user that the measured water the DI tanks is outside of the AAMI standards (1 megohm). The Alarm Panel has two 24VAC outputs that can be used to power solenoid valves to divert the water flow to the drain when the resistivity is below the set-point.

The High Conductivity alarm warns the user that the measured water conductivity is higher than the limit that has been pre-determined by the Facility Director. The Alarm Panel has two 24VAC outputs that can be used to power solenoid valves to divert the water flow to the drain when the conductivity is above the set-point.

The R/O Alarm warns the user that the measured conductivity of the RO is higher than what has been determined to be appropriate by the Facility Director, and has been programmed into the RO controller.

The Low Storage Tank alarm warns the user that the low water float switch has been activated in the storage tank, and that the RO is not producing water flow sufficient to stay above this low water level.

The Low Bicarb Level alarm indicates when the Bicarb Distribution tank is low and may need to be re-filled if use is to continue.

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The 5 additional dry contact inputs are labeled IN4 – 8. When one of these receives a closure from the external source, the LCD will indicate an alarm and display the appropriate AUX #. IN4 = AUX2, IN6 = AUX3, IN7 = AUX4 & IN8 = AUX5.

F 3

An Alarm Silence function is also provided. The Nurse's Station Remote has a set of lights and audible alarm that will indicate with the main panel in the water room. There is no "Alarm Silence" on the Remote Panel. To silence alarm, it will require the user's attention, in the water room. Using the "ALARM SILENCE" button on the main monitoring panel will "silence" the alarm for 3 minutes only. The alarm will re-indicate 3 minutes after each time it is silenced until the condition causing the alarm has been rectified. In the event that there are multiple alarms active at once, the display on the alarm panel will scroll through the alarms.

Indications for Use: The AmeriWater Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeriWater Water Purfication System (WPS) for hemodialysis applications. The AmeriWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operator's attention. The AmeriWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water. The Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The Alarm Panels are designed to meet current AAMI and Federal (U.S.) standards.

Model 00850250 - Base Model & Remote. This model includes R/O Alarm, Low Storage Tank, and Low Bicarb. There are also 5 additional dry contact inputs. When one of these receives a closure from the external source, such as a low tank level in a chemical feed system, the LCD will indicate an alarm and display the input number in the alarm display. The alarm panel also includes an Alarm Silence function.

The Remote is installed at the Nurse's Station on the treatment floor. It has a set of lights and audible alarm that corresponds to what is indicated on the main panel in the water room however there is no "Alarm Silence" available on the Remote Panel. To silence the alarm, it will require the user's attention in the water room.

Model 00850251 – Base Model & Remote with Conductivity. This model includes all of the features of the base model with the addition of a conductivity sensor and high conductivity alarm. The Alarm Panel can be used to power solenoid valves to divert the water flow to the drain when the conductivity is above the set-point.

Model 00850252 – Base Model & Remote with Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a resistivity sensor and low resistivity alarm with dump valve. The Alarm Panel can be used to power solenoid valves to divert the water flow to the drain when the resistivity is below the set-point. A solenoid valve (dump valve) is included with this model to divert water to drain during a low resistivity alarm condition.

Model 00850253 – Base Model & Remote with Conductivity, Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a conductivity sensor, high conductivity alarm, resistivity sensor, and low resistivity alarm with dump valve.

Statement of Substantial Equivalence: The AmeriWater Alarm Panel in this submission is substantially equivalent to the AmeriWater Alarm Panel currently cleared for market with the AmeriWater Water Purification System under K991519. The original Alarm Panel has been modified to go from the existing panel with switches operating relays, to a digital panel controlled by a microprocessor. The following table compares and contrasts the predicate device 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.

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121022 3 OF 3

K991519 Alarm Panel	K121022 Alarm Panel
Central monitor of the water treatment system.	Central monitor of the water treatment system.
Switches operating relays	Digital operation controlled by microprocessor
Operated on 115V electrical circuit	Operated on 115V electrical circuit
Transforms down to a 24V for the remote alarm	Transforms down to a 24V for the remote alarm
Off the shelf conductivity and resistivity monitorsinstalled in panel	Conductivity and resistivity monitoring integratedinto control
Audible and visible alarms	Audible and visible alarms
Interfaces with the remote alarm; also with audioand visual alarms	Interfaces with the remote alarm; also with audioand visual alarms
Silence button only located on the main panel in thewater room	Silence button only located on the main panel in thewater room
Silence button has a 180 second reset.	Silence button has a 180 second reset.
Visible alarms remain active when audible alarm issilenced.	Visible alarms remain active when audible alarm issilenced.
Good Water Light	Water quality digital display
RO Alarm light w/ audible alarm	Alarm light w/ audible alarm and digital display
Storage Tank Low light w/ audible alarm	Alarm light w/ audible alarm and digital display
Conductivity Alarm light w/ audible alarm	Alarm light w/ audible alarm and digital display
Resistivity Alarm light w/ audible alarm	Alarm light w/ audible alarm and digital display
Bicarb Low light w/ audible alarm	Alarm light w/ audible alarm and digital display
No additional contact inputs	5 additional dry contact inputs
Remote Good Water Light	Remote Good quality light
Remote RO Alarm light w/ audible alarm	Remote Alarm light w/ audible alarm*
Remote Storage Tank Low light w/ audible alarm	Remote Alarm light w/ audible alarm*
Remote Conductivity Alarm light w/ audible alarm	Remote Alarm light w/ audible alarm*
Remote Resistivity Alarm light w/ audible alarm	Remote Alarm light w/ audible alarm*
Remote Bicarb Low light w/ audible alarm	Remote Bicarb Low light w/ audible alarm

Summary of Performance Testing: The objective of the performance testing was to verify and validate the operation of the new design AmeriWater Alarm Panel for use with the AmeriWater Water Purification System (WPS). The test was conducted on alarm panels with all possible features. Performance testing was conducted on initial production units representing the approved final design of the AmeriWater Alarm Panel. Each of the test units was bench tested to verify that all alarm functions operate as intended. Each unit was tested. simulating normal operation to ensure that all functions operate as intended and meet design specifications and AAM requirements. 24 VAC lights were used to verify operation of 24 VAC outputs. Bench testing was iustified based on the fact that the device does not have any unique interactions with other components in the system. There are no factors that will affect operation of the installed device that cannot be tested in bench testing. Furthermore, 100% of distributed product will be subjected to performance testing prior to shipment. Performance testing was successful and all acceptance criteria were met. Software validation has been conducted in accordance with requirements for a software device with a moderate level of concern. Test data indicates that the monitors are accurate when compared to a known standard over the operation ranges expected. Clinical tests were not completed for this device, but nonclinical tests provided sufficient evidence to support the safety and effectiveness of the device. The results of testing demonstrate that the device is as safe, as effective, and performs as safely and effectively as the predicate device.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 17 2012

Mr. Brian Bowman Quality & Regulatory Administrator. AmeriWater . 1303 Stanley Avenue DAYTON OH 45404

Re: K121022

Trade/Device Name: AmeriWater Alarm Panel Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: September 12, 2012 Received: September 14, 2012

Dear Mr. Bowman:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your Section 310(x) promation is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstant for use stated in the encrosule) to regary manated to of the Medical Device Amendments, or to commerce prior to May 20, 1970, the chacinement call of the Federal Food, Drug, devices that have been reclassified in acordantee what approval appliciation (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval opensions of t and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, inerelore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the Act mendo road prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDNT docs not ovarante must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), car If your device is classified (see above) moved in the major regulations affecting your device can be
it may be subject to additional controls. Existing major regulation affe it may be subject to additional controls. Extraing major Touria in the Code of I cacal resguablems)
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 Please be advised that FDA s issuates of a bases of a states with other requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA nas made a decisimilation and regulations administered by other Federal agencies. You must or any Federal statules and regulations administed to: registration and listing in the compring of medical comply with all the Act s requirements, morading, out:not career ing (reporting of medical

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Page 2 -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-itlated adverse ovents) (21 CENC 00), good if applicable, the electronic (200 1060 for ur ur une quality systems (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 IT you desire specific davite toryour as not es interse et contrices/ucm115809.html for go to mup://www.loa.gov.ri/ http://www.load.org/cal Health's (CDRH's) Office of Compliance of Compliance of Comple the Center for Devices and reading by reference to premarket notification" (21CFR Patt note the regulation ontined, "Misoranaling of activerse 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 Tou may obtain other general mormations 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

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

INDICATIONS FOR USE

510(k) Number (if known): K121022

Device Name: AmeriWater Alarm Panel

Indications For Use: The AmeriWater Alarm Panel is intended for use in hospitals and dialysis clinics as an optional component in the AmeriWater Water Purification System (WPS) for hemodialysis applications. The AmeriWater Alarm Panel is intended to notify the operator of conditions that exist with the Water Purification System requiring the operator's attention. The AmeriWater WPS is intended to remove organic and inorganic substances and microbial contaminants from water. The Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare dilute solutions for reprocessing procedures in multiple-use dialyzers. The Alarm Panels are designed to meet current AAMI and Federal (U.S.) standards.

Model 00850250 -Base Model & Remote Panel. This model includes R/O Alarm, Low Storage Tank, and Low Bicarb. There are also 5 additional dry contact inputs. When one of these receives a closure from the external source, such as a low tank level in a chemical feed system, the LCD will indicate an alarm and display the input number in the alarm display. The alarm panel also includes an Alarm Silence function.

Model 00850251 - Base Model & Remote with Conductivity. This model includes all of the features of the base model with the addition of a conductivity sensor and high conductivity alarm. The Alarm Panel to power solenoid valves to divert the water flow to the drain when the conductivity is above the set-point.

Model 00850252 - Base Model & Remote with Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a resistivity sensor and low resistivity alarm with dump valve. The Alarm Panel can be used to power solenoid valves to divert the drain when the resistivity is below the set-point. A solenoid valve (dump valve) is included with this model to divert water to drain during a low resistivity alarm condition.

Model 00850253 - Base Model & Remote with Conductivity, Resistivity and Dump Valve. This model includes all of the features of the base model with the addition of a conductivity sensor, high conductivity alarm, resistivity sensor, and low resistivity alarm with dump valve.

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 Eyalyation (ODF)

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.