Matrix Pre-Treatment Controller is designed to safely and effectively provide monitoring and control of the pre-treatment components for water purification for dialysis applications.

These pre-treatment components include media-tanks with controllable valves (for example, but not limited to: multimedia depth filters, filox media filters, water softeners, dealkalizers, organic scavengers, and carbon media filters), city booster pump, ultra-violet light dump valve, blend-valve, and the main water shut-off valve.

It monitors water pressures, water temperature, Delta-P pressure between two points), water flowrate, water pH, empty bed contact time for carbon media filters, and the status of the media-tanks' valve cycles. This operational data is displayed on a HMI-touch screen along with trends, alarms, and events.

It controls the regeneration and backwash cycles for media tanks, the city booster pump, the ultra-violet light dump valve for cooling purposes, the blend-valve to allow greater flow during backwash and regeneration, and the main water shut-off valve if a leak is detected.

Although it is designed to work with Better Water LLC equipment, it can be used with non-Better Water equipment provided certain components are added or replaced to ensure compatibility.

Device Description

The Matrix Pre-Treatment Controller is a control box which provides control and monitoring of the pretreatment system. This includes the city water entering into the water treatment system, as well as the various pre-treatment components providing filtration and treatment.

The unique feature of this Controller is the digital touch-screen (HMI – human machine interface, OIT - operator interface terminal). This displays various system pressures, water temperature, alarms, and messages related to the pre-treatment system, and allows for touch-screen control and setup of the pre-treatment components.

AI/ML Overview

This document describes the regulatory submission for the Matrix Pre-Treatment Controller, a device primarily for monitoring and controlling aspects of water purification systems used in hemodialysis. The information provided is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than an independent clinical study demonstrating a specific acceptance criterion for a medical device's performance (e.g., accuracy of a diagnostic tool).

Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria," particularly regarding metrics like sensitivity, specificity, or reader performance, cannot be fully addressed using the provided text. This document is for a Class II device (water purification system component) and focuses on engineering and safety standards, and functional equivalence, not on clinical performance metrics typically associated with AI/diagnostic devices.

However, I can extract and interpret the available information relative to the spirit of the request, focusing on how the device's functional performance was "proven" for regulatory purposes.

Understanding "Acceptance Criteria" in this Context

For this device, "acceptance criteria" are primarily related to its functional specifications, safety features, and compliance with relevant standards and regulations, rather than diagnostic accuracy or human-AI performance. The "study" proving it meets these is the design validation and software validation testing.

1. Table of Acceptance Criteria (Functional/Safety) and Reported Device Performance

Acceptance Criterion (Implicit/Explicit)	Reported Device Performance/Validation
Functional Monitoring and Control
Monitoring of water pressures, temperature, Delta-P, flow-rate, pH, empty bed contact time (carbon media filters), media-tanks' valve cycles. Display of operational data, trends, alarms, events on HMI-touch screen.	Reported as designed and tested. The device "monitors water pressures, water temperature, Delta-P pressures (change in pressure between two points), water flow-rate, water pH, empty bed contact time for carbon media filters, and the status of the media-tanks' valve cycles. This operational data is displayed on a HMI-touch screen along with trends, alarms, and events." (Pages 2, 4)
Control of regeneration and backwash cycles for media tanks, city booster pump, UV light dump valve, blend-valve, main water shut-off valve (leak detection).	Reported as designed and tested. The device "controls the regeneration and backwash cycles for media tanks, the city booster pump, the ultra-violet light dump valve for cooling purposes, the blend-valve to allow greater flow during backwash and regeneration, and the main water shut-off valve if a leak is detected." (Pages 2, 4)
Interoperability/Compatibility (with Better Water LLC and non-Better Water equipment with modifications).	Stated capability. "Although it is designed to work with Better Water LLC equipment, it can be used with non-Better Water equipment provided certain components are added or replaced to ensure compatibility." (Pages 2, 4) The testing involved connection to "various pre-treatment components and a Reverse Osmosis (RO) machine" (Page 6).
Safety Features
Electrical safety and protection (breakers, fuses, grounds).	System includes these features. Device comparison table lists "Breakers, fuses, and grounds for electrical safety and protection" for the proposed device and predicates. (Page 5)
Alarms and shut-off mechanisms (e.g., main water shutoff, high temperature, low pressure).	System includes these features. Device comparison table lists "Main water shutoff alarm," "High temperature alarm," "Low pressure alarm." (Page 5) The device also "Supplies the power to the pre-treatment interlock and will shut-off the RO if the interlock is broken." (Page 5)
Compliance with Standards & Regulations
Design controls per 21 CFR Part 820, Subpart C.	Stated adherence. "This product was designed, developed, tested, and validated according to Better Water LLC's quality assurance procedures per Title 21, CFR Part 820, Subpart C, 'Design Controls'." (Page 5)
Conformity to specific standards (IEC 60601-1, IEC 26722, IEC 62304).	Declaration of Conformity provided. "The Declaration of Conformity presented in a separate section of this submission is based on the following standards: IEC 60601-1: 2005, IEC 26722: 2014 (AAMI), IEC 62304: 2011." (Page 5)

Study Proving Device Meets Acceptance Criteria:

The "study" in this context refers to the Design Validation and Software Validation testing performed by the manufacturer.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a numerical "sample size" in the conventional sense of a clinical trial (e.g., number of patients/cases). Instead, it states that "Detailed Software Validation and Design Validation were performed with the Pre-Treatment Controller installed onto a Pre-Treatment Rack." This implies testing of one or more actual devices under various operational scenarios.
Data Provenance: The testing was "in Better Water's water room." This indicates an in-house, controlled laboratory/simulation environment, likely in the USA (given the manufacturer's address in Smyrna, TN). The testing conditions were "under realistic conditions," "connected to various pre-treatment components and a Reverse Osmosis (RO) machine and operated as part of a complete water system, under power and connected to the incoming water supply." This would be best described as prospective, in-house functional and safety testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This type of device validation (functional, safety, and software) typically does not involve medical "experts" (like radiologists) establishing ground truth in the way a diagnostic AI would. The "ground truth" here is the correct functional operation of the system according to its design specifications and compliance with engineering and safety standards.
The validation would have been performed by qualified engineers, testers, and quality assurance personnel from Better Water LLC, ensuring the device met its design inputs. Their qualifications are implicit in the quality system (21 CFR Part 820) under which the device was developed. No specific number or qualifications are stated for "experts" establishing ground truth in the clinical sense.

4. Adjudication Method for the Test Set:

Not applicable in the context of this functional/software validation. Adjudication methods like 2+1 or 3+1 are used for human reader agreement on clinical findings (e.g., lesion detection), which is not the nature of this device's testing. The "adjudication" is essentially the manufacturer's internal quality system sign-off that the test results confirm the device meets design specifications and relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. This device is a water purification system controller and does not involve human interpretation of clinical cases or AI assistance for such interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in spirit. The testing described ("Detailed Software Validation and Design Validation were performed...") evaluates the device's functional performance as a standalone automated controller. While a human touch-screen interface (HMI) is part of the device, the core "algorithm" (control logic) operates automatically based on sensor inputs and pre-programmed parameters. The validation confirms that this automated operation meets specifications. The concept of "standalone" for this device relates to its automated control and monitoring functions without human intervention in the continuous operational process, beyond initial setup and response to alarms.

7. The Type of Ground Truth Used:

The "ground truth" was engineering specifications, functional requirements, and safety standards. The testing verified that the device's outputs (e.g., digital readings, control actions, alarms) matched the expected behavior based on calibrated inputs and defined specifications. For example, if a pressure sensor reading was 10 PSI, the "ground truth" was that the device should display 10 PSI and trigger an alarm if that value was outside a set threshold. Compliance with standards like IEC 60601-1 (medical electrical safety) and IEC 62304 (medical device software lifecycle) served as ground truth for safety and software quality.

8. The Sample Size for the Training Set:

This device is not an AI/machine learning device in the sense that it requires a "training set" of data to learn patterns. It's a deterministic control system. Therefore, the concept of a "training set" as understood for AI models is not applicable. The device operates based on pre-programmed logic, parameters, and algorithms derived from engineering principles and standards, not from statistical learning on a dataset.

9. How the Ground Truth for the Training Set Was Established:

As there is no "training set" for this deterministic control device, this question is not applicable. The "ground truth" for its development was established through engineering design, requirements definition, and adherence to relevant industry and regulatory standards.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

December 13, 2016

Better Water, LLC Michael Cline President 698 Swan Dr. Smyrna, TN 37167

Re: K161844

Trade/Device Name: Matrix Pre-Treatment Controller Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: September 9, 2016 Received: September 14, 2016

Dear Michael Cline:

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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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 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" (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 vours.

For Division

Douglas Silverstein -S 2016.12.13 08:16:28 -05'00'

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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Indications for Use

510(k) Number (if known) K161844

Device Name Matrix Pre-Treatment Controller

Indications for Use (Describe)

Matrix Pre-Treatment Controller is designed to safely and effectively provide monitoring and control of the pre-treatment components for water purification for dialysis applications.

Although it is designed to work with Better Water LLC equipment, it can be used with non-Better Water equipment provided certain components are added or replaced to ensure compatibility.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Better Water, Inc. 698 Swan Dr Smyrna, TN 37167

Image /page/3/Picture/1 description: The image is a logo for "Better Water, LLC" located in Smyrna, Tennessee. The logo is circular with a blue border and yellow interior. Inside the circle is a cartoon water droplet character with a smiling face and stick figure arms and legs, standing above a blue water puddle.

Phone (615) 355-6063 Fax (615) 355-6065

Premarket Notification 510(k) Summary K161844

1.0 Date Prepared

June 27, 2016

2.0 Reason for 510(k) Submission

This Abbreviated 510(k) Submission is presented to introduce a new device into commercial distribution, based on the Substantial Equivalence to Predicate Devices, Guidance Documents, and Product Conformity to Standards detailed in this submission.

2.1 Prior Submissions

No prior submissions for this device.

3.0 Submitting Company

Name	Better Water, LLC	Phone	(615) 355-6063
Address	698 Swan Dr	Fax	(615) 355-6065
City, St, Zip	Smyrna, TN 37167

3.1 Establishment Registration Number

Establishment Registration Number 1055109

3.2 Contact

Name Michael Cline Phone (615) 355-6063 Title President (615) 355-6065 Fax Email mikecline@betterwater.com

4.0 Device Classification

Product Code: FIP Device Class: Class II CFR Section: 21 CFR 876.5665 "Water purification system for hemodialysis" Panel: Gastroenterology/Urology

4.1 Device Name

Proprietary Name:	Matrix Pre-Treatment Controller
Common Name:	Matrix Pre-Treatment Controller

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5.0 Device Intended Use

Matrix Pre-Treatment Controller is designed to safely and effectively provide monitoring and control of the pre-treatment components for water purification for dialysis applications.

These pre-treatment components include media-tanks with controllable valves (for example, but not limited to: multi-media depth filters, filox media filters, water softeners, dealkalizers, organic scavengers, and carbon media filters), city booster pump, ultra-violet light dump valve, blend-valve, and the main water shut-off valve.

It monitors water pressures, water temperature, Delta-P pressures (change in pressure between two points), water flow-rate, water pH, empty bed contact time for carbon media filters, and the status of the media-tanks' valve cycles. This operational data is displayed on a HMI-touch screen along with trends, alarms, and events.

Although it is designed to work with Better Water LLC equipment, it can be used with non-Better Water equipment provided certain components are added or replaced to ensure compatibility.

5.1 Device Description, Summarized

Image /page/4/Picture/9 description: The image shows a close-up of a digital control panel, likely part of an industrial or building automation system. The screen displays a graphical user interface with various buttons and numerical readouts, suggesting it's used for monitoring and adjusting different parameters. The panel is encased in a black frame and mounted on a white surface, with indicator lights visible at the top.

6.0 Substantial Equivalence to Predicate Devices

Specifications	Matrix Pre-TreatmentController	Predicate Device#1	Predicate Device#2	Predicate Device#3
510(k) Number	-	K920186	K051620	K041163
Description	Pre-TreatmentController Box	Water PurificationSystem forHemodialysis	Matrix Digital ReverseOsmosis WaterTreatment System,Model EQRMD Series	Complete Water Systemfor Hemodialysis, MD400and MD600 Series
Manufacturer	Better Water LLC	Better Water Inc	Better Water Inc	Isopure Corporation
Decision Date	-	06/13/1995	11/18/2005	10/07/2004
Classification	Class II	Class II	Class II	Class II
Product Code	FIP	FIP	FIP	FIP
SpecificComparison	Digital touch-screen formonitor and controlfunctions of Pre-Treatment.	Pre-Treatment Rackwith control box, analogpressure andtemperature gauges.	Reverse Osmosisdevice with digitaltouch-screen and PLCfor monitor and controlfunctions. Comparingcontrol technology.	Reverse Osmosis deviceswith digital touch-screenand PLC for monitor andcontrol functions.Comparing controltechnology.

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OperationalFeatures	- HMI touch-screen formonitor/control- Turns pump on/off- Monitors pressuresdigitally- Monitor temperaturedigitally- Monitor flow digitally- Monitors pH digitally- Controls valvesopening and closing(blend valvebypass/main watershutoff)- Supplies the power tothe pre-treatmentinterlock and will shut-off the RO if theinterlock is broken- Logs and trendsoperational data	- Turns pump on/off- Monitors pressuresvia analog gauges- Monitor temperaturevia analog gauge- Monitor flow viaanalog flow-meter- Controls valvesopening and closing(blend valvebypass/main watershutoff)	- HMI touch-screen formonitor/control- Turns pump on/off- Monitors pressuresdigitally- Monitors temperaturedigitally- Monitors flow digitally- Controls valvesopening and closing(product/reject)- Supplies power to thepre-treatment interlockand will shut-off if theinterlock is broken- Logs and trendsoperational data	- HMI touch-screen formonitor/control- Turns pump on/off- Monitors pressuresdigitally- Monitors temperaturedigitally- Monitor flow digitally- Monitors pH digitally- Controls valves openingand closing(product/reject)- Logs and trendsoperational data
Safety Features	- Breakers, fuses, andgrounds for electricalsafety and protection- Main water shutoffalarm- High temperaturealarm- Low pressure alarm	- Breakers, fuses, andgrounds for electricalsafety and protection- Main water alarm &shutoff	- Breakers, fuses, andgrounds for electricalsafety and protection- High temperaturealarm & shut-off- Low pressure alarm &shut-off	- Breakers, fuses, andgrounds for electricalsafety and protection- High temperature alarm- Low pressure alarm

More detailed information is provided in the separate Substantial Equivalence to Predicate Devices section of this submission.

7.0 Product Design

This product was designed, developed, tested, and validated according to Better Water LLC's quality assurance procedures per Title 21, CFR Part 820, Subpart C, "Design Controls".

7.1 Product Conformity to Standards

The Declaration of Conformity presented in a separate section of this submission is based on the following standards:

Standard	Standard-Description
IEC 60601-1 : 2005	Medical electrical equipment – Part 1-1: Generalrequirements for safety – Collateral standard: Safetyrequirements for medical electrical systems.
IEC 26722 : 2014	(AAMI) – Water Treatment Equipment for HemodialysisApplications and Related Therapies
IEC 62304 : 2011	Medical Device Software – Software Lifecycle Processes

7.2 Guidance Documents

The following FDA guidance documents were referenced in preparation of this submission:

Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis - May 30, 1997

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – May 11, 2005

Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices - September 9, 1999

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8.0 Testing

Detailed Software Validation and Design Validation were performed with the Pre-Treatment Controller installed onto a Pre-Treatment Rack in Better Water's water room and tested under realistic conditions. It was connected to various pre-treatment components and a Reverse Osmosis (RO) machine and operated as part of a complete water system, under power and connected to the incoming water supply. More detailed information is provided in the Software Validation and Device Validation sections of this submission.

8.1 Conclusion

In conclusion, testing proved that the Matrix Pre-Treatment Controller operated as designed, conforming to the specifications detailed, the design controls employed during its development, and is substantially equivalent as stated.

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.