Matrix Pre-Treatment Controller

K161844 · Better Water, LLC · FIP · Dec 13, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K161844
• Device Name: Matrix Pre-Treatment Controller
• Applicant: Better Water, LLC
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Dec 13, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Indications for 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: 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 Story

Matrix Pre-Treatment Controller is a control box for hemodialysis water purification pre-treatment systems. It monitors inputs including water pressure, temperature, flow rate, pH, empty bed contact time, and valve cycle status. It controls media-tank regeneration/backwash cycles, city booster pumps, UV dump valves, blend valves, and main shut-off valves. Operated via HMI touch-screen by clinical staff; displays real-time data, trends, and alarms. Provides interlock power to RO systems; shuts off water if leaks or out-of-spec conditions occur. Benefits patient by ensuring consistent, monitored water quality for dialysis. Designed for use with Better Water LLC or compatible third-party equipment.

Clinical Evidence

Bench testing only. Validation performed with the controller installed on a pre-treatment rack in a water room under realistic conditions. Connected to pre-treatment components and an RO machine to verify operational control, monitoring, and alarm functions. Conformance to IEC 60601-1, IEC 26722, and IEC 62304 standards confirmed.

Technological Characteristics

Control box with HMI touch-screen interface. Monitors digital sensors for pressure, temperature, flow, and pH. Controls electromechanical valves and pumps. Connectivity includes interlock power supply to RO systems. Complies with IEC 60601-1 (safety), IEC 26722 (hemodialysis water treatment), and IEC 62304 (software lifecycle).

Indications for Use

Indicated for monitoring and controlling pre-treatment components in water purification systems for hemodialysis applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Better Water Inc Water Purification System for Hemodialysis (K920186)
• Matrix Digital Reverse Osmosis Water Treatment System, Model EQRMD Series (K051620)
• Complete Water System for Hemodialysis, MD400 and MD600 Series (K041163)

Submission Summary (Full Text)

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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 [phone] or [phone] 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.

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> 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 [phone] Fax [phone]

# 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 | [phone] |
|---------------|-------------------|-------|----------------|
| Address | 698 Swan Dr | Fax | [phone] |
| City, St, Zip | Smyrna, TN 37167 | | |

## 3.1 Establishment Registration Number

Establishment Registration Number 1055109

## 3.2 Contact

Name Michael Cline Phone [phone] Title President [phone] Fax Email [e-mail]

#### 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.

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.

### 5.1 Device Description, Summarized

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. More detailed information is provided in the Device Description and Software Information sections of this submission.

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-Treatment<br>Controller | Predicate Device#1 | Predicate Device#2 | Predicate Device#3 |
|------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - | K920186 | K051620 | K041163 |
| Description | Pre-Treatment<br>Controller Box | Water Purification<br>System for<br>Hemodialysis | Matrix Digital Reverse<br>Osmosis Water<br>Treatment System,<br>Model EQRMD Series | Complete Water System<br>for Hemodialysis, MD400<br>and 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 |
| Specific<br>Comparison | Digital touch-screen for<br>monitor and control<br>functions of Pre-<br>Treatment. | Pre-Treatment Rack<br>with control box, analog<br>pressure and<br>temperature gauges. | Reverse Osmosis<br>device with digital<br>touch-screen and PLC<br>for monitor and control<br>functions. Comparing<br>control technology. | Reverse Osmosis devices<br>with digital touch-screen<br>and PLC for monitor and<br>control functions.<br>Comparing control<br>technology. |

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| Operational<br>Features | - HMI touch-screen for<br>monitor/control<br>- Turns pump on/off<br>- Monitors pressures<br>digitally<br>- Monitor temperature<br>digitally<br>- Monitor flow digitally<br>- Monitors pH digitally<br>- Controls valves<br>opening and closing<br>(blend valve<br>bypass/main water<br>shutoff)<br>- Supplies the power to<br>the pre-treatment<br>interlock and will shut-<br>off the RO if the<br>interlock is broken<br>- Logs and trends<br>operational data | - Turns pump on/off<br>- Monitors pressures<br>via analog gauges<br>- Monitor temperature<br>via analog gauge<br>- Monitor flow via<br>analog flow-meter<br>- Controls valves<br>opening and closing<br>(blend valve<br>bypass/main water<br>shutoff) | - HMI touch-screen for<br>monitor/control<br>- Turns pump on/off<br>- Monitors pressures<br>digitally<br>- Monitors temperature<br>digitally<br>- Monitors flow digitally<br>- Controls valves<br>opening and closing<br>(product/reject)<br>- Supplies power to the<br>pre-treatment interlock<br>and will shut-off if the<br>interlock is broken<br>- Logs and trends<br>operational data | - HMI touch-screen for<br>monitor/control<br>- Turns pump on/off<br>- Monitors pressures<br>digitally<br>- Monitors temperature<br>digitally<br>- Monitor flow digitally<br>- Monitors pH digitally<br>- Controls valves opening<br>and closing<br>(product/reject)<br>- Logs and trends<br>operational data |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety Features | - Breakers, fuses, and<br>grounds for electrical<br>safety and protection<br>- Main water shutoff<br>alarm<br>- High temperature<br>alarm<br>- Low pressure alarm | - Breakers, fuses, and<br>grounds for electrical<br>safety and protection<br>- Main water alarm &<br>shutoff | - Breakers, fuses, and<br>grounds for electrical<br>safety and protection<br>- High temperature<br>alarm & shut-off<br>- Low pressure alarm &<br>shut-off | - Breakers, fuses, and<br>grounds for electrical<br>safety and protection<br>- High temperature alarm<br>- 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: General<br>requirements for safety – Collateral standard: Safety<br>requirements for medical electrical systems. |
| IEC 26722 : 2014 | (AAMI) – Water Treatment Equipment for Hemodialysis<br>Applications 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.