(161 days)
Not Found
No
The summary describes a control system for water purification components, focusing on monitoring, display, and control of physical parameters and cycles. There is no mention of AI or ML algorithms for data analysis, prediction, or adaptive control.
No.
This device is designed to monitor and control pre-treatment components for water purification for dialysis applications, rather than directly treating a patient or disease.
No
The device monitors and controls pre-treatment components for water purification for dialysis; it does not diagnose medical conditions in patients.
No
The device description explicitly states it is a "control box" and mentions a "digital touch-screen (HMI – human machine interface, OIT - operator interface terminal)". This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to monitor and control the pre-treatment components for water purification for dialysis applications. This is focused on the treatment of water, not on the analysis of biological samples from a human body.
- Device Description: The device is a control box that manages water treatment components. It monitors water parameters like pressure, temperature, flowrate, and pH, which are related to the quality and flow of the water itself, not to diagnostic information from a patient.
- Lack of Biological Sample Analysis: There is no mention of the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.) from a patient. IVDs are specifically designed to perform tests on such samples to provide diagnostic information.
- Predicate Devices: The predicate devices listed are all related to water purification systems for hemodialysis. These are not IVD devices.
In summary, the Matrix Pre-Treatment Controller is a water treatment control system for dialysis applications. Its function is to ensure the water used in dialysis is properly purified, which is a crucial part of the dialysis process, but it does not perform diagnostic tests on patients.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FIP
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. More detailed information is provided in the Device Description and Software Information sections of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
4
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
Controller | Predicate Device#1 | Predicate Device#2 | Predicate Device#3 |
|------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - | K920186 | K051620 | K041163 |
| Description | Pre-Treatment
Controller Box | Water Purification
System for
Hemodialysis | Matrix Digital Reverse
Osmosis Water
Treatment System,
Model EQRMD Series | Complete Water System
for Hemodialysis, MD400
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
Comparison | Digital touch-screen for
monitor and control
functions of Pre-
Treatment. | Pre-Treatment Rack
with control box, analog
pressure and
temperature gauges. | Reverse Osmosis
device with digital
touch-screen and PLC
for monitor and control
functions. Comparing
control technology. | Reverse Osmosis devices
with digital touch-screen
and PLC for monitor and
control functions.
Comparing control
technology. |
5
| Operational
Features | - HMI touch-screen for
monitor/control
- Turns pump on/off
- Monitors pressures
digitally - Monitor temperature
digitally - Monitor flow digitally
- Monitors pH digitally
- Controls valves
opening and closing
(blend valve
bypass/main water
shutoff) - Supplies the power to
the pre-treatment
interlock and will shut-
off the RO if the
interlock is broken - Logs and trends
operational data | - Turns pump on/off - Monitors pressures
via analog gauges - Monitor temperature
via analog gauge - Monitor flow via
analog flow-meter - Controls valves
opening and closing
(blend valve
bypass/main water
shutoff) | - HMI touch-screen for
monitor/control - Turns pump on/off
- Monitors pressures
digitally - Monitors temperature
digitally - Monitors flow digitally
- Controls valves
opening and closing
(product/reject) - Supplies power to the
pre-treatment interlock
and will shut-off if the
interlock is broken - Logs and trends
operational data | - HMI touch-screen for
monitor/control - Turns pump on/off
- Monitors pressures
digitally - Monitors temperature
digitally - Monitor flow digitally
- Monitors pH digitally
- Controls valves opening
and closing
(product/reject) - Logs and trends
operational data |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety Features | - Breakers, fuses, and
grounds for electrical
safety and protection - Main water shutoff
alarm - High temperature
alarm - Low pressure alarm | - Breakers, fuses, and
grounds for electrical
safety and protection - Main water alarm &
shutoff | - Breakers, fuses, and
grounds for electrical
safety and protection - High temperature
alarm & shut-off - Low pressure alarm &
shut-off | - Breakers, fuses, and
grounds for electrical
safety 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: General |
| requirements for safety – Collateral standard: Safety | |
| requirements for medical electrical systems. | |
| IEC 26722 : 2014 | (AAMI) – Water Treatment Equipment for Hemodialysis |
| 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
6
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.