(154 days)
Not Found
No
The document describes a water treatment system for hemodialysis and does not mention any AI or ML capabilities.
No
The device purifies water for hemodialysis applications, making it an accessory device for a therapeutic procedure rather than a therapeutic device itself.
No
The device is a water treatment system for hemodialysis applications, described as an "accessory device" intended to purify water. It does not perform any diagnostic functions by identifying disease, assessing health conditions, or providing information for diagnosis.
No
The device description clearly states it is a "Water Treatment System" and describes its function in removing substances from water, indicating it is a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide purified water for use in hemodialysis applications. This is a treatment process performed on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The device description reinforces its role in purifying water for hemodialysis, specifically for diluting dialysate concentrate. This is a functional component of a medical treatment system.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays to detect specific substances
The device is clearly described as an accessory device for a medical treatment (hemodialysis) and its function is to prepare a necessary component (purified water) for that treatment.
N/A
Intended Use / Indications for Use
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device that is intended for use with a hemodialysis applications and is intended to remove organic and inorganic substances and microbial contaminants from tap water used to dilute dialysate concentrate to form dialysate. The Matrix Series Digital Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device designed to safely and effectively provide water purification for use in hemodialysis applications. The water produced will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
Product codes
FIP
Device Description
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device that is intended for use with a hemodialysis applications and is intended to remove organic and inorganic substances and microbial contaminants from tap water used to dilute dialysate concentrate to form dialysate. The Matrix Series Digital Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.
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)
Not required for determination of substantial equivalence for this type and class of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NOV 1 8 2005
Image /page/0/Picture/2 description: The image is a black and white drawing of a cartoon water droplet with a smiling face. The droplet has large eyes and a simple, curved mouth. It appears to be standing in a puddle of water. The drawing is set within a circular frame, with text around the edge of the circle.
510(K) SUMMARY 510(K) Number : K051620
1 Date Prepared August 26, 2005
2 Contact Person
Mike Cline President, Better Water, Incorporated 698 Swan Drive Smyrna, TN 37167 615-355-6063
3 Device Name
| Proprietary Name: | Matrix Series Digital Reverse Osmosis
Water Treatment System |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Reverse Osmosis Water Purification
System For Hemodialysis with Digital
Controls |
| Panel: | Gastroenterology/Urology |
| Classification Name: | Water Purification System For
Hemodialysis; Class II; Water
purification system for hemodialysis (21
CFR 876.5665); Product Code 78 FIP |
1
K051620
PAGE 2 OF 5
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4 Device Description
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device that is intended for use with a hemodialysis applications and is intended to remove organic and inorganic substances and microbial contaminants from tap water used to dilute dialysate concentrate to form dialysate. The Matrix Series Digital Reverse Osmosis Water Treatment System will produce water as prescribed by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard provided adequate flow rate of the feed (tap) water and compliance with existing drinking water standards and proper pre-treatment.
5 Substantial Equivalence To Predicate Device
The Matrix Series Digital Reverse Osmosis Water Treatment System is based upon the technology of the Water Purification System For Hemodialysis manufacturered by Better Water (K920186) with respect to "wetted-contact materials", pump size and the selection of the type and number of membranes.
Additionally, the Matrix Series features an electronic PLC with firmware as well as an Operator Interface Touch Screen. These electronic features are equivalent to the electronic features incorporated in the MD 400 (K993200) and 600 (K041163) Series Water Systems manufactured by Isopure Incorporated.
See the table below for detailed comparison.
Appendix 5 - Page 2 of 5
2
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Table of Comparison To Predicate Devices
| Predicate Devices | |||||
|---|---|---|---|---|---|
| Specifications | Matrix Current 510(K) | Water Purification System | |||
| For Hemodialysis | Complete Water System | ||||
| Models MD 610, 620, 630 | |||||
| and 640 | Multi-Patient Reverse | ||||
| Osmosis - Models MD 420, | |||||
| 440, 460, 470, 480 and 490 | |||||
| Manufacturer | Better Water, Inc | Better Water, Inc | Isopure Corporation | Isopure Corporation | |
| 510(K) | |||||
| Number | - | K920186 | K041163 | K993200 | |
| Decision Date | - | 6/13/1995 | 10/7/2004 | 1/24/2000 | |
| Classification | 876.5665, Class II | 876.5665, Class II | 876.5665, Class II | 876.5665, Class II | |
| Product Code | FIP | FIP | FIP | 78 FIP | |
| Water-Contact | |||||
| Materials | FDA - NSFCompliant | FDA - NSFCompliant | FDA - NSFCompliant | FDA - NSFCompliant | |
| Pre-Treatment | |||||
| Options | Based upon site-specific feed water | ||||
| chemical analysis. | Based upon site-specific | ||||
| feed water chemical | |||||
| analysis. | Based upon site-specific | ||||
| feed water chemical | |||||
| analysis. | Based upon site-specific | ||||
| feed water chemical | |||||
| analysis. | |||||
| Feed water Pre-Treatment may | |||||
| include | Feed water Pre-Treatment | ||||
| may include : | Feed water Pre-Treatment | ||||
| may include : | Feed water Pre-Treatment | ||||
| may include : | |||||
| · Carbon Filtration | · Carbon Filtration | · Carbon Filtration | · Carbon Filtration | ||
| · Softners | · Softners | · Softners | · Softners | ||
| · Temperature Control | · Temperature Control | · Temperature Control | · Temperature Control | ||
| · Pressure Compensation | · Pressure Compensation | · Pressure Compensation | · Pressure Compensation | ||
| · Special Filtration | · Special Filtration | · Special Filtration | · Special Filtration | ||
| · Ultra-Violet (UV) | · Ultra-Violet (UV) | NA | NA | ||
| · Ozone | NA | NA | NA | ||
| Operational | |||||
| Features | Electronic touch screen interface | Manual Controls | Electronic touch screen | ||
| interface | Electronic touch screen | ||||
| interface | |||||
| All components mounted on an | |||||
| open frame for assessibility | All components mounted | ||||
| on an open frame for | |||||
| assessibility | All components mounted | ||||
| on an open frame for | |||||
| assessibility | All components mounted on | ||||
| an open frame for | |||||
| assessibility | |||||
| Electronic Monitoring of | Analog Monitoring of | Electronic Pressure | |||
| Monitoring of | Electronic Pressure | ||||
| Monitoring of | |||||
| · Feed water pressure / flow | · Feed water pressure | · Feed water pressure | · Feed water pressure | ||
| · Product water pressure/ flow | · Product water pressure | · Product water pressure | · Product water pressure | ||
| · Membrane feed pressure | · Membrane feed pressure | · Membrane feed pressure | · Membrane feed pressure | ||
| · Pump Pressure | · Pump Pressure | · Pump Pressure | · Pump Pressure | ||
| · Reject Water Pressure/Flow | · Reject Water | ||||
| Pressure/Flow | · Reject Water | ||||
| Pressure/Flow | · Reject Water | ||||
| Pressure/Flow | |||||
| · Product Water Conductivity | · Product Water | ||||
| Conductivity | · Product Water | ||||
| Conductivity | · Product Water | ||||
| Conductivity | |||||
| · Feed water Conductivity | · Feed water Conductivity | · Feed water Conductivity | · Feed water Conductivity | ||
| · System Flush | · Manual | · System Flush | · System Flush | ||
| · Clean/Disinfect Flow Rate | · NA | · Semi-Automated | · Semi-Automated | ||
| Manual or Automated | |||||
| System cleaning and | |||||
| sanitizing by: | Manual or Automated | ||||
| System cleaning and | |||||
| sanitizing by: | Manual or Automated | ||||
| System cleaning and | |||||
| sanitizing by: | |||||
| Cleaning | • chemicals agents | Not Applicable | • chemical agents | • chemical agents | |
| Safety | |||||
| Features | 100% diversion-to-drain | ||||
| above product | |||||
| conductivity set-point | 100% diversion-to-drain | ||||
| above product conductivity | |||||
| set-point | 100% diversion-to-drain | ||||
| above product | |||||
| conductivity set-point | Not Applicable | ||||
| Low Supply (Feedwater) | |||||
| Pressure (Alarm) | Low Supply (Feedwater) | ||||
| Pressure (Alarm) | Low Supply (Feedwater) | ||||
| Pressure (Alarm) | Low Supply (Feedwater) | ||||
| Pressure (Alarm) | |||||
| High Product Water | |||||
| Conductivity (alarm) | High Product Water | ||||
| Conductivity (shut down) | High Product Water | ||||
| Conductivity (shut down) | High Product Water | ||||
| Conductivity (shut | |||||
| down) | |||||
| High supply water | |||||
| temperature (shut | |||||
| down) | High supply water | ||||
| temperature (shut down) | High supply water | ||||
| temperature (shut down) | High supply water | ||||
| temperature (shut | |||||
| down) | |||||
| High product water | |||||
| conductivity alarm | High product water | ||||
| conductivity alarm | High product water | ||||
| conductivity alarm | High product water | ||||
| conductivity alarm | |||||
| System Recovery | |||||
| Notification | Not Applicable | System Recovery | |||
| Notification | System Recovery | ||||
| Notification | |||||
| Power Disturbance | |||||
| (Alarm) | Power Disturbance (Alarm) | Power Disturbance | |||
| (Alarm) | Power Disturbance | ||||
| (Alarm) | |||||
| Post- | |||||
| Treatment | |||||
| Options | Remote Alarm (Nurse's | ||||
| Station) | |||||
| May include 0.5 micron | |||||
| or better ultra-filtration | Remote Alarm (Nurse's | ||||
| Station) | |||||
| May include 0.5 micron or | |||||
| better ultra-filtration | Remote Alarm (Nurse's | ||||
| Station) | |||||
| May include 0.5 micron | |||||
| or better ultra-fitration | Remote Alarm (Nurse's | ||||
| Station) | |||||
| May include 0.5 micron | |||||
| or better ultra-filtration | |||||
| Performance | Delivery of AAMI | ||||
| Standard Water | Delivery of AAMI Standard | ||||
| Water | Delivery of AAMI | ||||
| Standard Water | Delivery of AAMI | ||||
| Standard Water |
:
3
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12051620
PAGE 4 OF
Table of Comparison To Predicate Devices cont'
:
4
8051620 5 OF 5
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Indications For Use 6
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device designed to safely and effectively provide water purification for use in hemodialysis applications. The water produced will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
Safety and Effectiveness 7
The intended use and technological characteristics of the Matrix Series Digital Reverse Osmosis Water Treatment System are similar or equivalent to the Predicate Devices. Any difference between the device and the Predicate Devices have no significant influence on the safety or effectiveness of the product.
Clinical Performance Data 8
Not required for determination of substantial equivalence for this type and class of device.
Conclusion Drawn From Clinical and 9 Nonclinical Test Data
As compared with the predicate devices, K920186, K993200 and K041163, the Matrix Series Digital Reverse Osmosis Water Treatment System will produce purified water that will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features a stylized bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2005
Mr. Michael Cline President Better Water, Inc. 698 Swan Drive SMYRNA TN 37167
Re: K051620
Trade/Device Name: Matrix Digital Reverse Osmosis Water Treatment System -EQRMD Series Regulation Number: 21 CFR $876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: November 16, 2005 Received: November 17, 2005
Dear Mr. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. 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); 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.
6
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
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Indications For Use Statement
K051620 510(K) Number :
Device Name :
Matrix Series Digital Reverse Osmosis Water Treatment System
Indications For Use:
The Matrix Series Digital Reverse Osmosis Water Treatment System is an accessory device designed to safely and effectively provide water purification for use in hemodialysis applications. The water produced will meet the minimum water quality requirements as specified by Association for the Advancement of Medical Instrumentation (AAMI) standard RD62:2003 when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Title
Date
510(K) Number : K051620
Appendix 3 - Page 1 of 1
ﺃﺷﻬﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ Prescription Use
OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
David le. Lymon
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Dev 510(k) Number