(154 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Matrix Series Digital Reverse Osmosis Water Treatment System:
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a new clinical or performance study with specific acceptance criteria and performance metrics in the way a novel device might be evaluated.
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device is its ability to produce water that meets the standards set by the Association for the Advancement of Medical Instrumentation (AAMI) RD62:2003 standard for hemodialysis water quality.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Delivery of AAMI Standard Water for Hemodialysis | "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." (Page 1, 4) "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." (Page 4, 9) |
Study Information
Based on the provided 510(k) summary, the device's acceptance is based on demonstrating substantial equivalence to predicate devices, not on a new, standalone performance study with detailed clinical or non-clinical data as one might expect for a novel device.
- Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of a new performance study. The evaluation is primarily a comparison to predicate devices, relying on their historical performance and regulatory clearance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the AAMI RD62:2003 standard, which is an industry-accepted benchmark, not an expert-derived opinion for a specific test set.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There's no human adjudication process described for a test set.
- If a multi-reader multicase (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a water treatment system, not an imaging or diagnostic device involving human readers or AI.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No; a standalone algorithm performance study is not relevant for this type of device. The "standalone" performance is the water treatment system's output meeting AAMI standards. The FDA's conclusion explicitly states: "Clinical Performance Data: Not required for determination of substantial equivalence for this type and class of device." (Page 4, 8)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for compliance is the AAMI RD62:2003 standard for water quality in hemodialysis. This is a technical performance standard.
- The sample size for the training set: Not applicable. This is not a machine learning or AI-driven device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of How the Device Meets Acceptance Criteria
The Matrix Series Digital Reverse Osmosis Water Treatment System meets its acceptance criteria by demonstrating substantial equivalence to existing, legally marketed predicate devices (Better Water K920186, Isopure MD 400 K993200, and MD 600 K041163 Series Water Systems).
The basis for this substantial equivalence primarily rests on:
- Technological Characteristics: Similar "wetted-contact materials," pump size, and membrane selection to the Better Water predicate.
- Operational Features: The electronic PLC and Operator Interface Touch Screen features are deemed equivalent to those in the Isopure predicate devices.
- Intended Use: The device shares the same intended use as an accessory for hemodialysis applications.
- Performance Claim: The device is intended to and will produce water meeting the AAMI RD62:2003 standard, mirroring the performance of the predicate devices.
The 510(k) process allows a new device to be cleared if it is "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, those characteristics do not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate device.
In this case, the manufacturer asserts that "Any difference between the device and the Predicate Devices have no significant influence on the safety or effectiveness of the product," and that the device will meet the specific AAMI standard for water quality, which is the established acceptance criterion for such devices. No new clinical or detailed performance studies were required by the FDA because of this demonstrated substantial equivalence.
{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 OsmosisWater Treatment System |
|---|---|
| Common Name: | Reverse Osmosis Water PurificationSystem For Hemodialysis with DigitalControls |
| Panel: | Gastroenterology/Urology |
| Classification Name: | Water Purification System ForHemodialysis; Class II; Waterpurification system for hemodialysis (21CFR 876.5665); Product Code 78 FIP |
{1}------------------------------------------------
K051620
PAGE 2 OF 5
Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a cartoon water droplet with a smiling face. The droplet is positioned above a stylized representation of water or waves. The text "WATER DROP" is arranged around the upper perimeter of the circle. There are two small circles on the left and right sides of the text.
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}------------------------------------------------
Image /page/2/Picture/0 description: The image shows a document with the text "K051620 PAGE 3 OF 5" at the top. Below the text is a circular logo with a cartoon character in the center. The cartoon character appears to be a water droplet with a face and arms, sitting on a cloud-like shape. The logo is surrounded by a ring with text, though the text is not clear enough to read.
Table of Comparison To Predicate Devices
| Predicate Devices | |||||
|---|---|---|---|---|---|
| Specifications | Matrix Current 510(K) | Water Purification SystemFor Hemodialysis | Complete Water SystemModels MD 610, 620, 630and 640 | Multi-Patient ReverseOsmosis - 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-ContactMaterials | FDA - NSFCompliant | FDA - NSFCompliant | FDA - NSFCompliant | FDA - NSFCompliant | |
| Pre-TreatmentOptions | Based upon site-specific feed waterchemical analysis. | Based upon site-specificfeed water chemicalanalysis. | Based upon site-specificfeed water chemicalanalysis. | Based upon site-specificfeed water chemicalanalysis. | |
| Feed water Pre-Treatment mayinclude | Feed water Pre-Treatmentmay include : | Feed water Pre-Treatmentmay include : | Feed water Pre-Treatmentmay 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 | ||
| OperationalFeatures | Electronic touch screen interface | Manual Controls | Electronic touch screeninterface | Electronic touch screeninterface | |
| All components mounted on anopen frame for assessibility | All components mountedon an open frame forassessibility | All components mountedon an open frame forassessibility | All components mounted onan open frame forassessibility | ||
| Electronic Monitoring of | Analog Monitoring of | Electronic PressureMonitoring of | Electronic PressureMonitoring 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 WaterPressure/Flow | · Reject WaterPressure/Flow | · Reject WaterPressure/Flow | ||
| · Product Water Conductivity | · Product WaterConductivity | · Product WaterConductivity | · Product WaterConductivity | ||
| · 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 AutomatedSystem cleaning andsanitizing by: | Manual or AutomatedSystem cleaning andsanitizing by: | Manual or AutomatedSystem cleaning andsanitizing by: | |||
| Cleaning | • chemicals agents | Not Applicable | • chemical agents | • chemical agents | |
| SafetyFeatures | 100% diversion-to-drainabove productconductivity set-point | 100% diversion-to-drainabove product conductivityset-point | 100% diversion-to-drainabove productconductivity 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 WaterConductivity (alarm) | High Product WaterConductivity (shut down) | High Product WaterConductivity (shut down) | High Product WaterConductivity (shutdown) | ||
| High supply watertemperature (shutdown) | High supply watertemperature (shut down) | High supply watertemperature (shut down) | High supply watertemperature (shutdown) | ||
| High product waterconductivity alarm | High product waterconductivity alarm | High product waterconductivity alarm | High product waterconductivity alarm | ||
| System RecoveryNotification | Not Applicable | System RecoveryNotification | System RecoveryNotification | ||
| Power Disturbance(Alarm) | Power Disturbance (Alarm) | Power Disturbance(Alarm) | Power Disturbance(Alarm) | ||
| Post-TreatmentOptions | Remote Alarm (Nurse'sStation)May include 0.5 micronor better ultra-filtration | Remote Alarm (Nurse'sStation)May include 0.5 micron orbetter ultra-filtration | Remote Alarm (Nurse'sStation)May include 0.5 micronor better ultra-fitration | Remote Alarm (Nurse'sStation)May include 0.5 micronor better ultra-filtration | |
| Performance | Delivery of AAMIStandard Water | Delivery of AAMI StandardWater | Delivery of AAMIStandard Water | Delivery of AAMIStandard Water |
:
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image is a black and white drawing of a logo. The logo is circular and contains a cartoon water droplet with a smiling face. The droplet is sitting on a dark, cloud-like shape. The text around the edge of the circle is not legible.
12051620
PAGE 4 OF
Table of Comparison To Predicate Devices cont'
:
{4}------------------------------------------------
8051620 5 OF 5
Image /page/4/Picture/1 description: The image is a black and white logo featuring a cartoon water droplet character inside a circle. The water droplet has a smiling face and is wearing a cape. The text "WATER WIZARD INC" is written around the top half of the circle. There are two small circles on either side of the text.
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}------------------------------------------------
Image /page/7/Picture/0 description: The image is a logo for "Better Water, Inc." The logo is circular and features a cartoon water droplet with a smiling face, eyes, and small legs. The droplet is standing on a dark, wavy shape, presumably representing water. The text "BETTER WATER, INC." is arranged around the top half of the circle, and "Since 1988" is arranged around the bottom half.
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
§ 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.