(106 days)
The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers.
Osmosis is a natural process where two liquids of different concentration are separated by a semi-permeable membrane and the liquid moves from the lower concentration to the higher concentration in order to achieve chemical equilibrium. Reverse osmosis, the scientific concept used in the AmeriWater MRO Portable Reverse Osmosis System, is the opposite of osmosis. Liquid is forced from a region of higher solute concentration through a semi-permeable membrane to a region of lower solute concentration. This is achieved by applying a pressure in excess of the osmotic pressure. Osmotic pressure is the pressure which needs to be applied to a solution to prevent the inward flow of water across a semi-permeable membrane. The MRO system uses a submersible pump to apply the pressure required for reverse osmosis.
The semi-permeable membrane used in the MRO system is a thin film composite (TFC) membrane. A TFC membrane is essentially a molecular sieve constructed in the form two or more layered materials. The membranes are made out of polyamide, chosen for its permeability to water and relative impermeability to various dissolved impurities and unfilterable molecules.
The MRO Portable Reverse Osmosis System purifies tap water by applying pressure (greater than the osmotic pressure difference) to the feed water supply in order to reverse the water flow through the semi-permeable reverse osmosis membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the tap water is supplied to the MRO pump where ist is pressurized and sent to the membrane splits the tap water into permeate, which has passed through the membrane, and the concentrate, which passes over the membrane and carries the contaminants to drain. The AmeriWater MRO Reverse Osmosis System produces water that meets ANSI/AAMI RD62 requirements for water used in hemodialysis applications. It provides quiet operation for bedside use and may be used for acute care cases, small dialysis wings in a hospital, or for home care. Materials that contact the product water include: ABS, Acrylic, Carbon, Nylon, PVC, Polyester, Polyethylene, Polypropylene, Stainless Steel, Tygon, EPDM, Viton, and Buna N.
Tap water enters the AmeriWater MRO Portable Reverse Osmosis System and passes through dual carbon block filters to remove chlorine, chloramines, and sediment which may damage the RO membranes. The dual chloramine removal carbon cartidges are a special blended carbon that salisfies AAMI and CMS requirements. Rated at 1 micron, the filters have a capacity of 8000 gallons with 3 PPM of chloramine at 9.5 pH. The submersible RO pump then pressurizes the feed water to pressures greater than the osmotic pressure. The pressurized feed water is sent through the RO membranes where contaminants are removed, and the feed water is split into permeate, or product water, and concentrate, or reject water. The purified permeate water passes through a Nephros Dsu filter capsule (K110285) to remove microbiological contaminants (down to 0.005 microns) and then is directed to the point of use. A portion of the reject water is returned to the RO pump to reduce waste, and the remainder is sent to drain. Optional antiscalant (K991519) may be included for use on un-softened water supplies to remove hardness minerals that may scale the membrane.
The AmeriWater MRO Portable Reverse Osmosis System includes safety features for the user and to protect patient safety. The safety features meet current and include product water conductivity monitor with audible alarm, a low -pressure cut-off switch to prevent damage to the RO pump in low pressure situations, and a divert to drain feature that prevents product water with conductivity above the alarm set point limit from being used for patient treatment. The MRO also includes a simple disinfection procedure using hydrogen peroxide/peroxyacetic acid (PAA).
This document describes the AmeriWater MRO Portable Reverse Osmosis System, a water purification system for hemodialysis. However, the provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert involvement, or comparative effectiveness studies (MRMC, standalone). It primarily functions as a 510(k) Summary and FDA clearance letter, focusing on device description, intended use, and substantial equivalence to predicate devices.
Therefore, many of the requested elements cannot be directly extracted from the provided text. I will address the points that can be gleaned from the document and explicitly state where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device "produces water that meets ANSI/AAMI RD62 requirements for water used in hemodialysis applications" and "meet current AAMI and Federal (U.S.) standards." It also mentions specific performance characteristics related to filtration and microbiological contaminants. However, it does not provide a table outlining specific acceptance criteria values (e.g., maximum allowable conductivity, minimum removal rates for specific contaminants) nor detailed reported device performance values against these criteria.
| Acceptance Criteria (Stated broadly in text due to lack of specific values) | Reported Device Performance (Stated broadly in text due to lack of specific values) |
|---|---|
| ANSI/AAMI RD62 requirements for water used in hemodialysis applications | Produces water that meets these requirements. |
| Current AAMI and Federal (U.S.) standards | Designed to meet these standards. |
| Remove chlorine, chloramines, and sediment | Dual carbon block filters remove these. |
| Chloramine removal capacity | 8000 gallons with 3 PPM of chloramine at 9.5 pH (for 1 micron filters). |
| Microbiological contaminants removal | Nephros Dsu filter capsule (K110285) removes contaminants down to 0.005 microns. |
| Product water conductivity | Monitor with audible alarm; divert to drain feature if conductivity exceeds alarm. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text is a 510(k) summary, which generally focuses on substantial equivalence rather than detailed clinical or performance study results with specific sample sizes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned or implied in the document. The device is a water purification system, not an imaging or diagnostic AI requiring human reader interaction.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
While the device operates "standalone" in the sense that it performs water purification automatically, the document does not describe a specific "standalone study" with detailed results in the context of the prompt's likely interpretation (e.g., an AI algorithm's performance vs. a human's). The performance evaluation is implied to be against chemical and microbiological standards.
7. Type of Ground Truth Used
The ground truth for this device's performance would be:
- Chemical and microbiological analysis: Water quality measurements (e.g., conductivity, levels of specific contaminants, microbiological counts) compared against established standards like ANSI/AAMI RD62. This is implied by the statements that the device "produces water that meets ANSI/AAMI RD62 requirements" and "removes microbiological contaminants."
8. Sample Size for the Training Set
This information is not provided in the document. The device is a physical water purification system, not an AI model that typically requires a "training set" of data in the common sense. Its "training" would be its engineering design and manufacturing processes to achieve the desired water quality.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of an AI algorithm is not applicable here. The "ground truth" for the device's design would stem from the engineering specifications and regulatory requirements (like AAMI standards) for hemodialysis water quality. The design and construction of the system are based on established scientific principles of reverse osmosis, filtration, and disinfection to achieve these standards.
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303 STANLEY AVENUE AYTON, OH 45404 USA 937-461-8833, 800-535-5585 นี / 937-461-1988 /ww.AMERIWATER.com
OCT - 5 2011
Image /page/0/Picture/3 description: The image shows the text "PAGE 1 OF 2" at the top. Below the text are three overlapping circles. The largest circle on the left contains the text "Suez environnement". The circle on the right contains the text "Degrémont" and an image of a bird.
510(K) SUMMARY
| 510(K) Number: | K111740 |
|---|---|
| Submitter: | AmeriWater |
| Contact: | Brian R. Bowman, Quality & Regulatory Administrator1303 Stanley Avenue, Dayton, OH 45404Phone: (937)461-8833 Fax: (937)461-1988brianbowman@ameriwater.com |
| Date Prepared: | September 6, 2011 |
| Proprietary Name: | AmeriWater MRO Portable Reverse Osmosis System |
| Common Name: | Reverse Osmosis System |
| Classification Name: | Water purification system for hemodialysis |
| Classification: | Class II Medical Device under §876.5665Panel: GastroenterologyProduct Code:FIP |
| Equivalent Device: | K924695, AmeriWater (Dayton Water Systems) Aseptech Portable RO+ systemK991519, AmeriWater Water Purification System |
Device Description: Osmosis is a natural process where two liquids of different concentration are separated by a semi-permeable membrane and the liquid moves from the lower concentration to the higher concentration in order to achieve chemical equilibrium. Reverse osmosis, the scientific concept used in the AmeriWater MRO Portable Reverse Osmosis System, is the opposite of osmosis. Liquid is forced from a region of higher solute concentration through a semi-permeable membrane to a region of lower solute concentration. This is achieved by applying a pressure in excess of the osmotic pressure. Osmotic pressure is the pressure which needs to be applied to a solution to prevent the inward flow of water across a semi-permeable membrane. The MRO system uses a submersible pump to apply the pressure required for reverse osmosis.
The semi-permeable membrane used in the MRO system is a thin film composite (TFC) membrane. A TFC membrane is essentially a molecular sieve constructed in the form two or more layered materials. The membranes are made out of polyamide, chosen for its permeability to water and relative impermeability to various dissolved impurities and unfilterable molecules.
The MRO Portable Reverse Osmosis System purifies tap water by applying pressure (greater than the osmotic pressure difference) to the feed water supply in order to reverse the water flow through the semi-permeable reverse osmosis membrane so that the water moves from a more concentrated solution to a less concentrated solution resulting in purified permeate flow. Basically, the tap water is supplied to the MRO pump where ist is pressurized and sent to the membrane splits the tap water into permeate, which has passed through the membrane, and the concentrate, which passes over the membrane and carries the contaminants to
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AmeriWater 144888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888
303 STANLEY AVENUE AYTON, OH 45404 USA El 937-461-8833, 800-535-5585 937-461-1988 ww.AMERIWATER.com
Image /page/1/Picture/2 description: The image shows two logos, one for Suez environnement and one for Degremont. The Suez environnement logo is a black circle with the word "Suez" in white, stylized letters. Below "Suez" is the word "environnement" in smaller, white letters. The Degremont logo is a smaller black circle with a white bird-like symbol and the word "Degremont" in white letters below it. At the top of the image is the text "K111740 PAGE 2 OF 2".
drain. The AmeriWater MRO Reverse Osmosis System produces water that meets ANSI/AAMI RD62 requirements for water used in hemodialysis applications. It provides quiet operation for bedside use and may be used for acute care cases, small dialysis wings in a hospital, or for home care. Materials that contact the product water include: ABS, Acrylic, Carbon, Nylon, PVC, Polyester, Polyethylene, Polypropylene, Stainless Steel, Tygon, EPDM, Viton, and Buna N.
Tap water enters the AmeriWater MRO Portable Reverse Osmosis System and passes through dual carbon block filters to remove chlorine, chloramines, and sediment which may damage the RO membranes. The dual chloramine removal carbon cartidges are a special blended carbon that salisfies AAMI and CMS requirements. Rated at 1 micron, the filters have a capacity of 8000 gallons with 3 PPM of chloramine at 9.5 pH. The submersible RO pump then pressurizes the feed water to pressures greater than the osmotic pressure. The pressurized feed water is sent through the RO membranes where contaminants are removed, and the feed water is split into permeate, or product water, and concentrate, or reject water. The purified permeate water passes through a Nephros Dsu filter capsule (K110285) to remove microbiological contaminants (down to 0.005 microns) and then is directed to the point of use. A portion of the reject water is returned to the RO pump to reduce waste, and the remainder is sent to drain. Optional antiscalant (K991519) may be included for use on un-softened water supplies to remove hardness minerals that may scale the membrane.
The AmeriWater MRO Portable Reverse Osmosis System includes safety features for the user and to protect palient safety. The safety features meet current and include product water conductivity monitor with audible alarm, a low -pressure cut-off switch to prevent damage to the RO pump in low pressure situations, and a divert to drain feature that prevents product water with conductivity above the alarm set point limit from being used for patient treatment. The MRO also includes a simple disinfection procedure using hydrogen peroxide/peroxyacetic acid (PAA).
Indications for Use: The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two patients in a hospital, clinic, or dialysis centers. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician per 21CFR §801.109 (b)(1).
Statement of Substantial Equivalence: The AmeriWater MRO Portable Reverse Osmosis System is substantially equivalent in intended use, function, and technology to the AmeriWater Systems) Aseptech Portable RO+ systems currently cleared for market under K924695, and the AmeriWater RO+ systems currently cleared for market under K991519. The new device is basically the same design as the predicate device with the exception of controller modifications to meet the requirements of UL 60601-1. In addition, new features have been added to meet current AAMI requirements. These include dual carbon block filters equivalent to carbon beds with 10-minute empty bed contact time. The carbon block filters replace the single carbon tank previously used in the MRO. A product water divert to drain feature has also been added. This feature diverts all water to drain if the permeate conductivity exceeds the alarm set point limit. The Nephros Dsu filter capsule (K110285) has also been added in order to help meet the new AAM requirements for microbiological contaminants. The basic flow path and scientific concepts for the device have not changed, nor has the intended use, electrical requirements, or environmental and incoming water specifications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002
Mr. Brian R. Bowman Quality & Regulatory Administrator AmeriWater, Inc. 1303 Stanley Avenue DA Y TON OH 45404
OCT -- 5 2011
Re: K111740
Trade/Device Name: AmeriWater MRO Portable Reverse Osmosis System Regulation Number: 21 CFR$ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: September 6. 2011 Received: September 19, 2011
Dear Mr. Bowman:
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. 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
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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/AboutlTDA/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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Huchard Zemer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
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Image /page/4/Picture/0 description: The image contains the word "AmeriWater" in a bold, sans-serif font. The text is black against a white background. The letters are closely spaced, creating a compact appearance.
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303 STANLEY AVENUE AYTON, OH 45404 USA El 937-461-8833, 800-535-5585 937-461-1988 /ww.AMERIWATER.com
Image /page/4/Picture/3 description: The image shows a logo with the words "Suez environnement" and "Degremont". The logo consists of three overlapping circles. The largest circle contains the words "Suez environnement" in white text. The second largest circle contains a stylized image of a bird and the word "Degremont" in white text. The smallest circle is located at the bottom of the image and is mostly obscured by the other two circles.
Indications for Use
K111740 510(k) Number (if known):
AmeriWater MRO Portable Reverse Osmosis System Device Name:
Indications For Use:
The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat and purify potable water for use in making dialysate for hemodialysis and to meet current AAMI and Federal (U.S.) standards. The AmeriWater Portable MROS model is intended for use in a hospital, clinic, dialysis center, or for home care for single patient use. The AmeriWater Portable MRO1 model is for treatment of up to two palients in a hospital, clinic, or dialysis centers.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helentenn
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K111740
§ 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.