(141 days)
The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.
Reverse osmosis, the scientific concept used in the AmeriWater MEDIQA Reverse Osmosis System, is the opposite of osmosis. The MEDIQA system uses a pump to apply the pressure required for reverse osmosis. Potable tap water enters the MEDIQA through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RQ modules, each module containing a high performance membrane. The water entering the RO module is split into two flows. The water which passes through the membrane is known as permeate and is purified water. The water rejected by the membrane contains an increased level of dissolved contaminants. It passes out of the RO module as the second flow stream called concentrate, and is sent to drain.
The MEDIQA is available as a single pass or a double pass reverse osmosis (RO) unit. In a double pass (two RO stages) system, permeate from the first stage is pressurized by a second high pressure oump and fed to the second stage RO module set. Permeate from the second stage RO module set is fed via a manifold to the distribution loop. Unused permeate returning from the distribution loop is fed back into the feed tank. The concentrate from the first stage is sent to drain while the concentrate from the second stage is returned to the feed water tank for reprocessing. The feed and permeate water flows are monitored at various points in the process to verify temperature, conductivity, and flow. This data is displayed on a touch screen panel to give instant feedback of water quality and process activity. The MEDIQA system is controlled and operated by a touch screen mounted on the machine.
The AmeriWater MEDIQA Reverse Osmosis System also includes a built in heat sanitization feature to enable a heat sanitization of the reverse osmosis membranes and its pipe work. Heat sanitization can be activated manually using the HEATSAN buttons on the touch screen display or automatically if timer clock settings are implemented. The frequency of heat sanitization will depend upon usage and application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for heat sanitization.
The provided text describes the AmeriWater MediQA Reverse Osmosis System, a water purification system for hemodialysis. The document is a 510(k) summary for premarket notification to the FDA.
Here's an analysis of the provided information, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format with specific quantifiable targets for the performance parameters. Instead, it describes the intended performance in comparison to standards and the predicate device.
However, based on the "Summary of Performance Testing" and the "Statement of Substantial Equivalence," we can infer the following performance goals and reported outcomes:
| Performance Aspect | Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|---|
| Water Quality (RO Function) | Meet current AAMI and Federal (U.S.) standards for hemodialysis dialysate | Device "produces water that meets current AAMI and Federal (U.S.) standards." |
| Heat Sanitization Efficacy | Effective in the reduction of bacteria (implied to meet relevant microbiological standards) | "Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria." |
| Biocompatibility | Safe for intended purpose (implied to meet biocompatibility standards) | "Test results from biocompatibility testing... indicate that the device is safe and effective for its intended purpose." |
| Software Validation | Functional and safe (implied to meet software validation standards) | "Test results from... software validation... indicate that the device is safe and effective for its intended purpose." |
| Electrical Safety | Safe for intended purpose (implied to meet electrical safety standards) | "Test results from... electrical safety testing indicate that the device is safe and effective for its intended purpose." |
| Flow Rates (Permeate) | Within the range of 4.5 - 12.0 gpm | The device is available in models that "supply from 4.5 to 12.0 gallons per minute (gpm) of product water." (Specific models mentioned: MSP1 to MPS3 and MDP1 to MDP4 with corresponding flow rates within this range). Predicate device: 3.4 - 9.2 gpm. |
| Heated Temperature (Sanitization) | Achieve and maintain specified temperature for sanitization (compare to predicate) | The device operates within 185 - 203°F during heat sanitization. Predicate device: 185°F. |
| Indications for Use | Match or be substantially equivalent to predicate device | "The AmeriWater MEDIQA Reverse Osmosis System is a water treatment systems intended for use in hemodialysis applications... The AmeriWater MEDIQA is intended for use in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process." (Comparable to predicate but also includes heat sanitization for the RO system itself, not just distribution). |
| For Use In | Hospitals, clinics, or dialysis centers | "Hospitals, clinics, or dialysis centers." Predicate device: Hospitals. |
| RO Disinfection Method | Chemical or Heat | "Chemical or Heat." Predicate device: Chemical. |
| Heat Sanitization For | MEDIQA System only | "MEDIQA System only." Predicate device: Water Distribution System. |
| Substantial Equivalence (Overall Safety & Effectiveness) | No new issues of safety or effectiveness compared to predicate device (K974899) | "This table along with the documentation included in this submission demonstrates that there are no new issues of safety or effectiveness associated with this design change, and that the new device is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific "sample size" for physical units of the device tested, nor does it detail the specific "country of origin of the data" or whether the studies were "retrospective or prospective."
It refers to "Non-clinical testing" and "Clinical studies."
- Non-clinical testing: This likely involved laboratory testing of the device performance, including the RO function and heat sanitization efficacy.
- Clinical studies: These "show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis." This suggests human use or simulation to verify the output water quality under real-world conditions, but no details on patient numbers or study design are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes tests against established standards (AAMI and Federal (U.S.) standards for water quality) rather than relying on expert consensus for a ground truth in the typical sense of medical imaging or diagnostic studies. The evaluation of microbial reduction, for example, would likely follow standardized microbiology testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not mentioned in the document. The device's performance is measured against objective physical, chemical, and microbiological standards, not subject to human interpretation requiring adjudication.
5. If a multi reader multi case (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
This is not applicable and not mentioned. The device is a water purification system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and not mentioned. The device performs a physical process (reverse osmosis and heat sanitization), and its performance is evaluated by measuring the quality of the water it produces, not by an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is defined by established regulatory and industry standards:
- Current AAMI (Association for the Advancement of Medical Instrumentation) standards for hemodialysis water quality.
- Federal (U.S.) standards for hemodialysis water quality.
- Microbiological testing protocols to determine bacterial reduction efficacy of heat sanitization.
- Biocompatibility, software validation, and electrical safety standards relevant to medical devices.
8. The sample size for the training set
This is not applicable and not mentioned. The AmeriWater MediQA Reverse Osmosis System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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AmeriWater .
បានចំបងប្រពន្ធបានប្រជាប្រ ប្រ
1303 STANLEY AVENUE DAYTON, OH 45404 USA TEL 937-461-8833, 800-535-5585 FAX 937-461-1988 www.AMERIWATER.com
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510(K) SUMMARY
| November 5, 2013 | |
|---|---|
| 510(K) Number: | K131904 |
| Submitter: | AmeriWater |
| Contact: | Brian R. Bowman, Quality & Regulatory Administrator1303 Stanley Avenue, Dayton, OH 45404Phone: (937)461-8833 Fax: (937)461-1988brianbowman@ameriwater.com |
| Proprietary Name: | AmeriWater MediQA 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: | K974899, Gambro Central Water Treatment System CWP 100 - WRO H |
NOV 1 3 2013Device Description: Reverse osmosis, the scientific concept used in the AmeriWater MEDIQA Reverse Osmosis System, is the opposite of osmosis. The MEDIQA system uses a pump to apply the pressure required for reverse osmosis. Potable tap water enters the MEDIQA through an inlet solenoid valve filling the feed water tank. A high pressure pump forces water from the feed tank through the RQ modules, each module containing a high performance membrane. The water entering the RO module is split into two flows. The water which passes through the membrane is known as permeate and is purified water. The water rejected by the membrane contains an increased level of dissolved contaminants. It passes out of the RO module as the second flow stream called concentrate, and is sent to drain.
The MEDIQA is available as a single pass or a double pass reverse osmosis (RO) unit. In a double pass (two RO stages) system, permeate from the first stage is pressurized by a second high pressure oump and fed to the second stage RO module set. Permeate from the second stage RO module set is fed via a manifold to the distribution loop. Unused permeate returning from the distribution loop is fed back into the feed tank. The concentrate from the first stage is sent to drain while the concentrate from the second stage is returned to the feed water tank for reprocessing. The feed and permeate water flows are monitored at various points in the process to verify temperature, conductivity, and flow. This data is displayed on a touch screen panel to give instant feedback of water quality and process activity. The MEDIQA system is controlled and operated by a touch screen mounted on the machine.
The AmeriWater MEDIQA Reverse Osmosis System also includes a built in heat sanitization feature to enable a heat sanitization of the reverse osmosis membranes and its pipe work. Heat sanitization can be activated manually using the HEATSAN buttons on the touch screen display or automatically if timer clock settings are implemented. The frequency of heat sanitization will depend upon usage and
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application demands. Monitoring of the system for bacterial content should be conducted at regular intervals to determine the optimum frequency for heat sanitization.
Indications for Use: The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not a complete water treatment system. It must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.
The MediQA is available in both single pass and double pass models that supply from 4.5 to 12.0 gallons per minute (gpm) of product water. Model MSP1 is a single membrane RO that produces up to 5.0 gpm of product water. Model MSP2 is a single pass, dual-membrane RO that produces up to 9.4 gpm of product water. Model MSP3 is a single pass, 3-membrane RO that produces up to 12.6 gpm of product water. Model MDP1 is a double pass, 2-membrane RO that produces up to 5.0 pm of product water. Model MDP2 is a double pass, 3-membrane RO that produces up to 7.0 gpm of product water. Model MDP3 is a double pass, 4-membrane RO that produces up to 10.0 gpm of product water. Model MDP4 is a double pass, 5-membrane RO that produces up to 12.0 gpm of product water.
Statement of Substantial Equivalence: The AmeriWater MEDIQA is substantially equivalent to the Gambro Central Water Treatment System CWP 100 - WRO H cleared for market under K974899. The following table compares and contrasts the predicate device and the new device. This table alona with the documentation included in this submission demonstrates that there are no new issues of safety or effectiveness associated with this design change, and that the new device is substantially equivalent to the predicate device.
| Predicate Device | AmeriWater | |
|---|---|---|
| CWP 100 - WRO H (K974899) | MEDIQA | |
| Indications for use | The Gambro Central Water TreatmentSystem CWP 100-WRO H is designed toproduce water of adequate quality forhemodialysis, both chemically andmicrobiologically with an adequate flow,provided that the feed water complies withthe existing standards for drinking waterand has been properly pre-treated. | The AmeriWater MEDIQA ReverseOsmosis System is a water treatmentsystems intended for use in hemodialysisapplications. The MEDIQA is designed topre-treat and purify potable water for use inmaking dialysate for hemodialysis and tomeet current AAMI and Federal (U.S.)standards. The AmeriWater MEDIQA isintended for use in a hospital, clinic, ordialysis center. The device includes anintegrated heat sanitization process. |
| For Use In: | Hospitals | Hospitals, clinics, or dialysis centers |
| Power Requirements | 120/208V, 60 Hz, 3-phase | 208/230V; 60 Hz; 3-phase |
| Permeate Flow Rates | 3.4 - 9.2 gpm | 4.5 - 12.0 gpm |
| RO Disinfection | Chemical | Chemical or Heat |
| Heat Sanitization For | Water Distribution System | MEDIQA System only |
| Heater Power Rating | 7.0 - 9.0 kW | 9.0 kW |
| Heated Temperature | 185°F | 185 - 203°F |
| Working Tank Volume | 68 - 87 gallons | 16 gallons |
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Summary of Performance Testing: Non-clinical testing was conducted to verify and validate the performance of the reverse osmosis function and the efficacy of the heat sanitization in the reduction of bacteria. Results of performance testing indicate that the device produces water that meets current AAM and Federal (U.S.) standards. Microbiological testing results show evidence that the heat sanitization function is effective in the reduction of bacteria. Clinical studies show evidence that the device, when used in accordance with the instructions for use, will produce water that meets current AAMI and Federal (U.S.) standards for hemodialysis. Test resuits from biocompatibility testing, software validation, and electrical safety testing indicate that the device is safe and effective for its intended purpose.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2013
Ameri Water Brian R. Bowman Quality & Regulatory Administrator 1303 Stanley Avenue Dayton, OH 45404
Re: K131904
Trade/Device Name: AmeriWater MediQA Reverse Osmosis System Regulation Number: 21 CFR$ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: August 12, 2013 Received: August 15, 2013
Dear Brian R. 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 10 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.
1f 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
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Page 2 - Brian R. Bowman
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.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/yem115809.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/ReportalProblem/delault.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 yours.
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AmeriWater
្រប្រចម្ជីដនរបស់ប្រជាជនជន្រ
1303 STANLEY AVENUE DAYTON, OH 45404 USA TEL 937-461-8833.800-535-5585 FAX 937-461-1988 www.ANGERIWATER.com
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Indications for Use
510(k) Number (if known): K131904
AmeriWater MediQA Reverse Osmosis System Device Name:
Indications For Use:
The AmeriWater MediQA Reverse Osmosis System is one component of a water treatment system designed to pre-treat and purify potable water using reverse osmosis for making dialysate for hemodialysis applications. The device is intended to be a component in a complete water purification system, and is not applioditions. The do not no must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well to meet current AAMI and Federal (U.S.) standards. The AmeriWater MediQA is intended for use in water rooms in a hospital, clinic, or dialysis center. The device includes an integrated heat sanitization process.
The MediQA is available in both single pass and double pass models that supply from 4.5 to 12.0 gallons t no moute (gpm) of product water. Model MSP1 is a single membrane RO that produces up to 5.0 gom of product water. Model MSP2 is a single pass, dual-membrane RO that produces up to 9.4 gpm 5.0 gplires product water. Model more pass, 3-membrane RO that produces up to 12.6 gpm of product water. Model MDP1 is a double pass, 2-membrane RO that produces up to 5.0 gpm of product water. Water MDP2 is a double pass, 3-membrane RO that produces up to 7.0 gpm of product water. Model MDP3 is a double pass, 4-membrane RO that produces up to 10.0 gpm of product water. Model MDP4 is a double pass, 5-membrane RO that produces up to 12.0 gpm of product water.
× 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)
Herbert P. Lerner -S 2013.11.13 15:10:58 -05'00'
§ 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.