(368 days)
This device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.
The PURE WATER Solutions' Water Purification System for Hemodialysis is designed to provide water of the required quality to meet AAMI standards for riohodialysto is actigate will remove organic, inorganic and microbial contaminants from the influent water supplied to Hemodialysis clinics. This system comes in various sizes to provide the proper volume of water for each individual clinic. It is easily used and maintained by clinic technicians. The water treatment phase or pretreatment includes multi-media filtration to reduce suspended solids, water softening to reduce hardness and granular activated carbon filters to remove chlorine and chloramines. If finer filtration is required, cartridges with appropriate housings may be used. The purifier phase includes reverse osmosis (RO) and or portable-exchange deionization (DI). The primary method will be reverse osmosis using an existing FDA cleared device. DI may be selected for use either independently or in conjunction with RO depending upon the influent water analysis, the available space and the demand required. If DI is selected, then 0.1 micron, absolute, final filters will be installed downstream of the DI and a temperaturecompensated, conductivity instrument will be used to monitor the quality. The circulation phase or post treatment may consist of an RO storage tank with an appropriate 0.2 micron, absolute, vent filter, a stainless steel repressurization pump, ultraviolet sterilization, and 0.05 micron, absolute, final filter. Auxiliary devices such as booster pumps, temperature blending valves, pressure gauges, sample ports, fittings, piping, level control switches and remote alarms are used as needed throughout the system. A clean-in-place system consisting of an inert plastic or stainless steel pump and a solution tank is used to clean RO membranes. A paracetic acid disinfection product may be used to chemically disinfect the RO while ozone is used to disinfect the circulation phase.
The provided text is a 510(k) summary for the PURE WATER-CDS (Central Dialysis Solution) system. This document is for a medical device that purifies water for hemodialysis, and thus the acceptance criteria and study information typically refer to the performance of the water purification system itself, rather than a diagnostic algorithm or AI.
Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Water Quality for Hemodialysis (AAMI Standards) | "designed to provide water of the required quality to meet AAMI standards for hemodialysis" |
| Removal of Organic Contaminants | "will remove organic... contaminants from the influent water" |
| Removal of Inorganic Contaminants | "will remove... inorganic... contaminants from the influent water" |
| Removal of Microbial Contaminants | "will remove... microbial contaminants from the influent water" |
| Materials of Construction Safety | "All components used in the system are components with existing safety records. Materials of construction consist of stainless steel, polypropylene... meet and do not contribute contaminants to treated water systems." |
| Resin Conformance to FDA Standards | "Water treatment resins are standard resins used in potable and high poryonifications and conform to FDA standards 21 CFR 173.25" |
| Filter Validation | "filters are validated for low media migration and with demonstrated microbial retentiveness." |
| Substantial Equivalence to Predicate Device (Mar Cor Services, Inc. #K945559) | "We believe this system is equivalent to an FDA approved system currently on the market, namely, the predicate device from Mar Cor Service, Inc. 510(k) #K945559." |
2. Sample size used for the test set and the data provenance:
The document describes a water purification system, not a diagnostic device with a "test set" of data in the typical sense of AI/ML. The "testing" appears to be based on the characterization of individual components and the overall system's design to meet established standards.
- Sample size: Not applicable in the context of a dataset for an AI/ML model. The evaluation is based on the system's design, component specifications, and adherence to industry standards.
- Data provenance: Not applicable as there is no specific dataset for a "test set" of patient data. The provenance relates to the standards (AAMI, FDA) and the safety records of individual components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The "ground truth" for a water purification system is defined by established industry and regulatory standards for water quality (e.g., AAMI standards, FDA standards 21 CFR 173.25 for resins). The device's performance is measured against these objective standards, rather than expert consensus on a test set.
4. Adjudication method for the test set:
Not applicable. There is no "test set" of cases requiring adjudication by experts. The system's performance is assessed against objective, measurable water quality parameters and material specifications.
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:
Not applicable. This device is a water purification system, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI performance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical water purification system, not an algorithm.
7. The type of ground truth used:
The ground truth used for this device's acceptance is based on:
- Established Industry Standards: AAMI (Association for the Advancement of Medical Instrumentation) standards for water quality in hemodialysis.
- Regulatory Standards: FDA standards (e.g., 21 CFR 173.25 for resins).
- Safety Records and Specifications: Existing safety records and specifications for individual components (e.g., stainless steel, polypropylene, filters).
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
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DEC 22 2000
510 (k) Summary
| Submitter: | PURE WATER Solutions, Inc.14550 East Easter Avenue, Suite 800Englewood, Colorado 80112Phone 303/693-7610, Fax 303/693-4479Contact Name: Dean S. Lewis | |
|---|---|---|
| Classification Name: | Water Purification System for Hemodialysis | |
| Device Name: | PURE WATER-CDS (Central Dialysis Solution) | |
| Predicate Device: | Mar Cor Services, Inc. #K945559 |
The PURE WATER Solutions' Water Purification System for Description of System: Hemodialysis is designed to provide water of the required quality to meet AAMI standards for riohodialysto is actigate will remove organic, inorganic and microbial contaminants from the influent water supplied to Hemodialysis clinics. This system comes in various sizes to provide the proper volume of water for each individual clinic. It is easily used and maintained by clinic technicians.
The water treatment phase or pretreatment includes multi-media filtration to reduce suspended solids, water softening to reduce hardness and granular activated carbon filters to remove chlorine and chloramines. If finer filtration is required, cartridges with appropriate housings may be used.
The purifier phase includes reverse osmosis (RO) and or portable-exchange deionization (DI). The primary method will be reverse osmosis using an existing FDA cleared device. DI may be selected for use either independently or in conjunction with RO depending upon the influent water analysis, the available space and the demand required. If DI is selected, then 0.1 micron, absolute, final filters will be installed downstream of the DI and a temperaturecompensated, conductivity instrument will be used to monitor the quality.
The circulation phase or post treatment may consist of an RO storage tank with an appropriate 0.2 micron, absolute, vent filter, a stainless steel repressurization pump, ultraviolet sterilization, and 0.05 micron, absolute, final filter.
Auxiliary devices such as booster pumps, temperature blending valves, pressure gauges, sample ports, fittings, piping, level control switches and remote alarms are used as needed throughout the system.
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A clean-in-place system consisting of an inert plastic or stainless steel pump and a solution tank is used to clean RO membranes. A paracetic acid disinfection product may be used to chemically disinfect the RO while ozone is used to disinfect the circulation phase.
All components used in the system are components with Safety and Effectiveness: existing safety records. Materials of construction consist of stainless steel, polypropylene, existing survey records. Water treatment resins are standard resins used in potable and high poryonifications and conform to FDA standards 21 CFR 173.25 and filters are validated for low media migration and with demonstrated microbial retentiveness. All of these materials 10 i meet and do not contribute contaminants to treated water systems. The PURE WATERare mere and is assembled using existing technologies, an RO unit with existing FDA marketing clearance and personnel with certification to Water Quality Association, Lisle, Illinois, standards of system design, maintenance and treatment.
Conclusion: PURE WATER Solutions, Inc. has designed a water treatment system for Hemodialysis. We believe this system is equivalent to an FDA approved system currently on the market, namely, the predicate device from Mar Cor Service, Inc. 510(k) #K945559. The the mailed, amazerials that are safe and effective and methods of design, construction and installation sanctioned by current standards in industry. We therefore request that PURE WATER Solutions' PURE WATER-CDS be granted substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 2000
Mr. Dean S. Lewis President Pure Water Solutions, Inc. 14550 East Easter Avenue Suite 800 ENGLEWOOD CO 80112 Re: K994279
Pure Water - CDS (Central Dialysis Solution) Dated: October 1, 2000 Received: October 6, 2000 Regulatory Class: II 21 CFR §876.5665/Procode: 78 FIP
Dear Mr. Lewis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21.CFR Part 820) and that, through periodic QS inspections, the Food and Drug, Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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|---|---|
| ------ | ---- |
K994279 510(k) Number
PURE WATER-CDS Device Name
Indications For Use:
This device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Sezman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
(Optional Format 3-10-98)
Prescription Use (Per 21 CFR 801.109)
000452
§ 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.