(221 days)
Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
Virginia Water Systems' Water Purification for Hemodialysis is complete water treatment system used in the production of ultrapure water used in hemodialysis facilities. The components consist of the following: Blend Valve, Inlet Booster Pump, Multimedia Filter, Softener, Carbon Tanks, Reverse Osmosis Unit, Water Storage Tank, Repressure Pumps, Deionizer, Ultraviolet Light, Submicron Filter, Hollow Fiber Filter.
The provided document is a 510(k) summary for the Virginia Water Systems' Water Purification for Hemodialysis. It outlines the device description, intended use, and claims substantial equivalence to predicate devices. However, it does not contain information related to specific acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance in the sense typically associated with AI/ML-driven medical devices.
The document is for a physical water purification system, not a software algorithm, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as defined in the prompt (e.g., related to sensitivity, specificity, PPA, NPA, expert adjudication, training/test sets, etc.) are not applicable here.
Instead, for this type of medical device, "acceptance criteria" would refer to its ability to meet water quality standards (e.g., AAMI standards for hemodialysis water) and "proof" would be through engineering specifications, performance testing of the physical components, and comparison to existing predicate devices. The document explicitly states:
"Virginia Water systems claims equivalence in terms of technological characteristics, including design, material, chemical composition, and energy source as the predicate devices."
Therefore, I cannot extract the requested information because it is not present in the provided text.
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K991916
p.1/3
SECTION 8
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
May 25, 1999
Hemodialysis
Submitted by: VIRGINIA WATER SYSTEMS, INC. 7433 Whitepine Road Richmond, VA 23237 (804) 743-0034
Contact: William G. Garrahan
Dated :
Classification Name:
Proprietary Name:
Claiming Substantial _Equivalence To:
Osmonics Osmo 23G Series Reverse Osmosis / K931595B
Water Purification System for
Virginia Water Systems' Water Purification for Hemodialysis
MarCor Complete Water Treatment System for Kidney Dialysis / K945559
Gambro Central Water Treatment System CWP100-W / K974899
Dayton Water Systems Ultrapure Water Treatment System for Hemodialysis K981680
Device Description:
Virginia Water Systems' Water Purification for Hemodialysis is complete water treatment system used in the production ਰ of ultrapure water used in hemodialysis facilities. The components consist of the following:
Blend Valve - used to temper the incoming water to 77°F.
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991916 p. 2/3
CHARACTERISTICS
| Design | Material | ChemicalComposition | EnergySource | |
|---|---|---|---|---|
| Va. Water | CompleteSystem | PretreatmentRO, Post-treatment | FRP, PVC, SSPolypro | 110/220V |
| Osmonics | RO only | Exact ROunit | Same | 110/220V |
| MarCor | CompleteSystem | Same | Same | 110/220V |
| Gambro | CompleteSystem | Same | Same | 110/220V |
| Dayton | CompleteSystem | Same | Same | 110/220V |
Statement of Intended Use:
Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
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Device Description (cont'd)
Inlet Booster Pump - increases incoming water pressure to the pre-treatment and RO unit.
Multimedia Filter - removes incoming particles to a level of ten (10) microns.
Softener - reduces hardness constituants in incoming water.
Carbon Tanks - two (2) tanks in series that remove chlorine, chloramine, and organics. Ten (10) minutes empty bed time ensures complete chloramine removal.
Reverse Osmosis Unit - removes 95-98% of incoming minerals and 99% of organics. This is the primary treatment in most instances.
Water Storage Tank - retains product water from reverse osmosis unit as well as water recirculated through dialysis loop.
Repressure Pumps - supply pressure of water out of storage tank to the post-treatment equipment and the loop.
Deionizer - removes remaining minerals in RO product water as well as functions as a back-up to the reverse osmosis unit during periods of pre-teatment or RO problems.
Ultraviolet Light - kills bacteria in product water of RO, DI, or from the recirculation loop.
Submicron Filter - removes bacteria and particles greater than .2 micron from the product water and loop.
Hollow Fiber Filter - provides pyrogen removal with .05 micron filtration.
Technological Characteristics - Virginia Water systems claims equivalence in terms of technological characteristics, including design, material, chemical composition, and energy source as the predicate devices. A summary is as follows:
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
JAN 1 4 2000
Mr. William G. Garrahan Virginia Water Systems, Inc. 7433 Whitepine Road Richmond, VA 23237
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K991916
Virginia Water Systems' Water Purification System for Hemodialysis Dated: October 13, 1999 Received: October 20,1999 Requiatory Class: II 21 CFR §876.5665/Procode: 78 FIP
Dear Mr. Garrahan:
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, 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 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) 594-4613. 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"(21 CFR 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 7
INDICATION FOR USE STATEMENT
from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
Prescription Use . (Per 21 CFR 801.109)
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 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.