(379 days)
Not Found
Not Found
No
The description focuses on the physical and chemical processes of reverse osmosis and water purification, with no mention of AI or ML technologies.
No
The device purifies water for use with a hemodialysis system and for other purposes like dialyzer reprocessing; it does not directly treat a patient.
No
This device is a water purification system designed to produce purified water for hemodialysis systems. It does not diagnose any medical condition or disease.
No
The device description clearly outlines a physical system involving reverse osmosis, pumps, filters, tanks, and other hardware components for water purification. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for purifying water used in hemodialysis systems and for other purposes like dialyzer reprocessing and equipment rinse/disinfection. This is a water purification system for medical use, not a device designed to perform tests on biological samples (in vitro).
- Device Description: The description details the process of reverse osmosis and the components involved in purifying water. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health
- Using reagents or assays for testing
The device's function is to prepare water to a specific purity standard for use in a medical procedure (hemodialysis), not to diagnose or monitor a patient's condition through in vitro testing.
N/A
Intended Use / Indications for Use
A ZyzaTech Portable, V, Z or T Series Reverse Osmosis System and its pretreatment and product water distribution components is intended for use with a hemodialysis system 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 other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
Product codes (comma separated list FDA assigned to the subject device)
78 FIP
Device Description
The ZyzaTech series RO systems purify feed water through reverse osmosis which is the opposite of osmosis. Osmosis is the natural process wherein concentrated and dilute solutions, separated by a semipermeable membrane, flow to equalize concentrations. Solvent will flow from the dilute to the concentrated side of the membrane creating equal levels of concentration. Reverse osmosis is the application of high hydrostatic pressure on the concentrated solution; the direction of flow is reversed so that high solute concentrations flow across a semi-permeable membrane and become dilute concentrations. This results in two streams of water; one that is purer than the feed water, and the other that is higher in concentrates than the feed water. The pure flow is product water. The high concentrate flow is waste water.
The purpose of a pretreatment section of the system is to remove chlorine/chloramines and to condition the feed water supplying the RO unit. Conditioning the feed water can include: boosting the pressure, tempering, removal of particulates and, often, membrane scaling factors, along with volatile inorganic and organic solutes. The pretreatment section can include: feed water booster pumps, a temperature blend valve, chemical feed unit, cartidge filters, multi-media (sediment) filters, water softeners, dealkalizers and carbon filtration tanks.
The RO unit removes dissolved inorganic solutes with a molecular weight greater than 300, bacteria, viruses, endotoxins and particles. The primary elements of a RO unit are: a prefilter, RO pump and RO membranes housed in pressure vessels.
The purpose of a product water distribution section of a system is to deliver product water that meets AAMI standards to the points of use. Additional post-treatment measures are intended to control or eliminate bacteria prior to the points of use, especially in an indirect feed type of system. The product water distribution section can include: a storage tank, distribution repressurization pumps, distribution loop, UV irradiators, ultra and sub-micron filters.
Depending upon the series and model, ZyzaTech water purification systems produce typically from 250 gpd to 42,000 gpd of product water with a range of 17-75 percent recovery rate. Rejection of total dissolved solids (TDS) and monovalent and polyvalent ions is in the range of 95-99% depending upon feed water characteristics. Bacteria and pyrogens are rejected 99%. Organic size cut-off is a molecular weight greater than 300 Dalton.
ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD5-1992, Hemodialysis Systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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K964539 p 1/2
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ZyzaTech Water Purification 510(k)
9/11/96
SECTION 8
510(k) Summary of Safety and Effectiveness
This 510(k) Summary of Safety and Effectiveness is provided as part of this Premarket Notification to This 910(i) Sunmiller of the Safe Medical Device Act of 1990 requiring that either a summary be included in a submission or a statement that a summary is available upon request.
Submitter
NOV 26 1997
Emanuel Amato ZyzaTech Water Systems, Inc. 7848 South 202nd Street Kent, WA 98032 Phone: (206) 395-2200 Fax: (206) 395-2363 September 16, 1996
Device Names
Trade names .
ZyzaTech Portable Series Reverse Osmosis Systems: -700 Series -System 750 -MRE-NF
-F800-F801 -RO-Secura ZyzaTech V-Series Reverse Osmosis Systems ZyzaTech Z-Series Reverse Osmosis Systems ZyzaTech T-Series Reverse Osmosis Systems ZyzaTech Water Purification Pretreatment System Components ZyzaTech Water Product Water Distribution System Components
. Common or usual name
Reverse Osmosis systems with pretreatment and product water distribution components.
- Classification name .
Water purification system for hemodialysis (21 CFR 876.5665)
Intended Use
ZyzaTech Reverse Osmosis Systems and their pretreatment and product water distribution components are intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysis concentrate to form dialysate, reprocessing of hemodialyzers and equipment rinse and disinfection.
Device Description
The ZyzaTech series RO systems purify feed water through reverse osmosis which is the opposite of osmosis. Osmosis is the natural process wherein concentrated and dilute solutions, separated by a semipermeable membrane, flow to equalize concentrations. Solvent will flow from the dilute to the concentrated side of the membrane creating equal levels of concentration. Reverse osmosis is the application of high hydrostatic pressure on the concentrated solution; the direction of flow is reversed so that high solute concentrations flow across a semi-permeable membrane and become dilute concentrations. This results in two streams of water; one that is purer than the feed water, and the other
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K964539 p.2/2
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ZyzaTech Water Purification 510(k)
that is higher in concentrates than the feed water. The pure flow is product water. The high concentrate flow is waste water.
The purpose of a pretreatment section of the system is to remove chlorine/chloramines and to condition the feed water supplying the RO unit. Conditioning the feed water can include: boosting the pressure, tempering, removal of particulates and, often, membrane scaling factors, along with volatile inorganic and organic solutes. The pretreatment section can include: feed water booster pumps, a temperature blend valve, chemical feed unit, cartidge filters, multi-media (sediment) filters, water softeners, dealkalizers and carbon filtration tanks.
The RO unit removes dissolved inorganic solutes with a molecular weight greater than 300, bacteria, viruses, endotoxins and particles. The primary elements of a RO unit are: a prefilter, RO pump and RO membranes housed in pressure vessels.
The purpose of a product water distribution section of a system is to deliver product water that meets AAMI standards to the points of use. Additional post-treatment measures are intended to control or eliminate bacteria prior to the points of use, especially in an indirect feed type of system. The product water distribution section can include: a storage tank, distribution repressurization pumps, distribution loop, UV irradiators, ultra and sub-micron filters.
Depending upon the series and model, ZyzaTech water purification systems produce typically from 250 gpd to 42,000 gpd of product water with a range of 17-75 percent recovery rate. Rejection of total dissolved solids (TDS) and monovalent and polyvalent ions is in the range of 95-99% depending upon feed water characteristics. Bacteria and pyrogens are rejected 99%. Organic size cut-off is a molecular weight greater than 300 Dalton.
ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard issued by the American National Standard Institute and the Association for the Advancement of Medical Instrumentation: ANSI/AAMI RD5-1992, Hemodialysis Systems.
Predicate Devices
The ZyzaTech series RO systems and pretreatment and product water distribution components are substantially equivalent to the following legally marketed devices: Water Purification System manufactured by Better Water Inc., HD-100 Hemodialysis Systems & Accessories manufactured by Water Pure Corporation, and Hemo-ROMilli RO Water Purification Systems manufactured by Millipore All these devices use reverse osmosis technology to purify water for hemodialysis Corporation. applications.
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1997
Mr. Emanual J. Amato President ZyzaTech Water System, Inc. 7848 S. 202nd Street Kent, Washington 98032
Re: K964539
Water Purification Systems and Components and Portable Reverse Osmosis Systems Dated: August 25, 1997 Received: September 9, 1997 Regulatory class: II 21 CFR §876.5665/Product code: 78 FIP
Dear Mr. Amato:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 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 requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 of the regulation of the regulation of the "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/dsmamain.html".
Sincerely yours
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
Page 1 of 1
510(k) Number: K964539
Device Name: Reverse Osmosis Systems Trade Names: ZyzaTech Portable Series, 700 Series, System 750, MRE-NF, F800-F801, RO-Scura
Central Systems ZyzaTech V-Series Reverse Osmosis Systems ZyzaTech Z-Series Reverse Osmosis Systems ZyzaTech T-Series Reverse Osmosis Systems
ZyzaTech Water Purification Pretreatment Svstem Components ZyzaTech Product Water Distribution System Components
Classification name Water purification system for hemodialysis (21 CFR 876.5665)
Indications for use:
A ZyzaTech Portable, V, Z or T Series Reverse Osmosis System and its pretreatment and product water distribution components is intended for use with a hemodialysis system 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 other purposes such as dialyzer reprocessing and equipment rinse and disinfection.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Druce J. H. Lee
Division Sign Off) Division of Reproductive, Abdominal, ENT, 1 Radiological Devices
10(k) Number_10(k) Number 10(k) 10 3 3 9
Prescription Use (Pcr 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)