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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the ZyzaTech Water Purification Systems, which are intended for use with hemodialysis systems. While the document outlines the device's function, intended use, and general performance claims, it does not contain the detailed study information typically found when evaluating acceptance criteria against specific scientific studies.

The document claims the device meets the voluntary standard ANSI/AAMI RD5-1992, Hemodialysis Systems, but it does not provide the specific acceptance criteria from that standard nor a detailed study report demonstrating compliance.

Therefore, much of the requested information cannot be extracted from the provided text. I will complete what is available and note what is missing.

Acceptance Criteria and Device Performance

The document states that ZyzaTech's water purification systems produce product water that meets the requirements of the voluntary standard ANSI/AAMI RD5-1992, Hemodialysis Systems. While the specific numerical acceptance criteria from that standard are not provided in the input text, the document does report general performance characteristics of the ZyzaTech systems.

Performance Metric	Acceptance Criteria (from ANSI/AAMI RD5-1992)	Reported Device Performance
Total Dissolved Solids (TDS) Rejection	Not specified in text	95-99% (depending on feed water characteristics) for TDS and monovalent/polyvalent ions.
Bacteria Rejection	Not specified in text	99%
Pyrogen Rejection	Not specified in text	99%
Organic Size Cut-off	Not specified in text	Molecular weight greater than 300 Dalton
Product Water Production Rate	Not specified in text	Typically 250 gpd to 42,000 gpd (depending on series and model)
Recovery Rate	Not specified in text	17-75 percent
Compliance with Standards	Not specified in text	Meets the requirements of ANSI/AAMI RD5-1992, Hemodialysis Systems (voluntary standard).

Study Details (Information Not Available in the Provided Text)

The provided text is a 510(k) summary, which typically summarizes the equivalence to predicate devices rather than providing full study protocols and results for device performance against specific acceptance criteria. Therefore, the detailed study information requested below is not available within the input.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states general performance characteristics ("typically," "range of," "depending upon") but does not detail specific test sets or studies performed to arrive at these numbers.
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):
- Not applicable/Not provided. This type of information is relevant for studies involving human interpretation (e.g., medical imaging diagnostics). For a water purification system's performance, ground truth would typically be established through analytical laboratory methods, not expert consensus on interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As above, this is typical for studies involving human reviewers and diagnostic interpretations.
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/Not provided. This is a water purification system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a physical water purification system, not an algorithm. Its performance is inherent to its mechanical and chemical processes, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For water purification systems, ground truth is typically established by chemical and microbiological laboratory analysis of water samples before and after purification against established standards (e.g., AAMI RD5-1992 chemical limits, bacterial counts). However, the specific methodology is not detailed in the provided document.
The sample size for the training set:
- Not applicable/Not provided. The device is a physical system, not a machine learning algorithm that requires a "training set." Its effectiveness is based on engineering design and physical principles.
How the ground truth for the training set was established:
- Not applicable/Not provided. See the explanation for point 7.

Summary

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K964539 p 1/2

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ZyzaTech Water Purification 510(k)

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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

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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.

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

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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:

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)

Regulation Number and Section

§ 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.