FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS by FLUID PROCESS SYSTEMS, INC.

The intended use of this system, comprising of the following components, is to provide water to dilute dialysate for use in HEMODIALYSIS applications.

Carbon Tank (see description inside the application)
Cation Deionization Tank
Anion Deionization Tank
Mixed Bed Deionization Tank
Mixed Bed Deionization Tank (used as a polisher tank)

The combination of the above listed components will deliver water which exceeds AAMI Standards for water used to dilute dialysate for HEMODIALYSIS. The system does not come into contact with any patient and is used solely as indicated. The components are used in this series (without exception) and are not designed to be bypassed at any point. The process requires additional components which are added or furnished by the end user. These include a UNIT-ULTRAVIOLET DISINFECTION and an ULTRAFILTER, with a rating of .05 micron, to reduced the risk of pyrogens being passed through the system. The instruction manual outlines several tests which are required prior to use prior to every patient shift. The final decision to use the water for HEMODIALYSIS rests with the medical director.

Device Description

Deionization has long been a standard to treat water used in hemodialysis. Because of the patient safety include several hemodialysis. Because of the pactanding system must include several types of Deionization, as a freestanding addressed each issue in designing the satety precautions. We have addressed cach component is outlined below.

Technological Characteristics (ocheach time sufficient to remove 1. A carbon can't with an empey as blaced in front of the deionization any chloramines is placed in front of hoth conscate The deionization equipment consists of both separate equipment. equipment. The defonibility of the arrangement of the tanks is as follows:

Carbon Tank (used to remove chloramines and chlorines) Cation Tank (used to remove positively charged particles) (used to remove negatively charged particles) Anion Tank (used to removing polisher to cleanse the water) Mixed Bed (used as a final polisher) Mixed Bed

Other integral pieces of equipment are

The lines which flow the product. These must be from TOC The fines which first. Special materials are used in the hoses to The hose runs are as short as prevent the growth of bacteria. prevent the growth of Bacount of "Hide Out" space for bacteria possible to reduce ene amount of the Unit" is placed in line to The "Ultraviolet remove any remaining bacteria from the line. remove any removes 99.9% of the bacteria that is present. The use of "Ultra-violet Rays" creates pyrogens or the destroyed bodies of the bacteria. These pyrogens are further removed by using a "Submicron Filter" which is normally sized at .05 micron. This Filter is capable of collecting most anything that escapes the deionization process and the "Ultraviolet Disaffection Unit". A acronization probled at the inlet to the Hemodialysis This monitor measures the quality of the water coming from Stream. the deionization equipment. The monitor features an inline cell, which continually measures the quality of the water. It has both an audible and visual alarm to alert the operator to any alarm condition. The set point is adjustable but we recommend the setting at 2 megohms. This setting alerts the operator that the system is nearing exhaustion and steps are necessary to protect the patients.

AI/ML Overview

The document describes the Exchange Carbon and Deionization Tanks for Hemodialysis, manufactured by Fluid Process Systems, Inc., which is intended to provide water to dilute dialysate for use in hemodialysis applications.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Water Quality (based on AAMI/ANSI Standards):

Parameter	Acceptance Criteria (AAMI/ANSI Standards)	Reported Device Performance (from summary)
Resistivity	1 megohm (minimum)	The monitor's set point is recommended at 2 megohms, which "alerts the operator that the system is nearing exhaustion and steps are necessary to protect the patients." The summary also states, "the deionization equipment will produce water meeting AMMI/ANSI Standards" and that "the deionization meets the standards more readily" than specified.
Chloramines	Removal	"A carbon tank... is placed in front of the deionization equipment to remove any chloramines."
Chlorines	Removal	"A carbon tank... is placed in front of the deionization equipment to remove any... chlorines."
Bacteria	Removal	"The Ultraviolet Disinfection Unit removes 99.9% of the bacteria that is present."
Pyrogens	Removal	"These pyrogens are further removed by using a 'Submicron Filter' which is normally sized at .05 micron."
Total Organic Carbon (TOC)	Restricted	"The lines which flow the product... must be from TOC first. Special materials are used in the hoses to prevent the growth of bacteria."

Additional Performance Claims / Design Features fulfilling safety criteria:

Capacity: Sized with sufficient capacity to provide time and methodology for end-users to run equipment.
Redundancy: System always supported by a mirror image, which can be placed in service in minutes.
Checkpoints: Multiple checkpoints (inlet water volume, chloramines/chlorines Post-carbon tank, UV unit operation, Ultrafilter flow, Resistivity Monitor condition/water quality) are included and required to be checked prior to each patient shift.
Ultraviolet Disinfection Unit: Removes 99.9% of bacteria.
Submicron Filter (.05 micron): Removes pyrogens and other contaminants escaping deionization and UV disinfection.
Resistivity Monitor: Features an inline cell, continuous monitoring, audible and visual alarm, adjustable set point (recommended 2 megohms).
Log Book: Operational log required to record parameters prior to each patient shift.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a specific "sample size" in terms of number of units tested. The document mentions that "Equipment was placed in normal operation during a non-patient shift and water was circulated through the equipment for a period of time. Test samples were taken from the through put of the deionization tanks using treated water and non-treated water." The quantity of "test samples" taken is not specified.
Data Provenance: The data was collected under "normal operating clinical conditions." The country of origin is not explicitly stated, but the submission is to the U.S. FDA by Fluid Process Systems, Inc. in El Paso, Texas, suggesting the testing was likely conducted in the USA. The study design is prospective in the sense that the new equipment was set up and tested for its performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this device. This is not a diagnostic device where expert ground truth on patient data is typically established (e.g., radiologists interpreting images). Instead, the device's performance is measured against established chemical and physical water quality standards (AAMI/ANSI Standards), which are objective and do not require expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is based on objective chemical and physical measurements against AAMI/ANSI standards, there is no need for expert adjudication of results. The measurements speak for themselves against the quantitative criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images). This device is a water purification system, and its effectiveness is determined by objective water quality measurements, not by human interpretation of clinical cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was done. The testing described focuses on the device's ability to produce water meeting specified standards. The results of "test samples were taken from the through put of the deionization tanks" directly reflect the standalone performance of the equipment. While operators are required to check the system, the fundamental performance of the deionization process itself is independent of human interpretation during the test condition.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards for water quality in hemodialysis: AAMI/ANSI Standards. These standards provide objective, quantitative benchmarks for resistivity, and implicitly for the removal of contaminants like chloramines, chlorines, bacteria, and pyrogens.

8. The Sample Size for the Training Set

Not applicable. This device is a water purification system, not an artificial intelligence (AI) or machine learning (ML) algorithm that requires a "training set" of data. The performance is based on physical and chemical processes, not on learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a non-AI/ML device, there is no "training set" or "ground truth for the training set" involved in its development or evaluation.

Summary

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Image /page/0/Picture/1 description: The image is a black and white graphic that appears to be a stylized representation of a letter or symbol. The design is composed of thick, solid black lines and shapes against a white background. The overall shape is somewhat square, with a portion of the upper left corner cut off at an angle.

Fluid Process Systems, Inc.

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August 15, 2000

Food and Drug Administration 9200 Corporate Blvd Rockville, Md. 20820

RE: 510(k) Summary for K991495 per section 807.92(c)

Dear Sir or Madame:

Pursuit to section {807.92(a) (1) }, we are submitting a 510 (k) summary to complete our application

Trade Name: Exchange Carbon and Deionization Tanks for Hemodialysis per [807.02. (a) (2) ] Common Name: Exchange Deionization Classification Name: Deionization for Hemodialysis, Class II (generic class) section # 78, Gastroenterology/Urology section 21 CFR 807.87.C

Submitted by:

Stephen C. Hambric Vice President Fluid Process Systems, Inc. Phone: (915) 852-1007 Fax:

Exchange Deionization as a predicate device can be found in the legally marketed device submitted by the following companies: [807.92(a) (3)]

Aqua-Med Systems,Inc. 3607 Chapel Hill Road McHenry, Il. 60050

R.D. Baker,DBA Dayton Water Services 1288 McCook Ave. Dayton, Oh. 45404

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K991495

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In Summary: [807.92(a) (4) ]

Delonization has long been a standard to treat water used in hemodialysis. Because of the patient safety include several hemodialysis. Because of the pactanding system must include several types of Deionization, as a freestanding addressed each issue in designing the satety precautions. We have addressed cach component is outlined below.

Technological Characteristics [807.92(a)(6)]

Technological Characteristics (ocheach time sufficient to remove 1. A carbon can't with an empey as blaced in front of the deionization
any chloramines is placed in front of hoth conscate The deionization equipment consists of both separate equipment. equipment. The defonibility of the arrangement of the tanks is as follows:

Other integral pieces of equipment are

AMMI/ANSI Standards are normally set at 1 megohm and the above setting allow the operator to react prior to an emergency. Prior to each patient shift, the operator must as a minimum, check for chloramines, chlorines, resistivity and flow. The "Ultraviolet Disaffection Unit", "Ultrafilter" and resistivity monitor should be checked for operation.

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An operational log should be used to record each parameter prior to any patient shift. This log provides assurance that each test has been performed and all equipment has been checked prior to use.

p. 3/4

By providing the equipment and safety factors described above, the most comprehensive steps have been used to insure that the water quality is safe for hemodialysis.

By sizing the tanks with sufficient capacity, we can provide the 2. end User with both the time and methodology to run the equipment as The system is always supported by a mirror image, which desired. can be placed n service in a matter of minutes.
Several checkpoints are included as precautions to insure that each 3 . patient shift is safe to perform hemodialysis. The safety factors are:
- Check the inlet water volume. a.
- Check for Chloramines and Chlorines after the carbon tank. b.
- Check the operation of the "Ultraviolet Disaffection Unit". c.
- Check the flow across the "Ultrafilter". ದ .
- Check the condition of the Resistivity Monitor and measure the e . water quality.

These steps will insure that a safe and effective patient shift can be achieved.

4 . The water produced by the exchange carbon and deionization tanks is intended to dilute the Dialysate used to cleanse blood during hemodialysis. The purity of the water helps to determines how effective the dialysis procedure is accomplished. The steps taken to protect the patient are there to insure the quality of the dialysis program. The standards used to measure the water quality are put in place to protect the patient.
1. All data submitted as part of this package was collected under normal operating clinical conditions. Copies of the test results originally submitted to the FDA are included with this summary.
1. Equipment was placed in normal operation during a non-patient shift and water was circulated through the equipment for a period of time. Test samples were taken from the through put of the deionization tanks using treated water and non-treated water. The determination for using non-treated water was to illustrate that under the most adverse conditions, the deionization equipment will produce water meeting AMMI/ANSI Standards.

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K991495

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1. In conclusion, the deionization tanks will produce the quality of In Concrusion, che defenzadas for use in hemotialysis water as defined by raisea, because well water has high TDS, a applications. In our area, because new one megohm quality Neverse on defined by AMMI. For this reason, our consensus of finion is that deionization meets the standards more readily.
  Respectfully Submitted,

Stephen C. Hamble

Stephen C. Hambric Fluid Process Systems, Inc.

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Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be a stylized representation of a bird or a wing-like shape, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2000

Mr. Stephen C. Hambric Vice President Fluid Process Systems, Inc. 998A Peyton Road El Paso, Texas 79927

Re: K991495

Exchange Carbon and Deionization Tanks for Hemodialysis Dated: May 22, 2000 Received: May 30, 2000 Regulatory Class: II 21CFR 876.5665/Procode: 78 FIP

Dear Mr. Hambric:

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 market in interstate commerce pror to May 20, 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 manikot the borned 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 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 Radialion 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 نيرونالي diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 entilled, "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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Page 1 of 1

K991495 510(k) Number (if known):

Fluid Process Systems, Inc.

Device Name:_ Exchange Carbon and Deionization Tanks for Hemodialysis

Indications For Use:

The intended use of this system, comprising of the following components, is to provide water to dilute dialysate for use in HEMODIALYSIS applications.

1. Carbon Tank (see description inside the application)
1. Cation Deionization Tank
1. Anion Delonization Tank
Mixed Bed Deionization Tank 4.
1. Mixed Bed Deionization Tank (used as a polisher tank)

The combination of the above listed components will deliver water which exceeds AAMI Standards for water used to dilute dialysate for HEMODIAL YSIS. The system does not come into contact with any patient and is used solely as indicated. The components are used in this series (without exception) and are not designed to be bypassed at any point. The process requires aditional components which are added or furnished by the end user. These include a UNIT-ULTRAVIOLET DISINFECTION and an ULTRAFILTER, with a rating of .05 micron, to reduced the risk of pyrogens being passed through the system. The instruction manual outlines several tests which are required prior to use prior to every patient shift. The final decision to use the water for HEMODIAL YSIS rests with the medical director.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Timith h. Sefrom
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.