WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

K014169 · Bob J. Johnson & Assoc., Inc. · FIP · Feb 6, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K014169
• Device Name: WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
• Applicant: Bob J. Johnson & Assoc., Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Feb 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

Carbon Filters and Water Softeners are intended to be used as components of a water purification system to remove organic and inorganic substances 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 Story

Water purification components (softeners and carbon filters) for hemodialysis systems; remove organic/inorganic substances and microbial contaminants from water used for dialysate dilution, dialyzer reprocessing, and equipment maintenance. Softeners use single or duplex-twin alternating tanks to ensure continuous soft water supply; carbon filters use dual-series configuration with test ports to remove chlorine/chloramines. Operated by clinic staff; used in clinical hemodialysis settings. Output is purified water meeting AAMI standards. Healthcare providers monitor water quality via periodic testing. Benefits include consistent water quality for dialysis and reduced risk of contamination during patient shifts.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes water quality analysis, Total Organic Carbon (TOC) analysis, and adherence to AAMI water purification standards.

Technological Characteristics

Components: Water softeners and carbon filters. Materials: FDA/NSF approved. Configuration: Dual-series carbon filters; single or duplex-twin alternating softeners. Connectivity: Standalone. Standards: AAMI water purification requirements. Carbon filters: 10-minute empty bed contact time; Iodine number ≥ 900.

Indications for Use

Indicated for use as components in hemodialysis water purification systems to remove organic/inorganic substances and microbial contaminants from water used for dialysate dilution, dialyzer reprocessing, and equipment disinfection/rinsing.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• U.S. Filter Water Purification System (K980182)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "BJJ&A Total Water Treatment Bob J. Johnson & Associates, Inc." The logo includes a star on the left, followed by the text "BJJ&A" and a series of wavy lines. Below the wavy lines is the text "Total Water Treatment" and "Bob J. Johnson & Associates, Inc."

FEB 0 6 2002

K014169 Page 1 of 3

### San Antonio Office

7715 Mainland Suite 115 San Antonio, Texas 78250 [phone] [phone] Fax

#### Corporate Office

1313 FM 1960 E. Houston, Texas 77073 [phone] [phone] Fax

#### Dallas Office

2619 Farrington Street as. Texas 75207 (-- +) 631-4316 [phone] Fax

#### San Angelo Office

7433 Billo Dr. San Angelo, Tx. 76901 [phone]

#### Lubbock Office

516 84th Street Lubbock, Texas 79404 [phone] [phone] Fax

#### Harlingen Office

Federico Vaquera [phone] [phone] Fax

# PREMARKET NOTIFICATION 510(k) SUMMARY

November 30, 2001

Bob J. Johnson & Assoc., Inc. 7715 Mainland Dr. #115 San Antonio, Texas 78250 Robert Snyder

Ph: [phone]
Fax: [phone]

WATER PURIFICATION COMPONENTS FOR HEMODIAL YSIS Regulatory Classification: Class II CFR 876.5665(a)

> Product Code: 78 FIP

Note: In this summary the word "component" refers to an individual part of a water treatment system. Example : the water softener or the carbon filter. The word system refers to the water purification plant as a whole. Example: the water softener, carbon filter, reverse osmosis, storage tank, ultrafiltration, ultraviolet sterilizer, and pumping systems. We are claiming substantial equivance to components

Bob J. Johnson & Assoc., Inc. (BJJ&A) is applying for a 510(k) premarket notification for our "Water Purification Components for Hemodialysis". The following is a summary of our submission document. The regulatory classification is class II CFR 876.5665(a), Product Code 78 FIP. The device we are claiming substantial equivalence to is marketed by U.S. Filter. The registration number for this device is K980182, U.S. Filter Water. Purification System. Regulatory Class: II, 21 CFR 876.5665/Procode: 78 FIP.

The BJJ&A water purification system for hemodialysis will be used with a hemodialysis system. The Water purification system will remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.

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K014169
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The purified water will also be used in the equipment disinfection process, equipment rinsing and any other application the clinic/customer deems appropriate. This system will meet all the requirements put forth by the United States Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) and any other laws that may apply.

The BJJ&A water purification components utilize no new water purification techniques, carbon filtration and water softening. The predicate device system we are claiming SE to, utilizes the exact same water purification principles. The following is a comparison summary of the BJJ&A water treatment components and the predicate device.

BJJ&A and U.S. Filter both utilize a water softener made of materials, which are "NSF" and/or FDA approved. U.S. Filters' softener is installed with a single regeneration tank and electrically interlocked to shut down the RO unit operation during the softener regeneration cvcle. BJJ&A softeners are installed in a single regeneration tank configuration such as USF or in a duplex-twin alternating fashion to provide softened water to the system 24 hours a day. While one regeneration tank is in a regeneration cycle the other regeneration tank is on line providing soft water to the system. This will prevent the possibility of softener regeneration or a salt dump into the water purification system during a patient shift. This also eliminates the need to shut down the RO unit for softener regeneration. Information is available in the "purposes and operation" summary.

Carbon filtration is utilized by both BJJ&A and U.S. Filter to filter out chlorine and chloramines from the water. BJJ&A uses carbon filter made from materials, which are FDA or NSF approved. Both companies use two carbon filters in a series configuration with test ports installed after each filter. A minimum total contact time of 10 empty bed contact time minutes are incorporated into both designs as recommended by the FDA for chlorine and chloramine removal. Both BJJ&A and U.S. Filter recommended the chlorine and chloramine levels be checked before each patient shift. Hard plumbed bypass piping of the carbon tanks is not allowed on either component. Both components will utilize an activated carbon with an Iodine number of 900 or greater. Both BJJ&A and U.S. Filter uses in line carbon regeneration filters. U.S. Filter uses a single carbon filter in its single patient dialysis system. BIJ&A always uses a dual carbon filter in series in every dialysis water system installed, including single patient systems.

BJJ&A and U.S. Filter incorporate emergency equipment bypass lines and valving that are clearly labeled and tagged. Instructions for usage will be included with the water components and staff in-service will be provided to the clinic/customer by BJJ&A. The use of dead legged bypass piping will be avoided. Carbon filters will not have hard plumbed bypass lines. U.S. Filter emergency equipment bypass utilizes a dry bypass technique. This method uses breakable unions and isolation valves at the end of each bypass line so that stagnant water will not be present in the line in the event of an emergency bypass condition. BJJ&A emergency equipment bypass is a wt bypass method.

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In this method the bypass valve is installed with no more than one half pipe a diameter length in this methou the bypass valve to avoid water stagnation. The use of dead leg bypass piping is unacceptable.

BJJ&A water distribution piping will be configured with no dead legs longer than 6 pipe diameters. U.S. Filter installs sanitization/sanitant introduction valve(s) or introduction port must be incorporated to allow chemical injection of sanitants to allow sanitization of the RO must be incorporated to anow chemical injoined in connections or through the top of the storage system and storage and the the sites for sanitant introduction BJJ&A avoids having any additional deadleg bypass valving installed into the original piping system and this further avoids water stagnation.

Included in this document is labeling that is applied to the components of the water purification metuded in this doodinis. AAMI water purification standards are also included

With an actual water quality analysis and Total Organic Carbon analysis from existing water with an actual water quality dialysis. Dimensional drawings and product specification sheets pullincation components for analysis vith owner's manuals for each of the components models.

In summary, the BJJ&A water purification components and the U.S. Filter predicate device In summary, the Discore water parinother. The core water purification components and tomponents are very bithe same. The differences are in the application of the bypass econnology are exactly the differences in these two systems are derived from the fact BJJ&A is in a constant attempt to provide the best water quality and safest possible system to the public.

Note: The Renal Care Facilities will supply their own reverse osmosis system, ultra-filtration rack, DI, and storage tanks. BJJ&A will only be providing the water softener systems and carbon systems.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine and health. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Mr. Robert Snyder Regional Manager, South Texas Territory Bob J. Johnson & Assoc., Inc. 7715 Mainland Dr., #115 SAN ANTONIO TX 78250

Re: K014169 Trade/Device Name: Water Purification Components for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: November 30, 2001 Received: December 19, 2001

Dear Mr. Snyder:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section JTQ(x) premained is substantially equivalent (for the indications referenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regary manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Drug commerce prior to May 20, 1970, the charge with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ions of the Act and Cosmetic Act (Act) that do not require approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the general resigned reservation, You may, therefore, market the device, subject to use gentrements for annual registration, listing of the and general controls provisions of the Fectiver requires against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( if your device is classified (Sec above) moved regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affecting FDA ma it may be subject to additional controls. L'Aisang major sogo to 898. In addition, FDA may found in the Code of Pederal Regareering your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination are not mean Please be advised that IDA 3 issualled of a based on a suith other requirements of the Act
es and that FDA has made a decemination administered by other Federal agencies. You must of any Federal statutes and regulations administration of the limited to: registration and listing comply with all the Act STequirements, mouth, good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice due d (21 CFR Part 807), labelling (21 CFR Pair 800); government (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulations (SE-SE-SE) of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use K014169

Carbon Filters and Water Softeners are intended to be used as components of a water purification system to remove organic and inorganic substances 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

BOB J. JOHNSON & ASSOCIATES, INC.
1313 FM 1960 Ε.
HOUSTON, TX 77073
281-443-2225
1-800-341-2225

**Prescription Use**
(Per 21 CFR 801.109)

| (Division Sign Off) | |
|-------------------------------------|--------|
| Division of Reproductive Abdominal, | |
| and Rad | |
| 510(k) Number | K01416 |