MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

K153329 · Med-Tech Water Systems, Inc. · FIP · Aug 4, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K153329
• Device Name: MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
• Applicant: Med-Tech Water Systems, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.

Device Story

Device consists of Fiberglass Reinforced Polypropylene (FRP) tanks filled with virgin coal-based granular activated carbon (GAC). Used as a component in hemodialysis water purification systems; installed in worker/polisher configuration (primary tank followed by polisher/back-up tank). Operates via chemical adsorption to remove chlorine and chloramines from source water. Operated by dialysis facility staff; tanks are replaced upon exhaustion. Benefits patient by ensuring purified water meets AAMI standards for hemodialysis, preventing exposure to harmful contaminants.

Clinical Evidence

Bench testing only. Nonclinical tests conducted on product water from a replicated exchange tank configuration confirmed compliance with AAMI standards for carbon adsorption.

Technological Characteristics

Fiberglass Reinforced Polypropylene (FRP) tanks; virgin coal-based granular activated carbon (GAC) media (12x40 mesh, iodine number ≥ 1000); PVC tank heads, plugs, and distributors; glass-filled Noryl fittings. Sizes range from 6"x18" to 16"x65". Principle of operation is chemical adsorption.

Indications for Use

Indicated for use as a component in hemodialysis water purification systems to remove chlorine and chloramines from potable water. Not for standalone use; must be part of a system meeting AAMI standards.

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

• G.E.M. Water Systems REVERSE OSMOSIS SYSTEM (K944493)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 4, 2016

MED-TECH Water Systems, Inc. Brian C. Kim President 1755 Woolner Avenue, Suite B Fairfield, CA 94533

Re: K153329

> Trade/Device Name: MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water Purification System for Hemodialysis Regulatory Class: II Product Code: FIP Dated: May 2, 2016 Received: May 6, 2016

Dear Brian C. Kim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Douglas Silverstein -S 2016.08.04 12:39:35 -04'00'

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo and contact information for MED-TECH H2O. The logo includes a caduceus symbol. The address is listed as 1755 Woolner Ave. suite B, Fairfield, CA 94533. The phone number is [phone] and the fax number is [phone].

May 2, 2016

## Indications for Use

510(k) Number (if known): K153329

MED-TECH Water Systems Inc. Exchangeable Carbon Tanks For Dialysis Device Name:

Indications For Use:

The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing apprivations: "The extreatment in accordance with current AAMI standards. The exchange tanks are accidate problemanent and poss. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

005-1

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Image /page/3/Picture/0 description: The image shows the logo for MED-TECH H₂O. To the left of the company name is a blue medical symbol. Below the company name is the address 1755 Woolner Ave. suite B, Fairfield, CA 94533. The phone number [phone] and fax number [phone] are also listed.

## 510(K) SUMMARY

May 2, 2016

| 510(K) Number: | K153329 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | MED-TECH Water Systems Inc. |
| Contact: | Brian C. Kim<br>1755 Woolner Ave. suite B • Fairfield , CA 94533<br>Phone: [phone] Fax: [phone]<br>Email: [e-mail] |
| Proprietary Name: | MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis |
| Common Name: | Carbon Exchange Tanks for Dialysis |
| Classification Name: | Tank, Holding, Dialysis and Accessories |
| Classification: | Class II Medical Device under §876.5665<br>Panel: Gastroenterology<br>Product Code:<br>FIP |
| Equivalent Device: | K944493 G.E.M. Water Systems REVERSE OSMOSIS SYSTEM |

Device Description: MED-TECH Water Systems Inc. Exchangeable Carbon Tanks for Dialysis are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new virgin coal based granular activated carbon (GAC). The carbon media removes chlorine, chloramines, and other organics from the source water through the chemical process of adsorption. Only new virgin coal based granular activated carbon (GAC) of 12X40 mesh size with an iodine number of 1000 or greater is used in the exchange tanks.The tank sizes are range from 6" x 18" through 16" x 65" common for the dialysis industry. The Carbon Exchange Tanks are dedicated for carbon only. MED-TECH Water Systems Inc. recommends that tanks be installed in worker/polisher configuration with the first tank providing the primary purification and the second tank serving as a polisher and back-up to the primary purification.

Indications for Use: The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are intended to be used as a component of a hemodialysis water purification system designed to pretreat and purify potable water for hemodialysis applications. The exchange tanks are intended for use in complete water purification systems employing adequate pretreatment and post-treatment in accordance with current AAMI standards. The exchange tanks are not intended to be used alone. They are intended to remove chlorine and chloramines from water that will be purified by the water purification system and used for hemodialysis applications. Upon exhaustion, these tanks will be replaced with other tanks containing new activated carbon.

Statement of Substantial Equivalence: The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are substantially equivalent to the carbon exchange tanks included in G.E.M. Water Systems' REVERSE OSMOSIS SYSTEM (K944493). The MED-TECH design was originally based exclusively on the G.E.M. Water Systems exchange tanks. The following table compares and contrasts the predicate device and the new device. This table along with the documentation included in this submission demonstrates that there are no new issues of safety or effectiveness associated with this design change, and that the new device is substantially equivalent to the predicate device.

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| | MED-TECH Water Systems Inc. | G.E.M. Water Systems<br>K944493 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The MED-TECH Water Systems Inc.<br>Exchangeable Carbon Tanks are intended to be<br>used as a component of a hemodialysis water<br>purification system designed to pretreat and<br>purify potable water for hemodialysis<br>applications. The exchange tanks are intended<br>for use in complete water purification systems<br>employing adequate pretreatment and post-<br>treatment in accordance with current AAMI<br>standards. The exchange tanks are not intended<br>to be used alone. They are intended to remove<br>chlorine and chloramines from water that will<br>be purified by the water purification system and<br>used for hemodialysis applications. Upon<br>exhaustion, these tanks will be replaced with<br>other tanks containing new activated carbon. | The intended use of this device is to purify water to<br>meet AAMI standards for hemodialysis treatment. |
| Tanks | Park/Structural or Wave Cyber FRP tanks | Park/Structural<br>FRP tanks |
| Tank Heads / Fill Plug | Clack, Pentair, or American Water Products<br>PVC heads, PVC plug | Clack<br>PVC heads, PVC plug |
| Fittings | Glass-filled Noryl | Glass-filled Noryl |
| Distributor | Pentair or Clack<br>PVC distributor | Clack<br>PVC distributor |
| Stand Pipe | PVC | PVC |
| Carbon | Virgin, coal-based, granular activated carbon<br>(GAC) 12X40 mesh iodine number $≥$ 1000 | Virgin, coal-based, granular activated carbon (GAC)<br>12X40 mesh iodine number $≥$ 1000 |
| Principles of operation | Carbon adsorption<br>Granular activate carbon (GAC) removes<br>chlorine and chloramines from water through<br>the process of adsorption. | Carbon adsorption<br>Granular activate carbon (GAC) removes chlorine<br>and chloramines from water through the process of<br>adsorption. |

The MED-TECH Water Systems Inc. Exchangeable Carbon Tanks are substantially equivalent to Conclusion: the carbon exchange tanks included in G.E.M. Water Systems' REVERSE OSMOSIS SYSTEM (K944493). All of the components and technology included in this submission are identical to the predicate device and there are no new issues of safety or effectiveness. Nonclinical tests were conducted on product water from a replicated exchange tank configuration. Results verify that the device produces endpoints that comply with current AAMI standards for carbon adsorption.