BICARB MIXING AND DISTRIBUTION SYSTEM

K112427 · Isopure, Corp. · FIN · Jan 26, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K112427
• Device Name: BICARB MIXING AND DISTRIBUTION SYSTEM
• Applicant: Isopure, Corp.
• Product Code: FIN · Gastroenterology, Urology
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

Device Story

System mixes sodium bicarbonate powder with water to create liquid concentrate for hemodialysis. Input: dry bicarbonate powder and RO water. Operation: powder added to hopper; inductor draws powder into mix tank; water added via calibrated flow meter; vortex-style mixing dissolves powder; PLC-controlled cycle. Output: liquid bicarbonate concentrate transferred to storage tank for distribution loop or jugs. Used in hemodialysis clinics; operated by clinical staff. HMI touch screen displays status, levels, and alarms. Benefits: automated, consistent mixing; reduced microbial contamination via sealed design; reduced 'dead legs' in piping; automated disinfection cycles.

Clinical Evidence

Bench testing only. System performance validated by testing all selectable bicarbonate volumes. Primary endpoints included target conductivity verification to confirm mixture accuracy and successful transfer/circulation through the distribution loop. Testing conducted using standard clinical bicarbonate brands and RO water to ensure operational equivalence to the predicate device.

Technological Characteristics

Materials: High-density polyethylene (HDPE) tanks, schedule 80 PVC piping, glass fiber reinforced polypropylene pump, alumina ceramic spindle. Sensing: Signet 8860 conductivity/resistivity controller, electronic pulse flow meter. Energy: 24 VDC actuated valves, PLC-controlled. Connectivity: HMI touch screen interface. Sterilization: Automated disinfection cycle. Software: PLC-based ladder logic.

Indications for Use

Indicated for use in hemodialysis facilities for the preparation, storage, and distribution of bicarbonate liquid concentrate for the treatment of hemodialysis patients.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System (K993272)

Submission Summary (Full Text)

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JAN 2 6 2012

Isopure Corp

#### I. 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

| Submitter's Name: | Isopure Corp<br>141 Citizens Blvd.<br>Simpsonville, KY 40067<br>Telephone: [phone] |
|-------------------|-------------------------------------------------------------------------------------------|
| Contact person: | Kevin C. Gillespie |

Date of Summary: January 24, 2012

י

Device Name: Isopure Sodium Bicarbonate Mixing and Distribution System

Device Classification Name: Dialysis Holding Tank (876.5820, FIN)

Device Description: The Isopure Sodium Bicarbonate Mixing and Distribution System is designed to mix sodium bicarbonate powder into a liquid solution based on the recommended mixing procedures from the powder manufacturers. Once the powder is mixed into a liquid solution and verified for content accuracy, the solution is transferred to an independent distribution tank for transfer through a loop to the individual dialysis machines or to fill jugs which then can be transported to the individual dialysis machines when no distribution loop exists.

The Isopure Sodium Bicarbonate Mixing and Distribution System features the patented SOLUBILIZER™, which utilizes a large volume of water spinning in a vortex manner to dissolve dry powder into a liquid solution that is drawn into a mix tank. The solution is mixed with AAMI quality water according to specifications outlined by the manufactures for the bicarbonate powder. Once the solution has been dissolved and mixed, the solution can be transferred from the mixing tank to the storage delivery tank for distribution to the loop or jugs. The tanks and the SOLUBILIZER™ are sealed to reduce microbial contamination. The sealed design also facilitates CO2 recovery and gassing off of CO2 during the mixing procedure.

The entire system is controlled by programmable control logic (PLC), which operates the system. The PLC will control the mixing, the delivery and disinfection of the complete system. The system PLC is operated through an HMI touch screen which displays the critical aspects of the system. including the operational stages, real-time indication of various steps, and alarm conditions.

Intended Use: The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

Legally Marketed Devices to which Equivalence is Claimed: Isopure Corp purchased the Pure Water Inc's Bicarb Mixing, Storage and Distribution System from Pure Water Inc. Isopure intends to manufacture and market the device at its Simpsonville KY location. The intended use of the device has not change, nor have the functionality and any of the contacting components.

Descriptive Summary of Technological Characteristics and Those of Predicate Devices: The technological characteristics of the device are the same as the original submitted device under 501(k) K993272, Pure Water, Inc.'s Bicarb Mix, Storage and Distribution System cleared on April 10, 2000.

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| Summary of Comparisons of Components | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pure Water, Inc. K993272 | Isopure Corp K112427 |
| Physical and Operational Comparison | |
| Pure Water system features two separate tank<br>configuration one for mixing the solution and<br>one for storage of the solution. These tanks are<br>not connected together allowing the system to<br>be configured on site. | This was changed to a single system where<br>both tanks are secured on the same<br>skid/platform. This allows the ease of piping<br>the two tanks together and reduces the chance<br>of "dead legs" in the system |
| Mix tank features a one piece molded open-top<br>cone bottom high density polyethylene tank with a<br>welded NDPE stand and hinged bolt-on cover with<br>a mixer mounted on the cover. | Mix tank features a one piece molded closed top<br>cone bottom high density polyethylene tank with a<br>welded NDPE stand. A powder hopper consisting<br>of high density polyethylene mounted between the<br>tanks to hold powder and a inductor replaces the<br>mixer |
| Filling of the mix tank is operator dependent.<br>The operator must fill the mix tank to markings<br>on the side of the tank by turning on a valve<br>then turning off the same valve once the level<br>is achieved. This same process is required once<br>the powder is added. | This was changed to an automated process.<br>The operator can adjust the initial fill and the<br>final fill from a set-up screen, but once set, the<br>system will fill the exact same level every time<br>the mix is selected. The initial fill and the final<br>fill levels are determined by the operator<br>selecting the desired amount of bicarb to be<br>mixed i.e. 1 bag, 2 bags, 3 bags, or 4 bags. A<br>calibrated flow meter will determine the exact<br>amount of water entering the mix tank. |
| Mixing the solution is accomplished by small<br>batch mixer 1750 rpm which is clamped to the<br>side of the mix tank. | This was changed to an inductor located inside<br>the mix tank. The reason for this change is<br>recommendation for mixing by the powder<br>manufacturers as well as AAMI RD52:2004.<br>The powder is drawn into the system and<br>mixed with water at the hopper located on the<br>front of the system. |
| Mix for 30 minutes and check for correct<br>mixture by specific gravity method or<br>conductivity as per your facility requirements.<br>Once mixing is complete, the mixer switch<br>must be turned to the off position. | Mix will occur automatically once all of the<br>powder has been dissolved. The mix cycle has<br>been changed to 10 minutes per the powder<br>manufacturer's recommendations. |
| Connect the mix tank hose HM1 to the storage<br>tank. Operate transfer switch to the "ON"<br>position to pump liquid concentrate from the<br>mix tank to the storage tank. Remove hose<br>HM1 from the storage tank and replace plug<br>for the tank. | This was changed with the two tanks on the<br>same skid. Once the solution is automatically<br>mixed, the system will require the operator to<br>verify that the batch is correctly mixed. Once<br>the operator passes the batch, the system will<br>automatically turn on the mix/transfer pump<br>then rotate AV1 (3-way actuated valve), and<br>AV2 (3-way actuated valve) to transfer the<br>solution from the mix tank to the distribution<br>tank. Once the transfer is complete, the system |
| | |
| | will automatically turn off the mix/transfer<br>pump and rotate AV1 and AV2 back to their<br>original positions. After complete, the system<br>will open the drain valve and rinse down the<br>mix tank, hopper, and associated piping with<br>RO water in preparation to mix a new batch of<br>bicarb. If bicarb solution still exists in the<br>distribution tank, the system will hold the mix<br>solution in the mix tank until the low level<br>float is activated in the distribution tank. Once<br>activated, the system will automatically up to<br>75 gallons of mixed solution. If 100 gallons<br>(380 liters) is in the mix tank, the system will<br>only transfer over 2/3 of this solution on the<br>first low tank alarm then the remaining<br>solution on the next low tank activation. |
| Centrifugal direct drive transfer pump 25 gpm at 40<br>psi to transfer the mixed solution from the mix tank<br>to the distribution tank. The pump is constructed of<br>Glass Reinforced Noryl with a stainless steel wear<br>ring and impeller hub. | Centrifugal magnetic drive transfer pump 40 gpm<br>at 21 psi to mix the solution and transfer the<br>solution to the distribution tank. The pump is<br>constructed of Glass Fiber Reinforced<br>Polypropylene. With a Polypropylene magnetic<br>capsule and alumina ceramic spindle. |
| Piping used to supply RO treated water to the mix<br>tank and to transfer the mixed solution from the<br>mix tank to the distribution tank is schedule 80<br>PVC pipe and fittings. | Piping used to supply RO treated water to the mix<br>tank and to transfer the mixed solution from the<br>mix tank to the distribution tank is schedule 80<br>PVC pipe and fittings. |
| Two-way ball valve is used to drain the mix tank as<br>well as a container filling valve located on the front<br>of the tank. The two way valve is constructed of<br>schedule 80 PVC with Teflon seats and EPDM "O"<br>rings. | Two-way ball valve is used to drain the mix tank as<br>well as a container filling valve located on the front<br>of the tank. The two way valve is constructed of<br>schedule 80 PVC with Teflon seats and EPDM "O"<br>rings. A 24 VDC actuated ball valve is connected<br>to the valve which will allow automatic actuation<br>of the valve during operation |
| Three way true union ball valves are used to direct<br>the mixed solution from the mix tank to the<br>distribution tank. The valve is schedule 80 PVC<br>with Teflon seats and EPDM "O" rings. | Three way true union ball valves are used to direct<br>the mixed solution from the mix tank to the<br>distribution tank. The valve is schedule 80 PVC<br>with Teflon seats and EPDM "O" rings. |
| Auto lock fittings are used to connect lines from<br>the mix tank to the distribution tank. Auto lock<br>fittings are constructed of food grade Acetal and<br>Nitrite. | The Auto lock fittings and hose have been removed<br>from the system as a potential source of<br>contamination. |
| A conductivity meter has independent high/low set<br>points that control to SPDT relays. The controller<br>features a 1 mV per digit ± 0.5% ± 1 mV recorder<br>output interface with a recorder or data logger to<br>make permanent records. Automatic temperature<br>compensation is provided. By a 10KΩ thermistor<br>built in to the conductivity cell. | The Signet 8860 Dual Channel<br>Conductivity/Resistivity Controller is a two-<br>channel input device equipped with three saleable 4<br>to 20 mA outputs and four programmable relays. A<br>selector switch activates two open collector outputs<br>in place of two of the relays for extraordinary<br>output versatility. Dual input and advanced control<br>capability, including percent rejection, difference |
| | |
| The 27500 Teflon rotary tank cleaning nozzle<br>features a spray head that is rotated by the<br>pressurized flow of the spray solution. The<br>compact nozzle produces effective solid stream<br>sprays and can be operated at pressures of 10 - 50<br>psi.<br>3/8" Solenoid valve consisting of glass filled<br>polypropylene and a viton is used to administer RO<br>water to the mix tank. | and ratio calculations, together with Signet<br>Conductivity Sensors. Conductivity/Resistivity<br>electrodes are designed to provide versatile<br>installation and accurate sensing across a very<br>broad dynamic range. These electrodes are built<br>with a controlled surface finish to ensure accuracy<br>and repeatability. The standard electrode is<br>constructed 316 SS or Titanium, but there are other<br>materials available for maximum chemical<br>compatibility. Reversible threads or sanitary<br>flanges allow for maximum installation versatility.<br>The 27500 Teflon rotary tank cleaning nozzle<br>features a spray head that is rotated by the<br>pressurized flow of the spray solution. The<br>compact nozzle produces effective solid stream<br>sprays and can be operated at pressures of 10 - 50<br>psi.<br>3/8" Solenoid valve consisting of glass filled<br>polypropylene and a viton is used to administer RO<br>water to the mix tank. This valve is also used to<br>administer RO water to the hopper and used for |
| Storage tank is a high density cone bottom tank<br>with a sealed cap. A 0.2 uS vent filter provides<br>filtration of the replacement air in the tank. The<br>distribution tank is mounted to a NDPE tank stand.<br>Distribution of bicarb solution; verify Loop<br>Pump switch on the Bicarb Controller is in the<br>"ON" position. Automatic operation – ensure<br>that the power switch on AUTOCHEM 1000 is<br>in the "OFF" position and all indicator lamps<br>are extinguished. Verify LOOP PUMP switch<br>on the RELAY CONTROLLER is in the "ON"<br>position | disinfection.<br>Storage tank is a high density cone bottom tank<br>with a sealed cap. A 0.2 uS vent filter provides<br>filtration of the replacement air in the tank. The<br>distribution tank is mounted to a NDPE tank stand<br>Distribution is automated so when the<br>Distribute button is pushed, the distribution of<br>the bicarb will begin to purge the distribution<br>line with bicarb. The return loop valve will<br>divert the return loop to drain until the<br>conductivity of the return loop solution is <46<br>mS. |
| Loop pump is a centrifugal, direct connect pump<br>consisting of Glass Reinforced Noryl casing, 316<br>stainless steel wear ring and impeller hub. The<br>bicarb loop pump is used to move the bicarb liquid<br>concentrate, disinfect solution, and rinse water<br>from the storage tank to the distribution loop,<br>which goes to each dialysis machine. | Loop pump is a centrifugal, magnetic connect Fiber Reinforced<br>pump consisting of Glass<br>Polypropylene casing, With a Polypropylene<br>magnetic capsule and alumina ceramic spindle. The<br>bicarb loop pump is used to move the bicarb liquid<br>concentrate, disinfect solution, and rinse water<br>from the storage tank to the distribution loop,<br>which goes to each dialysis machine.<br>Inline Flow Meter was changed to an electronic |
| Inline Flow Meter consists of polysulfone body,<br>316 stainless steel float and viton seals. The flow<br>meter is placed in the bicarb distribution loop to<br>monitor the flow rate of the bicarb liquid<br>concentrate being distributed. | pulse flow meter. The Seametrics SPX low flow<br>meter employs jewel bearings to allow for very low<br>minimum flow rates and superior life. The SPX<br>flow meter has a body material of polypropylene.<br>The lens cover is acrylic for visual flow indication.<br>The rotor assembly is Kynar with tungsten carbide |
| | shaft (ceramic shaft optional). The O-ring is<br>EPDM. |
| | FT420 provides flow rate and total flow indication,<br>with 4-20 mA output capability. |
| UV Light Ideal Horizons SR series UV 316<br>stainless steel construction ½" FNPT connections.<br>All are constructed using plasma arc or fusion<br>welding, providing strong food grade<br>uncontaminated welds. | UV Trojan UV 316 stainless steel construction ½"<br>FNPT connections. All are constructed using<br>plasma arc or fusion welding, providing strong<br>food grade uncontaminated welds. |
| Submicron Filter a 0.2 micron pleated<br>polypropylene depth filter. Meets FDA<br>requirements for food contact. | Submicron Filter a 0.2 micron pleated<br>polypropylene depth filter. Meets FDA<br>requirements for food contact. |
| 6 Channel Alarm is used to provide warnings from<br>the water and bicarb system. The remote alarm is<br>equipped with indicator lamps and an audio horn. | 6 Channel Alarm is used to provide warnings from<br>the water and bicarb system. The remote alarm is<br>equipped with indicator lamps and an audio horn. |
| Autochem 1000 controller is used to provide<br>mixing control, distribution control and automatic<br>disinfection of the bicarb system. The start switch<br>is guarded to prevent accidental starts. During<br>automatic disinfect process; all switches except the<br>POWER switch are "locked out" to prevent<br>accidental interruption of the process. | The Autochem 1000 was replaced with a Koyo<br>PLC. The Programmable Control Logic (PLC)<br>operates the system utilizing ladder logic. The<br>ladder logic is designed as failsafe logic that in the<br>event of a failure, the system will stop operation.<br>The PLC controls all aspects of the operation<br>including mixing of solution, distribution of the<br>mixed solution, end-of-day process where the<br>sodium bicarbonate is rinsed from the distribution<br>loop, and the disinfection process where the entire<br>system is disinfected. A Human Machine Interface<br>(HMI) touch screen acts as the interface between<br>the operator and the PLC. The HMI provides<br>device operational characteristics such as tank<br>levels, flow rates, solution conductivity, and<br>pressures. The HMI also interfaces the different<br>mix levels in the system. |
| Labeling Comparison | |
| Exhibit A Label: Pure Water Concentrate<br>Distribution System Component Name:, Serial<br>No:, Model No:, with name and address of<br>manufacturing facility. | Image: Isopure Label |

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Isopure Corp

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MODIFICATION 510(K) NOTIFICATION
ISOPURE SODIUM BICARBONATE MIXING AND DISTRIBUTION SYSTEM

K112427
PAGE 4 OF 7

Isopure Corp

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K112427 PAGE 5 OF 7

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K112427
PAGE 6 OF 7

### MODIFICATION 510(K) NOTIFICATION ISOPURE SODIUM BICARBONATE MIXING AND DISTRIBUTION SYSTEM

ISOPURE CORP

Image /page/5/Figure/3 description: The image shows a collection of safety labels and warnings. There are labels indicating tank types with numerical values like 35x, 36.83x, and 45x for both mix and storage tanks. A warning label advises that a tank is sealed to prevent microbial contamination and requires disinfection if opened, and a danger label warns of high voltage and instructs to disconnect power before servicing. Other labels include product names like "Isopure Bicarb Solubilizer" and codes such as LA21108, LA21110, LA21112 REV A, and LA21114.

Performance Data: The basic functionality of the Isopure Sodium Bicarbonate Mixing and Distribution System remains the same as the device cleared on April 10, 2000. The mixing and distribution of the liquid solution still follows the mixing procedures recommended by the powder manufacturers, and all of the contacting materials used in the original cleared device also remain the same. The device physical characteristics did change to reduce the footprint of the device. Operating controls also changed from relays and timers to a PLC (Programmable Logic Control). The changes also address new ANSI/AAMI RD52-2004 requirements to update the mixing system to current regulations.

## Non-Clinical Testing Summary:

The purpose for the Sodium Bicarbonate Mixing and Distribution System, as for the predicate device, is to provide a bicarbonate solution suitable as part of the dialysate mixture which, along with an acid

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Isopure Cori

solution and RO water, is used to treat dialysis patients. The system has undergone 100% testing to ensure substantial equivalence to the Pure Water, Inc. predicate device. Both systems are fully capable of meeting the mix requirements specified for a suitable sodium bicarbonate solution.

The testing area consists of all components of a water room that would normally be present at a dialysis clinic, including media tanks, a softener, filtering devices, and a reverse osmosis machine. With pure water provided by the RO system and associated components, the Sodium Bicarbonate Mixing and Distribution System was tested repeatedly for proper operation.

The Mix procedure, which performs the operation of mixing the sodium bicarbonate powder into a solution suitable for delivery to a patient dialysis machine, was run for all selectable volumes of bicarbonate. Using the same brand of bicarbonate typically used in an operating clinic, each mix batch was tested for the target conductivity of the solution to confirm the correct mixture, and then transferred to the Distribution Tank. The distribution function was then tested to ensure that circulation of the solution through the loop occurred as expected.

The basic mixing and distribution of sodium bicarbonate in the Isopure system is equivalent to that of Pure Water, Inc.'s original Bicarbonate Mix, Storage and Distribution System cleared April 10, 2000 under Application number K993272. Changes to the mix portion of the system reflect current recommended mixing procedures outlined by the powder manufacturers such as "Vigorous mixing and propeller style mixers can drive carbon dioxide from the solution''. "Add water for total volume of mixed solution. Mix again for approx. 10 minutes. Ensure that the powder is dissolved in solution". Changes reflected in this submission to the mixing of the sodium bicarbonate were performed to meet the current requirements of the powder manufacturers, such as the removal of the small batch mixer with a propeller and replacement to a hopper and an inductor located in the mix tank.

Conclusion: The information and data provided in this 510(k) Notification establish that the Isopure Sodium Bicarbonate Mixing and Distribution System is as safe and as effective, and performs as well or better than the earlier versions of the Pure Water, Inc. Bicarbonate Mix, Storage and Distribution System cleared April 10, 2000 under Application number K993272.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

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

Mr. Kevin Gillespie President & CEO Isopure Corporation 141 Citizens Blvd SIMPSONVILLE KY 40067

JAN 2 6 2012

Re: K112427

. •

Trade/Device Name: Isopure Sodium Bicarbonate Mixing and Distribution System Regulation Number: 21 CFR§ 876.5820 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIN Dated: December 21, 2011 Received: December 27, 2011

Dear Mr. Gillespie:

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. 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Erks

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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#### I. INDICATIONS FOR USE STATEMENT

January 24, 2012

Page 1 of 1

## 510(k) Number: K112427

Device Name: Isopure Sodium Bicarbonate Mixing and Distribution System

## Indications for Use:

The Isopure Sodium Bicarbonate Mixing and Distribution System is intended to be used in Hemodialysis facilities for the mixing, storage and distribution of Bicarb liquid concentrate to be used in the treatment of Hemodialysis patients.

OR

!

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K//2427

Prescription Use √ (Per 21 CFR 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________