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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Isopure Sodium Bicarbonate Mixing and Distribution System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive de novo clinical trials. Therefore, the information typically requested in your prompt (e.g., acceptance criteria with reported device performance in a table, sample sizes for test/training sets, number and qualifications of experts for ground truth, MRMC studies, standalone performance, type of ground truth) is not explicitly present in the provided document.

The document primarily focuses on comparing the technological characteristics of the new device to its predicate and outlining non-clinical testing performed to establish equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with explicit acceptance criteria and corresponding reported device performance metrics in the format typically used for performance studies. Instead, it states that the system "was tested repeatedly for proper operation" and "each mix batch was tested for the target conductivity of the solution to confirm the correct mixture."

The implied acceptance criterion is:

Target conductivity of the solution: The mixed sodium bicarbonate solution must achieve the "target conductivity" to confirm correct mixture.

The reported device performance is:

"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 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."

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

Sample Size: The document does not specify a numerical sample size for the test set. It states the system "was tested repeatedly" and "each mix batch was tested for the target conductivity." This suggests multiple batches were tested for each selectable volume.
Data Provenance: The testing was non-clinical. The "testing area consists of all components of a water room that would normally be present at a dialysis clinic." It utilized "the same brand of bicarbonate typically used in an operating clinic." This implies the testing environment and materials were representative of real-world use within a dialysis facility. The country of origin for the data is implicitly the US, as the submitter is an American company and the approval is from the US FDA. The testing was prospective within the context of the device development and validation.

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

Experts: Not applicable. The "ground truth" for the device's function (correct mixing and distribution) was established through objective measurements (conductivity) and functional assessments (circulation). This is a technical performance verification, not a clinical interpretation requiring expert consensus.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The "ground truth" (correct mixture via conductivity, proper circulation) was determined by direct measurement and observation, not expert review or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a medical equipment system for mixing and distributing solutions, not an imaging or diagnostic device that would involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Not applicable in the context of typical AI/algorithm standalone performance. The device itself is an automated system controlled by a PLC, and its performance was assessed directly. There isn't a separate "algorithm" for human-in-the-loop interaction in the way AI diagnostics are often evaluated. The testing described focuses on the machine's ability to execute its programmed functions (mixing, distribution) correctly and automatically.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth was based on objective technical measurements and functional verification. Specifically:
- Conductivity Readings: To confirm the correct mixture of the sodium bicarbonate solution (compared against a target conductivity).
- Functional Assessment: To ensure proper circulation of the solution through the distribution loop.
- Compliance with Manufacturer Recommendations and Standards: Adherence to powder manufacturers' recommendations and AAMI RD52-2004 requirements for mixing procedures.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This device is not an AI/machine learning model in the conventional sense that would require a "training set" of data to learn from. Its operation is governed by pre-programmed logic (PLC) and engineering design, not statistical learning from a dataset.

9. How the Ground Truth for the Training Set was Established:

Training Set Ground Truth: Not applicable, as there is no training set for this type of device. The operating parameters and expected performance are established through engineering specifications, manufacturer guidelines, and relevant industry standards (like AAMI RD52-2004).

Summary

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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 Corp141 Citizens Blvd.Simpsonville, KY 40067Telephone: (502) 722-1000
Contact person:	Kevin C. Gillespie

Date of Summary: January 24, 2012

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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Isopure Corp

Summary of Comparisons of Components
Pure Water, Inc. K993272	Isopure Corp K112427
Physical and Operational Comparison
Pure Water system features two separate tankconfiguration one for mixing the solution andone for storage of the solution. These tanks arenot connected together allowing the system tobe configured on site.	This was changed to a single system whereboth tanks are secured on the sameskid/platform. This allows the ease of pipingthe two tanks together and reduces the chanceof "dead legs" in the system
Mix tank features a one piece molded open-topcone bottom high density polyethylene tank with awelded NDPE stand and hinged bolt-on cover witha mixer mounted on the cover.	Mix tank features a one piece molded closed topcone bottom high density polyethylene tank with awelded NDPE stand. A powder hopper consistingof high density polyethylene mounted between thetanks to hold powder and a inductor replaces themixer
Filling of the mix tank is operator dependent.The operator must fill the mix tank to markingson the side of the tank by turning on a valvethen turning off the same valve once the levelis achieved. This same process is required oncethe powder is added.	This was changed to an automated process.The operator can adjust the initial fill and thefinal fill from a set-up screen, but once set, thesystem will fill the exact same level every timethe mix is selected. The initial fill and the finalfill levels are determined by the operatorselecting the desired amount of bicarb to bemixed i.e. 1 bag, 2 bags, 3 bags, or 4 bags. Acalibrated flow meter will determine the exactamount of water entering the mix tank.
Mixing the solution is accomplished by smallbatch mixer 1750 rpm which is clamped to theside of the mix tank.	This was changed to an inductor located insidethe mix tank. The reason for this change isrecommendation for mixing by the powdermanufacturers as well as AAMI RD52:2004.The powder is drawn into the system andmixed with water at the hopper located on thefront of the system.
Mix for 30 minutes and check for correctmixture by specific gravity method orconductivity as per your facility requirements.Once mixing is complete, the mixer switchmust be turned to the off position.	Mix will occur automatically once all of thepowder has been dissolved. The mix cycle hasbeen changed to 10 minutes per the powdermanufacturer's recommendations.
Connect the mix tank hose HM1 to the storagetank. Operate transfer switch to the "ON"position to pump liquid concentrate from themix tank to the storage tank. Remove hoseHM1 from the storage tank and replace plugfor the tank.	This was changed with the two tanks on thesame skid. Once the solution is automaticallymixed, the system will require the operator toverify that the batch is correctly mixed. Oncethe operator passes the batch, the system willautomatically turn on the mix/transfer pumpthen rotate AV1 (3-way actuated valve), andAV2 (3-way actuated valve) to transfer thesolution from the mix tank to the distributiontank. Once the transfer is complete, the system

	will automatically turn off the mix/transferpump and rotate AV1 and AV2 back to theiroriginal positions. After complete, the systemwill open the drain valve and rinse down themix tank, hopper, and associated piping withRO water in preparation to mix a new batch ofbicarb. If bicarb solution still exists in thedistribution tank, the system will hold the mixsolution in the mix tank until the low levelfloat is activated in the distribution tank. Onceactivated, the system will automatically up to75 gallons of mixed solution. If 100 gallons(380 liters) is in the mix tank, the system willonly transfer over 2/3 of this solution on thefirst low tank alarm then the remainingsolution on the next low tank activation.
Centrifugal direct drive transfer pump 25 gpm at 40psi to transfer the mixed solution from the mix tankto the distribution tank. The pump is constructed ofGlass Reinforced Noryl with a stainless steel wearring and impeller hub.	Centrifugal magnetic drive transfer pump 40 gpmat 21 psi to mix the solution and transfer thesolution to the distribution tank. The pump isconstructed of Glass Fiber ReinforcedPolypropylene. With a Polypropylene magneticcapsule and alumina ceramic spindle.
Piping used to supply RO treated water to the mixtank and to transfer the mixed solution from themix tank to the distribution tank is schedule 80PVC pipe and fittings.	Piping used to supply RO treated water to the mixtank and to transfer the mixed solution from themix tank to the distribution tank is schedule 80PVC pipe and fittings.
Two-way ball valve is used to drain the mix tank aswell as a container filling valve located on the frontof the tank. The two way valve is constructed ofschedule 80 PVC with Teflon seats and EPDM "O"rings.	Two-way ball valve is used to drain the mix tank aswell as a container filling valve located on the frontof the tank. The two way valve is constructed ofschedule 80 PVC with Teflon seats and EPDM "O"rings. A 24 VDC actuated ball valve is connectedto the valve which will allow automatic actuationof the valve during operation
Three way true union ball valves are used to directthe mixed solution from the mix tank to thedistribution tank. The valve is schedule 80 PVCwith Teflon seats and EPDM "O" rings.	Three way true union ball valves are used to directthe mixed solution from the mix tank to thedistribution tank. The valve is schedule 80 PVCwith Teflon seats and EPDM "O" rings.
Auto lock fittings are used to connect lines fromthe mix tank to the distribution tank. Auto lockfittings are constructed of food grade Acetal andNitrite.	The Auto lock fittings and hose have been removedfrom the system as a potential source ofcontamination.
A conductivity meter has independent high/low setpoints that control to SPDT relays. The controllerfeatures a 1 mV per digit ± 0.5% ± 1 mV recorderoutput interface with a recorder or data logger tomake permanent records. Automatic temperaturecompensation is provided. By a 10KΩ thermistorbuilt in to the conductivity cell.	The Signet 8860 Dual ChannelConductivity/Resistivity Controller is a two-channel input device equipped with three saleable 4to 20 mA outputs and four programmable relays. Aselector switch activates two open collector outputsin place of two of the relays for extraordinaryoutput versatility. Dual input and advanced controlcapability, including percent rejection, difference

The 27500 Teflon rotary tank cleaning nozzlefeatures a spray head that is rotated by thepressurized flow of the spray solution. Thecompact nozzle produces effective solid streamsprays and can be operated at pressures of 10 - 50psi.3/8" Solenoid valve consisting of glass filledpolypropylene and a viton is used to administer ROwater to the mix tank.	and ratio calculations, together with SignetConductivity Sensors. Conductivity/Resistivityelectrodes are designed to provide versatileinstallation and accurate sensing across a verybroad dynamic range. These electrodes are builtwith a controlled surface finish to ensure accuracyand repeatability. The standard electrode isconstructed 316 SS or Titanium, but there are othermaterials available for maximum chemicalcompatibility. Reversible threads or sanitaryflanges allow for maximum installation versatility.The 27500 Teflon rotary tank cleaning nozzlefeatures a spray head that is rotated by thepressurized flow of the spray solution. Thecompact nozzle produces effective solid streamsprays and can be operated at pressures of 10 - 50psi.3/8" Solenoid valve consisting of glass filledpolypropylene and a viton is used to administer ROwater to the mix tank. This valve is also used toadminister RO water to the hopper and used for
Storage tank is a high density cone bottom tankwith a sealed cap. A 0.2 uS vent filter providesfiltration of the replacement air in the tank. Thedistribution tank is mounted to a NDPE tank stand.Distribution of bicarb solution; verify LoopPump switch on the Bicarb Controller is in the"ON" position. Automatic operation – ensurethat the power switch on AUTOCHEM 1000 isin the "OFF" position and all indicator lampsare extinguished. Verify LOOP PUMP switchon the RELAY CONTROLLER is in the "ON"position	disinfection.Storage tank is a high density cone bottom tankwith a sealed cap. A 0.2 uS vent filter providesfiltration of the replacement air in the tank. Thedistribution tank is mounted to a NDPE tank standDistribution is automated so when theDistribute button is pushed, the distribution ofthe bicarb will begin to purge the distributionline with bicarb. The return loop valve willdivert the return loop to drain until theconductivity of the return loop solution is <46mS.
Loop pump is a centrifugal, direct connect pumpconsisting of Glass Reinforced Noryl casing, 316stainless steel wear ring and impeller hub. Thebicarb loop pump is used to move the bicarb liquidconcentrate, disinfect solution, and rinse waterfrom the storage tank to the distribution loop,which goes to each dialysis machine.	Loop pump is a centrifugal, magnetic connect Fiber Reinforcedpump consisting of GlassPolypropylene casing, With a Polypropylenemagnetic capsule and alumina ceramic spindle. Thebicarb loop pump is used to move the bicarb liquidconcentrate, disinfect solution, and rinse waterfrom the storage tank to the distribution loop,which goes to each dialysis machine.Inline Flow Meter was changed to an electronic
Inline Flow Meter consists of polysulfone body,316 stainless steel float and viton seals. The flowmeter is placed in the bicarb distribution loop tomonitor the flow rate of the bicarb liquidconcentrate being distributed.	pulse flow meter. The Seametrics SPX low flowmeter employs jewel bearings to allow for very lowminimum flow rates and superior life. The SPXflow meter has a body material of polypropylene.The lens cover is acrylic for visual flow indication.The rotor assembly is Kynar with tungsten carbide
	shaft (ceramic shaft optional). The O-ring isEPDM.
	FT420 provides flow rate and total flow indication,with 4-20 mA output capability.
UV Light Ideal Horizons SR series UV 316stainless steel construction ½" FNPT connections.All are constructed using plasma arc or fusionwelding, providing strong food gradeuncontaminated welds.	UV Trojan UV 316 stainless steel construction ½"FNPT connections. All are constructed usingplasma arc or fusion welding, providing strongfood grade uncontaminated welds.
Submicron Filter a 0.2 micron pleatedpolypropylene depth filter. Meets FDArequirements for food contact.	Submicron Filter a 0.2 micron pleatedpolypropylene depth filter. Meets FDArequirements for food contact.
6 Channel Alarm is used to provide warnings fromthe water and bicarb system. The remote alarm isequipped with indicator lamps and an audio horn.	6 Channel Alarm is used to provide warnings fromthe water and bicarb system. The remote alarm isequipped with indicator lamps and an audio horn.
Autochem 1000 controller is used to providemixing control, distribution control and automaticdisinfection of the bicarb system. The start switchis guarded to prevent accidental starts. Duringautomatic disinfect process; all switches except thePOWER switch are "locked out" to preventaccidental interruption of the process.	The Autochem 1000 was replaced with a KoyoPLC. The Programmable Control Logic (PLC)operates the system utilizing ladder logic. Theladder logic is designed as failsafe logic that in theevent of a failure, the system will stop operation.The PLC controls all aspects of the operationincluding mixing of solution, distribution of themixed solution, end-of-day process where thesodium bicarbonate is rinsed from the distributionloop, and the disinfection process where the entiresystem is disinfected. A Human Machine Interface(HMI) touch screen acts as the interface betweenthe operator and the PLC. The HMI providesdevice operational characteristics such as tanklevels, flow rates, solution conductivity, andpressures. The HMI also interfaces the differentmix levels in the system.
Labeling Comparison
Exhibit A Label: Pure Water ConcentrateDistribution System Component Name:, SerialNo:, Model No:, with name and address ofmanufacturing 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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Page 2-

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 (800) 638-2041 or (301) 796-7100 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:

(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 _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.