AMERIWATER OZONE DISINFECTION SYSTEM by AMERIWATER

The AmeriWater Ozone Disinfection System is an optional accessory for the AmeriWater Bicarb Solution Mix and Distribution System (SDS) cleared for market under K051031 and the AmeriWater Water Purification System (WPS) for Hemodialysis cleared for market under K991519. It is intended for use in hospitals and dialysis clinics for the disinfection of the AmeriWater SDS and WPS system. The disinfection process is completed during off-hours when the SDS or WPS are not being used for patient treatment. The AmeriWater Ozone Disinfection System provides dissolved aqueous ozone concentrations of at least 0.5 ppm with a contact time of at least 30 minutes for disinfection of the WPS and SDS systems (the entire disinfection process takes approximately 2 hours to complete and longer contact times may be necessary based on microbial loads). The Ozone Disinfection System is designed to produce water with a microbial count of 50 CFU/ml or less.

Device Description

The AmeriWater Ozone Disinfection System is a compact portable device that connects to the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis for disinfection of the systems. Microbial reduction is achieved by a combination of disinfection by ozone and by physical removal by draining, flushing, and refilling the system being disinfected with fresh water. The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies.

The AmeriWater Ozone Disinfection System uses a high technology corona discharge process for producing ozone. Ozone is manufactured by drawing oxygen (O2) into the ozone generator and exposing it to multiple high voltage electrical discharges. This causes a percentage of the oxygen molecules to dissociate and reassemble as ozone (03). The ozone is drawn into the water by a venturi injector / mixer allowing the ozone to be injected into the water under a vacuum condition. The AmeriWater Ozone Disinfection System is a complete unit with ozone generator, venturi injector mixer, gas off chamber with excess ozone gas destruct, feed water flow meter, oxygen flow meter, and vacuum gauge.

The driving force of the AmeriWater Ozone Disinfection System is the distribution pump on the WPS water loop and the mix and distribution pumps on the SDS. A valve arrangement installed on the outlet of the WPS distribution pump and the SDS pumps allow for the diversion of purified water flow into the AmeriWater Ozone Disinfection System and back into the SDS or WPS storage tanks. The pumps force the purified water from the WPS storage tank into the Ozone Disinfection System, which enriches it with ozone and returns it to the WPS storage tank. Likewise, the purified water from the SDS mix and distribution tanks is pumped into the Ozone Disinfection System where it is enriched with ozone and returned to the tanks. When the water flow has been adjusted properly, a vacuum will draw oxygen (from a medical grade oxygen source) into the ozone generator and ozone will be created. The ozone generator has a vacuum switch and will not operate without an adequate vacuum from the venturi injector as indicated on the Ozone Disinfection System vacuum gauge.

The purified water from the WPS or SDS flows into the Ozone system through the feed flow meter and into a venturi injector creating a vacuum that draws the oxygen through the generator creating ozone in concentrations greater than 0.5 ppm. The ozone is then mixed in the ozone rich water enters the gas off tank to remove any excess, un-dissolved ozone gas. The water-ozone mixture enters and exits at the bottom of the gas off tank. The excess (un-dissolved) ozone will slowly displace the water in the tank and is vented at the top of the tank. The excess ozone gas then enters the ozone destruct chamber where it is destroyed while the ozone-rich water is directed back to the system being disinfected. Ozone concentrations are monitored using RPC Ozone Test strips, cleared for market under K132344.

The intended disinfection endpoint for the AmeriWater Ozone Disinfection System with the AmeriWater Water Disinfection System (WPS) and the AmeriWater Solution System (SDS) following disinfection and rinse is a total bacterial count less than or equal to 50 CFU/mL; when the system being disinfected is properly maintained (with bacterial counts < 100 CFU/mL; and endotoxin < 0.25 EU/mL). In the event that the system being disinfected has not been properly maintained, additional contact time or additional disinfection cycles may be required to achieve the desired end point. ANSI/AAMI/ISO 13959:2009 requires that monitoring of the water storage tanks for bacteria and endotoxin levels is accomplished indirectly by monitoring the water at the distribution loop. Water distribution systems are monitored by taking samples of the water at the first and last outlets of the water distribution loop. ANSI/AAMI/ISO 26722:2009 specifies that an ozone level of 0.5 ppm, sustained for at least 10 minutes, is considered necessary to kill bacterial organisms. AmeriWater recommends an ozone level of 0.5 ppm or greater for disinfection with a contact time of at least 30 minutes. The AmeriWater disinfection process takes approximately 2 hours to complete using the Ozone Disinfection System. This includes the time to build the ozone concentration in the storage tank and loop, as well as contact times.

AI/ML Overview

The AmeriWater Ozone Disinfection System is designed to disinfect the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis. The overall goal is to produce water with a microbial count of 50 CFU/ml or less.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Intended Disinfection Endpoint)	Reported Device Performance
Total bacterial count less than or equal to 50 CFU/mL (after disinfection and rinse)	Achieved the desired microbial endpoint of ≤ 50 CFU/mL. Demonstrated a 6 log reduction in bacteria, yeast, and mold, and a 3 log reduction in non-tuberculosis mycobacteria.
Ozone concentration of at least 0.5 ppm	System designed to provide dissolved aqueous ozone concentrations of at least 0.5 ppm. Test runs conducted at minimum recommended concentration (0.5 ppm).
Contact time of at least 30 minutes	System designed to provide a contact time of at least 30 minutes. Test runs conducted at minimum recommended contact time (30 minutes). The full disinfection process takes approximately 2 hours, including building ozone concentration and contact times.
Reduction of viruses	Complete inactivation of Herpes simplex virus type 1 and Poliovirus type 1 was demonstrated.
Absence of toxic leachables (following extended exposure to aqueous ozone)	No significant increases in toxins identified in AAMI standards; levels did not reach or exceed AAMI suggested maximum levels. Total organic carbon levels decreased. No visible signs of material degradation. Residual ozone levels reduced to <0.1 ppm after disinfection and rinse.
Ambient air ozone levels below permissible exposure limit (OSHA 29CFR and FDA 21CRFR) during use	Ambient air ozone levels remained below the permissible exposure limit during use.
Electrical safety and construction (UL 979 compliance)	Third-party tested and listed to UL 979 standard (Water Treatment Appliances). Passed starting current, power input, leakage current, resistance to grounding, temperature, dielectric voltage withstand, abnormal operation, strain relief, push back relief, operational, stability, humidity conditioning, insulation resistance, and thermal endurance tests.

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

Sample Size for Test Set:
- Microbial Challenge (Bacteria, Yeast, Mold, Mycobacteria): Not explicitly stated as a number of distinct samples, but tests were conducted with a "range of test organisms" in a "microbial challenge solution" under "worst-case conditions."
  - WPS Testing: Included test runs with 48-hour incubation, 30-day incubation (representing recommended disinfection frequency), and simulated use testing.
  - SDS Testing: Included test runs with 48-hour incubation, 6-day incubation (representing recommended disinfection frequency), and simulated use testing.
- Virucidal Efficacy: Not explicitly stated as a number of distinct samples, but tested using "Herpes simplex virus type 1" and "Poliovirus type 1" under "worst-case conditions."
- Biocompatibility/Leaching: Not explicitly stated as a number of samples, but involved "extended exposure" over the "expected operating life of the device."
- Electrical Safety: Not explicitly stated as a number of units, but device was "third-party tested and listed to UL 979."
Data Provenance: The document does not specify the country of origin for the data. The studies described are non-clinical testing and appear to be conducted as part of the device's validation. They are likely prospective studies specifically designed to test the device's performance against the established criteria.

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

The document does not provide information on the number of experts or their qualifications for establishing the ground truth for the test set in the context of typical diagnostic device studies (e.g., radiologist consensus).

In this case, the "ground truth" for the microbial efficacy testing would be the actual microbial count reductions and inactivation, determined through laboratory methods (e.g., plating, enumeration), rather than expert interpretation of images or clinical outcomes. For biocompatibility, the ground truth would be chemical analysis of leachates and material integrity. These are objective measures determined by validated laboratory assays.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where human interpretation or subjective assessment is involved, especially in clinical diagnostic accuracy studies where disagreements among readers need resolution.

For the non-clinical performance and safety tests described here (microbial efficacy, virucidal efficacy, biocompatibility, electrical safety), the results are typically quantitative and objectively measured by laboratory instruments and protocols. Therefore, a human "adjudication method" as described is not applicable. The results would be confirmed through repeat testing, calibration of equipment, and adherence to standard laboratory practices.

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

No, an MRMC comparative effectiveness study was not done. This type of study is used to assess the effectiveness of a diagnostic device when used by human readers, often comparing performance with and without AI assistance. The AmeriWater Ozone Disinfection System is a disinfection system, not a diagnostic device that involves human interpretation of results.

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

Yes, the studies described are essentially standalone performance studies for the device. The device (AmeriWater Ozone Disinfection System) is functioning as an automated system to achieve disinfection, and its performance is evaluated directly on its ability to meet the microbial reduction, virus inactivation, and safety criteria. There is no "human-in-the-loop" interaction in the core function of the disinfection process itself that would be evaluated in these non-clinical tests.

7. The Type of Ground Truth Used

Microbial Efficacy (Bacteria, Yeast, Mold, Mycobacteria): Laboratory-determined microbial counts (CFU/mL) and log reduction, based on standard microbiological assay methods.
Virucidal Efficacy: Laboratory-determined viral inactivation, based on standard virological assay methods.
Biocompatibility/Leaching: Chemical analysis of leachates (e.g., for specific toxins, TOC levels) and visual inspection for material degradation.
Safety (Ozone levels, Electrical): Instrumental measurements of ozone concentration (water and ambient air) and electrical parameters against established regulatory/safety standards (OSHA, FDA, UL 979).

8. The Sample Size for the Training Set

The document describes non-clinical performance and safety testing for a medical device (an ozone disinfection system). This is not an AI/machine learning device, so the concept of a "training set" in the context of algorithm development is not applicable. The device operates based on physical and chemical principles of ozone generation and disinfection, not on a machine learning model trained on a dataset.

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

As stated above, a "training set" is not relevant for this type of device.

Summary

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

December 10, 2014

AmeriWater, Inc. Mr. Brian R. Bowman Ouality & Regulatory Administrator 1303 Stanley Avenue Dayton, OH 45404

Re: K141213

Trade/Device Name: AmeriWater Ozone Disinfection System Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FIN Dated: November 5, 2014 Received: November 10, 2014

Dear Mr. Bowman:

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.

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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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

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Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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1303 STANLEY AVENUE DAYTON, OH 45404 USA TEL 937-461-8833, 800-535-5585 FAX 937-461-1988 www.AMERIWATER.com

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Indications for Use

510(k) Number (if known): K141213

Device Name: AmeriWater Ozone Disinfection System

Indications For Use:

The AmeriWater Ozone Disinfection System is an optional accessory for the AmeriWater Bicarb Solution Mix and Distribution System (SDS) cleared for market under K051031 and the AmeriWater Water Purification System (WPS) for Hemodialysis cleared for market under K991519. It is intended for use in hospitals and dialysis clinics for the disinfection of the AmeriWater SDS and WPS system. The disinfection process is completed during off-hours when the SDS or WPS are not being used for patient treatment. The AmeriWater Ozone Disinfection System provides dissolved aqueous ozone concentrations of at least 0.5 pm with a contact time of at least 30 minutes for disinfection of the WPS and SDS systems (the entire disinfection process takes approximately 2 hours to complete and longer contact times may be necessary based on microbial loads). The Ozone Disinfection System is designed to produce water with a microbial count of 50 CFU/ml or less.

Prescription Use (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)

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1303 STANLEY AVENUE DAYTON, OH 45404 USA TEL 937-461-8833, 800-535-5585 FAX 937-461-1988 www.AMERIWATER.com

510(K) SUMMARY

December 8, 2014

Classification Name: Hemodialysis System and Accessories Common/Usual Name: Ozone Generator/Ozone Generating System Proprietary Name: AmeriWater Ozone Disinfection System Classification: Class II Medical Device under 21 CFR §876.5820. Panel: Gastroenterology Product Code: FIN 510(k) Submitter: AmeriWater, Inc. Establishment Registration Number: 1530185 Owner Operator Number: 9009428 Contact Person: Brian Bowman, Quality and Regulatory Administrator Phone: (937) 461-8833, Fax: (937) 461-1988, Email: brianbowman@ameriwater.com Predicate Device: TANGO3 Water Storage Tank with Ozone Disinfection System (K093641)

Intended Use: The AmeriWater Ozone Disinfection System is an optional accessory for the AmeriWater Bicarb Solution Mix and Distribution System (SDS) cleared for market under K051031 and the AmeriWater Water Purification System (WPS) for Hemodialysis cleared for market under K991519. It is intended for use in hospitals and dialysis clinics for the disinfection of the AmeriWater SDS and WPS system. The disinfection process is completed during off-hours when the SDS or WPS are not being used for patient treatment. The AmeriWater Ozone Disinfection System provides dissolved aqueous ozone concentrations of at least 0.5 ppm with a contact time of at least 30 minutes for disinfection of the WPS and SDS systems (the entire disinfection process takes approximately 2 hours to complete and longer contact times may be necessary based on microbial loads). The Ozone Disinfection System is designed to produce water with a microbial count of 50 CFU/ml or less.

Device Description: The AmeriWater Ozone Disinfection System is a compact portable device that connects to the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis for disinfection of the systems. Microbial reduction is achieved by a combination of disinfection by ozone and by physical removal by draining. flushing, and refilling the system being disinfected with fresh water. The Heatsan system has been designed to be in compliance with the requirements of ANSI/AAMI/ISO 13959:2009 Water for hemodialysis and related therapies and ANSI/AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and related therapies.

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a medical grade oxygen source) into the ozone generator and ozone will be created. The ozone generator has a vacuum switch and will not operate without an adequate vacuum from the venturi injector as indicated on the Ozone Disinfection System vacuum gauge.

Summary of Performance Testing: Non-clinical testing was conducted to verify and validate the efficacy of the system in the reduction of bacteria in the AmeriWater Bicarb Solution Mix and Distribution System (SDS) and the AmeriWater Water Purification System (WPS) for Hemodialysis. Testing was conducted under worse case conditions (minimum recommended concentration and contact time) using a microbial challenge solution containing a range of test organisms that represents the waterborne bacteria found in hemodialysis water systems. The species included were Pseudomonas aeruginosa (Gram-negative bacterium), Staphylococcus aureus (Gram-positive bacterium), Candida albicans (yeast), Asperigillus fumigatus (mold), and Mycobacterium fortuitum (non tuberculosis mycobacterium). Test runs with the WPS were conducted with a 48-hour incubation time, a 30-day incubation time (based on the recommended disinfection frequency), and simulated use testing. The SDS testing included test runs with a 48-hour incubation time. 6-day incubation time (based on the recommended disinfection frequency), and simulated use testing. The 48-hour, 6-day, and 30-day incubation tests were designed to demonstrate a 6 log reduction in bacteria, yeast and mold levels, and a 3 log reduction in non tuberculosis mycobacteria. Simulated use testing was conducted to show evidence that the specified endpoints were achieved during normal operation of the Ozone Disinfection system with the WPS and SDS systems. The results of microbiological testing demonstrated a 6 log reduction in bacteria, yeast and mold levels, and a 3 log reduction in non tuberculosis mycobacteria; and the desired microbial endpoint. The results were achieved by a combination of disinfection by ozone and by physical removal by draining, and refilling the system being disinfected with fresh water.

Non-clinical virucidal efficacy testing was also conducted to evaluate the ability of the AmeriWater Ozone Disinfection System (ODS) to reduce viruses in water. Testing was conducted under worse case conditions (minimum recommended concentration and contact time). The Herpes simplex virus type 1 and Poliovirus type 1 were used in the virucidal efficacy testing. Under the conditions of this investigation, the AmeriWater Ozone Disinfection System demonstrated complete inactivation of the viruses used in the test.

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Biocompatibility testing was conducted to determine if extended exposure of the components of the AmeriWater Ozone Disinfection system (ODS) in conjunction with the AmeriWater Purification System (WPS) and the AmeriWater Bicarb Solution Mix and Distribution System (SDS) to aqueous ozone results in leaching, and to demonstrate the absence of toxic leachables. These tests were designed to expose the Ozone Disinfection System in conjunction with the AmeriWater WPS and SDS, when operating the system at the highest ozone level produced when operating the instructions for use for the device, for the expected operating life of the device. There were no significant increases in any of the toxins identified in the AAMI standards, and levels for the toxins did not reach or exceed the AAMI suggested maximum levels. Total organic carbon levels actually decreased during the test. There were no visible signs of material degradation in the WPS, SDS, or ODS systems. Residual ozone levels were reduced to <0.1 ppm following disinfection in both the WPS and SDS systems. Ambient air ozone levels remained below the permissible exposure limit per OSHA 29CFR and the permissible exposure limit indicated in FDA 21CRFR during use of the AmeriWater Ozone Disinfection System in conjunction with the AmeriWater WPS and SDS systems.

The AmeriWater Ozone Disifnection System has been third-party tested and listed to UL 979. The UL 979 standard is the UL standard for Water Treatment Appliances. The scope of the standard includes requirements covering electrically operated water treatment appliances for household and commercial use. These requirements cover appliances utilizing features that treat water through the use of cation exchange water softeners, ionization, filters, ultraviolet radiation, ozone generation, and reverse osmosis. Testing performed on the device to show evidence of product safety. These tests include starting current test, power input test, leakage current test, leakage current after humidity, resistance to grounding, temperature test, dielectric voltage withstand test, abnormal operation test, strain relief test, push back relief test, operational test, stability test, humidity conditioning, insulation resistance, and thermal endurance test.

UL 979 provides specific requirements for device construction, including requirements for frames and enclosures, accessibility of uninsulated live parts, protection aqainst corrosion, exposure to water, mechanical assembly, supply connected appliances, grounding, live parts, electrical insulation, internal and external wiring connections, separation of circuits, spacings (low-voltage and isolated limited-energy circuits, and high-voltage circuits), capacitors, switches and controls, transformers and power supplies, seals gaskets and diaphragms, motors, ratings, device markings, and installation instructions. These requirements are intended to ensure safe operation of an appliance when used in a home or commercial environment. AmeriWater has incorporated several safety features into the device design to protect the operator of the device. The unit is sealed by several fasteners that require a tool to open and access the inside of the device. UL 979 - compliant internal electrical wiring insulation, and wiring routed away from sharp edges. A user is protected by a sealed unit not exposing them to any electrical hazards, when the access panel is removed there is a door switch that kills power to the unit.

Test results from non-clinical testing, biocompatibility testing, and electrical safety testing indicate that the device is as safe and effective for its intended purpose as the predicate device.

Statement of Substantial Equivalence: The AmeriWater Ozone Disinfection System is substantially equivalent in intended use, function, and technology to the TANGOs Water Storage Tank with Ozone Disinfection System (K093641) marketed by TANGO3 LLC. It is also similar in intended use, function, and technology to the GE Infrastructure, Water & Process Technologies' O2Z Ozone System (K043207). The table on the following page, along with the documentation included in this submission, demonstrates that there are no new issues of safety or effectiveness, and that the AmeriWater Ozone Disinfection System is as safe and effective for its intended purpose as the predicate device.

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AmeriWater Ozone	TANGO3 Ozone	GE O3Z Ozone
Disinfection System	Disinfection System	Sanitizing System
Intended Use:Disinfection of AmeriWater SolutionMix and Distribution System (SDS) andAmeriWater Water Purification Systemfor Dialysis (WPS) storage tank anddistribution loop.	Intended Use:Disinfection of the water distributionsystem of a dialysis facility	Intended Use:Disinfection and decalcification of thebicarbonate portion of the GE SolutionDelivery System (SDS).
Water is pumped through a venturiinjector to create vacuum. The vacuumpulls oxygen through the ozonegenerator resulting in ozoneproduction.	Water is pumped through a venturiinjector to create vacuum. The vacuumpulls air through the ozone generatorresulting in ozone production.	Water is pumped through a venturiinjector to create vacuum. The vacuumpulls air through the ozone generatorresulting in ozone production.
Water is pumped into the ozonesystem by an external pump.	Water is pumped into the ozone systemby an external pump (TANGO3 RecircPump).	Water is pumped into the ozone systemby an external pump (the GE SDSsystem pumps).
The ozone generator uses a coronadischarge to create ozone.	The ozone generator uses a coronadischarge to create ozone.	The ozone generator uses a coronadischarge to create ozone.
Electrical requirements:115 VAC, 60 Hz, 15 Amps, 1 Ph	Electrical requirements:208 VAC 3 PH or 240 VAC 1 PH, 60Hz,25 Amp (pumps)120 VAC, 60 Hz (control)	Electrical requirements:115 VAC, 60 Hz, 3 Amps, 1 Phase.
Portable device	Not portable	Not portable
Complete system enclosed in a cabinetwith handle and casters.	Ozone disinfection system is part ofwater storage tank.	Wall-mounted in fixed location.
Uses medical grade oxygen to produceozone.	Uses ambient air for ozone production.	Uses ambient air for ozone production.
Manual Disinfection Process	Automated Disinfection ProcessSoftware (PLC) controlled	Manual Disinfection Process
Ozone concentration monitored with510K cleared test strips.	Ozone concentration monitored withinline ozone monitor.	Ozone concentration monitored withdigital Hach chlorine colorimeter withTotal Chlorine DPD test pillows.

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.