The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for additional reduction of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).

Device Description

The TANGO3 Water Storage Tank with Ozone Disinfection System is specifically designed to facilitate ozone induction into the storage tank, and then distribute the ozonated water through the distribution water loop during non-operational hours of a hemodialysis facility. The storage tank of the TANGO3 system is filled with adequate water and the ozone concentration is increased. The ozonated water is distributed throughout the distribution loop. The solution is recirculated throughout the distribution system. To complete the disinfection process, the system and distribution loop are then rinsed with adequate water. The described process is accomplished with 4 consecutive 30 minute cycles of ozone disinfection weekly. In addition, a disinfection cycle of 45 minutes multiple times per week may also be used for additional reduction of bioburden (as determined by user facility monitoring). After disinfection TANGO3 will leave the distribution loop with less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).

AI/ML Overview

The TANGO3 Water Storage Tank with Ozone Disinfection System is intended for disinfection of the water distribution system of a dialysis facility. The device's performance was evaluated through reliability validation, disinfection validation, and field testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Reliability Validation:
O3 generation capability (O3 level between 0.2 ppm and 0.3 ppm)	Passed: O3 levels maintained between 0.2 ppm and 0.3 ppm.
O3 Calibration (No variation greater than 5%)	Passed: No variation greater than 5% observed.
Valves and dissolved ozone destruct (No valve related alarms, Level of ozone not above 0 ppm)	Passed: No valve related alarms and ozone level not above 0 ppm.
Pump (Loop velocity maintained at 4 ft/sec ± 10%)	Passed: Loop velocity maintained at 4 ft/sec ± 10%.
Ambient ozone (< 0.1ppm (OSHA))	Passed: Ambient ozone readings on both automated ozone detector and badge were below OSHA limits.
FMEA (Failure of critical components detected)	Passed: Failure of critical components was detected.
Disinfection Validation:
Disinfection effectiveness to below contamination action levels (bacteria and LAL)	Passed: Disinfection efficacy shown to keep water at or below AAMI RD 62:2006 action levels for bacteria and LAL.
Field Testing:
Maintain water in distribution loop below AAMI RD 62:2006 action levels	Passed: TANGO3 was able to maintain water in the distribution loop below AAMI RD 62:2006 action levels in all four facilities.
Ozone Residual (Post-disinfection):
Distribution loop will have less than 0.1 mg/l (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5)	Achieved (stated in indications for use and device description).

2. Sample size used for the test set and the data provenance:

Reliability Validation: The system was tested to simulate 10 years of use. This implies continuous or simulated continuous operation for that duration to assess component function. The specific number of cycles or days of testing is not explicitly stated beyond "10 years of use". Data provenance is not specified, but typically, this type of testing is conducted in a controlled laboratory environment by the manufacturer.
Disinfection Validation: Not explicitly stated how many tests or samples were used for each organism. The testing was conducted to validate the disinfection performance. Data provenance is not specified, but likely laboratory-based.
Field Testing: Conducted in four (4) dialysis facilities. These facilities had documented histories of water contamination issues. This is retrospective for identifying the facilities, but the testing within those facilities with the TANGO3 system was prospective, conducted under a standard protocol.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a medical device for water disinfection, not an AI/imaging device requiring expert interpretation for ground truth. Therefore, the concept of "experts" and their qualifications to establish ground truth data in the context of diagnostic accuracy is not directly applicable here. The "ground truth" for the disinfection tests would be established through laboratory analytical methods (e.g., bacterial culture, LAL assays) and chemical analysis (e.g., ozone concentration measurements) performed by qualified laboratory personnel.

4. Adjudication method for the test set:

Not applicable. This device's performance is measured by objective physical and chemical parameters and microbiological counts, not subjective interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI diagnostic imaging device evaluating human reader performance.

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

The device itself is a standalone system with an automated disinfection process. The performance documented (O3 generation, disinfection efficacy, ambient ozone detection) is considered standalone performance. There isn't an "algorithm only" in the sense of a software-based diagnostic tool, but the device operates autonomously in its disinfection functions once initiated.

7. The type of ground truth used:

Reliability Validation: Engineering specifications and objective measurements (e.g., ozone sensor readings, pump velocity measurements, alarm detection).
Disinfection Validation: Microbiological assay results (e.g., bacterial counts, LAL endotoxin levels) compared against AAMI RD 62:2006 action levels. Chemical analysis for ozone concentration.
Field Testing: Bacterial counts and endotoxin levels obtained through standard laboratory water testing methods, compared against AAMI RD 62:2006 recommendations.

8. The sample size for the training set:

The term "training set" is typically used in the context of machine learning. This device does not appear to use machine learning in a way that requires a distinct "training set" of data for an algorithm. The system is designed based on established principles of ozone disinfection and validated through engineering tests and biological efficacy studies.

9. How the ground truth for the training set was established:

Not applicable for the reasons stated in point 8. The device's operational parameters (like ozone concentration, cycling times) are based on scientific evidence for microbial inactivation, not trained on a data set. Relevant ground truth is established through scientific literature, consensus standards (like AAMI/ISO), and previous laboratory research on ozone's bactericidal and virucidal properties.

Summary

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

January 12, 2015

TANGO3, LLC C/O Ms. Lori Holder Regulatory Affairs Consultant 141 Citizens Boulevard Simpsonville, Kentucky 40067

Re: K140984

Trade/Device Name: TANGO3 Water Storage Tank with Ozone Disinfection System Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: FIN Dated: December 11, 2014 Received: December 12, 2014

Dear Ms. Holder:

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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Page 2 - Ms. Holder

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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Indications for Use

510(k) Number (if known) K140984

Device Name

TANGO3 Water Storage Tank with Ozone Disinfection System

Indications for Use (Describe)

The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for addition of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K140984 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:	TANGO3, LLC141 Citizens Blvd.Simpsonville, KY 40067Telephone: (502) 722-8794
Contact person:	Hugh Doss, Manager

Date of Summary: January 9, 2015

Device Name: TANGO3 Water Storage Tank with Ozone Disinfection System

Device Classification Name: Hemodialysis System and Accessories (876.5820, FIN)

Device Classification: Class II

Device Description: The TANGO3 Water Storage Tank with Ozone Disinfection System is specifically designed to facilitate ozone induction into the storage tank, and then distribute the ozonated water through the distribution water loop during non-operational hours of a hemodialysis facility. The storage tank of the TANGO3 system is filled with adequate water and the ozone concentration is increased. The ozonated water is distributed throughout the distribution loop. The solution is recirculated throughout the distribution system. To complete the disinfection process, the system and distribution loop are then rinsed with adequate water. The described process is accomplished with 4 consecutive 30 minute cycles of ozone disinfection weekly. In addition, a disinfection cycle of 45 minutes multiple times per week may also be used for additional reduction of bioburden (as determined by user facility monitoring). After disinfection TANGO3 will leave the distribution loop with less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).

System Description and Theory of Operation

The TANGO3 Water Storage Tank with Ozone Disinfection System consists of the following components: a heat regenerative desiccant air dryer at a 20 SCFH of air flow, a Corona discharge ozone generator that produces a working concentration of 0.3ppm of ozone, a venturi based injection system, HDPE or Stainless Steel water storage tank, an off gas ozone destruct system, a multi-stage centrifugal distribution pump (duel distribution pumps are offered as an option), and a main controller and operator's interface. Sensors incorporated into the system include return and output flow sensors, an ozone sensor, a level sensor, a conductivity sensor, and an atmospheric ozone detector. Fluid contacting materials include: Stainless Steel 300 Series, High Density Polyethylene (HDPE), Lexan® (Polycarbonate), Acrylic (PMMA), Teflon® (PTFE), Viton® (FKM), Kynar® (PVDF), and PVC. The System produces a dissolved ozone concentration of 0.20 ppm to 0.30 ppm during the disinfection process.

The TANGO3 System has been designed to meet the applicable requirements of the following voluntary standards:

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AAMI /ANSI RD52:2004 Dialysate for hemodialysis ■
AAMI/ANSI RD62:2006 Water treatment equipment for hemodialysis applications ■
AAMI/ISO 26722:2009 Water treatment equipment for hemodialysis applications and ■ related therapies

Ozone is produced in a flat gas stream which results in low energy consumption and high ozone concentration. Energy consumption is less than 7 kW per kilo ozone produced.

The ozone disinfection process is derived through the generator located on the front of the device. Atmospheric air passes through silica beads removing humidity from the air. The air then passes through an air dryer to additionally remove all remaining moisture from the air. The dry air passes between two electrode plates consisting of high current. To prevent the air from breaking down electrically along a simple line of rupture or spark, a sheet of glass is placed between the metal plates. By this means the air is made to break down electrically throughout thus greatly increasing the amount of ozone produced.

The air in the system is not pressurized but operates under a vacuum produced when the ozone recirculation pump is operating. The pump uses the purified water from the storage tank to pressurize the water. Then the water passes through a venturi creating a vacuum which will pull atmospheric air through the acrylic tube with silica gel, through the air dryers, and then through the generating chamber. The ozone gas is mixed with the purified water at the venturi and diffused into the holding tank. The ozonated water is then distributed from the holding tank to the distribution loop through the distribution pump and returns back to the storage tank. The return loop is monitored for dissolved ozone level achieving a level of 0.2 ppm to 0.3 ppm. Upon completion of the disinfection dwell time, a flushing phase is activated to destroy the residual ozone prior to use with patients.

To protect the distribution piping and well as other water contacting materials, a low level of ozone is used. Laboratory testing has proven a 6 log reduction of microbiological contamination when using dissolved ozone concentration levels between 0.2 ppm to 0.3 ppm while showing no immediate effect on PVC distribution piping.

Operation Overview

Three operational modes are provided: Dialysis, Maintenance, and Disinfection. The system is set to dialysis mode when the water system is being used for dialysis. The system is set to maintenance mode to allow for manual control of the system. Ozone product only occurs in disinfection mode. A description of the disinfection process follows.

The disinfection process is divided into the following phases, as shown above:

1. Ozonation: During this phase the ozone generator is on and ozonated water is being recirculated through the loop.
1. Loop and Tank Emptying: Once the ozonation phase is complete a valve will be actuated and the returning flow will go to drain instead of returning to the tank. The distribution pump will be kept on until the LOW TANK level is detected. At this point, the distribution pump, ozone generator and recirculation pump will be turned off. The tank drain valve will open. allowing the tank to empty by gravity.

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1. Tank and Loop Refill: After the loop and tank are empty, TANGO3 will allow adequate water to enter the storage tank. Once the TOP FLOAT level is detected, no more water will be allowed to enter the tank.
1. During the weekly disinfection cycle, steps 1) through 3) will be repeated for each cycle.
1. Ozone Destruction: A flushing process will be done with non ozonated water until the ozone sensor detects that the level of ozone residual complies with the AAMI requirements

To avoid the possibility of dissolved 03 in the distribution loop while water is being used for other purposes, the system has two (2) flow meters to measure the input and the output of the storage tank. If those two (2) readings are not equal the ozone generator and the distribution pump will be turned off. In addition, daily manual checks may be performed to assure the absence of ozone in the loop prior to the beginning of the dialysis treatment using a properly calibrated digital colorimeter.

The presence of ozone in the room will also be monitored using an ambient ozone sensor and/or ambient ozone detection badges. Visual and audible alarms will be given if the levels are above normal OSHA and EPA exposure values.

Intended Use: The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO3 is also used as the water holding tank of the distribution system. The disinfection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. Weekly disinfection cycles should be for four periods of 30 minutes with adequate water flushes between them and after the last cycle. In addition to the weekly disinfection cycle, a 45 minute disinfection cycle with at least two rinse cycles may also be performed multiple times weekly for additional reduction of bioburden as determined by user facility monitoring. At the end of disinfection, the distribution loop will have less than 0.1 mg/l. (0.1 ppm) of ozone, in accordance with AAMI/ISO 26722:2009 (4.2.13.5).

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Legally Marketed Devices to which Equivalence is Claimed:

TANGO3 Water Storage Tank with Ozone Disinfection System K0903641 ■
Descriptive Summary of Technological Characteristics and Those of the Predicate Device: The features of TANGO3 are equivalent to the predicate device in terms intended use, technological characteristics, and operational characteristics as summarized in the following table:

	PREDICATE DEVICE:
	TANGO3, LLC TANGO3 Water Storage	PROPOSED DEVICE:
PARAMETER	Tank with Ozone Disinfection SystemK093641	TANGO3, LLC TANGO3 Water StorageTank with Ozone Disinfection System

Classification Name AndProduct Code	Hemodialysis System and AccessoriesFIN	Hemodialysis System and AccessoriesFIN
Intended Use	The TANGO3 Water Storage Tank withOzone Disinfection System is intended to beused for disinfection of the waterdistribution system of a dialysis facility.	The TANGO3 Water Storage Tank withOzone Disinfection System is intended to beused for disinfection of the water distributionsystem of a dialysis facility.
Indications for Use	The TANGO3 Water Storage Tank withOzone Disinfection System is intended to beused for disinfection of the waterdistribution system of a dialysis facility. Thetank of the TANGO3 is also used as thewater holding tank of the distributionsystem. The disinfection process iscompletely automated. Ozone concentrationduring disinfection is between 0.2 ppm and0.3 ppm. The distribution system will beexposed to ozone for one (1) period of 45minutes and three (3) periods of 30 minuteswith adequate water flushes between themand at the end, leaving the distribution loopwithout ozone.	The TANGO3 Water Storage Tank withOzone Disinfection System is intended to beused for disinfection of the water distributionsystem of a dialysis facility. The tank of theTANGO3 is also used as the water holdingtank of the distribution system. Thedisinfection process is completelyautomated. Ozone concentration duringdisinfection is between 0.2 ppm and 0.3ppm. Weekly disinfection cycles should befor four periods of 30 minutes with adequatewater flushes between them and after the lastcycle. In addition to the weekly disinfectioncycle, a 45 minute disinfection cycle with atleast two rinse cycles may also be performedmultiple times weekly for additionalreduction of bioburden as determined byuser facility monitoring. At the end ofdisinfection, the distribution loop will haveless than 0.1 mg/l. (0.1 ppm) of ozone, inaccordance with AAMI/ISO 26722:2009(4.2.13.5).

Materials in Contact WithFluids	Stainless Steel, Teflon, PVC	Stainless Steel, Teflon, PVC, HDPE
Water Requirements:Water Quality	AAMI Quality	AAMI Quality
Environmental Limits:Ambient Temperature	40° - 100° F (4.4° - 38° C)	40° - 100° F (4.4° - 38° C)
Relative Humidity	10 - 80%	10 - 80%
Ambient Ozone	< 0.1ppm (OSHA)	< 0.1ppm (OSHA)

Contact Time	30 or 45 minute cycles	30 or 45 minute cycles
Frequency	As required	As required
Used during	Non-operational hours	Non-operational hours
Rinsing	Automatic with water	Automatic with water
Alarms	Audible and visible indicators	Audible and visible indicators
Gas Feed	Dried air, with heat regenerative desiccants	Dried air, with heat regenerative desiccants
Ozone Generator	Corona discharge	Corona discharge
Injection System	Venturi based	Venturi based
Storage Tank	Stainless Steel or compatible with ozone	Stainless Steel or compatible with ozone

Applicable Standards	AAMI RD 62	AAMI RD 62

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Performance Data: The following performance data were provided in support of the substantial equivalence determination. The results from these tests show that the TANGO3 performed as expected.

Reliability Validation Testing

Reliability testing has been conducted to ensure that all components of the system function as designed for the intended life of the TANGO}. This testing included a validation of the software functions, including alarms. The system was tested to simulate 10 years of use.

The following table outlines the tests that were conducted as part of the reliability testing. All tests passed and demonstrated that the device works as intended.

Test	Evaluation or Test
O3 generation capability	• O3 level between 0.2 ppm and 0.3 ppm
O3 Calibration	• No variation greater than 5%
Valves and dissolved ozone	• No valve related alarms should be observed
destruct	• Level of ozone not above 0 ppm
Pump	• Loop velocity maintained at 4 ft/sec ± 10%
Ambient ozone	• Ambient ozone readings on both automated ozone detector and badge
FMEA	• Validate that a failure of critical components will be detected

Disinfection Validation

Testing was conducted to validate the disinfection performance of the ozone generator when used for water disinfection for dialysis and to determine the efficacy of O3 to disinfect water to below contamination action levels (bacteria and LAL). Overall, results of the disinfection validation show that the disinfection effectiveness of TANGO3 while keeping the water in the dialysis water distribution loop below AAMI RD 62:2006 action levels.

An overview of each test is provided in the table below.

Test	Organisms Tested
Disinfection of Clinically Relevant Waterborne Bacteria	Acidovorax, Pseudomonas Aeruginosa, Burkholderia Cepacia, Brevundimonas Diminuta Mycobacterium Fortuitum
Normal Inoculation (Simulated Use) Testing	Acidovorax, Pseudomonas Aeruginosa, Burkholderia Cepacia
Biofilm Reduction and Prevention Capability Testing	Acidovorax Pseudomonas Aeruginosa Burkholderia Cepacia
Elimination of Enveloped and Non-enveloped Viruses	Poliovirus Type 1 Rotavirus Herpes Simplex Virus Type 1
Fungi Elimination Efficacy	Candida Tropicallis Aspergillus

Field Testing

Field testing was performed in four (4) dialysis facilities with histories of water contamination. All four (4) facilities had documented water contamination issues and required periodic disinfection processes in order to maintain total bacterial counts and endotoxin levels below AAMI recommendations. This testing was conducted under a

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standard protocol, which was reviewed and approved by the Institutional Review Board (IRB) of the facility at which the testing was conducted. The IRB determined that the testing was to be non-significant risk. Disinfection with the TANGO3 System was performed based on the clinic's policies and procedures. Results show that TANGO3 was able to maintain the water in the distribution loop below AAMI RD 62:2006 action levels.

Software Verification and Validation Testing

Complete software validation, verification, and performance testing was performed to confirm that the features worked correctly and that the Programmable Logic Controller, the Human Machine Interface, and the Ozone systems hardware functioned together as expected. Documentation was provided as recommended by FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern since, prior to mitigation of hazards, a failure of the software could result in Minor Injury, either to a patient or to a user of the device.

Human Factors Testing

Human factors testing was conducted to verify that the user can safely operate the TANGO3. Different ranges to set up parameters were entered, and the readability of screens and messages was evaluated. Proper recognition of visual and audible alarms was also verified.

Conclusion: The information and data provided in this 510(k) Notification establish that the TANGO3 Water Storage Tank with Ozone Disinfection System is substantially equivalent to the legally marketed predicate device.

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.