(379 days)
No
The description focuses on automated ozone generation, injection, and distribution based on pre-defined parameters and sensor feedback (flow sensors, ozone levels). There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
No
This device is described as a water storage tank and ozone disinfection system for the water distribution system of a dialysis facility. Its purpose is to disinfect the water system, not to directly treat or diagnose a patient.
No
The device is intended for the disinfection of water distribution systems in dialysis facilities by generating and distributing ozonated water, not for diagnosing medical conditions or diseases.
No
The device description clearly outlines multiple hardware components including a water storage tank, ozone generator, air dryer, venturi injection system, centrifugal pump, and flow sensors. This is not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is the disinfection of the water distribution system within a dialysis facility. This is a process related to the infrastructure and equipment used in dialysis, not a test performed on a biological sample from a patient to diagnose or monitor a medical condition.
- Device Description: The device is a water storage tank with an ozone disinfection system. It generates ozone and circulates ozonated water through the dialysis facility's water loop. This is a water treatment and disinfection system.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples (blood, urine, tissue, etc.) from a patient. IVDs are designed to perform tests on such samples.
- Focus on Water Disinfection: The entire description revolves around the process of disinfecting the water used in dialysis, not diagnosing or monitoring a patient's health.
- Performance Studies: The performance studies mentioned focus on the device's ability to disinfect water and material compatibility with ozone, not on the accuracy or reliability of diagnostic results from biological samples.
In summary, the TANGO3 Water Storage Tank with Ozone Disinfection System is a water treatment and disinfection device used in the context of dialysis facilities. It does not perform diagnostic tests on biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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. The distribution system will be exposed to ozone for one (1) period of 45 minutes and three (3) subsequent periods of 30 minutes with adequate water flushes between them and at the end, leaving the distribution loop without ozone.
Product codes
FIN
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 the disinfection process, the system and distribution system. To complete the disinfection process, the system and distribution system. To complete The described process is repeated three (3) more times. After the last cycle TANGO3 will leave the system residual free of ozone.
To accomplish this, TANGO3 has a corona discharge generator that generates ozone from a source of dry air. The air dryer consists of two heat regenerative desiccant modules. The ozone if om a injected into the tank by means of a venturi based injection system. Once in the tank, the ozonated water is sent to the distribution loop with a centrifugal pump. Ozone levels are monitored at the return of the loop. Two (2) flow sensors, located at the input and output of the distribution loop will assure that the dialysis facility is not utilizing water while ozone is present in the loop.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Each function of the TANGO3 System was tested to see if it performed as intended. Any errors or failures detected during testing were corrected. In vitro testing was also performed to validate the disinfection capabilities of TANGO3 with waterborne organisms. All materials found in water distribution loops have been tested for material compatibility with ozone. A field test has been performed to validate that TANGO3 can address the needs of facilities with known water contamination issues. The results from these tests show that the TANGO3 performed as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K093641 PAGE 1 OF 2
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, LLC
141A Citizens Blvd
Simpsonville, KY 40067
Telephone: (502) 722-8794
DEC 8 - 2010
Contact person: Hugh Doss, Manager
Date of Summary: October X, 2009
Device Name: TANGO3 Water Storage Tank with Ozone Disinfection System
Device Classification Name: Disinfectant, Dialysate Delivery System (876.5860, NII)
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 TANGOs system is filled with adequate water and the ozone concentration is increased. The ozonated water is distributed throughout the the disinfection process, the system and distribution system. To complete the disinfection process, the system and distribution system. To complete The described process is repeated three (3) more times. After the last cycle TANGO3 will leave the system residual free of ozone.
To accomplish this, TANGO3 has a corona discharge generator that generates ozone from a source of dry air. The air dryer consists of two heat regenerative desiccant modules. The ozone if om a injected into the tank by means of a venturi based injection system. Once in the tank, the ozonated water is sent to the distribution loop with a centrifugal pump. Ozone levels are monitored at the return of the loop. Two (2) flow sensors, located at the input and output of the distribution loop will assure that the dialysis facility is not utilizing water while ozone is present in the loop.
Intended Use: The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disention 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 daintection process is completely automated. Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. The distribution system will be exposed to ozone for one (1) period of 45 minutes and three (3) subsequent periods of 30 minutes with adequate water flushes between them and at the end, leaving the distribution loop without ozone.
1
Devices with equivalent intended use:
- Minneare® (Minntech Corporation) and other Peracetic Acid products such as Renalin® . (K830575) (Minntech Corporation) and Peracidin® (K962959) (AlcavisHDC) whilah are commonly used in hemodialysis clinics to disinfect the reverse osmosis water prification equipment and the water distribution loop
- Sodium hypochlorite at 500 ppm dilution is commonly used in dialysis facilities with . soak times of 30 minutes.
Devices with equivalent intended use, technological characteristics and operational characteristics:
-
O3Z (K043207) The O3Z Ozone System is an optional accessory for the Solution 트 Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies, and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. This device and the bicarb distribution system have equivalent technological features with TANGO3 and the water distribution loop, respectively. The 03Z Ozone System disinfects with ozone and then flushes the system with adequate water after disinfection. Disinfection must be performed during non-operational hours just as TANGO3.
Devices with equivalent intended use and operational characteristics: -
CWP 100 WRO H (K974899) (heat disinfection unit for the distribution loop only) -. The CWP 100 - WRO H has a heat disinfection unit that produces enough heat to disinfect the water in the water distribution loop. This disinfection process is automatic and usually performed during non-operational hours. The device has automatic flushing programs to be used when the system is not in use just as TANGO2.
Descriptive Summary of Technological Characteristics and Those of Predicate Devices: The features of TANGO3 are equivalent to those of other medical devices, systems or disinfectants currently in distribution in the United States with equivalent intended uses, on technological characteristics, and operational characteristics.
Performance Data: Each function of the TANGO3 System was tested to see if it performed as intended. Any errors or failures detected during testing were corrected. In vitro testing was also performed to validate the disinfection capabilities of TANGO3 with waterborne organisms. All materials found in water distribution loops have been tested for material compatibility with ozone. A field test has been performed to validate that TANGO2 can address the needs of facilities with known water contamination issues. The results from these tests show that the TANGO3 performed as expected.
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 devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
.
Lori Kleinschrodt Holder, RAC Regulatory Affairs Consultant TANGO3, LLC 141A Citizens Blvd. SIMPSONVILLE KY 40067
DEC 8 2010
Re: K093641
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: November 26, 2010 Received: November 30, 2010
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.
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 of medical device-related
3
Page 2
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,
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
I. INDICATIONS FOR USE STATEMENT
November 23, 2010
Page 1 of 1
510(k) Number: K093641
Device Name: TANGO3 Water Storage Tank with Ozone Disinfection System
Indications for Use: The TANGO, Water Storage Tank with Ozone Disiafection System is intended to be used for disinfection of the water distribution system of a dialysis facility. The tank of the TANGO, 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. The distribution system will be exposed to ozone for one (1) period of 45 minutes and three (3) subsequent periods of 30 minutes with adequate water the (1) perfod of 45 milliurs and intee (1) subsequent periods of 30
ozone. ozone.
(Concurrence of CDRH, Office of Device Evaluation (ODE)
Heilut Reum
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
ological Devices
510(k) Number K093641-
Prescription Use X (Per 21 CFR 801.109)
OR
Over-the-Counter Use