(379 days)
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.
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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details for the TANGO3 Water Storage Tank with Ozone Disinfection System:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TANGO3 device are implied through its intended use and the description of its disinfection process, which must result in a disinfected water distribution system. The key performance metric is the ability to disinfect.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effective disinfection of the water distribution system of a dialysis facility. | In vitro testing was performed to validate the disinfection capabilities of TANGO3 with waterborne organisms. A field test was 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. |
| Automated disinfection process. | The disinfection process is completely automated. |
| Ozone concentration during disinfection between 0.2 ppm and 0.3 ppm. | Ozone concentration during disinfection is between 0.2 ppm and 0.3 ppm. |
| Specific exposure times for ozone: one (1) period of 45 minutes and three (3) subsequent periods of 30 minutes, with adequate water flushes. | 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. |
| System (and distribution loop) is residual-free of ozone after the process. | After the last cycle TANGO3 will leave the system residual free of ozone. |
| Material compatibility with ozone for all materials in water distribution loops. | All materials found in water distribution loops have been tested for material compatibility with ozone. |
| Performance as intended for each function. | Each function of the TANGO3 System was tested to see if it performed as intended. Any errors or failures detected during testing were corrected. |
Study Details
Based on the provided text, the available information regarding the studies is limited.
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Sample Size Used for the Test Set and Data Provenance:
- In vitro testing: The sample size for the waterborne organisms used is not specified.
- Field test: This involved "facilities with known water contamination issues." The number of facilities (sample size) is not specified.
- Data Provenance: The text does not explicitly state the country of origin. Given it's a 510(k) submission to the FDA, it's reasonable to infer the data was generated in support of US regulatory requirements, but specific locations are not provided. Both in vitro and field tests suggest prospective data collection for the purpose of the submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the text. The concept of "ground truth" as typically applied to expert consensus for diagnostic imaging or similar scenarios isn't directly applicable here, as the studies involve scientific testing of disinfection efficacy and functional performance. The "ground truth" for disinfection would be the actual reduction in waterborne organisms measured post-disinfection.
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Adjudication Method for the Test Set:
- This information is not provided and is not typically relevant for this type of device and testing. Adjudication methods like "2+1" or "3+1" are usually employed in studies where human readers interpret data (e.g., medical images) and their agreement (or disagreement leading to a tie-breaker) is resolved. The TANGO3 studies are focused on direct physical and biological performance.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' diagnostic performance changes with and without AI assistance, which is not applicable to a water disinfection system.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence, standalone performance was evaluated. The disinfection system operates automatically as described. The in vitro and field tests evaluated the system's performance (disinfection capabilities, functional performance) without direct human intervention in the disinfection process itself, beyond initiation and monitoring. The "algorithm" here would be the automated sequence of ozone generation, circulation, and flushing.
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Type of Ground Truth Used:
- For the in vitro testing, the ground truth would be the measured reduction in viable waterborne organisms (e.g., colony-forming units) before and after disinfection. This would be objective microbiological data.
- For the field test, the ground truth would be the measured water quality parameters and microbial counts in the dialysis facilities, showing a reduction in "known water contamination issues" after using TANGO3. This would be a combination of microbiological and chemical analysis.
- For functional testing, the ground truth would be the actual performance against design specifications (e.g., ozone concentration, timing, ozone-free residual).
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Sample Size for the Training Set:
- This information is not provided. The text describes performance testing, not the development of a machine learning model that would typically require a training set. The "training" here would be the engineering design and iteration process.
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How the Ground Truth for the Training Set Was Established:
- As there's no mention of a traditional machine learning training set, this question is not applicable. The "ground truth" in the context of engineering development would be established through established scientific principles, engineering standards, and iterative design and testing.
§ 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.