(93 days)
The TAGA Velocity™ Passover humidifier is a respiratory positive airway pressure accessory intended to add moisture to the airstream gases for administration to the patient. The humidifier increases the vapor content of the air as it passes through the device (Passover) and is directed by the array of baffles over the surface of a body of water. The humidifier can be used with standard CPAP and or Bi-level Positive Airway Pressure (BiPAP) devices which have a maximum operating pressure of 20 cm H2O, and do not have automatic pressure titration capabilities.
The TAGA Velocity Passover Humidifier is a plastic housing comprised of two (2) halves permanently joined to form an enclosed reservoir. The reservoir has two ports, an inlet and an outlet, on the upper portion, both being 22 mm conical connectors, which allow for the connection of commonly used respiratory CPAP flexible tubing. The inlet and outlet port are clearly identified on the device. The inlet port is typically attached to the pressure generating CPAP unit by means of a short piece (12" to 24") of tubing that is supplied with the humidifier. The air entering the humidifier is directed over the surface of the water in the basin through a series of baffles. The design intent of the baffles shape and placement is to create turbulence in the airflow over the water surface. The baffles also create an eddy effect, which in turn increase the duration that the air is exposed and travels across the surface of the water. The combination of both of these effects maximizes the evaporation process thereby elevating the humidity level of the gas before exiting the device. The air exits the device through the outlet port into a second piece of tubing supplied by the user that is connected the patients' mask.
The humidifier is filled with distilled or sterile water through either the inlet or outlet ports with the unit held in an upright position. The humidifier has a window with markings to allow the user to fill with the appropriate volume. The unit is manufactured out of a transparent plastic that allows the user to visually verify the volume level at all times. The volume of water is sufficient to provide 10 hours minimum use at 70 °F and 25% RH ambient conditions and a patient flow rate of 90 LPM. The humidifier is filled only when removed from the CPAP system.
The humidifier is used in a horizontal position and will act as a base for most marketed CPAP systems. This feature ensures that the water level is below the outlet port on the CPAP system to eliminate the potential hazard of water reaching any CPAP electrical components. The humidifier's moisture gain output exceeds 10mg H2O/L as required by ASTM F1690-96 and ISO 8185:1997. The maximum pressure drop throughout the range of flow rates does not exceed 2kPa per ASTM F1690-96 and ISO 8185:1997.
The Velocity humidifier will be cleaned daily by hand washing with a mild dish washing and warm water solution and weekly by soaking in a 25% vinegar/water solution for 30 minutes, both followed by a clean water rinse.
The TAGA Velocity™ Humidifier has the following acceptance criteria and reported performance:
A multicenter, prospective, clinical study was not mentioned in the provided text. The study proving the device meets its acceptance criteria is based on engineering testing and comparison to standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Moisture gain output >= 10 mg H2O/L (as required by ASTM F1690-96 and ISO 8185:1997) | Exceeds 10 mg H2O/L |
| Maximum pressure drop <= 2 kPa throughout the range of flow rates (per ASTM F1690-96 and ISO 8185:1997) | Does not exceed 2 kPa |
| Volume of water provides a minimum of 10 hours of use at 70°F and 25% RH ambient conditions and a patient flow rate of 90 LPM | 10 Hours @ 70° F, 25% RH |
| Relative Humidity Output > 25% | > 25% |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of clinical subjects. The testing appears to be primarily engineering-based, conducted on the device itself under controlled conditions.
- Data Provenance: Not explicitly stated as retrospective or prospective. Given the nature of the device (humidifier) and the standards cited (ASTM and ISO), the data likely originated from bench testing and laboratory measurements of the device's performance against defined parameters and environmental conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The "ground truth" for this device appears to be the standards themselves (ASTM and ISO) and direct measurements of the humidifier's physical performance (e.g., moisture output, pressure drop, operating duration). The document does not describe a process involving human expert consensus for establishing ground truth, as would be common for diagnostic imaging devices, for example.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This device's acceptance is based on meeting technical specifications derived from established standards, not on human interpretation or adjudication of outputs.
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 a medical device (humidifier) and not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device, not an algorithm. Its performance is inherent to its design and function.
7. The type of ground truth used:
The ground truth used consists of established engineering standards and physical measurements. Specifically:
- ASTM F1690-96
- ISO 8185:1997
- Measured physical parameters: moisture gain output, pressure drop, reservoir capacity, relative humidity output, and operating duration under specified environmental conditions.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML product that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML product that requires a training set.
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JUL 17 2003
TAGA Medical Technologies, Inc.
510(k) Notification: TAGA Velocity™ Humidifier
Attachment 2 – 510(k) Summary
The Summary of Safety and Effectiveness on the TAGA Velocity Humidifier reflects data available and represented at the time of ba The Summary of Salety and Ellectivelies on the TROY Villand Tellow of Lines on Circults and or tests may require altern of the conclusions or recommendations set forth.
| Applicant | Gary AustinTAGA Medical Technologies, Inc.7561 Tyler Road, Unit 8Mentor, Ohio 44060 | |||
|---|---|---|---|---|
| Telephone | 440/953-9605 | |||
| Facsimile | 440/953-9602 | |||
| Date | April 11, 2003 | |||
| Name | TAGA Velocity™ Passover Humidifier | |||
| Classification | Respiratory gas humidifier, 21 CFR 868.5450, 73BTT | |||
| Predicate: | TAGA Velocity™ Humidifier, (K#010578)Devilbiss 9100D (K#003626) | |||
| Description | The TAGA Velocity Passover Humidifier is a plastic housing comprised of two (2) halves permanently joined to form an enclosedreservoir. The reservoir has two ports, an inlet and an outlet, on the upper portion, both being 22 mm conical connectors, which allow forthe connection of commonly used respiratory CPAP flexible tubing. The inlet and outlet port are clearly identified on the device. Theinlet port is typically attached to the pressure generating CPAP unit by means of a short piece (12" to 24") of tubing that is supplied withthe humidifier. The air entering the humidifier is directed over the surface of the water in the basin through a series of baffles. Thedesign intent of the baffles shape and placement is to create turbulence in the airflow over the water surface. The baffles also create aneddy effect, which in turn increase the duration that the air is exposed and travels across the surface of the water. The combination ofboth of these effects maximizes the evaporation process thereby elevating the humidity level of the gas before exiting the device. The airexits the device through the outlet port into a second piece of tubing supplied by the user that is connected the patients' mask.The humidifier is filled with distilled or sterile water through either the inlet or outlet ports with the unit held in an upright position. Thehumidifier has a window with markings to allow the user to fill with the appropriate volume. The unit is manufactured out of atransparent plastic that allows the user to visually verify the volume level at all times. The volume of water is sufficient to provide 10hours minimum use at 70 °F and 25% RH ambient conditions and a patient flow rate of 90 LPM. The humidifier is filled only whenremoved from the CPAP system.The humidifier is used in a horizontal position and will act as a base for most marketed CPAP systems. This feature ensures that thewater level is below the outlet port on the CPAP system to eliminate the potential hazard of water reaching any CPAP electricalcomponents. The humidifier's moisture gain output exceeds 10mg H2O/L as required by ASTM F1690-96 and ISO 8185:1997. Themaximum pressure drop throughout the range of flow rates does not exceed 2kPa per ASTM F1690-96 and ISO 8185:1997.The Velocity humidifier will be cleaned daily by hand washing with a mild dish washing and warm water solution and weekly bysoaking in a 25% vinegar/water solution for 30 minutes, both followed by a clean water rinse. | |||
| Intended Use | The TAGA Velocity humidifier is a respiratory Continuous Positive Airway Pressure (CPAP) accessory intended to add moisture to theairstream gases for administration to the patient. The humidifier increases the vapor content of the air as it passes through the device(passover) and is directed by the array of baffles over the surface of a body of water. The humidifier can be used with standard CPAPdevices which have a maximum operating pressure of 20 cm H₂O, and do not have bi-level or automatic pressure titration capabilities. | |||
| Warning: | Disconnect the air tubes prior to cleaning, water entering the CPAP unit may result in electric shock hazard or damage to the CPAP unit.Do not use bleach or chlorine based solutions to clean the humidifier or tubing.The humidifier is for single-patient use only.The humidifier can be used with BiPAP and or CPAP devices which have a maximum operating pressure of 20 cm H₂O, and do not have automatic pressure titration capabilities.Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.Do not expose the tubing to direct sunlight as it may deteriorate over time.Do not mix the solution of vinegar with any disinfectants to clean the humidifier or tubing. | |||
| Caution: | Replace the humidifier if any sign of damage to the chamber or leaking appears. | |||
| TechnologicalCharacteristic | AAMI TIR No. 12 - 1994; Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: AGuide for Device Manufacturers. Low Level Disinfection. | |||
| Pressure Range: | 3 - 20 cm H₂O | Reservoir Capacity: | 600 ml | |
| Relative Humidity Output: | > 25% | Operating Duration: | 10 Hours @ 70° F, 25% RH |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing right, with flowing lines beneath them.
Public Health Service
JUL 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gary Austin Vice President TAGA Medical Technologies. Inc. 34675 Vokes Dr., Ste. 105 Eastlake, OH 44095
Re: K031179
Trade/Device Name: TAGA Velocity Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: April 14, 2003 Received: April 15, 2003
Dear Mr. Austin:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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 - Mr. Gary Austin
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); 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Runore
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 1 - Statement of Indications for Use
510(k) Number:
Device Name: TAGA Medical Technologies Inc. Velocity™ Humidifier
Intended Use / Indications for Use:
The TAGA Velocity™ Passover humidifier is a respiratory positive airway pressure accessory intended to add moisture to the airstream gases for administration to the patient. The humidifier increases the vapor content of the air as it passes through the device (Passover) and is directed by the array of baffles over the surface of a body of water. The humidifier can be used with standard CPAP and or Bi-level Positive Airway Pressure (BiPAP) devices which have a maximum operating pressure of 20 cm H2O, and do not have automatic pressure titration capabilities.
Environment of Use / Patient Population:
For single patient use in home, physician's office or hospital/institutional environment.
(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Penney
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031179
Prescription Use / (per 21 CFR 801.109) OR
Over the Counter Use Optional Format 1-2-96
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).