(6 days)
Not Found
No
The device description details a mechanical and electrical system for heating and humidifying air, with no mention of AI or ML algorithms for control, analysis, or decision-making.
Yes
The device is a humidifier intended to add moisture to the air stream gases for administration to the patient in conjunction with CPAP or BiPAP devices, which are used to treat conditions like sleep apnea. This function directly contributes to patient therapy.
No
This device is described as a "respiratory positive airway pressure accessory intended to add moisture to the air stream gases for administration to the patient." Its function is to humidify air for CPAP/BiPAP devices, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical components such as a plastic housing, O-ring, slide latches, ports, baffles, a heater plate assembly, On/Off switch, control knob, and indicator LEDs. It also mentions electrical ratings and a built-in safety device, indicating it is a hardware device with electrical and mechanical components, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "add moisture to the air stream gases for administration to the patient" in respiratory positive airway pressure therapy. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a humidifier and heater that physically alter the air being delivered to the patient. It does not describe any components or processes that analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Language: The text does not use any language typically associated with IVD devices, such as "diagnosis," "detection," "measurement of analytes," "in vitro," or "specimen."
- Performance Studies: The performance study described focuses on the humidifier's ability to increase relative humidity, which is a measure of its functional performance in humidifying air, not its diagnostic accuracy.
In summary, the TAGA Velocity Passover Humidifier with Velocity Humidifier Heater TM1000H is a medical device used for patient therapy and support, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The TAGA Velocity Passover Humidifier with Velocity Humidifier Heater TM1000H is a respiratory positive airway pressure accessory intended to add moisture to the air stream gases for administration to the patient. 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 H20, and do not have automatic pressure titration capabilities.
Product codes
BTT
Device Description
The non-sterile Velocity Passover Humidifier is a plastic housing comprised of two (2) halves, a top and bottom, assembled together to form an enclosed reservoir. An O-ring forms a seal between the two halves when assembled, with a plurality of slide latches maintaining the proper position and seal tensions between the two housing components. 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 Continuous Positive Airway Pressure (CPAP) or Bi-level Positive Airway Pressure (BiPAP) flexible tubing. The inlet and outlet port are clearly identified on the device. The inlet port is typically attached to the pressure generating CPAP or BiPAP 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 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 or BiPAP systems. The Passover Humidifier is used in a horizontal position and will act as a base for most marketed CPAP or BiPAP systems. This feature ensures that the water level is below the outlet port on the CPAP or BiPAP systems to eliminate the potential hazard of water reaching any CPAP or BiPAP electrical components.
The Velocity Humidifier Heater TM1000H consists of a plastic housing with an On/Off switch, control knob, heater plate assembly and two indicator LEDs. The Velocity passover humidifier rests on the heater plate assembly. The heater plate assembly operates at a scale of low (88°F (31°C)) to high (140°F (60°C)) as selected by the user by adjusting the control knob. The Velocity humidifier heater contains a built-in safety device to prevent the heater plate from reaching excessive temperatures under fault conditions. If the heater plate temperature exceeds approximately 90° C (194° F) power to the unit is terminated. The device has an electrical rating of 110 volts 60Hz, 110 Watts.
The device works by heating a metal plate that the plastic humidifier rests on. This in turn warms the water within the humidifier. As the air flows over the water, it picks up some of the moisture. As a result, the gas exiting the humidifier is warmed and humidified providing a continuous humid air stream gas to the patients that require continuous humid positive airway pressure. The system controls the temperature of the heater plate assembly only and not the water or gas temperature.
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
For single patient use in home, physician's office or hospital / institutional environment.
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)
The Velocity Humidifier Heater TM1000H relative humidity gain matched or exceeded the Devilbiss relative humidity gain at all flows and temperature settings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) SUMMARY
The Summary of Safety and Effectiveness information on the TAGA Velocity Humidifier Heatch The Summary of Safety and Effectiveles information of I.C.R. 2007.92 and effects data available and reserveres of there spolite of fitures spolities and TM1000H is being submitted in accordance with the requirements on 21 C.S. and white of the results of fiture studies and at the time the submission was prepared, but the conclusions or recommendations set forth.
| Applicant | Gary Austin
TAGA Medical Technologies, Inc.
34675 Vokes Dr., Suite 105
Eastlake, Ohio 44095 |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 440/602-8242 |
| Facsimile | 440/602-6989 |
| Date | September 19, 2003 |
| Name | TAGA Velocity Passover Humidifier with Velocity Humidifier Heater
TM1000H |
| Classification | Respiratory gas humidifier, 21 CFR 868.5450 |
| Predicate: | TAGA Medical Technologies, Inc., Velocity Passover Humidifier,
K031179 market clearance date July 17, 2003, which is used as a
component for the new Velocity Humidifier Heater TM1000H device and
the Sunrise Medical HHG, Inc. Devilbiss Model 9200D heated Humidifier
System, K020900, market clearance date June 03, 2002. |
| Description | The following is a summary of the Velocity Passover Humidifier
component for the new Velocity Humidifier Heater TM1000H device.
The non-sterile Velocity Passover Humidifier is a plastic housing
comprised of two (2) halves, a top and bottom, assembled together to form
an enclosed reservoir. An O-ring forms a seal between the two halves
when assembled, with a plurality of slide latches maintaining the proper
position and seal tensions between the two housing components. 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 Continuous Positive Airway Pressure (CPAP)
or Bi-level Positive Airway Pressure (BiPAP) flexible tubing. The inlet
and outlet port are clearly identified on the device. The inlet port is
typically attached to the pressure generating CPAP or BiPAP 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 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 or BiPAP
systems. The Passover Humidifier is used in a horizontal position and will
act as a base for most marketed CPAP or BiPAP systems This feature |
1
510(k) SUMMARY con't.
The Summary of Safety and Effectiveness information on the TAGA Velocity Humidifier Heater I the Summal y of Salety and Encareaes mith the requirements of 21 C.P.R. 8807.92 and reflects data available and represented I MINOUL II being submission was prepared, but cautions of 21 Oct 16 yourse the data. The results of future studies and at the this submission won of the conclusions or recommendations set forth.
| ensures that the water level is below the outlet port on the CPAP or BiPAP | |||
|---|---|---|---|
| systems to eliminate the potential hazard of water reaching any CPAP or | |||
| BiPAP electrical components. | |||
| The following is a description for the new Velocity Humidifier Heater | |||
| TM1000H component of the device. | |||
| The Velocity Humidifier Heater TM1000H consists of a plastic housing | |||
| with an On/Off switch, control knob, heater plate assembly and two | |||
| indicator LEDs. The Velocity passover humidifier rests on the heater plate | |||
| assembly. The heater plate assembly operates at a scale of low (88°F | |||
| (31°C)) to high (140°F (60°C)) as selected by the user by adjusting the | |||
| control knob. The Velocity humidifier heater contains a built-in safety | |||
| device to prevent the heater plate from reaching excessive temperatures | |||
| under fault conditions. If the heater plate temperature exceeds | |||
| approximately 90° C (194° F) power to the unit is terminated. The device | |||
| has an electrical rating of 110 volts 60Hz, 110 Watts. | |||
| The device works by heating a metal plate that the plastic humidifier rests | |||
| on. This in turn warms the water within the humidifier. As the air flows | |||
| over the water, it picks up some of the moisture. As a result, the gas | |||
| exiting the humidifier is warmed and humidified providing a continuous | |||
| humid air stream gas to the patients that require continuous humid positive | |||
| airway pressure. The system controls the temperature of the heater plate | |||
| assembly only and not the water or gas temperature. | |||
| Intended Use | The TAGA Velocity Passover Humidifier with Velocity Humidifier Heater | ||
| TM1000H is a respiratory positive airway pressure accessory intended to | |||
| add moisture to the air stream gases for administration to the patient. 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 H20, 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. | |||
| 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 Velocity Humidifier can be used with CPAP or Bi-level CPAP devices which have a maximum operating pressure of 20 cm H2O, and do not have automatic pressure titration capabilities. |
2
510(k) SUMMARY con't.
The Summary of Safety and Effectiveness information on the TAGA Velocity Humidifier Heater TM1000H is being submitted in accordance with the requirements of 21 C.F.R. §807.92 and reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.
| Caution: | 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. Replace the humidifier if any sign of damage to the chamber or leaking appears. Not recommended for use with auto-titrating (adjusting) CPAP device unless otherwise stated by the CPAP device. The heater is only for use with the Velocity Humidifier. |
|---|---|
| Technological | |
| Characteristics: | The Velocity Humidifier Heater TM1000H relative humidity gain matched or exceeded the Devilbiss relative humidity gain at all flows and temperature settings. |
| Standards: | The subject device conforms to the following voluntary standards: |
EN/IEC/UL 60601-1 Medical electrical equipment, Part 1:
General requirements for safety
EN/IEC/UL 60601-1-2 Medical Electrical Equipment—Part 1:
General Requirements for Safety,
Amendment No. 2. Collateral Standard:
Electromagnetic Compatibility
Requirements and Tests |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 2004
Mr. Gary Austin Vice President Taga Medical Technologies 34675 Vokes Drive Suite 105 Eastlake, Ohio 44095
Re: K040507
K040507
Trade/Device Name: Taga Velocity Passover Humidifier with Heater, Model TM1000H Regulation Number: 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: February 26, 2004 Received: February 27, 2004
Dear Mr. Austin:
We have reviewed your Section 510(k) premarket notification of intent to market the device
tion the states of the institution in the closes of the sevivalent (for the We have reviewed your Section 710(t) premainly equivalially equivalent (for the referenced above and nave detimined the development of dicated predicate devices marketed in
indications for use stated in the enclosure the enclicated of the Madical Devices indications for use stated in the caciosares to registered date of the Medical Device interstate commerce prior to May 20, 1 7 7 % accordance with the provisions of
Amendments, or to devices that have been reclassified in accordance approval of a premarket Amendments, or to devices that have been features and require approval of a premaints of the Federal Food, Drug, and Cosment Act (recy market the device, subject to the general
approval application (PMA). You may, therefore, market the det include approval application (FMA). Tou may, and controls provisions of the Act include controls provisions of the Act. The general of devices, good manufacturing practice, proctice, requirements for annual regions misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III
ns affect If your device is classified (see above) into controls. Existing major regulations affecting
(PMA), it may be subject to such additional controls. Existing Title 21 Parts (PMA), it may be subject to such additional controllar connects. Title 21, Parts 800 to 898. In the Federal your device can be found in the Code of reactar regaraces.
addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that I DA's issuance of a substantial equivalence determination does not Please be advised that IPDA s Issualice of a suisitantial oque not the requirements
mean that FDA has made a determination that your device complies with other requirements
4
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the First of all the Act's requirements, including, but not limited to: registration r out intist compry mart 807); labeling (21 CFR Part 801); good manufacturing practice and libang (2) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = requirements as bet resir product radiation control provisions (Sections 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), 11 you dontact 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 Inter count 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,
Chiu-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): .___________________________________________________________________________________________________________________________________________________
TAGA Velocity Passover Humidifier with Heater Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The TAGA Velocity Passover Humidifier with Velocity Humidifier Heater TM1000H is a respiratory positive airway pressure accessory intended to add moisture to the air stream respiratory positive all way pressure accesses J michies of the used with standard CPAP and gases for administration to the patient. The namistices, which have a maximum operating
or Bi-level Positive Airway Pressure (BiPAP) devices, which have a maximum operating of Bi-level I ostuve An way I rossure (2006) - 100 mot have automatic pressure titration capabilities.
Environment of Use / Patient Population Environment of Ose / I anche I openiator.
For single patient use in home, physician's office or hospital / institutional environment.
× Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f. R.W. Webster
Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number:
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