TAGA VELOCITY HUMIDIFIER

K031179 · Taga Medical Technologies, Inc. · BTT · Jul 17, 2003 · Anesthesiology

Device Facts

• Record ID: K031179
• Device Name: TAGA VELOCITY HUMIDIFIER
• Applicant: Taga Medical Technologies, Inc.
• Product Code: BTT · Anesthesiology
• Decision Date: Jul 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Passover humidifier; plastic reservoir with inlet/outlet ports. Input: pressurized air from CPAP/BiPAP device. Operation: air directed over water surface via internal baffles; turbulence/eddy effects increase air-water contact duration; evaporation increases humidity. Output: humidified air delivered to patient mask. Used in home, clinic, or hospital; operated by patient or clinician. Device acts as base for CPAP unit; horizontal orientation prevents water ingress into electrical components. Benefits: reduces airway dryness during positive pressure therapy.

Clinical Evidence

Bench testing only. Performance validated against ASTM F1690-96 and ISO 8185:1997 standards. Moisture gain output exceeds 10mg H2O/L; maximum pressure drop does not exceed 2kPa across flow rates. Reservoir capacity 600ml provides 10 hours of operation at 70°F, 25% RH, and 90 LPM flow rate.

Technological Characteristics

Transparent plastic reservoir; 22mm conical inlet/outlet ports. Passive passover humidification via internal baffle array. Pressure range 3-20 cm H2O. Reservoir capacity 600ml. Complies with ASTM F1690-96 and ISO 8185:1997. Reprocessing per AAMI TIR No. 12-1994.

Indications for Use

Indicated for patients requiring respiratory positive airway pressure therapy (CPAP or BiPAP) who need supplemental moisture in the airstream. Used in home, physician's office, or hospital/institutional environments. Contraindicated for use with devices having automatic pressure titration capabilities or operating pressures exceeding 20 cm H2O.

Regulatory Classification

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.

Predicate Devices

• TAGA Velocity™ Humidifier (K010578)
• Devilbiss 9100D (K003626)

Submission Summary (Full Text)

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## JUL 17 2003

TAGA Medical Technologies, Inc.

510(k) Notification: TAGA Velocity™ Humidifier

K031179

## 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 Austin<br>TAGA Medical Technologies, Inc.<br>7561 Tyler Road, Unit 8<br>Mentor, 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)<br>Devilbiss 9100D (K#003626) | | | |
| Description | The TAGA Velocity Passover Humidifier is a plastic housing comprised of two (2) halves permanently joined to form an enclosed<br>reservoir. The reservoir has two ports, an inlet and an outlet, on the upper portion, both being 22 mm conical connectors, which allow for<br>the connection of commonly used respiratory CPAP flexible tubing. The inlet and outlet port are clearly identified on the device. The<br>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<br>the humidifier. The air entering the humidifier is directed over the surface of the water in the basin through a series of baffles. The<br>design intent of the baffles shape and placement is to create turbulence in the airflow over the water surface. The baffles also create an<br>eddy effect, which in turn increase the duration that the air is exposed and travels across the surface of the water. The combination of<br>both of these effects maximizes the evaporation process thereby elevating the humidity level of the gas before exiting the device. The air<br>exits the device through the outlet port into a second piece of tubing supplied by the user that is connected the patients' mask.<br><br>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<br>humidifier has a window with markings to allow the user to fill with the appropriate volume. The unit is manufactured out of a<br>transparent plastic that allows the user to visually verify the volume level at all times. The volume of water is sufficient to provide 10<br>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<br>removed from the CPAP system.<br><br>The humidifier is used in a horizontal position and will act as a base for most marketed CPAP systems. This feature ensures that the<br>water level is below the outlet port on the CPAP system to eliminate the potential hazard of water reaching any CPAP electrical<br>components. The humidifier's moisture gain output exceeds 10mg H2O/L as required by ASTM F1690-96 and ISO 8185:1997. The<br>maximum pressure drop throughout the range of flow rates does not exceed 2kPa per ASTM F1690-96 and ISO 8185:1997.<br><br>The Velocity humidifier will be cleaned daily by hand washing with a mild dish washing and warm water solution and weekly by<br>soaking 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 the<br>airstream gases for administration to the patient. The humidifier increases the vapor content of the air as it passes through the device<br>(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<br>devices 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. | | | |
| Technological<br>Characteristic | AAMI TIR No. 12 - 1994; Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A<br>Guide 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 [phone]. 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 [phone] or [phone] 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