NEB-U-MASK SYSTEM, MODELS 1895, 1896

K080230 · Teleflexmedical, Inc. · CAF · Jun 9, 2008 · Anesthesiology

Device Facts

• Record ID: K080230
• Device Name: NEB-U-MASK SYSTEM, MODELS 1895, 1896
• Applicant: Teleflexmedical, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

For the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations. This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler. Patients include pediatric and adult. Environment of Use: To be used under medical supervision in hospitals, pre-hospital (EMS), nursing homes, extended care facilities and outpatient clinics.

Device Story

Neb-U-Mask System is a jet nebulizer assembly for delivery of aerosolized medications with oxygen or Heliox gas mixtures. Device consists of a non-rebreathing mask, a valved wye adaptor with an MDI port, a reservoir bag, and a small volume nebulizer. Clinicians connect gas sources to the nebulizer and wye adaptor via delivery tubing, allowing independent flow control. The valved port enables connection/disconnection of the nebulizer without interrupting primary gas flow. Used in hospitals, EMS, nursing homes, and clinics under medical supervision. Output is aerosolized medication delivered to the patient via mask. Benefits include continuous gas flow during drug administration and compatibility with Heliox mixtures for improved aerosol delivery.

Clinical Evidence

Bench testing only. Performance verified via particle size characterization using a cascade impactor to ensure aerosol delivery efficacy. No clinical data provided.

Technological Characteristics

Jet nebulizer system; includes non-rebreathing mask, valved wye adaptor, reservoir bag, and delivery tubing. Operates with oxygen (8 Lpm) or Heliox (up to 12 Lpm). Single-patient, disposable design. Materials verified for gas/fluid pathway contact.

Indications for Use

Indicated for pediatric and adult patients requiring delivery of high concentrations of oxygen or Heliox gas mixtures combined with aerosolized medications or diagnostic formulations. Contraindicated for use with Pentamidine or the combination of Heliox and metered dose inhalers.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• B&B Technology - Hope nebulizer (K980407)
• DHD Healthcare - Trust nebulizer (K040718)
• Teleflex Medical / Hudson RCI - Micro Mist Nebulizer (K930525)

Submission Summary (Full Text)

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Premarket Notification 510(k) Section 5 - 510(k) Summary

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K080230

## Non-Confidential Summary of Safety and Effectiveness Page 1 of 2 29-Jan-08

| Teleflex Medical, Inc.<br>2917 Weck Drive<br>Research Triangle Park, NC 27709 | Tel - [phone]<br>Fax - [phone] | JUN - 9 2008 |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official Contact: | Michael Crader, VP Global RA/QA | |
| Proprietary or Trade Name: | Neb-U-Mask® System | |
| Common/Usual Name: | Nebulizer | |
| Classification Name: | Nebulizer (direct patient interference)<br>CAF -- 868.5630 | |
| Predicate Devices: | B&B Technology - Hope nebulizer - K980407<br>DHD Healthcare - Trust nebulizer - K040718<br>Teleflex Medical / Hudson RCI - Micro Mist Nebulizer<br>- K930525 | |

## Device Description:

The Neb-U-Mask® System is intended to be with oxygen-helium (Heliox) mixtures that include a non-rebreathing mask connected to a wye adaptor featuring a valved port. This valve allows a small volume nebulizer to be connected / disconnected to the wye adapter for drug administration without interrupting primary medical gas flow to patient. Attached to the adaptor is a reservoir bag and a nebulizer, both linked to the gas sources with delivery tubing allowing clinicians to independently control the flow to each side. The Neb-U-Mask® System is comprised of:

- Non-rebreathing oxygen mask (several sizes) �
- Wyc is valved, .
- o contains an MDI port,
- connectors for nebulizer and reservoir, and 0

None

- o inlet port for Heliox mixture
- . Delivery tubing
- Heliox / Oxygen to nebulizer ం
- Heliox / oxygen to ported wye o
- . Small volume nebulizer

| Indications for Use: | For the delivery of high concentrations of oxygen or Heliox gas<br>mixtures in combination with aerosolized medications and diagnostic<br>formulations. This device has not been tested for use with Pentamidin<br>or the combination of Heliox and metered dose inhaler. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Adult and pediatric |
| Environment of Use: | To be used under medical supervision in hospitals, pre-hospital (EMS),<br>nursing homes, extended care facilities and outpatient clinics |

Contraindications:

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| Premarket Notification 510(k)<br>Section 5 - 510(k) Summary | Neb-U-Mask® System<br>Non-Confidential Summary of Safety and Effectiveness<br>Page 2 of 2<br>29-Jan-08 | | | | Formatted: Top: 78 pt |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------|
| Attribute | Proposed<br>Neb-U-Mask® System | Teleflex Medical/<br>Hudson RCI<br>nebulizer<br>K930525<br>Used as a nebulizer | B&B Hope<br>K980407 | DHD Trust<br>K040718 | |
| Indications for Use<br>(all are not for use with<br>pentamidine) | For the delivery of high concentrations of<br>oxygen or Heliox gas mixtures in<br>combination with aerosolized medications.<br>This device has not been tested for use with<br>Pentamidine or the combination of Heliox<br>and metered dose inhaler.<br>Indication for high concentrations of oxygen<br>via a non-rebreather mask is an exempt<br>indication | | High output nebulizer to<br>be used to deliver<br>aerosolized medications<br>and diagnostic formulas. | Uses as a nebulizer<br>aerosolized medications<br>and diagnostic<br>formulations | |
| Used with Heliox<br>80/20 and 70/30 mixtures | Yes | No | Yes | Yes | |
| Environments of use home care,<br>nursing home, sub-acute institutions<br>or hospitals, pre-hospital (EMS) | Yes | Yes | Yes | Yes | |
| Patient population | Pediatric<br>Adult | Not listed | Asthma, pneumonia,<br>COPD and general<br>conditions | Asthma, pneumonia,<br>COPD and general<br>conditions | |
| Nebulizer technology | Jet nebulizer | Jet nebulizer | Jet nebulizer | Jet nebulizer | |
| Single patient, disposable | Yes | Yes | Yes | Yes | |
| Operational Flow Rates | Standard oxygen 8 Lpm<br>Heliox up to 12 Lpm | Standard oxygen<br>8 Lpm | Not listed | Not listed | |
| Used with face mask | Yes | Yes | Yes | Yes | |
| Materials Common materials in<br>contact with gas and fluid pathway | Yes | Yes | N/A | N/A | |
| Particle size characterization via<br>Cascade Impactor | Yes | Yes | N/A | N/A | |
| Differences Between Other Legally Marketed Predicate Devices:<br>There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices. | | | | | |
| Page 5.2 | | | | | |

ాలు విద్యాల

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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teleflex Medical, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Re: K080230

Trade/Device Name: Neb-U-Mask® System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 2, 2008 Received: June 3, 2008

Dear Mr. Dryden:

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.

JUN - 9 2008

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 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.

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Page 2 – Mr. Dryden

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 (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), 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/industry/support/index.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

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## Indications for Use Statement

Page 1 of 1

510(k) Number:

Device Name:

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(To be assigned)

Neb-U-Mask® System

Indications for Use:

For the delivery of high concentrations of oxygen or Heliox gas mixtures in combination with aerosolized medications and diagnostic formulations. This device has not been tested for use with Pentamidine or the combination of Heliox and metered dose inhaler.

Patients include pediatric and adult.

Environment of Use:

To be used under medical supervision in hospitals, pre-hospital (EMS), nursing homes, extended care facilities and outpatient clinics.

Prescription Use XX (Part 21 CFR 801 Subpart D) 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)

Mis Vhnd

(Division Sign-Off) Division of Anesthesiology, General Hospltal Infection Control, Dental Devices

510(k) Number:

K080230