DEVILBISS NASAL CPAP MASK, 9354 SERIES

K042455 · Sunrise Medical · BZD · Jan 14, 2005 · Anesthesiology

Device Facts

• Record ID: K042455
• Device Name: DEVILBISS NASAL CPAP MASK, 9354 SERIES
• Applicant: Sunrise Medical
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The new Nasal CPAP Mask is intended to be used with nasal continuous positive airway pressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of adult (>30kg) Obstructive Sleep Apnea (OSA). The device is to be used in home and clinical environments by or on order of a physician. The device can be used with auto-adjusting PAP devices which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.

Device Story

Nasal CPAP mask connects adult patients (>30kg) to CPAP, auto-adjusting CPAP, or bilevel positive airway pressure systems; maintains open airway via non-invasive positive pressure ventilation. Device consists of mask assembly with soft facial contact area, headgear for secure fit, and 22mm tubing connection. Patient inhales from mask; exhales into mask; continuous airflow purges CO2 through diffusion-based exhaust holes. Used in home or clinical environments; operated by patient or clinician. Output is delivery of prescribed positive airway pressure to patient's airway. Benefits include treatment of Obstructive Sleep Apnea by preventing airway collapse.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, intended use, and functional characteristics compared to legally marketed predicate devices.

Technological Characteristics

Nasal mask with headgear; 22mm tubing interface; diffusion-based exhaust holes. Materials are similar to legally marketed devices. Non-invasive positive pressure ventilation interface. No electronic components or software.

Indications for Use

Indicated for adult patients (>30kg) diagnosed with Obstructive Sleep Apnea (OSA) requiring continuous or bilevel positive airway pressure therapy. Used in home and clinical settings under physician order.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Respironics Gel Mask (K954207)
• Invacare Twilight Nasal Mask (K022642)

Submission Summary (Full Text)

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JAN 1 4 2005

K042455

16.0 510(k) Summary

| Submitter's Name: | Sunrise Medical HHG, Inc.<br>Respiratory Products Division<br>100 DeVilbiss Drive<br>Somerset PA 15501 | |
|-------------------------------------|--------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Allan Jones<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared: | September 1, 2004 | |
| Device Name: | Nasal CPAP Mask | |
| Common or Usual Name: | Nasal CPAP Mask | |
| DeVilbiss Model Number: | Model 9354 Series | |
| Trade Proprietary Name: | DeVilbiss Nasal CPAP Mask | |
| Established Registration<br>Number: | 2515872 | |
| Classification Panel: | Anesthesiology | |
| FDA Classification: | Class II | |
| CFR Section: | 868.5905 - Noncontinuous Ventilator (IPPB) | |
| Product Code: | BZD | |
| Legally Marketed Predicate Devices: | | |
| Respironics Gel MaskK954207 | | |

#### Description of Device:

Invacare Twilight Nasal Mask

The new DeVilbiss Nasal CPAP Mask serves as a mechanism for reliably connecting an adult (>30kg) patient diagnosed with sleep apnea to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The nasal mask is securely fastened over a patient's nose by use of specialized headgear. A soft contact area is provided on the side of the mask that contacts the patient's face; the front side of the mask assembly has a tubing connection which is compatible with the industry standard 22mm air tubing.

The CPAP mask is required to be secure fitting to insure proper pressure delivery to the patient, but comfortable enough to maintain patient compliance with the treatment.

K022642

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Air is supplied to the mask by a CPAP device (the CPAP device can be a standard CPAP, AutoAdiust CPAP or Bi-Level type device). Air is channeled to the nose chamber via the tubing/swivel adapter connections. The patient inhales air from the mask and exhales into the mask where continuous airflow from the CPAP device purges the exhaled carbon dioxide from the mask through the mask diffusion based exhaust holes. The mask will be held in place on the patient through the use of a cloth/elastic headgear.

### Statement of Intended Use:

The new Nasal CPAP Mask is intended to be used with nasal continuous positive airway rressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of adult (>30kg) Obstructive Sleep Apnea (OSA). The device is to be used in home and clinical environments by or on order of a physician. The device can be used with auto-adjusting PAP devices which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.

## Statement of Safety and Effectiveness:

The new Nasal CPAP Mask is equivalent in both function and indications for use to the Respironics Gel Mask (K954207) and Invacare Twilight Nasal Mask (K022642) legally marketed predicate devices.

The new Nasal CPAP Mask is designed for use on the order of a physician for the treatment of adult (>30kg) Obstructive Sleep Apnea. The mask is constructed of materials that are similar or identical to legally marketed devices. The unit is designed and manufactured to comply with voluntary standards applicable to this type of device.

The new Nasal CPAP Mask is designed to serve as a mechanism for reliably connecting an adult (>30kg) patient to a source of continuous or bilevel positive air pressure needed to maintain an open airway. The method of serving as the mechanism of connection to a continuous or Bilevel positive air pressure and other characteristics of the new Nasal CPAP Mask are substantially equivalent to other legally marketed devices.

## Technological Characteristics:

The new Nasal CPAP Mask is strapped to the patient's face covering the nose, and connected via 22mm tubing to a source of continuous or Bilevel positive air pressure, creating an airway splint in the throat. Positive pressure ventilation is thus applied to the lungs in a non-invasavive way. The new Nasal CPAP Mask is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all function in providing a reliable mechanism of connection to a continuous, auto adjust or Bilevel positive air pressure source for the treatment of Obstructive Sleep Apnea. No new technologies have been introduced in the new Nasal CPAP Mask device.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized symbol that resembles three overlapping chevrons or stripes.

JAN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allan Jones Manager, Sleep Products Engineering Sunrise Medical 100 DeVilbiss Drive Somerset, Pennsylvania 15501-2125

Re: K042455

Trade/Device Name: DeVilbiss Nasal CPAP Mask, Model 9354 Series Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 24, 2004 Received: November 29, 2004

Dear Mr. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to art cosmetic Act (Act) that do not require approval of a premarket the Federal F 000, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions on 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 (1 Mrs), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Jones

Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advisod that I Da determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal statues and reguirements, including, but not limited to: registration rou must comply with and are rebeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as sot form in the quasily ion 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) This letter will anow you to organ mading of substantial equivalence of your device to a premiarket notification. This 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), IT you desire specific advice for your de 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 may overnment general 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,

Carls
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

510(k) Number (if known):_K042455

Device Name: DeVilbiss 9354 Series Nasal CPAP Mask

Indications For Use:

The new Nasal CPAP Mask is intended to be used with nasal continuous positive rine fressure (CPAP), auto-adjusting CPAP and Bilevel systems for the treatment of allway pressure (Or A. )) and on Apnea (OSA). The device is to be used in home and autit ( ourgy Oberably or on order of a physician. The device can be used with autoonlined on virentherite - which depend on patient flow signals or flow-based snoring signals for the determination of pressure adjustment.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sta. Luvill
(Division Sign-Off)

General Hospital,

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510(k) Number: Ko42455