COMFORTGEL FULL FACE MASK

K073600 · Respironics Inc., Sleep & Home Respiratory Group · BZD · Apr 25, 2008 · Anesthesiology

Device Facts

• Record ID: K073600
• Device Name: COMFORTGEL FULL FACE MASK
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: BZD · Anesthesiology
• Decision Date: Apr 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient use in the home or hospital/institutional environment. The mask is to be used on patients (>66 lbs./30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system.

Device Story

The Respironics ComfortGel Full Face Mask serves as a patient interface for CPAP or bi-level therapy. It consists of a polycarbonate faceplate and a gel cushion encapsulated in a urethane seal. The device features an integrated entrainment valve with a silicone flapper, allowing room air intake if positive pressure is discontinued, and integrated exhalation ports. It connects to a standard 22mm patient circuit. The mask is secured via a headgear attached to the faceplate using a mushroom-shaped quick-clip mechanism. It is intended for multi-patient use in home or clinical environments. By providing a sealed interface, the mask delivers prescribed therapeutic pressure to the patient's airway, facilitating effective ventilation therapy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Polycarbonate faceplate; gel cushion encapsulated in urethane seal; silicone flapper in entrainment valve. Dimensions vary by size (small, medium, large). Features integrated exhalation ports and pressure pick-off port. Non-powered, passive interface device.

Indications for Use

Indicated for patients >66 lbs (30 kg) requiring CPAP or bi-level therapy prescribed for use with a CPAP or bi-level system. Suitable for multi-patient use in home or hospital/institutional settings.

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 Spectrum 2 Full Face Mask (K002465)
• Respironics Gel Mask (K954207)

Submission Summary (Full Text)

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| Date of Submission | 20 December 2007 | | APR 2 5 2008 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| Official Contact | Zita A. Yurko<br>Director, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[e-mail]<br>724-387-4120 t<br>724-882-4120 c<br>724-387-4216 f | | |
| Classification Reference | 21 CFR 868.5905 | | |
| Product Code | BZD - Ventilator, Non-Continuous (respirator) | | |
| Common/Usual Name | Ventilator, continuous, non-life supporting | | |
| Proprietary Name | Respironics ComfortGel Full Face Mask | | |
| Predicate Device(s) | Respironics Spectrum 2 Full Face Mask (K002465) - BZD<br>Respironics Gel Mask (K954207) - BZD | | |
| Reason for submission | new device | | |

### Substantial Equivalence

The Respironics ComfortGel Full Face Mask has the following similarities to the previously cleared predicate device:

- □ Same intended use.
- Same operating principle. o
- Same technology. ට
- Same manufacturing process. a

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This premarket notification submission demonstrates that the ComfortGel Full Face Mask is substantially equivalent to the design of the Respironics Spectrum 2 Full Face Mask (K002465) and the Respironics Gel Mask (K954207 for the gel cushion feature only). Design modifications have been made to the ComfortGel Full Face Mask for this submission. These modifications are described here in. Based on the testing performed, none of the design modification affect the safety or effectiveness of the device.

The following changes have been made:

- 1. The addition of gel to the mask cushion design of the full face mask
2. The change in the dimensional specifications of the mask, including the change to the size and shape of the mask faceplate and cushion

- 3. The addition of available mask sizes
- 4. The addition of the claim for multi-patient use to be added
- 5. Change to the headgear clip design
- 6. The change to add a removable cushion
- 7. The change to the forehead support mechanism
- 8. The addition of a pressure pick-off port to the faceplate of the mask
- 9. The increased weight of the mask cushion due to use of gel
- 10. The change to the mask materials
- 11. Change to the dead space of the mask
- 12. Change to the intentional leak of the mask

#### Intended Use

The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient use in the home or hospital/institutional environment. The mask is to be used on patients (>66 lbs./30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system.

### Device Description

The Respironics ComfortGel Full Face Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a urethane seal for the face. The mask includes exhalation ports and an entrainment

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valve that allows the patient to breath room air if positive pressure is discontinued. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K002465 and K954207, based on performance data. The mask with the integrated entrainment valve has integrated exhalation features that are located on the top of the valve. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains a socket for attachment of the headgear via use of a mushroom-shaped "quick clip" mechanism. The mask is available in three sizes - small, medium and large.

The Respironics ComfortGel Full Face Mask is intended for use with a patient circuit that is used to connect a therapy device to the patient interface device (mask). A typical patient circuit consists of a sixfoot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.

(End of Tab.)

©2007 Respironics Inc.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 5 2008

Ms. Zita A. Yurko Director, Regulatory Affairs Respironics Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K073600

Trade/Device Name: Respironics ComfortGel Full Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 18, 2008 Received: April 21, 2008

Dear Ms. Yurko:

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 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 - Ms. Yurko

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device 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,

Sybil y. Michie Oms.

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): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient use in the home or hospital/institutional environment. The mask is to be used on patients (>66 Ibs/30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system.

Prescription 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)

Minh Hung

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

510{k} Number: