REVOLUTIONFULL FACE MASK

K082866 · Respironics Inc., Sleep & Home Respiratory Group · BZD · Jan 30, 2009 · Anesthesiology

Device Facts

• Record ID: K082866
• Device Name: REVOLUTIONFULL FACE MASK
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Revolution Full Face Mask serves as patient interface for CPAP or bi-level therapy delivery. Device consists of Hytrel frame and replaceable silicone cushion; features eight integrated exhalation vents on cushion; includes polycarbonate entrainment valve elbow with silicone flapper. Used in home or hospital settings by patients prescribed positive airway pressure therapy. Device connects to standard 22mm patient circuit tubing. Design modifications from predicates include Hytrel frame, removal of pressure pick-off port, updated headgear (top/back/side straps with chin support), and elimination of forehead arm/stability selector to improve field of vision. Device provides secure seal for therapy delivery; integrated vents allow CO2 washout. Clinicians or patients attach mask via headgear; therapy device (CPAP/bi-level) provides pressurized air through circuit. Benefits include effective therapy delivery and improved patient comfort/visibility.

Clinical Evidence

Bench testing only. Performance testing confirmed functionality of the entrainment valve and integrated exhalation vents. No clinical data provided.

Technological Characteristics

Materials: Hytrel frame, silicone cushion, polycarbonate entrainment valve. Interface: 22mm tubing connection. Features: Integrated exhalation vents (8), entrainment valve with silicone flapper. Sizes: Small, medium, large. Non-powered, passive interface device.

Indications for Use

Indicated for patients >66lbs/30kg requiring CPAP or bi-level therapy. Suitable for single-patient home use or multi-patient hospital/institutional use.

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 ComfortGel Full Face Mask (K073600)
• MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068)

Submission Summary (Full Text)

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Respironics RevolutionFull Face Mask

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Respironics RevolutionFull Face Mask
K082866 page 1 of

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# 510(K) SUMMARY

| Date of Submission | 25 September 2008 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Andrew Zeltwanger<br>Manager, Regulatory Affairs<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[e-mail]<br>724-387-7442 t<br>724-448-0543 c<br>724-387-7490 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 RevolutionFull Face Mask |
| Predicate Device(s) | Respironics ComfortGel Full Face Mask (K073600) – BZD<br>MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068) - BZD |
| Reason for submission | New device |

## Substantial Equivalence

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

- Same intended use. 0
- Same operating principle. 0
- Same technology. ロ
- Same manufacturing process. 0

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This premarket notification submission demonstrates that the Respironics RevolutionFull Face Mask is substantially equivalent to the Respironics ComfortGel Full Face Mask (K073600) and the MAP Medizintechnik Fur ARZT UND Papillon Mask Set (K023068). Design modifications have been made to the predicate masks for this submission. These modifications are described herein. Based on the testing performed, none of the design modification affects the safety or effectiveness of the device.

The following changes have been made:

- 1. The exhalation vent location was changed from the entrainment valve to the mask cushion.
- 2. The number of exhalation vents was changed from two to eight.
- 3. The traditional polycarbonate mask faceplate was changed to a Hytrel frame.
- 4. The pressure pick-off port was removed.

5. The tubing quick release design that allows the accessory swivel to be released along with the mask tubing was changed to a swivel design, without release tabs, which can be directly pulled from the end of the entrainment valve.

6. The traditional four-point headgear design was changed to top, back and side headgear straps with a lower headgear band and a chin support band.

7. Change from a ball & socket "quick release" clip.

- 8. Change in dead space volume, due to mask design.
- 9. Change to the Occluded End Tidal CO2 due to larger dead space resulting from mask design.
- 10. Change to the dimensional specifications of the faceplate and cushion including the change to the size and shape of the mask frame (faceplate) and cushion and to the weight of the mask.
- 11. Elimination of the forehead arm, stability selector and forehead pad to open the users field of vision.
- 12. The change to the mask materials.

#### Intended Use

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

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#### Device Description

The RevolutionFull Face Mask consists of a Hyrel faceplate that holds multiple sizes of a removable and replaceable silicone cushion seal for the face. The mask cushion has eight integrated exhalation vents, four on either side of the cushion. The location of the exhalation vents on the silicone mask cushion is unchanged from K023068. A separate exhalation device is not required for the integrated exhalation vent design. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The functionality and performance of the entrainment valve with fresh air inlets is unchanged from K073600, based on performance test data. The mask frame contains slots for attachment of the headgear straps, lower headgear band and chin support band. The mask is available in three sizes - small, medium and large.

The Respironics RevolutionFull 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 six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.

(End of Tab.)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 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 a stylized image of an eagle or bird-like figure with three wing-like shapes extending upwards.

JAN 3 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Andrew P. Zeltwanger Manager, Regulatory Affairs Respironics Incorporated. Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K082866

> Trade/Device Name: Revolution Full Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 12, 2009 Received: January 14, 2009

Dear Mr. Zeltwanger:

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 - Mr. Zeltwanger

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

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Ginette Y. Michaud, M.D. Acting 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): K082866

Device Name: Revolution Full Face Mask

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

Prescription Use ____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082866