REVOLUTION FULLFACE MASK

K140580 · Respironics Inc. (Dba Philips Respironics) · BZD · Jan 16, 2015 · Anesthesiology

Device Facts

• Record ID: K140580
• Device Name: REVOLUTION FULLFACE MASK
• Applicant: Respironics Inc. (Dba Philips Respironics)
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Revolution Full Face Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.

Device Story

Revolution Full Face Mask serves as patient interface for CPAP or bi-level therapy; delivers pressurized air to patient airways. Device consists of frame, silicone cushion, and elbow with integrated entrainment valve. Features eight exhalation vents on cushion and additional vents on valve body; eliminates need for separate exhalation device. Headgear includes top strap adjustments, side/back straps, and chin support band. Used in home or hospital environments by patients >66lbs/30kg. Healthcare provider fits mask to patient; patient wears mask during therapy. Device facilitates delivery of prescribed pressure, potentially improving patient compliance and therapeutic outcomes for sleep-disordered breathing.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical bench testing, including intentional/total leak, deadspace volume, pressure drop, anti-asphyxia valve function, CO2 rebreathing, and cleaning/disinfection efficacy.

Technological Characteristics

Materials: Silicone cushion, polycarbonate valve body. Design: Full face mask with integrated entrainment valve and exhalation vents. Standards: ISO 17510-2 (sleep apnea masks), ISO 10993-1 (biocompatibility), ISO 14971 (risk management). Connectivity: None (mechanical interface).

Indications for Use

Indicated for patients >66lbs/30kg requiring CPAP or bi-level therapy via a full face mask interface in home or hospital 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 Revolution Full Face Mask (K082866)
• Respironics Comfort Gel Full Face Mask (K073600)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

Respironics, Inc. Colleen Witt Manager, Regulatory Affairs, Patient Interface 1001 Murry Ridge Lane Murrysville, PA 15668

Re: K140580

Trade/Device Name: Revolution Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 18, 2014 Received: December 19, 2014

### Dear Mrs. Witt:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

### Indications for Use

510(k) Number (if known)

#### K140580

Device Name Revolution Full Face Mask

#### Indications for Use (Describe)

The Revolution Full Face Mask is intended to provide an interface for continuous possitive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Services [phone] PP

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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## Section 6: 510(k) Summary

| Date of Submission | 3/3/14 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 510(k) Owner | Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668<br>[phone]<br>[phone] (fax) |
| Official Contact | Colleen Witt<br>Regulatory Affairs Manager, Patient Interface |
| Establishment<br>Registration # | 2518422 |
| Proprietary Name | Respironics Revolution Full Face Mask |
| Common/Usual Name | Mask Accessory to a Non-Continuous Ventilator |
| Classification Panel | Anesthesiology Devices |
| Classification<br>Reference | 21 CFR 868.5905 |
| Classification Name /<br>Product Code | BZD - Ventilator, non-continuous (respirator) |
| Predicate Device(s) | Respironics Revolution Full Face Mask (K082866)<br>Respironics Comfort Gel Full Face Mask (K073600) |

# Device Description

The Respironics Revolution Full Face Mask consists of a frame (faceplate) with a silicone cushion and an elbow with an integral entrainment valve. The faceplate holds multiple sizes in order to exchange mask cushion sizes on one (frame) faceplate. The Revolution Full Face Mask cushion has eight exhalation vents, with four vents located on either side of the mask cushion. As a result, a separate exhalation device is not required for use of this mask. The mask has an integrated entrainment valve elbow with a two-piece polycarbonate valve body with a silicone flapper and exhalation vents located on the valve body. This feature was modified from Revolution Full Face (K082866) from a "stream-line" design however this elbow design was cleared under K073600. The design of the Revolution Full Face Mask headgear has two slide-through top strap adjustments, side and back straps, a Lower

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Headgear Band and a Chin Support Band. The mask is available in four sizes – small, medium, and large.

## Indications for Use

The Revolution Full Face Mask is intended to provide an interface for continuous positive airway pressure (CPAP) or bi-level therapy. The mask is intended for single-patient reuse in the home or hospital/institutional environment. The mask is to be used by patients greater than 66lbs/30kg.

# Similarities and Differences of the Subject Device Compared to the Predicate Devices

The Revolution Full Face Mask (subject device) has the following similarities in the technological characteristics to the previously cleared devices (Revolution Full Face Mask K082866 and Comfort Gel Full K073600):

- . Same intended use
- . Same operating principle
- . Similar technology
- . Same elbow, and swivel materials used
- Similar device design and physical properties
- Same scientific concepts that form the basis for the device ..

The Revolution Full Face Mask (subject device) has the following differences in the technological characteristics to the previously cleared device (Revolution Full Face Mask K082866 and ComfortGel Full K073600):

- . Additional material that has been added to the current cushion material that comes into contact with the face.
These differences do not raise new questions of safety and effectiveness.

# Clinical Tests

Clinical tests were not required to demonstrate the safety and effectiveness of the Revolution Full Face Mask. Product functionality has been adequately assessed by nonclinical tests.

©2014 Respironics Inc.

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### Section 6: 510(k) Summary

## Non-Clinical Tests

Performance testing was performed before and after cleaning and disinfection treatments to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:

- . Intentional Leak
- . Total Mask Leak
- Deadspace Volume .
- . Pressure Drop
- . Anti- Asphyxia Feature Open to Atmosphere Pressure
- . Anti- Asphyxia Feature Closed to Atmosphere Pressure
- CO2 Rebreathing .
- . Cleaning and Disinfection Efficacy
- . Storage

The Revolution Full Face Mask has been designed to meet the requirements of the following standards:

- . ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories
- . ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 14971 Medical devices – Application of risk management to medical devices

## Conclusion

The performance and technological characteristics of the modified Revolution Full Face Mask are substantially equivalent to those of the Revolution Full Face Mask (K082866). The differences described above do not raise new questions of safety and effectiveness.

©2014 Respironics Inc.