Revolution Full Face Mask

K142554 · Respironics, Inc. · BZD · Jan 9, 2015 · Anesthesiology

Device Facts

• Record ID: K142554
• Device Name: Revolution Full Face Mask
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 9, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient 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.

Device Story

Shimmer Full Face Mask provides interface for CPAP or bi-level therapy; covers patient nose and mouth; secured via 4-point headgear. Mask seal directs positive pressure into airway. Features integrated fresh air inlet valve (FAIV) within cushion design; FAIV opens to atmosphere during inspiratory airflow and closes during expiratory airflow under single fault conditions, allowing exhaust through patient connection port. Used in home or hospital/institutional settings; operated by patient or clinician. Output is delivery of prescribed positive airway pressure. Benefits patient by maintaining airway patency during sleep therapy.

Clinical Evidence

Bench testing only. Performance testing included pressure drop, mask leak, anti-asphyxia feature resistance/activation/deactivation, deadspace volume, CO2 rebreathing, and cleaning/disinfection efficacy. Testing performed before and after cleaning/disinfection to verify safety and effectiveness.

Technological Characteristics

Full face mask with 4-point headgear; integrated fresh air inlet valve (FAIV) in cushion. Designed per ISO 17510-2 (with deviations for rebreathing and single fault condition), ISO 10993-1 (biocompatibility), and ISO 14971 (risk management).

Indications for Use

Indicated for patients >66lbs/30kg requiring CPAP or bi-level therapy.

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)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name in a ring around a central symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, overlaid on a human profile.

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

January 9, 2015

Respironics, Inc. Ms. Amy Macevoy Senior Regulatory Affairs Engineer, PI 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K142554

Trade/Device Name: Shimmer Full Face Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: December 8, 2014 Received: December 8, 2014

Dear Ms. Macevoy:

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.

{1}------------------------------------------------

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 (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.

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/Resourcesfor You/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,

Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a stylized font. The name appears to be a person's name, likely a doctor, given the "M.D." abbreviation. The text is black and is set against a light background. The font is elegant and easy to read.

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

{2}------------------------------------------------

## Section 5: Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K142554 |
| Device Name | Shimmer Full Face Mask |

Indications for Use (Describe)

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for
single patient use in the home or multi-patient 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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="12"></rect> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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) | |

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14) THE END

{3}------------------------------------------------

# 510(k) Summary

| 510(k) Owner | Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
|---------------------------------------|---------------------------------------------------------------------|
| | [phone]<br>[phone] (fax) |
| Official Contact | Amy Macevoy<br>Sr. Regulatory Affairs Engineer |
| Establishment<br>Registration # | 2518422 |
| Proprietary Name | Shimmer 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) |

### Indication for Use

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

# Device Description

The Shimmer Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient 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.

The Shimmer Full Face Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. Like the predicate device, Revolution Full

{4}------------------------------------------------

#### Section 6: 510(k) Summary

Face Mask (K082866), this mask covers the patients' nose and mouth, and is secured using a 4-point headgear. The mask seal directs positive pressure into the patient's nose and mouth.

The Shimmer Full Face Mask incorporated the anti-asphyxia feature into the cushion design, as opposed to the traditional full face mask anti-asphyxia feature typically located in the mask elbow component. Refer to Figure 3.

The anti-asphyxia feature incorporated into the Shimmer full face cushion is called a fresh air inlet valve (FAIV), and it is designed to work differently than other antiasphyxia valves. A traditional anti-asphyxia valve opens to atmosphere during a single fault condition, which routes inspiratory and expiratory airflow through the same open to atmosphere hole, while occluding the patient connection port. The FAIV, in a single fault condition, opens to atmosphere during inspiratory airflow and it closes to atmosphere during expiratory airflow. Since the patient connection port is no longer occluded during single fault condition, air will exhaust through the patient connection port and mask exhalation features.

# Substantial Equivalence

The Respironics Shimmer Full Face Mask has the following similarities to the previously cleared predicate devices Respironics Revolution Full Face Mask (K082866):

- Same intended use .
- Same operating principle .
- Similar design .
- Similar materials .
- Similar manufacturing process

The Shimmer Full Face Mask has the following differences in the technological characteristics to the previously cleared predicate devices Revolution Full Face Mask (K082866):

- Cushion design ●
- Number of sizes .
- Anti-asphyxia feature .
- Patient circuit connection

Design verification tests were performed on the Respironics Shimmer Full Face Mask. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate device.

### General Safety and Effectiveness

The performance and technological characteristics of the Shimmer Full Face Mask are equivalent to those of the Revolution Full Face Mask (K082866) and raise no new types of safety or effectiveness questions.

#### 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:

{5}------------------------------------------------

#### Section 6: 510(k) Summary

- . Pressure Drop
- Total Mask Leak .
- Intentional Leak .
- Anti-Asphyxia Feature Resistance
- Anti- Asphyxia Feature Activation Pressure
- . Anti- Asphyxia Feature Deactivation Pressure
- Deadspace Volume
- CO2 Rebreathing .
- . Cleaning and Disinfection Efficacy
- Storage .

The Shimmer Full Face Mask has been designed per the following standards:

- ISO 17510-2 Sleep Apnoea Devices Part 2: Masks and Application Accessories . o Deviations
- Clause 5.3 Protection against rebreathing .
- . Clause 5.5 Breathing during single fault condition
- 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