COMFORT TWIN NASAL MASK

K091066 · Respironics Inc., Sleep & Home Respiratory Group · BZD · Sep 3, 2009 · Anesthesiology

Device Facts

• Record ID: K091066
• Device Name: COMFORT TWIN NASAL MASK
• Applicant: Respironics Inc., Sleep & Home Respiratory Group
• Product Code: BZD · Anesthesiology
• Decision Date: Sep 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

Device Story

Comfort Twin Nasal Mask is a single-patient-use respiratory accessory for CPAP or bi-level therapy. Device features dual-cushion design with built-in bellows and inner sealing flap to minimize unintentional leaks. Mask is strapped to patient's face, covering nose, and connected via tubing to a flow generator. Used in hospital, clinic, or home environments. Provides non-invasive positive pressure ventilation to lungs. Output is the delivery of prescribed air pressure to patient airway; healthcare providers use this to treat respiratory conditions. Benefits include improved seal and patient comfort during therapy.

Clinical Evidence

Bench testing only. Performance characteristics were validated to be within specification and equivalent to predicate devices.

Technological Characteristics

Nasal mask with dual-cushion design, built-in bellows, and inner sealing flap. Non-invasive interface for CPAP/bi-level flow generators. Single-patient use.

Indications for Use

Indicated for adult patients prescribed CPAP or bi-level therapy requiring non-invasive positive pressure ventilation.

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 Reusable II Contour Nasal Mask (K991648)
• Resmed Mirage Activa (K032916)

Submission Summary (Full Text)

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# TAB 5

Comfort Twin Nasal Mask

K091066

SEP - 3 2009

## 510(K) SUMMARY

### Date of Submission

9 April 2009

Official Contact

.. . Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 [e-mail]

724-387-4120 t 724-882-4120 c 724-387-7490 f

Classification Reference

21 CFR 868 5905

Product Code

BZD - Non-Continuous ventilator (IPPB)

Nasal Mask Common/Usual Name

Proprietary Name

Respironics Comfort Twin Nasal Mask

Predicate Device(s)

Respironics Reusable II Contour Nasal Mask (K991648) Resmed Mirage Activa (K032916)

Reason for submission new device

### Substantial Equivalence

The Comfort Twin Nasal Mask has the following similarities to the previously cleared predicate device:

- O Same intended use.
- Same operating principle.

Same technology

Same manufacturing process.

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The Respironics Reusable II Contour Nasal Mask was cleared in K991648. The Resmed Mirage Activa was cleared in K032916. To update the design of the Reusable II, an inter sealing cushion was added to this device design. This cushion within a cushion design has been reviewed and cleared by the agency in K032916. The new device was validated using bench data. All performance characteristics performed within specification and comparable to the cited device predicates. This testing has confirmed that the Comfort Twin Nasal Mask performs equivalently to the cited device predicates.

### Intended Use

The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

### Device Description

The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a single patient use accessory for use with CPAP or bi-level devices.

The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.

(End of Tab.)

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

SEP - 3 2009

Re: K091066

Trade/Device Name: Comfort Twin Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 21, 2009 Received: August 24, 2009

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 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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 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,

for

Susan Runner, D.D.S., M.A. Acting Division 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): _ |< 0 9 / 0 66

Device Name: _________________________________________________________________________________________________________________________________________________________________

The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

Over-The-Counter Use Prescription Use × 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)

Ashull5
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: k091066