PAPILLON MASK SET

K023068 · Map Medizintechnik Fur Arzt Und Patient GmbH · BZD · May 28, 2003 · Anesthesiology

Device Facts

• Record ID: K023068
• Device Name: PAPILLON MASK SET
• Applicant: Map Medizintechnik Fur Arzt Und Patient GmbH
• Product Code: BZD · Anesthesiology
• Decision Date: May 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Papillon® Mask Set is used to treat patients who require a nasal positive airway pressure therapy (CPAP or bi-level).

Device Story

Papillon® Mask Set is a patient interface accessory for CPAP/bi-level systems; used in treatment of Obstructive Sleep Apnea (OSA). Device consists of mask cushion, forehead pad, mask frame, hose connector system, and AeroFix headgear. Mask cushion and forehead pad are hypoallergenic silicone; frame features adjustable hinge design. Exhalation system includes six vents; hose connector includes ports for external pressure measurement and O2 administration. Device secures to patient head via headgear; connects to standard respiratory hose. Used in clinical or home settings; operated by patient. Provides interface for delivery of positive airway pressure to nasal area; facilitates therapy compliance and treatment of OSA.

Clinical Evidence

Bench testing only. Device tested for compliance with ISO 10993-1 (Biological Evaluation) and prEN ISO 17510-2 (Sleep apnoea breathing therapy - Masks and application accessories). Verification testing demonstrated equivalent exhalation vent performance compared to the predicate.

Technological Characteristics

Materials: Hypoallergenic silicone (cushion, forehead pad). Design: Integrated mask/forehead frame with adjustable hinge; six-vent exhalation system; hose connector with pressure/O2 ports. Standards: ISO 10993-1, prEN ISO 17510-2. Connectivity: Standard respiratory hose interface. Energy: None (passive interface).

Indications for Use

Indicated for adult patients with obstructive sleep apnea requiring positive airway pressure therapy (CPAP or bi-level) at or above 4 cm H2O. Single patient reusable.

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

• Sullivan® Mirage™ Mask System (K984428)

Submission Summary (Full Text)

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K023068

# 1.2 510(k) SUMMARY of Safety & Effectiveness

## 1.2.1 General Information

| Submitter | MAP Medizin-Technologie GmbH<br>Fraunhoferstrasse 16<br>82152 Martinsried<br>GERMANY |
|--------------------------|--------------------------------------------------------------------------------------|
| Contact Person | Torsten Schlichtholz<br>Manager QA and Regulatory Affairs |
| Date of Submission | 06 September 2002 |
| Phone No. | [phone] |
| Fax No. | [phone] |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD – noncontinuous ventilator |
| Device Class | Class II |
| Common/Usual Name | nasal mask |
| Proprietary Name | Papillon® Mask Set |
| Predicate Device | Sullivan® Mirage™ Mask System (K984428) |
| Reason for submission | New Device |

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### 1.2.2 Substantial Equivalence

The Papillon® Mask Set is substantially equivalent to the predicate ResMed Sullivan® Mirage™ Mask System. Both masks have the same intended use, environment of use and patient population. Verification testing has been performed and demonstrates that the exhalation vents perform equivalently in preventing CO, re-breathing as compared to the predicate mask system. Based on verification testing, we conclude that the differences (e.g. design of mask cushion, mask frame, forehead pads, adaptation to the respiratory hose) do not affect safety and effectiveness of the Papillon® Mask Set.

#### 1.2.3 Intended Use

The Papillon® Mask Set is used to treat patients who require a nasal positive airway pressure therapy (CPAP or bi-level).

#### 1.2.4 Device Description

The Papillon® Mask Set is a patient interface accessory for use with nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems used in the treatment of Obstructive Sleep Apnea (OSA).

One mask set consists of a mask cushion, forehead pad, mask frame, hose connector system and the AeroFix headgear with the AeroFix plus hose clip. The mask cushion is available in two different sizes.

The mask fame integrates the standard mask frame and the forehead frame into one piece with an adjustable hinge design, which forms the central and supporting part of the Papillon nasal mask cushion and forehead pad are fixed to the mask frame prior to use. The mask cushion and forehead pad are both made of a hypoallergenic silicone material. The mask cushion and outer shell are comprised of a single, soft, silicone piece that covers the entire nasal area. The cushion includes an exhalation system consisting of six exhalation vents. The hose connection system allows a standard respiratory hose to be connected to the Papillon nasal mask. The hose connection system includes two connectors for external pressure measurement and for administering O.. The Aerofix headgear and Aerofix plus hose clip are easily connected to the mask frame and the respiratory hose using fasteners. The Aerofix headgear secures the nasal mask to the head of the patient.

The mask was tested and found compliant with ISO 10993-1 "Biological Evaluation of Medical Devices" and with the European Standard prEN ISO 17510-2 "Sleep apnoea breathing therapy -- Part 2: Masks and application accessories".

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure or a flame.

Public Health Service

MAY 28 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAP Medizintechnik Für Arzt Und Patient C/O Mr. Roger Kotter Resmed Corporation 14040 Danielson Street Poway, California 92064

Re: K023068

Trade/Device Name: Papillon® Mask Set Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 24, 2003 Received: February 27, 2003

Dear Mr. Kotter:

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. Kotter

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 (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.

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/dsma/dsmamain.html

Sincerely yours,

Susan Dunne

Susan Runner, DDS, MA Interim 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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page 1 of 1

| 51.0 (k) NUMBER (IF KNOWN): | K023068 |
|-----------------------------|--------------------------------|
| DEVICE NAME: | Papillon ^® Mask Set |

INDICATIONS FOR USE:The Papillon® Mask Set is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 4 cm H,O for the treatment of adult obstructive sleep apnea. The mask is single patient reusable.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGI IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21. CFR 801.109)
OR

(Division Sign-Off)
Division of Anesthesiology General Hospital

Over-The-Counter-Use (Optional Format I

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: KO23068