(254 days)
Not Found
No
The description focuses solely on the physical components and function of a CPAP mask, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a mask set intended to be used with positive airway pressure devices for the treatment of obstructive sleep apnea, but it is not the therapeutic device itself; it is an accessory.
No.
The device is a mask set used with positive airway pressure devices for the treatment of obstructive sleep apnea; it does not perform diagnostic functions.
No
The device description clearly outlines multiple physical components made of materials like silicone, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of adult obstructive sleep apnea using positive airway pressure devices. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a mask set that interfaces with a CPAP machine. It's a physical accessory used to deliver air pressure, not to perform tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Papillon® Mask Set is used to treat patients who require a nasal positive airway pressure therapy (CPAP or bi-level).
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.
Product codes
BZD
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal area
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sullivan® Mirage™ Mask System (K984428)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
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.(b)
Classification. Class II (performance standards).
0
1.2 510(k) SUMMARY of Safety & Effectiveness
1.2.1 General Information
| Submitter | MAP Medizin-Technologie GmbH
Fraunhoferstrasse 16
82152 Martinsried
GERMANY |
|--------------------------|--------------------------------------------------------------------------------------|
| Contact Person | Torsten Schlichtholz
Manager QA and Regulatory Affairs |
| Date of Submission | 06 September 2002 |
| Phone No. | +49 89 89518723 |
| Fax No. | +49 89 89518820 |
| 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 |
1
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".
2
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.
3
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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