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.

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.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria for performance metrics or a study designed to prove the device meets such criteria. This document is a 510(k) summary for a medical device (a nasal mask for CPAP therapy) and generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.

However, based on the available information, here's what can be extracted and inferred regarding the study that demonstrated substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary)
Equivalency in preventing CO2 re-breathing	Demonstrated through verification testing to perform equivalently to the predicate mask system.
Biocompatibility	Compliant with ISO 10993-1 "Biological Evaluation of Medical Devices".
Mask performance for sleep apnea therapy	Compliant with prEN ISO 17510-2 "Sleep apnoea breathing therapy -- Part 2: Masks and application accessories".
Intended use, environment, and patient population similarity	Confirmed to be the same as the predicate device.
Safety and effectiveness despite design differences	Differences (e.g., design of mask cushion, mask frame, forehead pads, adaptation to respiratory hose) do not affect safety and effectiveness.

Explanation:
The document states that "Verification testing has been performed and demonstrates that the exhalation vents perform equivalently in preventing CO2 re-breathing as compared to the predicate mask system." This implies that the acceptance criterion was "equivalent performance in CO2 re-breathing prevention" compared to the predicate device. The other criteria are inferred from the statements about compliance with standards and the claim of substantial equivalence, meaning the new device performs similarly to the predicate for its intended purpose.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document refers to "verification testing," but the number of subjects or samples included in this testing is not provided.
Data Provenance: Not explicitly stated. Given that the submitter is a German company (MAP Medizin-Technologie GmbH), it's plausible the testing was conducted in Germany or a European context. It's also not specified if the data was retrospective or prospective, though "verification testing" generally implies prospective testing specifically for the device approval.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Not mentioned. The focus of this 510(k) is on the physical device and its performance against standards and a predicate, not on subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (nasal mask), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As stated above, this device is a physical medical device and does not involve an algorithm. Performance testing was likely focused on mechanical and physiological parameters (e.g., CO2 re-breathing, fit, biocompatibility).

7. The Type of Ground Truth Used

The "ground truth" for the device's performance appears to be established through:
- Direct measurement and comparison: For CO2 re-breathing, the performance was compared directly to a legally marketed predicate device (Sullivan® Mirage™ Mask System) through verification testing.
- Compliance with established standards: The mask was tested and found compliant with ISO 10993-1 (biocompatibility) and prEN ISO 17510-2 (mask performance for sleep apnea therapy). These standards themselves define the "ground truth" or acceptable benchmarks for these aspects.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, this question is not relevant.

Summary

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K023068

1.2 510(k) SUMMARY of Safety & Effectiveness

1.2.1 General Information

Submitter	MAP Medizin-Technologie GmbHFraunhoferstrasse 1682152 MartinsriedGERMANY
Contact Person	Torsten SchlichtholzManager 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

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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).

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 (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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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

Regulation Number and Section

§ 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).