The Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

Device Description

Mirage FFM Series 2 is a respiratory mask covering the nose and the mouth. It is a patient interface accessory for use with CPAP and bi-level devices.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Mirage Full Face Mask (FFM) Series 2:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicit or Implied)	Reported Device Performance
Durability/Compatibility with Disinfection Methods: The semi-critical mask components (excluding valve membrane and air tubing) must withstand high-level disinfection for multiple-patient use.	The semi-critical mask components can withstand 15 cycles of high-level disinfection. This was validated for: Liquid chemical 3.4% glutaraldehyde solutionLiquid chemical 0.08% peroxyacetic acid and 1% hydrogen peroxideHigh-level thermal disinfection (hot water pasteurization)
Material Compatibility (Air-path): Materials used for mask components in the air-path should be identical to the predicate device.	Materials used for the mask components in the air-path are identical with materials used in the predicate mask Mirage FFM.
Safety and Effectiveness with New Disinfection Method: The addition of high-level thermal disinfection should not negatively affect safety and effectiveness.	The addition of the high-level thermal disinfection method (hot water pasteurization) does not affect safety and effectiveness of the Mirage FFM Series 2.
Biocompatibility/Material Safety (General): Components should be made of safe materials.	The components of Mirage FFM Series 2 are made of the same materials as those of Mirage FFM, with the exception of the headgear and the ports caps. Polyurethane-based fabric for headgear is reported as "more comfortable, allowing the skin to breathe."
Functionality/Performance (Design Changes): Design changes (e.g., 5-point headgear, luer-lock fittings, elbow retainer shape, cushion sizes) should maintain or improve performance.	Enhanced stability (5-point headgear). Improved connection (luer-lock fittings). More user-friendly assembly and disassembly (elbow retainer). Two cushion sizes provide more fitting options. (While not explicitly "performance" in a measurable sense, these are design improvements).

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

Sample Size: Not explicitly stated for each disinfection method. The text mentions "The semi-critical mask components can withstand 15 cycles of high-level disinfection." This implies that a sufficient number of components were tested through these cycles to validate the claim. However, the exact number of masks or components constituting the "test set" is not specified.
Data Provenance: The study was conducted by ResMed Ltd, an Australian company. The context suggests this was an internal prospective validation study conducted to support the 510(k) submission.

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

Not Applicable. This device is a medical mask validated for its disinfection compatibility and material equivalence. The "ground truth" here relates to the physical integrity and continued functionality of the components after disinfection, not a diagnostic interpretation that would involve medical experts establishing a "ground truth" for a test set. The validation would have been performed by engineers, material scientists, or laboratory technicians.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, there is no "adjudication" in the sense of expert review for diagnostic accuracy. The assessment would have involved objective measurements or visual inspections following the disinfection cycles to determine if the components met predefined criteria for integrity and functionality.

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

Not Applicable. This is a physical medical device (a mask), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was physical validation of device components' integrity and functionality after undergoing specified disinfection cycles, and material composition comparison to the predicate device. This would likely involve:
- Visual inspection for damage, degradation, or changes.
- Functional testing of connections, flexibility, and overall fit after disinfection.
- Material analysis to confirm equivalence or safety.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, and the evaluation described is a validation study, not a machine learning study that would have a "training set."

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

Not Applicable. See point 8.

Summary

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K023284

PREMARKET NOTIFICATION

510(k) SUMMARY

[As required by 21 CFR 807.92(c)]

Submitter Name:	ResMed Ltd
Submitter Address:	97 Waterloo Road, North Ryde NSW 2113, Australia
Contact Person:	Roger Kotter
Phone Number:	(858) 746 2400
Fax Number:	(858) 746 2282
Date Prepared:	September 2002
Device Trade Name:	Mirage Full Face Mask (FFM) Series 2
Device Common Name/Classification Name:	Face mask
Predicate devices:	Mirage Full Face Mask (FFM) K982530Mirage Nasal Mask System K984428
Device Description:	Mirage FFM Series 2 is a respiratory mask covering the noseand the mouth. It is a patient interface accessory for use withCPAP and bi-level devices.
Intended Use:	Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positiveairway pressure (CPAP) and bi-level therapy in hospital, clinic,and home environments.

Device Technological Characteristics and Comparison to Predicate Device(s):

The Mirage FFM Series 2 is strapped to the patient's face covering the nose and the mouth, and connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way.

The Mirage FFM Series 2 comes in three frame sizes (small, medium, large), and two cushion sizes (standard and shallow) for each frame size.

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The Mirage FFM Series 2 is substantially equivalent to the Mirage FFM. The two masks have the same intended use. Below is a summary of the similarities and differences in design between the Mirage FFM Series 2 and Mirage FFM:

The components of Mirage FFM Series 2 are made of the same materials as those of ● Mirage FFM, with the exception of the headgear and the ports caps.
The headgear of Mirage FFM Series 2 is made of a Polyurethane-based fabric. The . Polyurethane-based fabric is more comfortable, allowing the skin to breathe whilst the headgear is worn.
. Mirage FFM Series 2 has a 5-points headgear connection, whereas Mirage FFM has a 4-points connection headgear. The additional attachment point for the head strap provides enhanced stability.
Mirage FFM Series 2 has pressure port luer-lock fittings, whereas Miraqe FFM has . pressure port plugs. The luer-lock fittings provide improved connection. The ports caps material has been changed.
. Mirage FFM Series 2 has two cushion sizes per frame size (standard and shallow). whereas Mirage FFM has only one cushion size per frame size (standard).
The shape of the elbow retainer was slightly changed in Mirage FFM Series 2 to . enable a more user-friendly assembly and disassembly.
Mirage FFM has been validated for high-level disinfection using the following liquid . chemical disinfectants: 3.4% glutaraldehyde solution (e.g. Cidex Plus made by ASP); and 0.08% peroxyacetic acid and 1% hvdrogen peroxide (e.g. Cidex PA made by ASP). Mirage FFM Series 2 has been validated for these two liquid chemicals, and in addition, for high-level thermal disinfection (hot water pasteurisation).

Performance Data:

The Miraqe FFM Series 2 was validated for multiple-patient use, with the following high-level disinfection methods:

. Liquid chemical 3.4% glutaraldehyde solution (e.g. Cidex Plus made by ASP),
Liquid chemical 0.08% peroxyacetic acid and 1% hydrogen peroxide (e.g. Cidex PA . made by ASP), and
High-level thermal disinfection (hot water pasteurisation). .

The semi-critical mask components can withstand 15 cycles of high-level disinfection. One conditioning cycle consists of: disassembly, cleaning, disinfecting, and re-assembly. As an exception, the valve membrane and air tubing cannot be disinfected and therefore must be replaced before reusing on another patient. This is highlighted in the user instructions.

The headgear is a non-critical item, i.e., it comes into contact only with intact skin, and as such it does not require high-level disinfection.

Materials used for the mask components in air-path are identical with materials used in predicate mask Mirage FFM.

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Conclusion:

The Mirage FFM Series 2 is substantially equivalent to the Mirage FFM. The addition of the highlevel thermal disinfection method (hot water pasteurisation) does not affect safety and effectiveness of the Mirage FFM Series 2.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited. C/O Mr. Roger Kotter Senior Director, QA & RA ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

K023284 Re:

Trade Name: Mirage Full Face Mask Series 2 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: 73 BZD Dated: September 30, 2002 Received: October 2, 2002

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. Roger 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 (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.

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

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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RESMED

Mirage Full Face Mask Series 2, High Level Thermal Disinfection Special 510(k) Premarket Notification

Applicant:

ResMed Ltd

Device Name:

Mirage Full Face Mask (FFM) Series 2

510(k) Number (if known):

K023284

INDICATIONS FOR USE:

S. Awender

(Division Sign-Off) (Qivision Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K023784

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-896)

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).