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

The provided text describes the Mirage Full Face Mask Series 2 and its substantial equivalence to the predicate device, Mirage FFM. The primary focus of this submission is to validate the addition of a new sterilization method (Sterrad 100S System) for multi-patient use.

Here's an analysis based on the information provided, keeping in mind that this document is a 510(k) submission, which focuses on substantial equivalence rather than detailed performance studies like those for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
For High-Level Disinfection (Liquid Chemicals):	Validation performed: Mirage FFM Series 2 was validated for multiple-patient use with: - 3.4% glutaraldehyde solution (e.g., Cidex Plus) - 0.08% peroxyacetic acid and 1% hydrogen peroxide (e.g., Cidex PA).Semi-critical mask components withstand 15 cycles of high-level disinfection. (The predicate Mirage FFM was already validated for these methods, and the new device maintains this.)
For Sterilization (Sterrad 100S System):	Validation performed: Mirage FFM Series 2 was validated for multiple-patient use with sterilization using the Sterrad 100S System made by ASP (K991999).Semi-critical mask components withstand 15 cycles of sterilization.
Functional Integrity after Disinfection/Sterilization (15 cycles):	Implied successful performance as the device is deemed "substantially equivalent" and the sterilization method "does not affect safety and effectiveness."
Material Compatibility after Disinfection/Sterilization:	Implied successful performance, as the materials in air-path are identical to the predicate, and new materials (headgear, port caps) are deemed compatible with the cleaning/sterilization processes.
Headgear (non-critical item) does not require high-level disinfection/sterilization:	The headgear is classified as a non-critical item and thus does not require high-level disinfection/sterilization, as stated.
Valve membrane and air tubing replacement requirement (post-disinfection/sterilization for multi-patient use):	The user instructions highlight that the valve membrane and air tubing cannot be disinfected/sterilized and must be replaced before reusing on another patient.

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

The document does not specify a "test set" in the context of clinical performance or a specific patient cohort for the sterilization validation. The validation is focused on the device's ability to withstand disinfection/sterilization processes.

Sample Size: Not explicitly stated for number of units tested or patient data. The statement "15 cycles" refers to the number of disinfection/sterilization cycles the components were subjected to.
Data Provenance: Not applicable in the context of country of origin for clinical data, as this is a device reprocessing validation, not a clinical trial. The validation was conducted to support the 510(k) submission to the FDA.

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

Not applicable. The ground truth for this submission relates to the efficacy of the disinfection/sterilization processes and the material integrity of the device components. This is typically established through laboratory testing and engineering analysis rather than expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a human-reviewed "test set" 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

Not applicable. This is a medical device for respiratory therapy, not an AI diagnostic tool.

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 for this submission is based on:

Performance Standards for Disinfection/Sterilization: The ability of the device components to withstand 15 cycles of specified high-level disinfection methods and the Sterrad 100S System sterilization method, while maintaining functionality and material integrity.
Material Compatibility: Confirmation that the materials used are compatible with the reprocessing methods and maintain their intended properties.
Predicate Device Equivalence: The foundation of the submission is demonstrating substantial equivalence to the predicate "Mirage FFM," which means its performance and safety characteristics, including its reprocessing capabilities, are comparable.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning for this device submission.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is generally referred to as "Performance Data" within the submission. It involves validation studies related to the reprocessing of the device for multi-patient use.

The Mirage FFM Series 2 was subjected to 15 cycles of:
- High-level disinfection with 3.4% glutaraldehyde solution.
- High-level disinfection with 0.08% peroxyacetic acid and 1% hydrogen peroxide.
- Sterilization with the Sterrad 100S System made by ASP.
A "conditioning cycle" for each reprocessing method included disassembly, cleaning, disinfection/sterilization, and re-assembly.
The acceptance criterion was that the "semi-critical mask components can withstand 15 cycles" of these processes. While the specific metrics of "withstanding" (e.g., burst pressure, leakage, material degradation assessment) are not detailed in this summary, they would have been part of the underlying validation reports.
The "performance data" effectively demonstrates that the device's semi-critical components retain their integrity and functionality after repeated reprocessing, thus supporting its suitability for multiple-patient use with these methods. The conclusion of substantial equivalence further implies that this reprocessing does not compromise the device's safety or effectiveness compared to the predicate.

Summary

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K023306

Mirage Full Face Mask Series 2, Sterilization Method Special 510(k) Premarket Notification

RESMED

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 Mirage 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 liguid . chemical disinfectants: 3.4% glutaraldehyde solution (e.g. Cidex Plus made by ASP); and 0.08% peroxyacetic acid and 1% hydrogen peroxide (e.g. Cidex PA made by ASP). Mirage FFM Series 2 has been validated for these two liquid chemicals, and, in addition, for sterilization with the Sterrad 100S System made by ASP (K991999).

Performance Data:

The Mirage FFM Series 2 was validated for multiple-patient use, with the following methods:

. High-level disinfection with liquid chemical 3.4% glutaraldehyde solution (e.g. Cidex Plus made by ASP),
High-level disinfection with liquid chemical 0.08% peroxyacetic acid and 1% hydrogen ● peroxide (e.g. Cidex PA made by ASP), and
Sterilization with the Sterrad 100S System made by ASP. .

The semi-critical mask components can withstand 15 cycles of high-level disinfection or sterilization. One conditioning cycle consists of: disassembly, cleaning, disinfecting/sterilization, and re-assembly. As an exception, the valve membrane and air tubing cannot be disinfected/ sterilized 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 confact only with intact skin, and as such it does not require high-level disinfection / sterilization.

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 sterilization method with the Sterrad 100S System made by ASP does not affect safety and effectiveness of the Mirage FFM Series 2.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

ood and Drug Administratio 200 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

Re: K023306

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 3, 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, Sterilization Method Special 510(k) Premarket Notification

Applicant:

ResMed Ltd

Device Name:

Mirage Full Face Mask (FFM) Series 2

510(k) Number (if known):

K023306

INDICATIONS FOR USE:

Jm. Schlatmot

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

510(k) Number _

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).