The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

Device Description

Mirage ActivaTM is a respiratory nasal mask using dual cushion design with built-in bellows. It is a single-patient-use interface accessory for use with CPAP and bi-level devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Mirage Activa™ Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Functional Performance	Pressure-flow characteristic	Equivalent with the predicate mask
	Dead space (CO2 re-breathing)	Equivalent with the predicate mask
	Flow impedance	Equivalent with the predicate mask
Biocompatibility	Materials in contact with skin/air-path are either predicate materials or compliant with ISO 10993 standards.	All materials meet this criterion.
Safety and Effectiveness	Changes in design compared to the predicate device do not affect safety and effectiveness.	Concluded as unchanged, supporting substantial equivalence.

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

The provided document does not specify a sample size for a test set. This report focuses on comparing engineering characteristics of the new device to a predicate device, rather than a clinical study with patient data.

The data provenance is not explicitly stated. The tests conducted were likely prospective engineering tests performed by ResMed Ltd. in a lab setting to assess the physical properties of the mask.

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

This type of information is not applicable to this submission. The "ground truth" here is established through engineering and material testing standards (e.g., ISO 10993 for biocompatibility) and direct comparison of functional parameters to a known predicate device. There is no mention of human expert consensus for interpreting test results in the context of clinical "ground truth."

4. Adjudication Method for the Test Set

This is not applicable here as there is no mention of a human expert panel or adjudication process for the engineering test results.

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

This is not applicable. The Mirage Activa™ Mask is a physical medical device (a nasal mask) and does not involve AI or human readers in the context of image interpretation or diagnostic tasks.

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

This is not applicable as the device is a physical nasal mask, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the functional performance criteria (pressure-flow, dead space, flow impedance), the "ground truth" is established by engineering measurements against pre-defined specifications and direct comparison to the physical characteristics of the predicate device.

For biocompatibility, the "ground truth" is established by compliance with ISO 10993 standards and the use of previously cleared materials.

8. The Sample Size for the Training Set

This is not applicable. The Mirage Activa™ Mask is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This is not applicable as there is no training set for this device.

Summary

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APR 0 9 2003

510(k) SUMMARY---Mirage Activa™ Mask

Submitter Name:	ResMed Ltd
Submitter Address:	97 Waterloo Road, North Ryde NSW 2113, Australia
Contact Person:	David D'Cruz, VP Regulatory & Clinical Affairs US
Phone Number:	(858) 746 2238
Fax Number:	(858) 746 2282
Date Prepared:	March 10, 2003
Device Trade Name:	Mirage ActivaTM Mask
Device Common Name/Classification Name:	Nasal Mask
Predicate Devices:	Modular Nasal Mask K961783
Device Description:	Mirage ActivaTM is a respiratory nasal mask using dual cushiondesign with built-in bellows. It is a single-patient-use interfaceaccessory for use with CPAP and bi-level devices.
Intended Use:	Mirage ActivaTM mask is an accessory to a non-continuousventilator (respirator) intended for single-patient use for adultpatients prescribed continuous positive airway pressure(CPAP) and bi-level therapy in hospital, clinic, and homeenvironments.

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

The Mirage Activa™ mask is strapped to the patient's face covering the nose, 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 Activa™ mask comes in one frame size and three cushion sizes (standard, large and shallow).

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Sponsor:	Mirage Activa™ Mask
ResMed Ltd	Special 510(k) Premarket Notification

The Mirage Activa™ mask is substantially equivalent to the Modular nasal mask. The two masks have the same intended use, operating principle, technological characteristics and manufacturing process. Below is a summary of the similarities and differences in design between the Mirage Activa™ mask and the Modular nasal mask:

. The functional performance parameters of the Mirage Activa™ mask with respect to pressure-flow characteristic, dead space (CO2 re-breathing) and flow impedance are equivalent with those of the predicate mask, and are aimed at making the mask compatible with existing flow generators.
. The Activa™ mask has a dual wall cushion design with built-in bellows, which allows relative movement of the mask frame while keeping the cushion seal intact. This design ensures improved mask to patient seal as compared to the predicate mask. To increase the mask stability, the Mirage Activa™ mask has a short air tubing made of polyolefin to remove the weight and drag of the main tube from the elbow. The lightweight tube helps lower the center of gravity and hence improve the stability of the mask.
The Mirage Activa™ Mask incorporates an elbow able to rotate through 360°, which . allows free rotation of the air supply tube, similar to the Modular mask. But while the elbow of the Modular mask is not removable, the Mirage Activa™ elbow can be removed to enable easy access for cleaning.
The Mirage Activa™ elbow incorporates a baffle, which creates a separate channel to . improve the exhaust flow and thus reduce CO2 re-breathing.
. The exhaust vent in the Mirage Activa™ mask is positioned in the elbow, which is similar in layout with the Modular mask. The exhaust vent of the Mirage Activa™ mask is made of silicone, while the exhaust vent of the Modular mask is made of polycarbonate.
. The Mirage Activa™ mask has a cushion clip to attach the cushion to the frame, allowing the patient to remove the cushion for cleaning. The Modular mask does not have a clip to attach the cushion to the mask frame.
. The Mirage Activa™ mask has an adjustable angular forehead support with detachable forehead pads to ensure a better fit for a range of facial profiles and to increase patient comfort. The Modular mask has a fixed forehead support with an adhesive forehead pad.
The Mirage Activa™ mask has a 2-port cap made of silicone that can be used to seal one . or both ports available for connection to pressure sensing tubing. The Modular mask uses polyethylene ports caps.
The Mirage Activa™ mask has clips for attaching the headgear to the frame to enable fast . removal of the mask, which is an improvement to the Modular mask that uses hook tabs.
. The Mirage Activa™ headgear is made of "Breathoprene" fabric for the core structure, which allows the skin to breathe whilst the headgear is worn, whereas the Modular mask headgear is made of "Velstrech" fabric.

Performance Data:

The Mirage Activa™ mask was tested to determine the pressure-flow characteristic, dead space (CO2 re-breathing) and flow impedance. The results of the performance data show that the mask is substantially equivalent with the unmodified predicate mask.

The materials used for the mask components, which contact the skin and/or the air-path, are either predicate materials (i.e., cleared previously for the same intended use), or are compliant with ISO 10993 standards.

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Sponsor:	Mirage Activa™ Mask
ResMed Ltd	Special 510(k) Premarket Notification

Conclusion:

The Mirage Activa™ mask is substantially equivalent to the Modular mask. The changes in design do not affect safety and effectiveness of the Mirage Activa™ mask.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 9 2003

°Mr. David D'Cruz VP Regulatory & Clinical Affairs ResMed Ltd. c/o ResMed Corporation 14040 Danielson Street Poway, CA 92064-6857

Re: K030798

Trade/Device Name: Mirage Activa Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 11, 2003 Received: March 13, 2003

Dear Mr. D'Cruz:

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. David D'Cruz

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 Munro

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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Sponsor: ResMed Ltd

510(k) Number (if known):

KO30198

Device Name:

Mirage Activa™ Mask

Indications for Use:

The Mirage Activa™ Mask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic and home environments.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
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Over-The-Counter Use
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	(Optional Format 1-2-96)
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(Division Sign-Off)

Division of Anesthesiology General Hospital,

Infection Controle Devices1.030798 510(K, N.ID. 00 ..

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).