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

Device Description

Mirage Activa™ is a respiratory nasal mask using a dual cushion design with built-in bellows. It is a multiple-patient, multiple-use interface accessory for use with CPAP or bi-level devices.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ResMed Mirage Activa™ Mask, seeking clearance for its use as a multiple-patient, multiple-use device. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly regarding disinfection and reuse protocols.

Here's an analysis of the acceptance criteria and study data, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Ability to withstand multiple reprocessing cycles for disinfection/sterilization.	ResMed developed specific protocols for validating multiple-patient use, following AAMI TIF No. 12-1994. These protocols were reviewed and validated for the Full Face Mask Series 2 (K023244, K023284, K023306), which are predicate devices. The Mirage Activa™ mask intends to use the same Disinfection Guide provided for the predicate devices. This implies the device is designed to withstand these validated disinfection procedures.
Maintenance of functional performance post-reprocessing.	Not explicitly stated as a separate criterion or performance metric, but implied by the overall conclusion of substantial equivalence for multiple-patient, multiple-use.
Biocompatibility and safety after reprocessing.	Not explicitly stated as a separate criterion or performance metric in relation to this specific submission, but implied by the general regulatory requirements for medical devices. The use of validated disinfection protocols (likely including residue testing) would address this.
Substantial equivalence to predicate device for multiple-patient, multiple-use.	The conclusion states: "The Mirage Activa™ mask is substantially equivalent to the previously cleared predicate masks and can be relabeled for multiple-patient, multiple-use." This is the primary reported "performance" in the context of the regulatory submission.

Crucially, the document does not provide quantitative performance metrics (e.g., specific disinfection efficacy logs, number of cycles tested, or mechanical integrity after x cycles) for the Mirage Activa™ mask itself. Instead, it relies on the validation of the protocols against predicate devices.

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

Sample Size for Test Set: Not explicitly stated. The document refers to "specific protocols for validating multiple-patient use" developed by ResMed and validated for the Full Face Mask Series 2. It does not mention a specific number of masks or test cycles performed for the Mirage Activa™ mask in this summary.
Data Provenance: The document does not specify the country of origin for the validation data. It refers to ResMed, which has a US address as the submitter, so it could be assumed the validation was conducted or overseen in the US, following AAMI standards. The data is retrospective in the sense that the protocols were developed and validated for previous devices (Full Face Mask Series 2) and are now being applied to the Mirage Activa™ mask. The text does not describe a new, prospective study specifically for the Mirage Activa™ mask involving human patients or extensive lab testing.

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

Not applicable. This type of submission (device reprocessing validation) does not typically involve expert review of clinical images or patient data to establish "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the efficacy of the disinfection protocols as per AAMI standards. The document mentions that the protocols were "reviewed and validated" but does not specify who performed this review and validation (e.g., internal ResMed experts, external lab personnel, regulatory body representatives).

4. Adjudication Method for the Test Set

Not applicable for this type of device validation study.

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 not a diagnostic AI device.

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

Not applicable. This is an accessory device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the validation of disinfection protocols against recognized standards (AAMI TIF No. 12-1994) for achieving a specified level of microbial inactivation and material compatibility. This is generally established through laboratory testing (e.g., inoculated samples, residue analysis, material degradation studies) on devices subjected to the reprocessing cycles. The document implies that this ground truth was established for the predicate devices, and the Mirage Activa™ mask is expected to perform similarly due to substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows a handwritten number, "32916", oriented diagonally. The numbers are written in a simple, slightly rounded style, with the digits stacked vertically from bottom left to top right. The background is plain white.

Sponsor: ResMed Ltd

510(K) SUMMARY 3

510(k) SUMMARY-Mirage Activa™ Mask

Submitter Name:	ResMed Corp.
Submitter Address:	14040 Danielson Street, Poway CA 92064-6857USA
Contact Person:	David D'Cruz, VP US Clinical & Regulatory Affairs
Phone Number:	(858) 746 2238
Fax Number:	(858) 746 2890
Date Prepared:	September 15, 2003
Device Trade Name:	Mirage Activa™ Mask
Device Common Name/Classification Name:	Nasal Mask
Predicate Devices:	K030798 MIRAGE ACTIVA™ MASK (single-patient multiple use)K023244 MIRAGE FULL FACE SERIES 2 (Cidex Plus, Cidex OPA)K023306 MIRAGE FULL FACE SERIES 2 (Sterrad)

Device Description:

Mirage Activa™ is a respiratory nasal mask using a dual cushion design with built-in bellows. It is a multiple-patient, multiple-use interface accessory for use with CPAP or bi-level devices.

K023284 MIRAGE FULL FACE SERIES 2 (High Level Thermal) K961783 MODULAR Mask (cleared as part of the VPAP 2 system)

Intended Use:

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).

{1}------------------------------------------------

FDA cleared the Mirage Activa™ mask as a single-patient, multiple-use device in K030798 IFDA Gleated the Mirage Alontal "Thank as a predicate device. Resmed is seeking for the Mirage Activa™ mask to be cleared as a multiple patient, multiple use device

Performance Data:

Specific protocols for validating multiple-patient use have been developed by Resmed (following the guidance of AAMI TIF No. 12-1994). These protocols have been reviewed and (rollowing the Guldated of 7 the Full Face Mask Series 2 (K023244, K023284 and K023306) and represent current state-of-the-art infection control procedures. Resmed has adopted the represent current state of the art intends to include the Disinfection Guide provided in Appendix A with the sale of Mirage Activa™ masks.

Conclusion:

The Mirage Activa™ mask is substantially equivalent to the previously cleared predicate masks and can be relabeled for multiple-patient, multiple-use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and two wavy lines representing its legs. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 4 2003

ResMed Limited C/O Mr. David D'Cruz Vice President US Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K032916

Trade/Device Name: Mirage Activa Mask Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator Regulatory Class: II Product Code: BZD Dated: September 15, 2003 Received: September 22, 2003

Dear Mr. D'Cruz

We have reviewed your Section 510(k) premarket notification of intent to market the device
ty the state of the substantial the device is substantially equivalent (for the We have reviewed your Section 310(x) persualite is substantially equivalent (for the referenced above and have detembled the development of edicate devices marketed in
indications for use stated in the enclosure) to hegally marketed in indications for use stated in the enclosure to tegans the of the Medical Device interstate commerce prior to May 20, 1970, the cities and reservance with the provisions of
Amendments, or to devices that have been receives anoroval of a remarks Amendments, or to devices that have been results approval of approval of a prematket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require subject to the eeneral the Federal Food, Drug, and Cosment Act (rec) market the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the gen approval application (PMA). Tou may, increases provisions of the Act include
controls provisions of the Act. The general controls grovisions of the Act include controls provisions of the Act. The gential of devices, good manufacturing practice,
requirements for annual registration, listing of devices on requirements for annual rogistins misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III
ns affect of the started that the charges the Fivisting major regulations affect If your device is classified (see above) into class (spe major regulations affecting (PMA), it may be subject to such additions. Title 21, Parts 800 to 898. In the Federal your device can be found in the Code of I cachar regarations, wour device in the Federal Register.

{3}------------------------------------------------

Page 2 -Mr. 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. or the recess 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. 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 Runore

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):_K032916

Device Name:_ Mirage Activa™ Mask

Indications For Use:

Prescription Use ___ × (Part 21 CFR 801 Subpart D)

・・

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ettutuderson

sion Sinn-Off n of Anesthesiology, General Hospital.

510(k) Number: K032916

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).