The Hospital Full Face Mask is intended for single patient use for adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy in hospitals or clinics. This is a disposable mask. It is intended to be used for the short-term (maximum 7 days) treatment of a single patient only, then discarded.

Device Description

The Hospital Full Face Mask is a respirator mask covering the nose and the mouth. It is a patient interface accessory for use with CPAP and bilevel devices. The Hospital Full Face Mask is strapped to the patient's face covering the nose and mouth. It is connected via tubing to a CPAP or bilevel flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way. The Hospital Full Face Mask comes in 3 sizes, small, medium and large. Each size comprises a frame, cushion and cushion clip.

AI/ML Overview

This 510(k) summary describes a premarket notification for the ResMed Hospital Full Face Mask, a medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device, the Mirage Full Face Mask Series 2.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., specific leakage rates, pressure limits, material degradation percentages) that the new device needed to meet. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device, the Mirage Full Face Mask Series 2.

The "Performance Data" section states: "Testing is provided to demonstrate that the Hospital Full Face mask is substantially equivalent to the Full Face Mask series 2. The original testing that was performed for the Full Face Mask Series 2 was reviewed as an input to the selected test methods."

Therefore, the reported device performance is that the ResMed Hospital Full Face Mask performs substantially equivalently to the Mirage Full Face Mask Series 2.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially equivalent to predicate device (K023244) in terms of:	"The Hospital Full Face Mask is substantially equivalent to the Mirage Full Face Mask Series 2."
- Intended use	Similar intended use, with the Hospital mask being single patient use only for short-term.
- Operating principle	Same operating principle (strapped to face, connected to CPAP/bilevel to apply positive pressure).
- Technological characteristics	Same technological characteristics (comes in 3 sizes, comprises frame, cushion, clip).
- Manufacturing process	Same manufacturing process.
Biocompatibility of materials	Materials are either predicate, comply with ISO10993-1, or were tested for conformance to ISO10993-1.
Not affecting safety and effectiveness of the device	"The changes in design do not affect safety and effectiveness of the Hospital Full Face Mask."

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

The document does not specify the sample size used for any performance testing. It mentions "Testing is provided to demonstrate that the Hospital Full Face mask is substantially equivalent" and refers to "the original testing that was performed for the Full Face Mask Series 2."

Test Set Sample Size: Not specified.
Data Provenance: Not explicitly stated as "country of origin." The submitter is ResMed Ltd, located in Australia, but the testing itself might have occurred elsewhere. The reference to "ResMed's state of the art knowledge and procedures" suggests internal company testing. It is a retrospective review of testing previously performed for the predicate device, along with new testing for the current device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this type of device submission. The submission is for a physical medical device (mask interface), not an AI/ML algorithm that requires expert-established ground truth for classification or prediction. The "ground truth" here is the performance characteristics of the predicate device and the new device's ability to meet those.

4. Adjudication Method for the Test Set:

This information is not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or for establishing ground truth in AI/ML performance evaluations involving human interpretation. For a physical device, performance is evaluated against engineering and usability standards.

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 information is not applicable. The device is a full face mask, not an AI or imaging diagnostic tool that would involve human readers or AI assistance for interpretation.

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

This information is not applicable. The device is a physical medical device; it does not involve algorithms or AI.

7. The Type of Ground Truth Used:

The primary "ground truth" used for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Mirage Full Face Mask Series 2). The new device's performance is compared against the known and accepted performance of this predicate. Additionally, ISO10993-1 standards serve as a ground truth for biocompatibility.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable. As stated above, this device does not involve a training set for an AI/ML algorithm.

Summary

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510(k) SUMMARY—Hospital Full Face 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 2915
Date Prepared:	May 17, 2004
Device Trade Name:	ResMed Hospital Full Face Mask
Device Common Name/Classification Name:	Full Face Mask
Predicate Devices:	K023244: Mirage Full Face Mask Series 2
Device Description:	The Hospital Full Face Mask is a respirator mask covering thenose and the mouth. It is a patient interface accessory for usewith CPAP and bilevel devices.
Intended Use:	The Hospital Full Face Mask is intended for single patient usefor adult patients (>30 Kg) prescribed continuous positiveairway pressure or bilevel therapy in hospitals or clinics.This is a disposable mask. It is intended to be used for theshort-term (maximum 7 days) treatment of a single patientonly, then discarded.

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

The Hospital Full Face Mask is strapped to the patient's face covering the nose and mouth. It is connected via tubing to a CPAP or bilevel flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way.

The Hospital Full Face Mask comes in 3 sizes, small, medium and large. Each size comprises a frame, cushion and cushion clip.

The Hospital Full Face Mask is substantially equivalent to the Mirage Full Face Mask Series 2. The two masks have a substantially equivalent intended use (Hospital Full Face Mask for single patient use only), same operating principle, same technological characteristics and same manufacturing process. The Mirage Full Face Mask is cleared for multi patient multi use. The Hospital Full Face Mask is for single patient multiple use only.

Performance Data:

Testing is provided to demonstrate that the Hospital Full Face mask is substantially equivalent to the Full Face Mask series 2. The original testing that was performed for the Full Face Mask Series 2 was reviewed as an input to the selected test methods. This testing provided represents ResMed's state of the art knowledge and procedures.

Materials Biocompatibility

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), are in compliance with ISO10993-1 or have been submitted to an independent accredited laboratory for conformance to ISO10993-1. ResMed has procedures in place to ensure that the ISO10993-1 test results are reviewed and accepted prior to implementation and release of the material for use in producing masks products.

Conclusion:

The Hospital Full Face Mask is substantially equivalent to the Mirage Full Face Mask Series 2. The changes in design do not affect safety and effectiveness of the Hospital Full Face Mask.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, possibly representing the interconnectedness of health and human services.

Public Health Service

JUL 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041362

Trade/Device Name: ResMed Hospital Full Face Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 17, 2004 Received: May 20, 2004

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. 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 (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,

Suva Runne
fz 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

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Indications for Use

510(k) Number (if known): K041362

Device Name: ResMed Hospital Full Face Mask

Indications for Use:

The Hospital Full Face Mask is intended for single patient use for adult patients (>30 Kg) prescribed continuous positive airway pressure or bilevel therapy in hospitals or clinics.

This is a disposable mask. It is intended to be used for the short-term (maximum 7 days) treatment of a single patient only, then discarded.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auy Sylum

(Division Signesiology, General Hospital Infection

510(k) Number: K041362

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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).