The Meridian Nasal Mask is intended for Single Patient multi-use by adult patients (>66lb/30Kg) prescribed continuous positive airway pressure (CPAP) or bilevel therapy in hospitals, clinics and/or home environments.

Device Description

The Meridian Mask is a respirator mask covering the nose. It is a patient interface accessory to CPAP and bilevel devices for use in hospitals, clinics and at home.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Meridian Mask:

It's important to note that the provided documents (K050142) primarily describe a 510(k) submission for a medical device that claims substantial equivalence to a predicate device. This type of submission often focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving performance against specific acceptance criteria through a large, independent clinical trial with detailed statistical analysis.

Based on the provided text, the information is limited regarding explicit acceptance criteria and a detailed study report that would typically accompany a more rigorous performance validation.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate device)	Reported Device Performance (Summary from submission)
Intended Use	Mask intended for single patient multi-use by adult patients (>66lb/30Kg) prescribed CPAP or bilevel therapy in hospitals, clinics, and/or home environments.	The Meridian Mask is shown to be substantially equivalent to the Modular Mask (predicate device) and has the same intended use.
Nasal Mask Functionality	Respiratory mask covering the nose, connected via tubing to CPAP/bilevel device, applying pressure ventilation non-invasively to the lungs.	Functions as a nasal mask for CPAP/bilevel devices, providing non-invasive positive airway pressure.
Substantial Equivalence	Demonstrates that the new device has similar technological characteristics, intended use, and is as safe and effective as the predicate device (Modular Mask K961783).	"The Meridian Mask is shown to be substantially equivalent to the Modular Mask... The Meridian Mask and the Modular Mask have the same intended use, similar technological characteristics and a similar manufacturing process."
Risk Analysis	Risks associated with the modified device are identified and addressed.	Risk analysis for the modified device is provided (section 5.2.1 of original submission, not detailed here).
Performance Testing	Design input requirements are met, demonstrating safety and effectiveness.	"Performance testing derived from the risk analysis is provided (section 5.2.2) in order to demonstrate safety and effectiveness of the Meridian Mask and ensure that the design input requirements have been met." (Specific metrics are not detailed in the provided text).
Biocompatibility	Materials in contact with skin/air-path are compliant with biocompatibility standards (e.g., ISO 10993).	"The materials used for the mask components... are compliant in accordance with FDA guidance documents and ISO 10993 reports..."

Study Information (Based on Available Text)

The document describes a submission for substantial equivalence, which typically relies on demonstrating that the new device is as safe and effective as a predicate device, rather than a standalone clinical study to establish novel performance metrics or acceptance criteria for a new class of device.

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated. The document refers to "Performance testing" and "materials biocompatibility testing" but does not detail the sample sizes for these tests (e.g., how many masks were tested, how many subjects were involved if human factors testing was performed).
Data Provenance: Not specified. Given it's a 510(k) for a modified version of an existing product, it's likely internal testing by the manufacturer (ResMed Ltd, Australia). It's generally retrospective data concerning the modifications being evaluated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Ground truth establishment as typically understood in clinical or AI studies (e.g., expert consensus for diagnostic accuracy) is not relevant or described for this type of submission which focuses on engineering performance and substantial equivalence.

3. Adjudication method for the test set:

This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple readers interpret images or data to establish a definitive ground truth. This submission describes engineering and biocompatibility testing.

4. 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:

No. An MRMC study is not mentioned and is not relevant for this type of device (a nasal mask) or this type of 510(k) submission, which focuses on hardware equivalence and performance rather than AI-assisted interpretation by human readers.

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

No. This device is a physical nasal mask, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "Performance Data," the "ground truth" would be established by engineering specifications, regulatory standards (e.g., ISO for biocompatibility), and comparison to the predicate device's established performance. For biocompatibility, it's adherence to international standards and material safety data. For functional performance (e.g., seal, pressure delivery), it would be against predefined engineering design requirements.

7. The sample size for the training set:

This information is not applicable/provided. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

This information is not applicable/provided for the same reason as above.

Summary of the Study:

The "study" described in K050142 is not a traditional clinical trial or performance study with detailed acceptance criteria and statistical analysis as one might see for a diagnostic device or a new therapeutic. Instead, it is a substantial equivalence determination process.

The "study" involves:

Risk Analysis: Identifying potential risks associated with the modifications of the Meridian Mask compared to its predicate.
Performance Testing: Conducting tests specified by the risk analysis to ensure the device meets its design input requirements for safety and effectiveness. The specific tests are not detailed but would likely include evaluations of:
- Seal integrity
- Comfort (potentially subjective user feedback, though not detailed)
- Durability
- Compatibility with CPAP/bilevel devices
- Airflow characteristics
Materials Biocompatibility Testing: Ensuring that the materials used in the mask are safe for human contact and air path, typically by conforming to ISO 10993 standards and FDA guidance. This often involves laboratory tests on the materials themselves rather than human subjects.
Comparison to Predicate Device: Demonstrating that the Meridian Mask has the same intended use, similar technological characteristics, and a similar manufacturing process to the Modular Mask (K961783), thereby establishing it is "substantially equivalent" and thus "as safe and as effective" as the predicate.

The document concludes that "The results of the performance data and materials biocompatibility testing show that the mask is substantially equivalent with the unmodified predicate mask." This statement serves as the overall "proof" that the device meets the implicit acceptance criteria of being equivalent to a legally marketed device.

Summary

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K050142

MAR 1 - 2005

510(k) SUMMARY—Meridian 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:	January 20, 2005
Device Trade Name:	ResMed Meridian Mask
Name/DeviceCommonClassification Name:	Nasal Mask
Predicate Devices:	K961783 Modular Mask -- cleared as part of the VPAP II STsystem
Device Description:	The Meridian Mask is a respirator mask covering the nose. It isa patient interface accessory to CPAP and bilevel devices foruse in hospitals, clinics and at home.
Intended Use:	The Meridian Nasal Mask is intended for Single Patientmulti-use by adult patients (>66lb/30Kg) prescribedcontinuous positive airway pressure (CPAP) or bileveltherapy in hospitals, clinics and/or home environments.

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	Meridian Mask
Sponsor:ResMed Ltd	Special 510(k) Premarket Notification

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

The Meridian Mask is strapped to the patient's face covering the nose. It is connected via tubing to a CPAP I rie Mendian Mask is brapped to the passure ventilation is thus applied to the lungs in a non-invasive way. The Meridian Mask is a single patient re-use medical accessory.

The Meridian Mask is a modified version of the Modular Mask (cleared by FDA in K961783). The Meridian I ho wondar mask to a mountially equivalent to the Modular Masks have the same intended Mask is snown to be substantially oquharent wisteristics and a similar manufacturing process.

Risk Analysis and Performance Data:

The risk analysis for the modified device is provided in section 5.2.1. Performance testing derived from the risk analysis is provided (section 5.2.2) in order to demonstrate safety and effectiveness of the Meridian Mask and ensure that the design input requirements have been met.

Materials Biocompatibility:

The materials used for the mask components, which contact the skin and/or the air-path, are compliant rrio hiatonale assamor in - Where materials have not been cleared for use by the FDA, the ISO 10993 reports have been included, section 5.4.

Conclusion:

The results of the performance data and materials biocompatibility testing show that the mask is substantially equivalent with the unmodified predicate mask.

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized eagle with three parallel lines forming its body and wings. The eagle is facing left. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Public Health Service

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050142

Trade/Device Name: Meridian Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 20, 2005 Received: January 24, 2005

Dear Mr. D'Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosare) (3 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are exactions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). alle Costience Act (71ct) that do not require of the general controls provisions of the Act. The r ou may, mercrore, mans. of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 If your device is clusined (600 as 100 m) and or regulations affecting your device can may be subject to suel addrents esulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or ents 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 Please be advised that I Dri- 3 issuance or our device complies with other requirements of the Act that FDA has made a decemmation and Journer Federal agencies. You must of any Pederal Statutes and regulations adminities. but not limited to: registration and listing (21 comply with an the Act 3 requirements, morable, and manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (QD) regarding (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) I ills lence with anow you to oegin maineg of substantial equivalence of your device to a legally prematicated predicated. The PDF intellight 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 If you desire specific at no 10. 90. (240) 276-0120. Also, please note the regulation entitled, Connaol the Office of Coase to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/industry/support/index.html.

Sincerely yours,

Suza Kunre

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): Ko50142

Meridian Mask Device Name:

Indications For Use:

The Meridian Nasal Mask is intended for Single Patient multi-use by adult patients (>66lb/30Kg) The Mendlan Nasal Mask is intended for Single Fatish Make and Market therapy in hospitals, clinics and/or home environments.

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)

Cuyberom

Theor Clan Off Infrancof Anestheriology, General Hospital, modion Control, Dental Devices 10:21 Number

Page 1 of 1

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).