The Lyra™ Nasal Mask is intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

Device Description

The Lyra™Nasal Mask is intended for the delivery of air from either a CPAP or bi-level instrument (delivery device). The breathing circuit consists of the Lyra, which directly interfaces with the patient, and a pair of tubes, which connect the Lyra to the delivery device. The delivery device provides positive pressure air to the patient via the tubes and the Lyra™. Exhalation ports on the Lyra™ allows patient-exhaled gases to exhaust to the atmosphere.

The Lyra™ consists of the following:

two nasal prongs, which are easily removed or installed into a mask body for the interchange of different sizes, and for easy cleaning of the device;
adjustable head gear, which keeps the nasal mask in place during use;
a pair of tubings, with one end of the tubings attached to the mask body;
a standard 22-mm swivel which attached to the other end of the tubings.

The delivery device interfaces with the swivel via corrugated tubing, with a standard 22mm fitting.

The Lyra™ nasal prongs, made from a soft, flexible silicone, form a seal with the patient's nares. The nasal prongs come in different sizes for better and more comfortable fit for patients with varying nares sizes.

The Lyra™ is packaged, along with instructions for use and recommended cleaning instructions, in a poly bag. The Lyra™ can be completely disassembled for cleaning. Mild soap and water may be used to clean the device.

AI/ML Overview

The provided text describes a medical device, the Lyra™ Nasal Mask, and its 510(k) submission for market clearance. While it discusses the device's description, intended use, and a comparison to a predicate device, it does not contain detailed information about a clinical study with specific acceptance criteria and performance metrics in the way that would typically be presented for an AI/ML device.

This submission is for a physical medical device (a nasal mask), and the "performance testing" described is much simpler and focuses on physical characteristics compared to a software-based diagnostic or prognostic device.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance (Based on "LACK OF" detailed clinical study)

Acceptance Criterion (Implicit)	Reported Device Performance
Leak Rates	Comparable to Nasal Aire™ (predicate device, K022465).
Dead Space	Comparable to Nasal Aire™ (predicate device, K022465).
Environmental Performance	Within parameters as claimed in Nasal Aire™'s labeling.
Cleaning Performance	Within parameters as claimed in Nasal Aire™'s labeling.
Substantial Equivalence	The Lyra™ Nasal Mask is substantially equivalent to the predicate device (Innomed Technologies' Nasal-Aire™ Nasal Mask K022465) for its intended use, particularly through "comparative bench testing" of leak rates, dead space, environmental, and cleaning tests. This is the overarching "acceptance criterion" for 510(k) clearance for a physical device like this, rather than specific performance metrics from a full clinical trial.

Missing Information (Not provided in the document for the Lyra™ Nasal Mask):

Many of your requested points relate heavily to the evaluation of AI/ML-based medical devices or more extensive clinical trials, which are not detailed in this 510(k) summary for a physical medical accessory.

Sample size used for the test set and the data provenance: Not applicable in the context of this device's "bench testing." The "test set" here refers to the actual physical devices tested, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device parameters (like leak rates) in bench testing does not involve medical experts in the same way an AI diagnostic would.
Adjudication method: Not applicable for bench testing of a physical device.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not mentioned. Such studies are typically for diagnostic AI systems.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
The type of ground truth used: For physical parameters like leak rates and dead space, the "ground truth" would be objective measurements obtained through standardized bench testing methods, not expert consensus, pathology, or outcomes data.
The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable for the same reason.

In summary: The provided text details a 510(k) submission for a physical nasal mask. The "study" proving it meets "acceptance criteria" is a comparative bench testing against a predicate device, focusing on physical parameters like leak rates, dead space, environmental performance, and cleaning. The primary "acceptance criterion" for 510(k) clearance in this context is demonstrating substantial equivalence to a legally marketed predicate device. The document explicitly states: "There are no known mandatory or voluntary performance standards applicable to this device classification."

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters and numbers. The sequence appears to be 'K03 1883'. The characters are written in a dark ink, contrasting with the white background. The style of writing is cursive, with some characters connected.

Summary of Safety and Effectiveness

Date of Preparation June 6, 2003

Applicant Name & Address SensorMedics Corporation a Subsidiary of VIASYS Healthcare 22705 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person Paul L. Kittinger Manager, Regulatory Affairs Phone: 714-283-2228

Fax: 714-283-8426 Trade Name of Device

Lyra™ Nasal Mask

Common Name of Device Nasal Mask or Nasal Interface

Classification Name of Device Non-continuous ventilator accessory

Classification & Classification Code 21 CFR 868.5905, 73 BZD, Class II

Device Description

The Lyra™ consists of the following:

two nasal prongs, which are easily removed or installed into a mask body for the 1. interchange of different sizes, and for easy cleaning of the device;
adjustable head gear, which keeps the nasal mask in place during use; 2.
1. a pair of tubings, with one end of the tubings attached to the mask body;
1. a standard 22-mm swivel which attached to the other end of the tubings.

The delivery device interfaces with the swivel via corrugated tubing, with a standard 22mm fitting.

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Intended Use

The Lyra™ Nasal Mask is an accessory intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

Predicate Device

Substantial equivalence is claimed to the Innomed Technologies' Nasal-Aire™ Nasal Mask having 510(k) No. K022465.

Summary of Performance Testing

There are no known mandatory or voluntary performance standards applicable to this device classification. The Lyra's performance is substantially equivalent to the performance of the Nasal Aire™ in comparative bench testing.

The Lyra's leak rates and dead space are comparable to Nasal Aire's data. Environmental and cleaning tests were also performed on Lyra™, the results of which are within the parameters as claimed in Nasal Aire's labeling.

Conclusion

Based on the above, we conclude that the Lyra™ Nasal Mask is substantially equivalent to the predicate device and, that, it is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2003

Mr. Paul L. Kittinger Manager, Regulatory Affairs SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, California 92887

Re: K031883

Trade/Device Name: Lyra Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Non-Continuous Ventilator, Accessory Regulatory Class: II Product Code: BZD Dated: June 16, 2003 Received: June 19, 2003

Dear Mr. Kittinger:

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. Isting 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. Paul L. Kittinger

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,

Shari Runon

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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Page _ 1 of

510(k) Number (if known): 长031883

Device Name: Lyra™ Nasal Mask

Indications for Use:

The Lyra™ Nasal Mask is intended for use with devices that deliver Continuous Positive Airway Pressure (CPAP) and bi-level positive airway pressure in treating adult patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runos

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Der

510(k) Number: KC031883

Prescription Use
(Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

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).