(68 days)
Not Found
No
The description focuses solely on the mechanical components and function of a nasal mask for CPAP/bi-level therapy. There is no mention of software, algorithms, or any features that would suggest AI/ML is involved.
No
The device is a nasal mask intended for use with CPAP devices, which are therapeutic; however, the mask itself is an accessory for delivery of air and not directly therapeutic.
No
A diagnostic device identifies a medical condition. This device is a nasal mask, intended for the delivery of air from CPAP (Continuous Positive Airway Pressure) or bi-level instruments to treat adult patients with conditions like sleep apnea, not to diagnose them.
No
The device description clearly outlines physical components such as nasal prongs, head gear, tubing, and a swivel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver air from CPAP and bi-level positive airway pressure devices to treat adult patients. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a nasal mask and associated components designed to interface with a delivery device and the patient's airway. It facilitates the delivery of air, not the analysis of biological samples.
- No mention of biological samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This document makes no mention of handling or analyzing any such samples.
The device is clearly a medical device used for respiratory therapy, not for in vitro diagnosis.
N/A
Intended Use / 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.
Product codes
BZD
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 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.
3. a pair of tubings, with one end of the tubings attached to the mask body;
4. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal/Nares
Indicated Patient Age Range
Adult patients.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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™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 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.
-
- 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.
1
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.
2
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.
3
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)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________