(406 days)
Not Found
Not Found
No
The device description and intended use clearly define the LiteAire as a mechanical, dual-valved holding chamber for MDIs, with no mention of any computational or learning capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device description and intended use state it is an "accessory device" that works with MDIs to facilitate drug delivery and reduce side effects, not to directly treat a disease itself.
No
The device, LiteAire, is described as a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister. Its stated functions are to reduce medication deposition in the mouth/throat, ease synchronization, and retain drug plume. These functions are therapeutic/delivery-aiding, not diagnostic.
No
The device description clearly states it is a "collapsible, disposable accessory device" and a "dual-valved holding chamber," indicating it is a physical hardware component used with an MDI. There is no mention of software.
Based on the provided information, the LiteAire device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- LiteAire's Function: The LiteAire is a device used with a metered dose inhaler (MDI) to help deliver medication to the patient's lungs. It is an accessory to a drug delivery system, not a diagnostic test performed on a biological sample.
- Intended Use: The intended use clearly states its purpose is to improve the delivery of MDI medication and reduce side effects, not to diagnose any condition.
Therefore, the LiteAire falls under the category of a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three major functions:
- To reduce the amount of MDI medication deposited in the patient's mouth and . throat, thus reducing the potential for unwanted local or systemic side effects.
- To ease the problems that many patients have in synchronizing actuation of the . MDI canister with the start of inhalation.
- To retain a significant portion of the MDI drug plume until the patient's next . inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.
Product codes
73 CAF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2000
Mr. David T. Sladek Thayer Medical Corporation 4575 South Palo Verde Road, Suite 337 Tucson, AZ 85714-1961
Re: K993101 LiteAire Regulatory Class: II (two) Product Code: 73 CAF October 2, 2000 Dated: October 4, 2000 Received:
Dear Mr. Sladek:
We have reviewed your Section 510 (X) notification of intent .to market we nave reviewed your section on the determined the device is the device relerenced above and we indications for use stated in the substantially equivalence (some marketed predicate devices marketed in enclosure) to regally marketed productions the enactment date of the interstate commerce provices that have been eeelessified Medical Device Amendments) of or actitie Federal Food, Drug, and in accordance with the provisions of the market the device, subject to
Cosmetic Act (Act). You may, therefore, market the development The general controls the general controls provisions of the Act. the general Controls provisions of the montal registration, provisions of the nee increase soquing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device Is crassiriou (boo asoroval), it may be subject to such Controls) of Crass III (Frencessor of regulations affecting your device 800 additional Concrolor. Thiroling and Regulations, Title 21, Parts 800 und in the ood equivalent determination assumes compliatie to 895. co 655. If babbeansed Banufacturing Practice requirements, as set with the Current Cood Hanarian (QS) for Medical Devices: rorth in the gaarry by Just 820) and that, through periodic QS General regulation (Er Origing Administration (FDA) will verify such no rood and broy with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. regulatory accron. In and the Federal Register. Please note: this concerning your device in the ification submission does not affect any obligation you might have under sections 531 through 542 of the act obligation you might have andor becoded Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. David T. Sladek
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
A James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Thayer Medical Corporation Page 5 510(k) Notification - LiteAire
1.8 Indications for Use Statement
Page 1 of 1
510(k) Number (if known):
Device Name: LiteAire
Indications For Use:
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three major functions:
- To reduce the amount of MDI medication deposited in the patient's mouth and . throat, thus reducing the potential for unwanted local or systemic side effects.
- To ease the problems that many patients have in synchronizing actuation of the . MDI canister with the start of inhalation.
- To retain a significant portion of the MDI drug plume until the patient's next . inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory
and Neurological Devices
510(k) Number K993/01
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)